janssen/Medidata/downloads/2026-05-21_06-26_EDC_MDD3003_QueryDetails.csv

1	Country/Region	Site Number	Sites	Subjects	Subject Status	Visits	Pages	Queries (Op/Ans/SDV)	RecordPosition	Field	Query Group	QueryID(ReQry)	QueryStatus	Opened By	Opened Date	Answered By	Answered Date	Closed By	Closed Date	DaysNotYetClosed	Days to Answer	Days to Close	QueryText	Answer Text (if any)	StudyParameter	SiteGroupParameter	SiteNumberParameter	SiteParameter	SubjectParameter	SubjectStatusParameter	FolderParameter	FormParameter	FieldParameter	MarkingGroupParameter	QueryStatusParameter	IncludeInactivePagesParameter	PageSDVParameter	PageFrozenParameter	PageLockedParameter	StartDateParameter	EndDateParameter	MilestoneParameter	ReportTypeParameter	VersionNumber	PrintDateTime	TimeZone	RunUser	ErrorString	OpenedDateSrtble	AnsweredDateSrtble	ClosedDateSrtble	VisitSiteLevel	VisitCountryLevel	VisitStudyLevel	PageSubjectLevel	PageSiteLevel	PageCountryLevel	PageStudyLevel
2	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?	Auto	15263510	Closed	systemuser	10 Aug 2025 18:13:22:080	systemuser	10 Aug 2025 18:14:02:703	systemuser	10 Aug 2025 18:14:02:703		0	0	Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:13:22.080	20250810 18:14:02.703	20250810 18:14:02.703	98	335	335	31	186	713	713
3	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260224 - Periodic Investigator's EDC Review Acknowledgement	0/0/N		As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.	Auto	18823240	Closed	systemuser	09 Feb 2026 08:04:37:693	systemuser	24 Feb 2026 07:13:51:017	systemuser	24 Feb 2026 07:13:51:140		15	0	NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260209 08:04:37.693	20260224 07:13:51.017	20260224 07:13:51.140	98	335	335	31	186	713	713
4	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933269	Closed	systemuser	20 May 2026 12:06:05:857			systemuser	20 May 2026 12:06:28:613			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 12:06:05.857		20260520 12:06:28.613	98	335	335	31	186	713	713
5	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	16456121	Closed	systemuser	17 Oct 2025 09:46:14:623			systemuser	20 Oct 2025 07:47:36:470			3	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 09:46:14.623		20251020 07:47:36.470	98	335	335	31	186	713	713
6	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	16431760	Closed	SanchariDutta@025	16 Oct 2025 06:15:51:413	BrezVe1	20 Oct 2025 08:56:17:217	SanchariDutta@025	26 Nov 2025 06:23:57:113		4	37	ECG: In vendor file, ECG data present for Screening visit of 08-Aug-2025 with EGREFID 143807412. However another collection date is recorded for 19-Aug-2025 with EGREFID 144307755 for Screening visit only. Please check and confirm for the Screening visit ECG was collected twice, if yes kindly provide the reason. Else clarify.	retest done on 19Aug2025 - hypertension	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251016 06:15:51.413	20251020 08:56:17.217	20251126 06:23:57.113	98	335	335	31	186	713	713
7	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	17300080 (16431760)	Closed	SanchariDutta@025	26 Nov 2025 06:23:57:173	gnovotna@email.cz2	28 Nov 2025 10:36:55:197	SanchariDutta@025	01 Dec 2025 06:43:56:800		2	3	RQ-ECG1: Thank you for your response. As confirmed, retest was done for ECG on the 19-Aug-2025 in the Screening visit due to hypertension hence kindly add the details for ECG collection of 19-Aug-2025 in the Comments form present in the Screening to end of study folder.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251126 06:23:57.173	20251128 10:36:55.197	20251201 06:43:56.800	98	335	335	31	186	713	713
8	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Amphetamine	Auto	15263437	Closed	systemuser	10 Aug 2025 17:49:04:123	systemuser	10 Aug 2025 17:50:30:437	systemuser	10 Aug 2025 17:50:30:440		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.123	20250810 17:50:30.437	20250810 17:50:30.440	98	335	335	31	186	713	713
9	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Barbiturate	Auto	15263438	Closed	systemuser	10 Aug 2025 17:49:04:130	systemuser	10 Aug 2025 17:50:30:440	systemuser	10 Aug 2025 17:50:30:440		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.130	20250810 17:50:30.440	20250810 17:50:30.440	98	335	335	31	186	713	713
10	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Benzodiazepine	Auto	15263439	Closed	systemuser	10 Aug 2025 17:49:04:137	systemuser	10 Aug 2025 17:50:30:440	systemuser	10 Aug 2025 17:50:30:440		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.137	20250810 17:50:30.440	20250810 17:50:30.440	98	335	335	31	186	713	713
11	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Cannabinoids	Auto	15263440	Closed	systemuser	10 Aug 2025 17:49:04:143	systemuser	10 Aug 2025 17:50:30:440	systemuser	10 Aug 2025 17:50:30:440		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.143	20250810 17:50:30.440	20250810 17:50:30.440	98	335	335	31	186	713	713
12	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Cocaine	Auto	15263441	Closed	systemuser	10 Aug 2025 17:49:04:150	systemuser	10 Aug 2025 17:50:30:440	systemuser	10 Aug 2025 17:50:30:440		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.150	20250810 17:50:30.440	20250810 17:50:30.440	98	335	335	31	186	713	713
13	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Collection Time	Auto	15263436	Closed	systemuser	10 Aug 2025 17:49:04:117	systemuser	10 Aug 2025 17:50:30:467	systemuser	10 Aug 2025 17:50:30:467		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.117	20250810 17:50:30.467	20250810 17:50:30.467	98	335	335	31	186	713	713
14	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		MDMA (Ecstasy)	Auto	15263442	Closed	systemuser	10 Aug 2025 17:49:04:160	systemuser	10 Aug 2025 17:50:30:467	systemuser	10 Aug 2025 17:50:30:467		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.160	20250810 17:50:30.467	20250810 17:50:30.467	98	335	335	31	186	713	713
15	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Methamphetamine	Auto	15263444	Closed	systemuser	10 Aug 2025 17:49:04:173	systemuser	10 Aug 2025 17:50:30:467	systemuser	10 Aug 2025 17:50:30:467		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.173	20250810 17:50:30.467	20250810 17:50:30.467	98	335	335	31	186	713	713
16	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Methadone	Auto	15263443	Closed	systemuser	10 Aug 2025 17:49:04:170	systemuser	10 Aug 2025 17:50:30:467	systemuser	10 Aug 2025 17:50:30:467		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.170	20250810 17:50:30.467	20250810 17:50:30.467	98	335	335	31	186	713	713
17	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Opiate	Auto	15263445	Closed	systemuser	10 Aug 2025 17:49:04:180	systemuser	10 Aug 2025 17:50:30:467	systemuser	10 Aug 2025 17:50:30:467		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.180	20250810 17:50:30.467	20250810 17:50:30.467	98	335	335	31	186	713	713
18	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Drug Testing	0/0/N		Was the collection date the same as the visit date?	Auto	15263435	Closed	systemuser	10 Aug 2025 17:49:04:103	systemuser	10 Aug 2025 17:50:30:467	systemuser	10 Aug 2025 17:50:30:467		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:49:04.103	20250810 17:50:30.467	20250810 17:50:30.467	98	335	335	31	186	713	713
19	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Neurologic Examination	0/0/N	5	Are there any findings?	Auto	15905765	Closed	systemuser	10 Sep 2025 17:03:52:293	systemuser	22 Sep 2025 07:37:28:777	systemuser	22 Sep 2025 07:37:28:780		12	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 17:03:52.293	20250922 07:37:28.777	20250922 07:37:28.780	98	335	335	31	186	713	713
20	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Lifetime Manic Episode	Auto	15263451	Closed	systemuser	10 Aug 2025 18:00:44:093	systemuser	11 Aug 2025 09:56:13:703	systemuser	11 Aug 2025 09:56:13:703		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.093	20250811 09:56:13.703	20250811 09:56:13.703	98	335	335	31	186	713	713
21	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Lifetime Hypomanic Episode	Auto	15263452	Closed	systemuser	10 Aug 2025 18:00:44:100	systemuser	11 Aug 2025 09:56:13:703	systemuser	11 Aug 2025 09:56:13:703		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.100	20250811 09:56:13.703	20250811 09:56:13.703	98	335	335	31	186	713	713
22	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		History of Primary psychotic or psychotic depression symptoms (except during past mood episodes)	Auto	15263453	Closed	systemuser	10 Aug 2025 18:00:44:110	systemuser	11 Aug 2025 09:56:13:703	systemuser	11 Aug 2025 09:56:13:703		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.110	20250811 09:56:13.703	20250811 09:56:13.703	98	335	335	31	186	713	713
23	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Moderate to severe Alcohol Use Disorder in past 6 months	Auto	15263454	Closed	systemuser	10 Aug 2025 18:00:44:120	systemuser	11 Aug 2025 09:56:13:703	systemuser	11 Aug 2025 09:56:13:703		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.120	20250811 09:56:13.703	20250811 09:56:13.703	98	335	335	31	186	713	713
24	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Moderate to severe Substance Use Disorder (other than nicotine) in past 6 months	Auto	15263455	Closed	systemuser	10 Aug 2025 18:00:44:127	systemuser	11 Aug 2025 09:56:13:703	systemuser	11 Aug 2025 09:56:13:703		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.127	20250811 09:56:13.703	20250811 09:56:13.703	98	335	335	31	186	713	713
25	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Obsessive-Compulsive Disorder in past year	Auto	15263456	Closed	systemuser	10 Aug 2025 18:00:44:133	systemuser	11 Aug 2025 09:56:13:703	systemuser	11 Aug 2025 09:56:13:703		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.133	20250811 09:56:13.703	20250811 09:56:13.703	98	335	335	31	186	713	713
26	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		PTSD in past year	Auto	15263457	Closed	systemuser	10 Aug 2025 18:00:44:140	systemuser	11 Aug 2025 09:56:13:703	systemuser	11 Aug 2025 09:56:13:703		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.140	20250811 09:56:13.703	20250811 09:56:13.703	98	335	335	31	186	713	713
27	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Anorexia Nervosa in past year	Auto	15263458	Closed	systemuser	10 Aug 2025 18:00:44:147	systemuser	11 Aug 2025 09:56:13:703	systemuser	11 Aug 2025 09:56:13:707		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.147	20250811 09:56:13.703	20250811 09:56:13.707	98	335	335	31	186	713	713
28	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Bulimia Nervosa in past year	Auto	15263459	Closed	systemuser	10 Aug 2025 18:00:44:153	systemuser	11 Aug 2025 09:56:13:707	systemuser	11 Aug 2025 09:56:13:707		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.153	20250811 09:56:13.707	20250811 09:56:13.707	98	335	335	31	186	713	713
29	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Panic Disorder past 2 years that was focus of tx	Auto	15263460	Closed	systemuser	10 Aug 2025 18:00:44:163	systemuser	11 Aug 2025 09:56:13:707	systemuser	11 Aug 2025 09:56:13:707		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.163	20250811 09:56:13.707	20250811 09:56:13.707	98	335	335	31	186	713	713
30	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Generalized Anxiety Disorder past 2 years that was focus of tx	Auto	15263461	Closed	systemuser	10 Aug 2025 18:00:44:173	systemuser	11 Aug 2025 09:56:13:707	systemuser	11 Aug 2025 09:56:13:707		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.173	20250811 09:56:13.707	20250811 09:56:13.707	98	335	335	31	186	713	713
31	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Social Anxiety Disorder past 2 years that was focus of tx	Auto	15263462	Closed	systemuser	10 Aug 2025 18:00:44:180	systemuser	11 Aug 2025 09:56:13:707	systemuser	11 Aug 2025 09:56:13:707		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.180	20250811 09:56:13.707	20250811 09:56:13.707	98	335	335	31	186	713	713
32	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Specific Phobia past 2 years that was focus of tx	Auto	15263463	Closed	systemuser	10 Aug 2025 18:00:44:187	systemuser	11 Aug 2025 09:56:13:707	systemuser	11 Aug 2025 09:56:13:707		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.187	20250811 09:56:13.707	20250811 09:56:13.707	98	335	335	31	186	713	713
33	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Symptoms of insomnia in the MDD criteria	Auto	15263450	Closed	systemuser	10 Aug 2025 18:00:44:087	systemuser	10 Aug 2025 18:01:03:923	systemuser	10 Aug 2025 18:01:03:927		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.087	20250810 18:01:03.923	20250810 18:01:03.927	98	335	335	31	186	713	713
34	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Current MDE	Auto	15263449	Closed	systemuser	10 Aug 2025 18:00:44:073	systemuser	10 Aug 2025 18:01:03:927	systemuser	10 Aug 2025 18:01:03:927		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 18:00:44.073	20250810 18:01:03.927	20250810 18:01:03.927	98	335	335	31	186	713	713
35	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Body Mass Index	Auto	15263433	Closed	systemuser	10 Aug 2025 17:46:10:080	systemuser	10 Aug 2025 17:47:40:230	systemuser	10 Aug 2025 17:47:40:230		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:46:10.080	20250810 17:47:40.230	20250810 17:47:40.230	98	335	335	31	186	713	713
36	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	15263432	Closed	systemuser	10 Aug 2025 17:46:10:053	systemuser	10 Aug 2025 17:47:54:423	systemuser	10 Aug 2025 17:47:54:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250810 17:46:10.053	20250810 17:47:54.423	20250810 17:47:54.427	98	335	335	31	186	713	713
37	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Screening Visit 2 (1)	CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS	0/0/N	2	Reason not done	Auto	15787176	Closed	systemuser	03 Sep 2025 14:15:49:967	systemuser	10 Sep 2025 16:48:15:237	systemuser	10 Sep 2025 16:48:15:240		7	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250903 14:15:49.967	20250910 16:48:15.237	20250910 16:48:15.240	98	335	335	31	186	713	713
38	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Maintenance	0/0/V	1	Start Date	Auto	18369265	Closed	systemuser	09 Jan 2026 09:18:24:037	BrezVe1	26 Jan 2026 07:30:33:603	systemuser	02 Feb 2026 15:49:39:993		17	7	Please enter study drug administration start date as soon as it's available	will be done	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260109 09:18:24.037	20260126 07:30:33.603	20260202 15:49:39.993	98	335	335	31	186	713	713
39	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	Number of tablets taken	Auto	15905547	Closed	systemuser	10 Sep 2025 16:46:44:563	systemuser	10 Sep 2025 16:49:08:590	systemuser	10 Sep 2025 16:49:08:590		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:46:44.563	20250910 16:49:08.590	20250910 16:49:08.590	98	335	335	31	186	713	713
40	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	Start Date	Auto	15831041	Closed	systemuser	05 Sep 2025 08:23:40:477			systemuser	10 Sep 2025 16:46:43:877			5	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:23:40.477		20250910 16:46:43.877	98	335	335	31	186	713	713
41	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	End Date	DM	17788857	Closed	Juhita@ksha4	09 Dec 2025 11:48:49:347	BrezVe1	15 Dec 2025 08:45:11:810	Ashwini201	16 Dec 2025 10:48:29:370		6	1	DM: Kindly update the end date.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251209 11:48:49.347	20251215 08:45:11.810	20251216 10:48:29.370	98	335	335	31	186	713	713
42	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	End Date	DM	18018621 (17788857)	Closed	Ashwini201	16 Dec 2025 10:48:29:537	BrezVe1	22 Dec 2025 10:50:22:210	shyamaprasad972	23 Dec 2025 07:56:58:290		6	1	RQ-DM1: Please enter end date for Study Drug during Induction Phase. Per CCGs, as first dose of Stabilization Phase SDA is entered as 14-Nov-2025, End Date for Induction Study Drug should be one day prior if subject did not have any missed doses. Please review and clarify/update.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251216 10:48:29.537	20251222 10:50:22.210	20251223 07:56:58.290	98	335	335	31	186	713	713
43	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	Start Date	Auto	16456120	Closed	systemuser	17 Oct 2025 09:46:14:593			systemuser	20 Oct 2025 06:26:36:430			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 09:46:14.593		20251020 06:26:36.430	98	335	335	31	186	713	713
44	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	End Date	DM	19612278	Closed	Juhita@ksha4	20 Mar 2026 07:16:42:790	BrezVe1	23 Mar 2026 13:18:41:113	Juhita@ksha4	25 Mar 2026 15:24:59:077		3	2	Medical Review I-3085477: Please provide end date.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260320 07:16:42.790	20260323 13:18:41.113	20260325 15:24:59.077	98	335	335	31	186	713	713
45	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	Start Date	Auto	17002734	Closed	systemuser	14 Nov 2025 07:48:41:920	BrezVe1	18 Nov 2025 09:13:35:153	Ashwini201	03 Dec 2025 12:23:16:810		4	15	Please enter study drug administration start date as soon as it's available	will be done asap	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251114 07:48:41.920	20251118 09:13:35.153	20251203 12:23:16.810	98	335	335	31	186	713	713
46	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	Start Date	DM	17543078	Closed	Ashwini201	03 Dec 2025 12:23:46:027	BrezVe1	15 Dec 2025 08:45:07:100	Ashwini201	15 Dec 2025 14:25:45:130		12	0	RQ-DM1: Thank you for the response. Please verify and update the data once available.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251203 12:23:46.027	20251215 08:45:07.100	20251215 14:25:45.130	98	335	335	31	186	713	713
47	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	Start Date	DM	17995921 (17543078)	Closed	Ashwini201	15 Dec 2025 14:25:45:323	BrezVe1	22 Dec 2025 10:50:05:273	shyamaprasad972	23 Dec 2025 08:02:26:950		7	1	RQ-DM2: Subject meet the evaluation repose at 1.5 visit so kindly update the start date as 14-Nov-2025, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251215 14:25:45.323	20251222 10:50:05.273	20251223 08:02:26.950	98	335	335	31	186	713	713
48	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 1.4 Induction (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	16728273	Closed	systemuser	03 Nov 2025 07:49:01:390	systemuser	03 Nov 2025 07:49:17:360	systemuser	03 Nov 2025 07:49:17:360		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251103 07:49:01.390	20251103 07:49:17.360	20251103 07:49:17.360	98	335	335	31	186	713	713
49	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 1.5 Induction (1)	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	17189582	Closed	systemuser	21 Nov 2025 11:21:32:253	systemuser	24 Nov 2025 08:21:37:273	systemuser	24 Nov 2025 08:21:37:273		3	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251121 11:21:32.253	20251124 08:21:37.273	20251124 08:21:37.273	98	335	335	31	186	713	713
50	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 1.5 Induction (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	17189564	Closed	systemuser	21 Nov 2025 11:20:47:400	systemuser	21 Nov 2025 11:20:54:560	systemuser	21 Nov 2025 11:20:54:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251121 11:20:47.400	20251121 11:20:54.560	20251121 11:20:54.563	98	335	335	31	186	713	713
51	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 2.2 Stabilization (1)	Clinical Global Impression - S (Depression)	0/0/V		Rater's Initials	Auto	17951601	Closed	systemuser	12 Dec 2025 08:52:46:550	systemuser	12 Dec 2025 08:52:56:350	systemuser	12 Dec 2025 08:52:56:353		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251212 08:52:46.550	20251212 08:52:56.350	20251212 08:52:56.353	98	335	335	31	186	713	713
52	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 2.2 Stabilization (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	17984649	Closed	systemuser	15 Dec 2025 08:23:50:930	systemuser	15 Dec 2025 08:23:56:007	systemuser	15 Dec 2025 08:23:56:007		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251215 08:23:50.930	20251215 08:23:56.007	20251215 08:23:56.007	98	335	335	31	186	713	713
53	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 2.3 Stabilization (1)	Clinical Global Impression - S (Depression)	0/0/V		Severity of illness	Auto	18237831	Closed	systemuser	29 Dec 2025 12:48:05:070	systemuser	29 Dec 2025 12:49:20:210	systemuser	29 Dec 2025 12:49:20:213		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251229 12:48:05.070	20251229 12:49:20.210	20251229 12:49:20.213	98	335	335	31	186	713	713
54	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 2.3 Stabilization (1)	Clinical Global Impression - S (Depression)	0/0/V		Rater's Initials	Auto	18237829	Closed	systemuser	29 Dec 2025 12:48:05:050	systemuser	29 Dec 2025 12:49:20:227	systemuser	29 Dec 2025 12:49:20:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251229 12:48:05.050	20251229 12:49:20.227	20251229 12:49:20.227	98	335	335	31	186	713	713
55	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 2.3 Stabilization (1)	Clinical Global Impression - S (Depression)	0/0/V		If Yes, was the collection date the same as the visit date?	Auto	18237830	Closed	systemuser	29 Dec 2025 12:48:05:063	systemuser	29 Dec 2025 12:49:20:227	systemuser	29 Dec 2025 12:49:20:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251229 12:48:05.063	20251229 12:49:20.227	20251229 12:49:20.227	98	335	335	31	186	713	713
56	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 2.3 Stabilization (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	18401903	Closed	systemuser	12 Jan 2026 17:14:06:993	systemuser	12 Jan 2026 17:14:19:247	systemuser	12 Jan 2026 17:14:19:247		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260112 17:14:06.993	20260112 17:14:19.247	20260112 17:14:19.247	98	335	335	31	186	713	713
57	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal Ideation1. Wish to be Dead	Auto	15905010	Closed	systemuser	10 Sep 2025 16:16:14:407	systemuser	10 Sep 2025 16:16:53:590	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.407	20250910 16:16:53.590	20250910 16:16:53.593	98	335	335	31	186	713	713
58	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		2. Non-Specific Active Suicidal Thoughts	Auto	15905011	Closed	systemuser	10 Sep 2025 16:16:14:420	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.420	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
59	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal BehaviorActual Attempt	Auto	15905012	Closed	systemuser	10 Sep 2025 16:16:14:490	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.490	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
60	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Has subject engaged in Non-Suicidal Self-Injurious Behavior?	Auto	15905013	Closed	systemuser	10 Sep 2025 16:16:14:513	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.513	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
61	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Interrupted Attempt	Auto	15905014	Closed	systemuser	10 Sep 2025 16:16:14:527	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.527	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
62	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Aborted Attempt	Auto	15905015	Closed	systemuser	10 Sep 2025 16:16:14:547	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.547	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
63	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Preparatory Acts or Behavior	Auto	15905016	Closed	systemuser	10 Sep 2025 16:16:14:570	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.570	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
64	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal Behavior	Auto	15905017	Closed	systemuser	10 Sep 2025 16:16:14:800	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.800	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
65	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicide	Auto	15905018	Closed	systemuser	10 Sep 2025 16:16:14:820	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.820	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
66	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Rater's Initials	Auto	15905009	Closed	systemuser	10 Sep 2025 16:16:14:400	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.400	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
67	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Was the collection date the same as the visit date?	Auto	15905008	Closed	systemuser	10 Sep 2025 16:16:14:380	systemuser	10 Sep 2025 16:16:53:593	systemuser	10 Sep 2025 16:16:53:593		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:16:14.380	20250910 16:16:53.593	20250910 16:16:53.593	98	335	335	31	186	713	713
68	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	EQ-5D-5L	0/0/N		Mobility	Auto	15905041	Closed	systemuser	10 Sep 2025 16:17:32:717	systemuser	10 Sep 2025 16:18:21:017	systemuser	10 Sep 2025 16:18:21:017		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:17:32.717	20250910 16:18:21.017	20250910 16:18:21.017	98	335	335	31	186	713	713
69	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	EQ-5D-5L	0/0/N		Self-Care	Auto	15905042	Closed	systemuser	10 Sep 2025 16:17:32:723	systemuser	10 Sep 2025 16:18:21:017	systemuser	10 Sep 2025 16:18:21:017		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:17:32.723	20250910 16:18:21.017	20250910 16:18:21.017	98	335	335	31	186	713	713
70	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	EQ-5D-5L	0/0/N		Usual Activities	Auto	15905043	Closed	systemuser	10 Sep 2025 16:17:32:733	systemuser	10 Sep 2025 16:18:21:017	systemuser	10 Sep 2025 16:18:21:017		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:17:32.733	20250910 16:18:21.017	20250910 16:18:21.017	98	335	335	31	186	713	713
71	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	EQ-5D-5L	0/0/N		Pain/Discomfort	Auto	15905044	Closed	systemuser	10 Sep 2025 16:17:32:740	systemuser	10 Sep 2025 16:18:21:017	systemuser	10 Sep 2025 16:18:21:017		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:17:32.740	20250910 16:18:21.017	20250910 16:18:21.017	98	335	335	31	186	713	713
72	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	EQ-5D-5L	0/0/N		Anxiety/Depression	Auto	15905045	Closed	systemuser	10 Sep 2025 16:17:32:747	systemuser	10 Sep 2025 16:18:21:017	systemuser	10 Sep 2025 16:18:21:017		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:17:32.747	20250910 16:18:21.017	20250910 16:18:21.017	98	335	335	31	186	713	713
73	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	EQ-5D-5L	0/0/N		Your health today	Auto	15905046	Closed	systemuser	10 Sep 2025 16:17:32:757	systemuser	10 Sep 2025 16:18:21:017	systemuser	10 Sep 2025 16:18:21:017		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:17:32.757	20250910 16:18:21.017	20250910 16:18:21.017	98	335	335	31	186	713	713
74	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	EQ-5D-5L	0/0/N		Was the collection date the same as the visit date?	Auto	15905040	Closed	systemuser	10 Sep 2025 16:17:32:697	systemuser	10 Sep 2025 16:18:21:020	systemuser	10 Sep 2025 16:18:21:020		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:17:32.697	20250910 16:18:21.020	20250910 16:18:21.020	98	335	335	31	186	713	713
75	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		1. Reported Sadness	Auto	15830634	Closed	systemuser	05 Sep 2025 08:04:37:280	systemuser	05 Sep 2025 08:07:08:753	systemuser	05 Sep 2025 08:07:08:753		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.280	20250905 08:07:08.753	20250905 08:07:08.753	98	335	335	31	186	713	713
76	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		2. Apparent Sadness	Auto	15830635	Closed	systemuser	05 Sep 2025 08:04:37:293	systemuser	05 Sep 2025 08:07:08:753	systemuser	05 Sep 2025 08:07:08:753		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.293	20250905 08:07:08.753	20250905 08:07:08.753	98	335	335	31	186	713	713
77	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		3. Inner Tension	Auto	15830636	Closed	systemuser	05 Sep 2025 08:04:37:303	systemuser	05 Sep 2025 08:07:08:753	systemuser	05 Sep 2025 08:07:08:753		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.303	20250905 08:07:08.753	20250905 08:07:08.753	98	335	335	31	186	713	713
78	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		4. Reduced Sleep	Auto	15830637	Closed	systemuser	05 Sep 2025 08:04:37:317	systemuser	05 Sep 2025 08:07:08:753	systemuser	05 Sep 2025 08:07:08:753		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.317	20250905 08:07:08.753	20250905 08:07:08.753	98	335	335	31	186	713	713
79	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		5. Reduced Appetite	Auto	15830638	Closed	systemuser	05 Sep 2025 08:04:37:330	systemuser	05 Sep 2025 08:07:08:753	systemuser	05 Sep 2025 08:07:08:753		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.330	20250905 08:07:08.753	20250905 08:07:08.753	98	335	335	31	186	713	713
80	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		6. Concentration Difficulties	Auto	15830639	Closed	systemuser	05 Sep 2025 08:04:37:340	systemuser	05 Sep 2025 08:07:08:753	systemuser	05 Sep 2025 08:07:08:753		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.340	20250905 08:07:08.753	20250905 08:07:08.753	98	335	335	31	186	713	713
81	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		7. Lassitude	Auto	15830640	Closed	systemuser	05 Sep 2025 08:04:37:350	systemuser	05 Sep 2025 08:07:08:753	systemuser	05 Sep 2025 08:07:08:753		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.350	20250905 08:07:08.753	20250905 08:07:08.753	98	335	335	31	186	713	713
82	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		8. Inability to Feel	Auto	15830641	Closed	systemuser	05 Sep 2025 08:04:37:367	systemuser	05 Sep 2025 08:07:08:757	systemuser	05 Sep 2025 08:07:08:757		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.367	20250905 08:07:08.757	20250905 08:07:08.757	98	335	335	31	186	713	713
83	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		9. Pessimistic Thoughts	Auto	15830642	Closed	systemuser	05 Sep 2025 08:04:37:377	systemuser	05 Sep 2025 08:07:08:757	systemuser	05 Sep 2025 08:07:08:757		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.377	20250905 08:07:08.757	20250905 08:07:08.757	98	335	335	31	186	713	713
84	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		10. Suicidal Thoughts	Auto	15830643	Closed	systemuser	05 Sep 2025 08:04:37:393	systemuser	05 Sep 2025 08:07:08:757	systemuser	05 Sep 2025 08:07:08:757		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.393	20250905 08:07:08.757	20250905 08:07:08.757	98	335	335	31	186	713	713
85	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		TOTAL MADRS SCALE SCORE	Auto	15830644	Closed	systemuser	05 Sep 2025 08:04:37:417	systemuser	05 Sep 2025 08:07:09:067	systemuser	05 Sep 2025 08:07:09:067		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.417	20250905 08:07:09.067	20250905 08:07:09.067	98	335	335	31	186	713	713
86	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		Rater's Initials	Auto	15830633	Closed	systemuser	05 Sep 2025 08:04:37:270	systemuser	05 Sep 2025 08:07:08:773	systemuser	05 Sep 2025 08:07:08:773		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.270	20250905 08:07:08.773	20250905 08:07:08.773	98	335	335	31	186	713	713
87	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		Was the collection date the same as the visit date?	Auto	15830632	Closed	systemuser	05 Sep 2025 08:04:37:240	systemuser	05 Sep 2025 08:07:08:773	systemuser	05 Sep 2025 08:07:08:773		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250905 08:04:37.240	20250905 08:07:08.773	20250905 08:07:08.773	98	335	335	31	186	713	713
88	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	15904916	Closed	systemuser	10 Sep 2025 16:10:32:050	systemuser	10 Sep 2025 16:10:43:000	systemuser	10 Sep 2025 16:10:43:003		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:10:32.050	20250910 16:10:43.000	20250910 16:10:43.003	98	335	335	31	186	713	713
89	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 3.5 Maintenance	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	20632399	Closed	systemuser	06 May 2026 05:30:19:990	systemuser	06 May 2026 05:30:26:263	systemuser	06 May 2026 05:30:26:263		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260506 05:30:19.990	20260506 05:30:26.263	20260506 05:30:26.263	98	335	335	31	186	713	713
90	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 5 Part 1 (1)	Date of Visit	0/0/N		Subject's Status	Auto	15905468	Closed	systemuser	10 Sep 2025 16:43:52:510	gnovotna@email.cz2	10 Sep 2025 16:50:15:550	Ashwini201	11 Sep 2025 11:34:29:740		0	1	Required field. Please complete or provide a response.	entry error	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:43:52.510	20250910 16:50:15.550	20250911 11:34:29.740	98	335	335	31	186	713	713
91	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 5 Part 1 (1)	Date of Visit	0/0/N		Did this visit occur?	Auto	15905467	Closed	systemuser	10 Sep 2025 16:43:52:497	gnovotna@email.cz2	10 Sep 2025 16:50:10:080	shyamaprasad972	12 Sep 2025 08:19:18:483		0	2	Required field. Please complete or provide a response.	entry error	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:43:52.497	20250910 16:50:10.080	20250912 08:19:18.483	98	335	335	31	186	713	713
92	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 5 Part 1 (1)	Date of Visit	0/0/N		Type of Contact	Auto	15905440	Closed	systemuser	10 Sep 2025 16:42:57:157	systemuser	12 Sep 2025 06:38:08:253	systemuser	12 Sep 2025 06:38:08:257		2	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:42:57.157	20250912 06:38:08.253	20250912 06:38:08.257	98	335	335	31	186	713	713
93	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 5 Part 1 (1)	Date of Visit	0/0/N		Visit Start Date	Auto	15905403	Closed	systemuser	10 Sep 2025 16:39:04:213			systemuser	10 Sep 2025 16:40:04:840			0	Data entered is in the future. Please correct.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:39:04.213		20250910 16:40:04.840	98	335	335	31	186	713	713
94	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 5 Part 1 (1)	Date of Visit	0/0/N		Visit Start Date	Auto	15905408	Closed	systemuser	10 Sep 2025 16:40:05:650			systemuser	12 Sep 2025 06:38:07:030			2	Data is not in the expected format. Please Correct.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 16:40:05.650		20250912 06:38:07.030	98	335	335	31	186	713	713
95	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	16047295	Closed	systemuser	19 Sep 2025 12:00:43:200	systemuser	19 Sep 2025 12:01:14:090	systemuser	19 Sep 2025 12:01:14:093		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250919 12:00:43.200	20250919 12:01:14.090	20250919 12:01:14.093	98	335	335	31	186	713	713
96	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Pulse	Auto	16047293	Closed	systemuser	19 Sep 2025 12:00:43:173	systemuser	19 Sep 2025 12:01:14:100	systemuser	19 Sep 2025 12:01:14:100		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250919 12:00:43.173	20250919 12:01:14.100	20250919 12:01:14.100	98	335	335	31	186	713	713
97	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	16047294	Closed	systemuser	19 Sep 2025 12:00:43:187	systemuser	19 Sep 2025 12:01:14:103	systemuser	19 Sep 2025 12:01:14:103		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250919 12:00:43.187	20250919 12:01:14.103	20250919 12:01:14.103	98	335	335	31	186	713	713
98	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	16047291	Closed	systemuser	19 Sep 2025 12:00:43:110	systemuser	19 Sep 2025 12:01:14:103	systemuser	19 Sep 2025 12:01:14:103		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250919 12:00:43.110	20250919 12:01:14.103	20250919 12:01:14.103	98	335	335	31	186	713	713
99	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Temperature	Auto	16047292	Closed	systemuser	19 Sep 2025 12:00:43:157	systemuser	19 Sep 2025 12:01:14:103	systemuser	19 Sep 2025 12:01:14:103		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250919 12:00:43.157	20250919 12:01:14.103	20250919 12:01:14.103	98	335	335	31	186	713	713
100	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Amphetamine	Auto	16456853	Closed	systemuser	17 Oct 2025 10:35:34:167	systemuser	17 Oct 2025 10:36:23:513	systemuser	17 Oct 2025 10:36:23:513		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.167	20251017 10:36:23.513	20251017 10:36:23.513	98	335	335	31	186	713	713
101	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Barbiturate	Auto	16456854	Closed	systemuser	17 Oct 2025 10:35:34:180	systemuser	17 Oct 2025 10:36:23:513	systemuser	17 Oct 2025 10:36:23:513		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.180	20251017 10:36:23.513	20251017 10:36:23.513	98	335	335	31	186	713	713
102	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Benzodiazepine	Auto	16456855	Closed	systemuser	17 Oct 2025 10:35:34:190	systemuser	17 Oct 2025 10:36:23:513	systemuser	17 Oct 2025 10:36:23:513		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.190	20251017 10:36:23.513	20251017 10:36:23.513	98	335	335	31	186	713	713
103	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Cannabinoids	Auto	16456856	Closed	systemuser	17 Oct 2025 10:35:34:200	systemuser	17 Oct 2025 10:36:23:513	systemuser	17 Oct 2025 10:36:23:513		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.200	20251017 10:36:23.513	20251017 10:36:23.513	98	335	335	31	186	713	713
104	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Cocaine	Auto	16456857	Closed	systemuser	17 Oct 2025 10:35:34:207	systemuser	17 Oct 2025 10:36:23:513	systemuser	17 Oct 2025 10:36:23:513		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.207	20251017 10:36:23.513	20251017 10:36:23.513	98	335	335	31	186	713	713
105	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Collection Time	Auto	16456852	Closed	systemuser	17 Oct 2025 10:35:34:150			systemuser	17 Oct 2025 10:36:23:530			0	The time entered is non-conformant. Please resolve.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.150		20251017 10:36:23.530	98	335	335	31	186	713	713
106	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		MDMA (Ecstasy)	Auto	16456858	Closed	systemuser	17 Oct 2025 10:35:34:217	systemuser	17 Oct 2025 10:36:23:530	systemuser	17 Oct 2025 10:36:23:530		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.217	20251017 10:36:23.530	20251017 10:36:23.530	98	335	335	31	186	713	713
107	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Methamphetamine	Auto	16456860	Closed	systemuser	17 Oct 2025 10:35:34:233	systemuser	17 Oct 2025 10:36:23:530	systemuser	17 Oct 2025 10:36:23:530		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.233	20251017 10:36:23.530	20251017 10:36:23.530	98	335	335	31	186	713	713
108	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Methadone	Auto	16456859	Closed	systemuser	17 Oct 2025 10:35:34:227	systemuser	17 Oct 2025 10:36:23:530	systemuser	17 Oct 2025 10:36:23:530		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.227	20251017 10:36:23.530	20251017 10:36:23.530	98	335	335	31	186	713	713
109	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Drug Testing	0/0/N		Opiate	Auto	16456861	Closed	systemuser	17 Oct 2025 10:35:34:243	systemuser	17 Oct 2025 10:36:23:530	systemuser	17 Oct 2025 10:36:23:530		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:35:34.243	20251017 10:36:23.530	20251017 10:36:23.530	98	335	335	31	186	713	713
110	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Neurologic Examination	0/0/N		Date of Assessment	Auto	16456518	Closed	systemuser	17 Oct 2025 10:06:24:577	systemuser	20 Oct 2025 07:46:24:710	systemuser	20 Oct 2025 07:46:24:713		3	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:06:24.577	20251020 07:46:24.710	20251020 07:46:24.713	98	335	335	31	186	713	713
111	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040001	Enrolled	Visit 8 Part 1 (1)	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	16456833	Closed	systemuser	17 Oct 2025 10:33:30:150	systemuser	20 Oct 2025 07:46:32:537	systemuser	20 Oct 2025 07:46:32:537		3	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 10:33:30.150	20251020 07:46:32.537	20251020 07:46:32.537	98	335	335	31	186	713	713
112	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	1	Action Taken with Study Treatment	DM	17675499	Closed	Juhita@ksha4	05 Dec 2025 13:33:46:587	BrezVe1	08 Dec 2025 08:37:54:710	Juhita@ksha4	09 Dec 2025 06:38:19:613		3	1	Medical Review I-941081: Start date for the AE was before the first dose of IP. Kindly update the Correct action taken.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 13:33:46.587	20251208 08:37:54.710	20251209 06:38:19.613	98	335	335	26	186	713	713
113	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	End Date	Auto	18402625	Closed	systemuser	12 Jan 2026 18:07:13:433	gnovotna@email.cz2	12 Jan 2026 18:07:21:143	Ashwini201	13 Jan 2026 10:43:01:710		0	1	If the Adverse Event is reported as 'Ongoing', an end date should not be present. Please resolve.	the symptom appeared after starting the medication	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260112 18:07:13.433	20260112 18:07:21.143	20260113 10:43:01.710	98	335	335	26	186	713	713
114	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Outcome	Auto	18402626	Closed	systemuser	12 Jan 2026 18:07:13:450	systemuser	12 Jan 2026 18:07:47:323	systemuser	12 Jan 2026 18:07:47:343		0	0	End of event is marked as 'Ongoing' so the outcome is expected to be 'Not Recovered/Not Resolved', 'Recovering/Resolving' or 'Unknown'. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260112 18:07:13.450	20260112 18:07:47.323	20260112 18:07:47.343	98	335	335	26	186	713	713
115	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Relationship to Study Treatment	DM	18328091	Closed	Juhita@ksha4	07 Jan 2026 09:46:00:683	gnovotna@email.cz2	12 Jan 2026 18:08:08:130	Juhita@ksha4	13 Jan 2026 14:07:13:497		5	1	Medical Review I-1712949: Kindly clarify rationality to consider AE to be related to study drug.	the symptom appeared after starting the medication	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260107 09:46:00.683	20260112 18:08:08.130	20260113 14:07:13.497	98	335	335	26	186	713	713
116	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Start Time	Auto	17058241	Closed	systemuser	18 Nov 2025 08:29:48:313			systemuser	18 Nov 2025 08:29:58:000			0	The time entered is non-conformant. Please resolve.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:29:48.313		20251118 08:29:58.000	98	335	335	26	186	713	713
117	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	3	Action Taken with Study Treatment	Auto	20758446	Closed	systemuser	11 May 2026 10:06:44:377	systemuser	11 May 2026 10:06:50:990	systemuser	11 May 2026 10:06:50:993		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260511 10:06:44.377	20260511 10:06:50.990	20260511 10:06:50.993	98	335	335	26	186	713	713
118	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	Dose Form	Auto	16068755	Closed	systemuser	22 Sep 2025 14:35:06:253	systemuser	22 Sep 2025 14:40:16:103	systemuser	22 Sep 2025 14:40:16:103		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:35:06.253	20250922 14:40:16.103	20250922 14:40:16.103	98	335	335	26	186	713	713
119	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	Frequency	Auto	16068756	Closed	systemuser	22 Sep 2025 14:35:06:263	systemuser	22 Sep 2025 14:40:16:103	systemuser	22 Sep 2025 14:40:16:103		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:35:06.263	20250922 14:40:16.103	20250922 14:40:16.103	98	335	335	26	186	713	713
120	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	Dose Unit	Auto	16068754	Closed	systemuser	22 Sep 2025 14:35:06:160	systemuser	22 Sep 2025 14:40:16:103	systemuser	22 Sep 2025 14:40:16:103		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:35:06.160	20250922 14:40:16.103	20250922 14:40:16.103	98	335	335	26	186	713	713
121	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	What was the individual dose of the medication/therapy?	Auto	16068753	Closed	systemuser	22 Sep 2025 14:35:06:147	systemuser	22 Sep 2025 14:40:16:120	systemuser	22 Sep 2025 14:40:16:120		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:35:06.147	20250922 14:40:16.120	20250922 14:40:16.120	98	335	335	26	186	713	713
122	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	What was the individual dose of the medication/therapy?	Auto	16068835	Closed	systemuser	22 Sep 2025 14:40:16:157			systemuser	22 Sep 2025 14:41:21:310			0	Dose contains a space or a comma or a non-numeric character; Please correct.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:40:16.157		20250922 14:41:21.310	98	335	335	26	186	713	713
123	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	What was the individual dose of the medication/therapy?	Auto	16068858	Closed	systemuser	22 Sep 2025 14:41:21:377	systemuser	22 Sep 2025 14:47:02:793	systemuser	22 Sep 2025 14:47:02:797		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:41:21.377	20250922 14:47:02.793	20250922 14:47:02.797	98	335	335	26	186	713	713
124	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	Route	Auto	16068757	Closed	systemuser	22 Sep 2025 14:35:06:273	systemuser	22 Sep 2025 14:40:16:120	systemuser	22 Sep 2025 14:40:16:120		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:35:06.273	20250922 14:40:16.120	20250922 14:40:16.120	98	335	335	26	186	713	713
125	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	Start Date	Auto	16068758	Closed	systemuser	22 Sep 2025 14:35:06:287	systemuser	22 Sep 2025 14:38:47:380	systemuser	22 Sep 2025 14:38:47:383		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:35:06.287	20250922 14:38:47.380	20250922 14:38:47.383	98	335	335	26	186	713	713
126	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260325 - Periodic Investigator's EDC Review Acknowledgement	0/0/N		As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.	Auto	19153601	Closed	systemuser	24 Feb 2026 13:57:12:293	systemuser	25 Mar 2026 07:21:44:973	systemuser	25 Mar 2026 07:21:45:313		29	0	NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260224 13:57:12.293	20260325 07:21:44.973	20260325 07:21:45.313	98	335	335	26	186	713	713
127	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	4	Stop date of menstrual period	DM	19438167	Closed	JThoma858	10 Mar 2026 08:43:47:730	gnovotna@email.cz2	20 Mar 2026 11:31:02:830	JThoma858	23 Mar 2026 05:44:09:063		10	3	DM :Please update the Menstrual Cycle Tracking Log for the month of Jan and Feb. Else clarify	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260310 08:43:47.730	20260320 11:31:02.830	20260323 05:44:09.063	98	335	335	26	186	713	713
128	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	4	Start date of menstrual period	DM	19438144	Cancelled	JThoma858	10 Mar 2026 08:43:21:033			JThoma858	10 Mar 2026 08:43:23:813				Please update the Menstrual Cycle Tracking Log for the month of Jan and Feb 2026. Else clarify		42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260310 08:43:21.033		20260310 08:43:23.813	98	335	335	26	186	713	713
129	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	17405294	Closed	systemuser	28 Nov 2025 09:37:45:270			systemuser	28 Nov 2025 10:43:14:937			0	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251128 09:37:45.270		20251128 10:43:14.937	98	335	335	26	186	713	713
130	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	17286870	Closed	Ashwini201	25 Nov 2025 13:52:22:370	gnovotna@email.cz2	28 Nov 2025 10:45:11:557	SanchariDutta@025	01 Dec 2025 07:18:19:053		3	3	DM: Please verify and update the data on Arizona Sexual Experiences Scale Summary and Local Labs for Background Antidepressant Compliance forms, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251125 13:52:22.370	20251128 10:45:11.557	20251201 07:18:19.053	98	335	335	26	186	713	713
131	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	General Medical History	0/0/N	1	Is the medical history disease/condition or event still ongoing?	DM	18269716	Closed	Juhita@ksha4	31 Dec 2025 12:22:45:913	BrezVe1	05 Jan 2026 09:54:32:967	Juhita@ksha4	06 Jan 2026 12:27:54:603		5	1	Medical Review I-941339: Please confirm if MH is still ongoing or else update the end date. Kindly mention the cause of MH term.	ongoing	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251231 12:22:45.913	20260105 09:54:32.967	20260106 12:27:54.603	98	335	335	26	186	713	713
132	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	General Medical History	0/0/N	2	What is the verbatim term for the medical history condition/event?	DM	16312156	Closed	CoderImport	08 Oct 2025 06:09:13:050	gnovotna@email.cz2	10 Oct 2025 09:55:24:083	systemuser	10 Oct 2025 09:55:24:197		2	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. CYSTS ON BOTH OVARIES and 2. LAPAROSCOPY.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251008 06:09:13.050	20251010 09:55:24.083	20251010 09:55:24.197	98	335	335	26	186	713	713
133	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	General Medical History	0/0/N	3	What is the verbatim term for the medical history condition/event?	DM	16312157	Closed	CoderImport	08 Oct 2025 06:09:15:857	gnovotna@email.cz2	10 Oct 2025 09:56:20:187	systemuser	10 Oct 2025 09:56:20:307		2	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. CYSTS ON BOTH OVARIES and 2. LAPAROSCOPY.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251008 06:09:15.857	20251010 09:56:20.187	20251010 09:56:20.307	98	335	335	26	186	713	713
134	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	General Medical History	0/0/N	4	What is the verbatim term for the medical history condition/event?	DM	16619228	Closed	CoderImport	28 Oct 2025 06:34:12:423	BrezVe1	03 Nov 2025 08:40:31:453	systemuser	03 Nov 2025 08:40:31:580		6	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1.CYSTS ON BOTH OVARIES and 2. LAPAROSCOPY.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251028 06:34:12.423	20251103 08:40:31.453	20251103 08:40:31.580	98	335	335	26	186	713	713
135	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	General Medical History	0/0/N	5	What is the verbatim term for the medical history condition/event?	DM	16619229	Closed	CoderImport	28 Oct 2025 06:34:15:197	BrezVe1	03 Nov 2025 08:40:44:253	systemuser	03 Nov 2025 08:40:44:430		6	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1.CYSTS ON BOTH OVARIES and 2. LAPAROSCOPY.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251028 06:34:15.197	20251103 08:40:44.253	20251103 08:40:44.430	98	335	335	26	186	713	713
136	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	Menstrual Cycle Tracking	0/0/N	1	Current Method(s) of Contraception	DM	16111828	Closed	Ashwini201	24 Sep 2025 10:28:47:630	BrezVe1	02 Oct 2025 07:00:55:593	Ashwini201	03 Oct 2025 07:36:10:310		8	1	DM: As the logline2 added by error, kindly inactive the same.	Inactivated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250924 10:28:47.630	20251002 07:00:55.593	20251003 07:36:10.310	98	335	335	26	186	713	713
137	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	Menstrual Cycle Tracking	0/0/N	1	If 'Estrogen/Gestagen', 'Hormonal IUD', or 'Non-hormonal IUD', choose the corresponding CM log line, start date, and term	Auto	16068121	Closed	systemuser	22 Sep 2025 14:00:15:630	systemuser	22 Sep 2025 14:41:44:780	systemuser	22 Sep 2025 14:41:44:783		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:00:15.630	20250922 14:41:44.780	20250922 14:41:44.783	98	335	335	26	186	713	713
138	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Lifetime Manic Episode	Auto	16068428	Closed	systemuser	22 Sep 2025 14:18:14:257	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.257	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
139	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Lifetime Hypomanic Episode	Auto	16068429	Closed	systemuser	22 Sep 2025 14:18:14:290	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.290	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
140	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		History of Primary psychotic or psychotic depression symptoms (except during past mood episodes)	Auto	16068430	Closed	systemuser	22 Sep 2025 14:18:14:323	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.323	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
141	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Moderate to severe Alcohol Use Disorder in past 6 months	Auto	16068431	Closed	systemuser	22 Sep 2025 14:18:14:360	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.360	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
142	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Moderate to severe Substance Use Disorder (other than nicotine) in past 6 months	Auto	16068432	Closed	systemuser	22 Sep 2025 14:18:14:393	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.393	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
143	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Obsessive-Compulsive Disorder in past year	Auto	16068433	Closed	systemuser	22 Sep 2025 14:18:14:430	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.430	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
144	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		PTSD in past year	Auto	16068434	Closed	systemuser	22 Sep 2025 14:18:14:503	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.503	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
145	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Anorexia Nervosa in past year	Auto	16068435	Closed	systemuser	22 Sep 2025 14:18:14:533	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.533	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
146	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Bulimia Nervosa in past year	Auto	16068436	Closed	systemuser	22 Sep 2025 14:18:14:550	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.550	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
147	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Panic Disorder past 2 years that was focus of tx	Auto	16068437	Closed	systemuser	22 Sep 2025 14:18:14:563	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.563	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
148	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Generalized Anxiety Disorder past 2 years that was focus of tx	Auto	16068438	Closed	systemuser	22 Sep 2025 14:18:14:573	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.573	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
149	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Social Anxiety Disorder past 2 years that was focus of tx	Auto	16068439	Closed	systemuser	22 Sep 2025 14:18:14:583	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.583	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
150	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Specific Phobia past 2 years that was focus of tx	Auto	16068440	Closed	systemuser	22 Sep 2025 14:18:14:597	systemuser	22 Sep 2025 14:19:12:960	systemuser	22 Sep 2025 14:19:12:960		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.597	20250922 14:19:12.960	20250922 14:19:12.960	98	335	335	26	186	713	713
151	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Symptoms of insomnia in the MDD criteria	Auto	16068427	Closed	systemuser	22 Sep 2025 14:18:14:217	systemuser	22 Sep 2025 14:19:12:963	systemuser	22 Sep 2025 14:19:12:963		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.217	20250922 14:19:12.963	20250922 14:19:12.963	98	335	335	26	186	713	713
152	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 1	SCID-CT	0/0/V		Current MDE	Auto	16068426	Closed	systemuser	22 Sep 2025 14:18:14:187	systemuser	22 Sep 2025 14:19:12:963	systemuser	22 Sep 2025 14:19:12:963		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250922 14:18:14.187	20250922 14:19:12.963	20250922 14:19:12.963	98	335	335	26	186	713	713
153	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Screening Visit 2 (1)	CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS	0/0/N	1	Assessment Completed?	DM	16909587	Closed	Juhita@ksha4	11 Nov 2025 07:20:30:677	BrezVe1	18 Nov 2025 09:10:21:810	Juhita@ksha4	24 Nov 2025 08:06:46:617		7	6	ECOA: Please verify and update the data for the field "Assessment Completed?"	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251111 07:20:30.677	20251118 09:10:21.810	20251124 08:06:46.617	98	335	335	26	186	713	713
154	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Maintenance	0/0/V	1	Start Date	Auto	19338057	Closed	systemuser	06 Mar 2026 10:03:12:880			systemuser	09 Mar 2026 10:23:01:597			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260306 10:03:12.880		20260309 10:23:01.597	98	335	335	26	186	713	713
155	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	End Date	DM	18527647	Closed	Juhita@ksha4	20 Jan 2026 09:18:41:697	BrezVe1	26 Jan 2026 07:32:25:360	Juhita@ksha4	27 Jan 2026 09:25:14:317		6	1	DM: Kindly refer the completion guideline and update the end date as appropriate.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260120 09:18:41.697	20260126 07:32:25.360	20260127 09:25:14.317	98	335	335	26	186	713	713
156	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	Start Date	Auto	16458267	Closed	systemuser	17 Oct 2025 11:41:10:687			systemuser	20 Oct 2025 07:50:24:940			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 11:41:10.687		20251020 07:50:24.940	98	335	335	26	186	713	713
157	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	Start Date	DM	18630752	Cancelled	Juhita@ksha4	27 Jan 2026 09:25:19:613			kminarov1	27 Jan 2026 12:23:46:467				DM: Kindly refer the completion guideline and update the end date as appropriate.		42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260127 09:25:19.613		20260127 12:23:46.467	98	335	335	26	186	713	713
158	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	Start Date	DM	20823448	Closed	JThoma858	13 May 2026 12:51:51:393	gnovotna@email.cz2	13 May 2026 13:52:53:817	Ashwini201	14 May 2026 07:08:45:327		0	1	DM: The Start Date of Part 1 should align with Visit Baseline Day 3 or Randomization Date. Kindly recheck and update	entry error	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260513 12:51:51.393	20260513 13:52:53.817	20260514 07:08:45.327	98	335	335	26	186	713	713
159	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	End Date	DM	18764037	Closed	Juhita@ksha4	04 Feb 2026 11:25:56:670	BrezVe1	09 Feb 2026 08:39:26:660	Juhita@ksha4	16 Feb 2026 14:37:41:227		5	7	Medical Review I-1908866: Please complete the end date.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260204 11:25:56.670	20260209 08:39:26.660	20260216 14:37:41.227	98	335	335	26	186	713	713
160	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	End Date	DM	19098873	Cancelled	Juhita@ksha4	20 Feb 2026 14:16:26:240			kminarov1	24 Feb 2026 10:38:43:130				RQ MR1 I-1908866: Please update the end date as per the completion guidelines.		42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 14:16:26.240		20260224 10:38:43.130	98	335	335	26	186	713	713
161	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	End Date	Auto	19138990	Closed	systemuser	24 Feb 2026 07:16:56:997	systemuser	24 Feb 2026 07:17:14:687	systemuser	24 Feb 2026 07:17:14:687		0	0	The End Date must be equal to or after the Start Date. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260224 07:16:56.997	20260224 07:17:14.687	20260224 07:17:14.687	98	335	335	26	186	713	713
162	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	Start Date	Auto	17405293	Closed	systemuser	28 Nov 2025 09:37:45:257			systemuser	01 Dec 2025 08:36:47:543			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251128 09:37:45.257		20251201 08:36:47.543	98	335	335	26	186	713	713
163	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	Number of tablets taken	Auto	19139010	Closed	systemuser	24 Feb 2026 07:17:57:280	systemuser	24 Feb 2026 07:18:18:727	systemuser	24 Feb 2026 07:18:18:727		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260224 07:17:57.280	20260224 07:18:18.727	20260224 07:18:18.727	98	335	335	26	186	713	713
164	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	End Date	DM	19613020	Closed	Juhita@ksha4	20 Mar 2026 07:53:07:357	BrezVe1	23 Mar 2026 13:19:13:727	Juhita@ksha4	25 Mar 2026 15:23:51:033		3	2	Medical Review I-3085480: Please provide end date.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260320 07:53:07.357	20260323 13:19:13.727	20260325 15:23:51.033	98	335	335	26	186	713	713
165	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	Start Date	Auto	18368673	Closed	systemuser	09 Jan 2026 08:54:57:037	BrezVe1	26 Jan 2026 07:33:23:667	Juhita@ksha4	20 Feb 2026 14:16:43:470		17	25	Please enter study drug administration start date as soon as it's available	will be done	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260109 08:54:57.037	20260126 07:33:23.667	20260220 14:16:43.470	98	335	335	26	186	713	713
166	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	Start Date	DM	19098884	Closed	Juhita@ksha4	20 Feb 2026 14:17:31:737	EHerman2	24 Feb 2026 07:18:30:140	Ashwini201	26 Feb 2026 08:32:26:103		4	2	RQ DM1: Please verify and update the start date as per the completion guidelines.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 14:17:31.737	20260224 07:18:30.140	20260226 08:32:26.103	98	335	335	26	186	713	713
167	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 1.4 Induction (1)	Clinical Global Impression - S (Depression)	0/0/V		If Yes, was the collection date the same as the visit date?	Auto	17984476	Closed	systemuser	15 Dec 2025 08:11:37:313	systemuser	15 Dec 2025 08:11:42:293	systemuser	15 Dec 2025 08:11:42:297		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251215 08:11:37.313	20251215 08:11:42.293	20251215 08:11:42.297	98	335	335	26	186	713	713
168	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 1.4 Induction (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	17984366	Closed	systemuser	15 Dec 2025 08:03:17:520	systemuser	15 Dec 2025 08:05:39:303	systemuser	15 Dec 2025 08:05:39:307		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251215 08:03:17.520	20251215 08:05:39.303	20251215 08:05:39.307	98	335	335	26	186	713	713
169	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 1.6 Induction (1)	Date of Visit	0/0/N		Visit Start Date	Auto	18368084	Closed	systemuser	09 Jan 2026 08:22:45:707			systemuser	09 Jan 2026 08:28:31:913			0	Date of visit should be greater than the last date of visit. Please reconcile.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260109 08:22:45.707		20260109 08:28:31.913	98	335	335	26	186	713	713
170	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.2 Stabilization (1)	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	18823558	Closed	systemuser	09 Feb 2026 08:26:27:617	systemuser	09 Feb 2026 08:26:45:607	systemuser	09 Feb 2026 08:26:45:610		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260209 08:26:27.617	20260209 08:26:45.607	20260209 08:26:45.610	98	335	335	26	186	713	713
171	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.2 Stabilization (1)	Vital Signs	0/0/N		Pulse	Auto	18823556	Closed	systemuser	09 Feb 2026 08:26:27:600	systemuser	09 Feb 2026 08:26:45:617	systemuser	09 Feb 2026 08:26:45:617		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260209 08:26:27.600	20260209 08:26:45.617	20260209 08:26:45.617	98	335	335	26	186	713	713
172	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.2 Stabilization (1)	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	18823557	Closed	systemuser	09 Feb 2026 08:26:27:610	systemuser	09 Feb 2026 08:26:45:620	systemuser	09 Feb 2026 08:26:45:620		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260209 08:26:27.610	20260209 08:26:45.620	20260209 08:26:45.620	98	335	335	26	186	713	713
173	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.2 Stabilization (1)	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	18823554	Closed	systemuser	09 Feb 2026 08:26:27:577	systemuser	09 Feb 2026 08:26:45:620	systemuser	09 Feb 2026 08:26:45:620		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260209 08:26:27.577	20260209 08:26:45.620	20260209 08:26:45.620	98	335	335	26	186	713	713
174	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.2 Stabilization (1)	Vital Signs	0/0/N		Temperature	Auto	18823555	Closed	systemuser	09 Feb 2026 08:26:27:590	systemuser	09 Feb 2026 08:26:45:620	systemuser	09 Feb 2026 08:26:45:620		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260209 08:26:27.590	20260209 08:26:45.620	20260209 08:26:45.620	98	335	335	26	186	713	713
175	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.2 Stabilization (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	18823561	Closed	systemuser	09 Feb 2026 08:26:45:663	systemuser	09 Feb 2026 08:27:03:847	systemuser	09 Feb 2026 08:27:03:850		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260209 08:26:45.663	20260209 08:27:03.847	20260209 08:27:03.850	98	335	335	26	186	713	713
176	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.4 Stabilization	Clinical Global Impression - S (Depression)	0/0/V		Severity of illness	Auto	19336124	Closed	systemuser	06 Mar 2026 08:28:08:773	systemuser	06 Mar 2026 08:28:40:480	systemuser	06 Mar 2026 08:28:40:480		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260306 08:28:08.773	20260306 08:28:40.480	20260306 08:28:40.480	98	335	335	26	186	713	713
177	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.4 Stabilization	Clinical Global Impression - S (Depression)	0/0/V		Rater's Initials	Auto	19336122	Closed	systemuser	06 Mar 2026 08:28:08:753	systemuser	06 Mar 2026 08:28:40:497	systemuser	06 Mar 2026 08:28:40:497		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260306 08:28:08.753	20260306 08:28:40.497	20260306 08:28:40.497	98	335	335	26	186	713	713
178	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.4 Stabilization	Clinical Global Impression - S (Depression)	0/0/V		If Yes, was the collection date the same as the visit date?	Auto	19336123	Closed	systemuser	06 Mar 2026 08:28:08:767	systemuser	06 Mar 2026 08:28:40:497	systemuser	06 Mar 2026 08:28:40:497		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260306 08:28:08.767	20260306 08:28:40.497	20260306 08:28:40.497	98	335	335	26	186	713	713
179	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 2.4 Stabilization	Neurologic Examination	0/0/N	5	Are there any findings?	Auto	19396887	Closed	systemuser	09 Mar 2026 10:41:43:360	systemuser	09 Mar 2026 10:41:56:387	systemuser	09 Mar 2026 10:41:56:390		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260309 10:41:43.360	20260309 10:41:56.387	20260309 10:41:56.390	98	335	335	26	186	713	713
180	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 3 Part 1 Baseline	Date of Visit	0/0/N		Did this visit occur?	DM	18173020	Closed	Ashwini201	23 Dec 2025 07:03:32:433	BrezVe1	05 Jan 2026 09:56:29:570	shyamaprasad972	06 Jan 2026 11:23:32:980		13	1	DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251223 07:03:32.433	20260105 09:56:29.570	20260106 11:23:32.980	98	335	335	26	186	713	713
181	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 3 Part 1 Baseline	Neurologic Examination	0/0/N		Date of Assessment	Auto	16459162	Closed	systemuser	17 Oct 2025 11:59:08:200	systemuser	17 Oct 2025 11:59:25:183	systemuser	17 Oct 2025 11:59:25:187		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 11:59:08.200	20251017 11:59:25.183	20251017 11:59:25.187	98	335	335	26	186	713	713
182	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 3 Part 1 Baseline	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	16459195	Closed	systemuser	17 Oct 2025 12:00:54:257	systemuser	20 Oct 2025 07:50:34:810	systemuser	20 Oct 2025 07:50:34:810		3	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 12:00:54.257	20251020 07:50:34.810	20251020 07:50:34.810	98	335	335	26	186	713	713
183	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	16729218	Closed	systemuser	03 Nov 2025 08:24:50:880	systemuser	03 Nov 2025 08:25:09:110	systemuser	03 Nov 2025 08:25:09:113		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251103 08:24:50.880	20251103 08:25:09.110	20251103 08:25:09.113	98	335	335	26	186	713	713
184	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Pulse	Auto	16729216	Closed	systemuser	03 Nov 2025 08:24:50:847	systemuser	03 Nov 2025 08:25:09:123	systemuser	03 Nov 2025 08:25:09:123		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251103 08:24:50.847	20251103 08:25:09.123	20251103 08:25:09.123	98	335	335	26	186	713	713
185	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	16729217	Closed	systemuser	03 Nov 2025 08:24:50:860	systemuser	03 Nov 2025 08:25:09:127	systemuser	03 Nov 2025 08:25:09:127		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251103 08:24:50.860	20251103 08:25:09.127	20251103 08:25:09.127	98	335	335	26	186	713	713
186	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	16729214	Closed	systemuser	03 Nov 2025 08:24:50:787	systemuser	03 Nov 2025 08:25:09:127	systemuser	03 Nov 2025 08:25:09:127		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251103 08:24:50.787	20251103 08:25:09.127	20251103 08:25:09.127	98	335	335	26	186	713	713
187	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Temperature	Auto	16729215	Closed	systemuser	03 Nov 2025 08:24:50:830	systemuser	03 Nov 2025 08:25:09:127	systemuser	03 Nov 2025 08:25:09:127		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251103 08:24:50.830	20251103 08:25:09.127	20251103 08:25:09.127	98	335	335	26	186	713	713
188	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	16729228	Closed	systemuser	03 Nov 2025 08:25:09:313	systemuser	03 Nov 2025 08:25:14:887	systemuser	03 Nov 2025 08:25:14:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251103 08:25:09.313	20251103 08:25:14.887	20251103 08:25:14.890	98	335	335	26	186	713	713
189	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.	Auto	17057786	Closed	systemuser	18 Nov 2025 08:18:55:217	systemuser	18 Nov 2025 08:19:32:423	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.217	20251118 08:19:32.423	20251118 08:19:32.427	98	335	335	26	186	713	713
190	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		2. Feeling down, depressed, or hopeless.	Auto	17057787	Closed	systemuser	18 Nov 2025 08:18:55:223	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.223	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
191	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		3. Trouble falling or staying asleep, or sleeping too much.	Auto	17057788	Closed	systemuser	18 Nov 2025 08:18:55:230	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.230	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
192	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		4. Feeling tired or having little energy.	Auto	17057789	Closed	systemuser	18 Nov 2025 08:18:55:240	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.240	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
193	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		5. Poor appetite or overeating.	Auto	17057790	Closed	systemuser	18 Nov 2025 08:18:55:250	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.250	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
194	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.	Auto	17057791	Closed	systemuser	18 Nov 2025 08:18:55:257	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.257	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
195	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		7. Trouble concentrating on things, such as reading the newspaper or watching television.	Auto	17057792	Closed	systemuser	18 Nov 2025 08:18:55:263	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.263	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
196	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.	Auto	17057793	Closed	systemuser	18 Nov 2025 08:18:55:283	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.283	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
197	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		9. Thoughts that you would be better off dead or of hurting yourself in some way.	Auto	17057794	Closed	systemuser	18 Nov 2025 08:18:55:293	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.293	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
198	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?	Auto	17057795	Closed	systemuser	18 Nov 2025 08:18:55:313	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.313	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
199	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Patient Health Questionnaire - 9 Item	0/0/V		Was the collection date the same as the visit date?	Auto	17057785	Closed	systemuser	18 Nov 2025 08:18:55:203	systemuser	18 Nov 2025 08:19:32:427	systemuser	18 Nov 2025 08:19:32:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:18:55.203	20251118 08:19:32.427	20251118 08:19:32.427	98	335	335	26	186	713	713
200	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040002	Enrolled	Visit 7 Part 1 (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	17057739	Closed	systemuser	18 Nov 2025 08:16:35:420	systemuser	18 Nov 2025 08:17:02:640	systemuser	18 Nov 2025 08:17:02:643		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:16:35.420	20251118 08:17:02.640	20251118 08:17:02.643	98	335	335	26	186	713	713
201	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Action Taken with Study Treatment	Auto	19645338	Closed	systemuser	23 Mar 2026 13:01:56:090	systemuser	23 Mar 2026 13:02:38:650	systemuser	23 Mar 2026 13:02:38:657		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260323 13:01:56.090	20260323 13:02:38.650	20260323 13:02:38.657	98	335	335	26	186	713	713
202	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Concomitant or additional therapy given for this adverse event?	Auto	19645339	Closed	systemuser	23 Mar 2026 13:01:56:100	systemuser	23 Mar 2026 13:02:38:680	systemuser	23 Mar 2026 13:02:38:680		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260323 13:01:56.100	20260323 13:02:38.680	20260323 13:02:38.680	98	335	335	26	186	713	713
203	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	End Time	Auto	19645336	Closed	systemuser	23 Mar 2026 13:01:56:067			systemuser	23 Mar 2026 13:02:38:680			0	The time entered is non-conformant. Please resolve.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260323 13:01:56.067		20260323 13:02:38.680	98	335	335	26	186	713	713
204	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Outcome	Auto	19645341	Closed	systemuser	23 Mar 2026 13:01:56:120	systemuser	23 Mar 2026 13:02:38:733	systemuser	23 Mar 2026 13:02:38:733		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260323 13:01:56.120	20260323 13:02:38.733	20260323 13:02:38.733	98	335	335	26	186	713	713
205	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Relationship to Study Treatment	Auto	19645340	Closed	systemuser	23 Mar 2026 13:01:56:110	systemuser	23 Mar 2026 13:02:38:710	systemuser	23 Mar 2026 13:02:38:710		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260323 13:01:56.110	20260323 13:02:38.710	20260323 13:02:38.710	98	335	335	26	186	713	713
206	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Is the adverse event serious?	Auto	19645344	Closed	systemuser	23 Mar 2026 13:01:56:147	systemuser	23 Mar 2026 13:02:38:733	systemuser	23 Mar 2026 13:02:38:733		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260323 13:01:56.147	20260323 13:02:38.733	20260323 13:02:38.733	98	335	335	26	186	713	713
207	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	2	Severity	Auto	19645337	Closed	systemuser	23 Mar 2026 13:01:56:080	systemuser	23 Mar 2026 13:02:38:710	systemuser	23 Mar 2026 13:02:38:710		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260323 13:01:56.080	20260323 13:02:38.710	20260323 13:02:38.710	98	335	335	26	186	713	713
208	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N		Were any medication(s)/therapy(ies) taken?	Site from Medical Reviewer	16450227	Closed	inayath1	17 Oct 2025 04:02:59:650	BrezVe1	20 Oct 2025 07:53:12:603	inayath1	21 Oct 2025 02:28:10:317		3	1	Eligibility: Please confirm the exact dose of Metoprolol subject is taking per day as 2 loglines (CM#5 and CM#6) are updated with different doses and both ongoing.	data are correct, subject is taking 50 mg in the morning and a different dose of 25 mg in the evening	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 04:02:59.650	20251020 07:53:12.603	20251021 02:28:10.317	98	335	335	26	186	713	713
209	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term	Auto	19065707	Closed	systemuser	19 Feb 2026 07:39:37:413	EHerman2	19 Feb 2026 07:40:52:457	Ashwini201	20 Feb 2026 06:57:43:423		0	1	The selected logline has been modified from '#002 > HYPERCHOLESTEROLÉMIA' to '#002 > HYPERCHOLESTEROLEMIA' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#	confirm	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260219 07:39:37.413	20260219 07:40:52.457	20260220 06:57:43.423	98	335	335	26	186	713	713
210	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	4	If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term	Auto	19065708	Closed	systemuser	19 Feb 2026 07:39:37:507	EHerman2	19 Feb 2026 07:41:34:817	Ashwini201	20 Feb 2026 06:57:54:033		0	1	The selected logline has been modified from '#002 > HYPERCHOLESTEROLÉMIA' to '#002 > HYPERCHOLESTEROLEMIA' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#	confirm	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260219 07:39:37.507	20260219 07:41:34.817	20260220 06:57:54.033	98	335	335	26	186	713	713
211	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260325 - Periodic Investigator's EDC Review Acknowledgement	0/0/N		As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.	Auto	19645327	Closed	systemuser	23 Mar 2026 13:00:57:817	systemuser	25 Mar 2026 07:22:24:580	systemuser	25 Mar 2026 07:22:24:920		2	0	NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260323 13:00:57.817	20260325 07:22:24.580	20260325 07:22:24.920	98	335	335	26	186	713	713
212	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933281	Closed	systemuser	20 May 2026 12:07:32:407			systemuser	20 May 2026 12:07:50:240			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 12:07:32.407		20260520 12:07:50.240	98	335	335	26	186	713	713
213	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	18121392	Closed	systemuser	19 Dec 2025 09:51:11:170			systemuser	22 Dec 2025 10:48:45:833			3	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251219 09:51:11.170		20251222 10:48:45.833	98	335	335	26	186	713	713
214	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	Site from Medical Reviewer	16450305	Closed	inayath1	17 Oct 2025 04:24:58:700	BrezVe1	20 Oct 2025 07:54:23:983	inayath1	21 Oct 2025 02:28:56:263		3	1	Eligibility: The subject had abnormal urinalysis with presence of bacteria and 3+ leukocyte esterase. Please confirm if this is a clinically significance, per investigator judgment, and exclusion #19 is ruled out.	not clinically significant	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 04:24:58.700	20251020 07:54:23.983	20251021 02:28:56.263	98	335	335	26	186	713	713
215	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	17286944	Closed	Ashwini201	25 Nov 2025 13:55:36:933	gnovotna@email.cz2	28 Nov 2025 10:45:47:890	SanchariDutta@025	01 Dec 2025 07:17:03:837		3	3	DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251125 13:55:36.933	20251128 10:45:47.890	20251201 07:17:03.837	98	335	335	26	186	713	713
216	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 1	General Medical History	0/0/N		Has the subject experienced any past and/ or concomitant diseases? If 'Yes', add a log line for each abnormality.	Auto	16381703	Closed	systemuser	13 Oct 2025 14:03:36:957	systemuser	13 Oct 2025 14:04:53:773	systemuser	13 Oct 2025 14:04:53:773		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251013 14:03:36.957	20251013 14:04:53.773	20251013 14:04:53.773	98	335	335	26	186	713	713
217	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 1	General Medical History	0/0/N	3	What is the verbatim term for the medical history condition/event?	DM	18305826	Closed	Juhita@ksha4	06 Jan 2026 06:49:22:013	gnovotna@email.cz2	13 Jan 2026 17:24:40:197	Juhita@ksha4	15 Jan 2026 14:17:15:253		7	2	Medical Review I-1707449: Kindly mention the type of arrhythmia, the clinical stability and frequency of Cardiac arrhythmia.	patient is clinical stably, after starting medication, the arrhythmias disappeared	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260106 06:49:22.013	20260113 17:24:40.197	20260115 14:17:15.253	98	335	335	26	186	713	713
218	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 1	General Medical History	0/0/N	4	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	16450258	Closed	inayath1	17 Oct 2025 04:12:12:890	BrezVe1	20 Oct 2025 07:58:22:110	inayath1	21 Oct 2025 02:34:06:163		3	1	Eligibility: Please consider updating the indication for surgery also in a separate logline.	please unfreeze logline 5 for data entry	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251017 04:12:12.890	20251020 07:58:22.110	20251021 02:34:06.163	98	335	335	26	186	713	713
219	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 1	General Medical History	0/0/N	4	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	16484927 (16450258)	Closed	inayath1	21 Oct 2025 02:34:06:307	gnovotna@email.cz2	24 Oct 2025 15:23:45:963	inayath1	25 Oct 2025 10:52:07:983		3	1	Eligibility: Please consider updating the details in a new logline.	cholecystectomia for cholecystolithiasis, updated in line 5	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251021 02:34:06.307	20251024 15:23:45.963	20251025 10:52:07.983	98	335	335	26	186	713	713
220	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	16381569	Closed	systemuser	13 Oct 2025 13:56:00:893	systemuser	13 Oct 2025 13:56:06:050	systemuser	13 Oct 2025 13:56:06:053		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251013 13:56:00.893	20251013 13:56:06.050	20251013 13:56:06.053	98	335	335	26	186	713	713
221	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 2 (1)	Date of Visit	0/0/N		Did this visit occur?	DM	17675428	Closed	Ashwini201	05 Dec 2025 13:31:24:357	BrezVe1	08 Dec 2025 08:29:58:700	Ashwini201	09 Dec 2025 10:08:48:947		3	1	DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 13:31:24.357	20251208 08:29:58.700	20251209 10:08:48.947	98	335	335	26	186	713	713
222	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Screening Visit 2 (1)	SIGH-D-17	0/0/N		Collection Date	Auto	16819247	Closed	systemuser	06 Nov 2025 08:08:02:013	systemuser	06 Nov 2025 08:09:23:450	systemuser	06 Nov 2025 08:09:23:450		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251106 08:08:02.013	20251106 08:09:23.450	20251106 08:09:23.450	98	335	335	26	186	713	713
223	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Maintenance	0/0/V	1	Start Date	Auto	19739140	Closed	systemuser	27 Mar 2026 09:57:52:020			systemuser	30 Mar 2026 09:19:06:300			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260327 09:57:52.020		20260330 09:19:06.300	98	335	335	26	186	713	713
224	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	End Date	DM	18527672	Closed	Juhita@ksha4	20 Jan 2026 09:19:32:410	BrezVe1	26 Jan 2026 06:40:04:157	Juhita@ksha4	27 Jan 2026 09:24:21:293		6	1	DM: Kindly refer the completion guideline and update the end date as appropriate.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260120 09:19:32.410	20260126 06:40:04.157	20260127 09:24:21.293	98	335	335	26	186	713	713
225	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	Start Date	Auto	16851126	Closed	systemuser	07 Nov 2025 10:11:08:747			systemuser	10 Nov 2025 12:38:14:997			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251107 10:11:08.747		20251110 12:38:14.997	98	335	335	26	186	713	713
226	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	Start Date	Auto	18121391	Closed	systemuser	19 Dec 2025 09:51:11:157			systemuser	22 Dec 2025 10:49:13:390			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251219 09:51:11.157		20251222 10:49:13.390	98	335	335	26	186	713	713
227	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/V	1	Start Date	Auto	18693645	Closed	systemuser	30 Jan 2026 08:08:11:847			systemuser	02 Feb 2026 15:51:40:760			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260130 08:08:11.847		20260202 15:51:40.760	98	335	335	26	186	713	713
228	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.5 Induction (1)	Date of Visit	0/0/N		Visit Start Date	Auto	18476460	Closed	systemuser	16 Jan 2026 09:27:36:950			systemuser	16 Jan 2026 09:27:52:367			0	Date of visit should be greater than the last date of visit. Please reconcile.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260116 09:27:36.950		20260116 09:27:52.367	98	335	335	26	186	713	713
229	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.5 Induction (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	18611495	Closed	systemuser	26 Jan 2026 06:36:35:650	systemuser	26 Jan 2026 06:36:42:390	systemuser	26 Jan 2026 06:36:42:393		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260126 06:36:35.650	20260126 06:36:42.390	20260126 06:36:42.393	98	335	335	26	186	713	713
230	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Sheehan Disability Scale	0/0/N		The symptoms have disrupted your work / school work	Auto	18715622	Closed	systemuser	02 Feb 2026 08:16:49:360	systemuser	02 Feb 2026 08:17:41:787	systemuser	02 Feb 2026 08:17:41:790		0	0	Either 'The symptoms have disrupted...' or 'I have not worked/studied ...' must be answered. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 08:16:49.360	20260202 08:17:41.787	20260202 08:17:41.790	98	335	335	26	186	713	713
231	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Sheehan Disability Scale	0/0/N		The symptoms have disrupted your social life / leisure activities	Auto	18715623	Closed	systemuser	02 Feb 2026 08:16:49:370	systemuser	02 Feb 2026 08:17:41:790	systemuser	02 Feb 2026 08:17:41:790		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 08:16:49.370	20260202 08:17:41.790	20260202 08:17:41.790	98	335	335	26	186	713	713
232	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Sheehan Disability Scale	0/0/N		The symptoms have disrupted your family life / home responsibilities	Auto	18715624	Closed	systemuser	02 Feb 2026 08:16:49:377	systemuser	02 Feb 2026 08:17:41:790	systemuser	02 Feb 2026 08:17:41:790		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 08:16:49.377	20260202 08:17:41.790	20260202 08:17:41.790	98	335	335	26	186	713	713
233	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Sheehan Disability Scale	0/0/N		On how many days in the last week did your symptoms cause you to miss school or work or leave you unable to carry out your normal daily responsibilities?	Auto	18715625	Closed	systemuser	02 Feb 2026 08:16:49:387	systemuser	02 Feb 2026 08:17:41:790	systemuser	02 Feb 2026 08:17:41:790		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 08:16:49.387	20260202 08:17:41.790	20260202 08:17:41.790	98	335	335	26	186	713	713
234	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Sheehan Disability Scale	0/0/N		On how many days in the last week did you feel so impaired by your symptoms, that even though you went to school or work or had other daily responsibilities, your productivity was reduced?	Auto	18715626	Closed	systemuser	02 Feb 2026 08:16:49:420	systemuser	02 Feb 2026 08:17:41:790	systemuser	02 Feb 2026 08:17:41:790		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 08:16:49.420	20260202 08:17:41.790	20260202 08:17:41.790	98	335	335	26	186	713	713
235	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Sheehan Disability Scale	0/0/N		Was the collection date the same as the visit date?	Auto	18715621	Closed	systemuser	02 Feb 2026 08:16:49:343	systemuser	02 Feb 2026 08:17:41:790	systemuser	02 Feb 2026 08:17:41:790		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 08:16:49.343	20260202 08:17:41.790	20260202 08:17:41.790	98	335	335	26	186	713	713
236	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	18715353	Closed	systemuser	02 Feb 2026 07:57:44:863	systemuser	02 Feb 2026 07:58:20:480	systemuser	02 Feb 2026 07:58:20:480		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 07:57:44.863	20260202 07:58:20.480	20260202 07:58:20.480	98	335	335	26	186	713	713
237	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Vital Signs	0/0/N		Pulse	Auto	18715351	Closed	systemuser	02 Feb 2026 07:57:44:847	systemuser	02 Feb 2026 07:58:20:490	systemuser	02 Feb 2026 07:58:20:490		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 07:57:44.847	20260202 07:58:20.490	20260202 07:58:20.490	98	335	335	26	186	713	713
238	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	18715352	Closed	systemuser	02 Feb 2026 07:57:44:857	systemuser	02 Feb 2026 07:58:20:497	systemuser	02 Feb 2026 07:58:20:497		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 07:57:44.857	20260202 07:58:20.497	20260202 07:58:20.497	98	335	335	26	186	713	713
239	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	18715348	Closed	systemuser	02 Feb 2026 07:57:44:817	systemuser	02 Feb 2026 07:58:20:497	systemuser	02 Feb 2026 07:58:20:497		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 07:57:44.817	20260202 07:58:20.497	20260202 07:58:20.497	98	335	335	26	186	713	713
240	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Vital Signs	0/0/N		Temperature	Auto	18715350	Closed	systemuser	02 Feb 2026 07:57:44:840	systemuser	02 Feb 2026 07:58:20:497	systemuser	02 Feb 2026 07:58:20:497		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 07:57:44.840	20260202 07:58:20.497	20260202 07:58:20.497	98	335	335	26	186	713	713
241	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 1.6 Induction (1)	Vital Signs	0/0/N		Weight	Auto	18715349	Closed	systemuser	02 Feb 2026 07:57:44:830	systemuser	02 Feb 2026 07:58:20:497	systemuser	02 Feb 2026 07:58:20:497		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 07:57:44.830	20260202 07:58:20.497	20260202 07:58:20.497	98	335	335	26	186	713	713
242	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 2.4 Stabilization	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	19753970	Closed	systemuser	30 Mar 2026 08:22:52:750	systemuser	30 Mar 2026 08:26:56:013	systemuser	30 Mar 2026 08:26:56:013		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260330 08:22:52.750	20260330 08:26:56.013	20260330 08:26:56.013	98	335	335	26	186	713	713
243	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 3 Part 1 Baseline	Date of Visit	0/0/N		Did this visit occur?	DM	18173047	Closed	Ashwini201	23 Dec 2025 07:06:45:213	BrezVe1	05 Jan 2026 09:58:58:060	shyamaprasad972	06 Jan 2026 11:28:52:937		13	1	DM: Please verify and update the data on Arizona Sexual Experiences Scale-Female form, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251223 07:06:45.213	20260105 09:58:58.060	20260106 11:28:52.937	98	335	335	26	186	713	713
244	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 3 Part 1 Baseline	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	17009071	Closed	systemuser	14 Nov 2025 11:50:50:913	systemuser	18 Nov 2025 09:11:02:790	systemuser	18 Nov 2025 09:11:02:790		4	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251114 11:50:50.913	20251118 09:11:02.790	20251118 09:11:02.790	98	335	335	26	186	713	713
245	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	17009181	Closed	systemuser	14 Nov 2025 11:54:11:523	systemuser	18 Nov 2025 09:11:11:500	systemuser	18 Nov 2025 09:11:11:500		4	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251114 11:54:11.523	20251118 09:11:11.500	20251118 09:11:11.500	98	335	335	26	186	713	713
246	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 3.2 Maintenance (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	20425827	Closed	systemuser	27 Apr 2026 06:58:00:870	systemuser	27 Apr 2026 06:59:40:830	systemuser	27 Apr 2026 06:59:40:833		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 06:58:00.870	20260427 06:59:40.830	20260427 06:59:40.833	98	335	335	26	186	713	713
247	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	17209130	Closed	systemuser	24 Nov 2025 08:01:09:403	systemuser	24 Nov 2025 08:05:24:837	systemuser	24 Nov 2025 08:05:24:840		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251124 08:01:09.403	20251124 08:05:24.837	20251124 08:05:24.840	98	335	335	26	186	713	713
248	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 7 Part 1 (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	17731113	Closed	systemuser	08 Dec 2025 07:58:36:403	systemuser	08 Dec 2025 07:58:42:790	systemuser	08 Dec 2025 07:58:42:793		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251208 07:58:36.403	20251208 07:58:42.790	20251208 07:58:42.793	98	335	335	26	186	713	713
249	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 8 Part 1 (1)	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	18149017	Closed	systemuser	22 Dec 2025 07:58:27:333	systemuser	22 Dec 2025 07:59:20:983	systemuser	22 Dec 2025 07:59:20:987		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251222 07:58:27.333	20251222 07:59:20.983	20251222 07:59:20.987	98	335	335	26	186	713	713
250	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 8 Part 1 (1)	Vital Signs	0/0/N		Pulse	Auto	18149015	Closed	systemuser	22 Dec 2025 07:58:27:317	systemuser	22 Dec 2025 07:59:20:993	systemuser	22 Dec 2025 07:59:20:993		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251222 07:58:27.317	20251222 07:59:20.993	20251222 07:59:20.993	98	335	335	26	186	713	713
251	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 8 Part 1 (1)	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	18149016	Closed	systemuser	22 Dec 2025 07:58:27:327	systemuser	22 Dec 2025 07:59:20:997	systemuser	22 Dec 2025 07:59:20:997		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251222 07:58:27.327	20251222 07:59:20.997	20251222 07:59:20.997	98	335	335	26	186	713	713
252	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 8 Part 1 (1)	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	18149012	Closed	systemuser	22 Dec 2025 07:58:27:280	systemuser	22 Dec 2025 07:59:20:997	systemuser	22 Dec 2025 07:59:20:997		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251222 07:58:27.280	20251222 07:59:20.997	20251222 07:59:20.997	98	335	335	26	186	713	713
253	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 8 Part 1 (1)	Vital Signs	0/0/N		Temperature	Auto	18149014	Closed	systemuser	22 Dec 2025 07:58:27:307	systemuser	22 Dec 2025 07:59:20:997	systemuser	22 Dec 2025 07:59:20:997		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251222 07:58:27.307	20251222 07:59:20.997	20251222 07:59:20.997	98	335	335	26	186	713	713
254	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 8 Part 1 (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	18149047	Closed	systemuser	22 Dec 2025 07:59:21:177	systemuser	22 Dec 2025 07:59:25:823	systemuser	22 Dec 2025 07:59:25:830		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251222 07:59:21.177	20251222 07:59:25.823	20251222 07:59:25.830	98	335	335	26	186	713	713
255	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040003	Enrolled	Visit 8 Part 1 (1)	Vital Signs	0/0/N		Weight	Auto	18149013	Closed	systemuser	22 Dec 2025 07:58:27:293	systemuser	22 Dec 2025 07:59:21:000	systemuser	22 Dec 2025 07:59:21:000		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251222 07:58:27.293	20251222 07:59:21.000	20251222 07:59:21.000	98	335	335	26	186	713	713
256	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260421 - Periodic Investigator's EDC Review Acknowledgement	0/0/N		As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.	Auto	19936664	Closed	systemuser	13 Apr 2026 10:17:06:907	systemuser	21 Apr 2026 10:23:54:673	systemuser	21 Apr 2026 10:23:54:840		8	0	NOTIFICATION: Please ensure the investigator performs periodic review and confirms his/her review by ticking the box.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260413 10:17:06.907	20260421 10:23:54.673	20260421 10:23:54.840	98	335	335	21	186	713	713
257	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933314	Closed	systemuser	20 May 2026 12:09:14:457			systemuser	20 May 2026 12:09:28:407			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 12:09:14.457		20260520 12:09:28.407	98	335	335	21	186	713	713
258	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	18611565	Closed	systemuser	26 Jan 2026 06:45:00:130			systemuser	26 Jan 2026 07:36:14:250			0	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260126 06:45:00.130		20260126 07:36:14.250	98	335	335	21	186	713	713
259	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	18136451	Cancelled	Ashwini201	19 Dec 2025 14:52:41:943			kminarov1	15 Jan 2026 08:59:00:713				DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.		42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251219 14:52:41.943		20260115 08:59:00.713	98	335	335	21	186	713	713
260	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 1	General Medical History	0/0/N	1	Is the medical history disease/condition or event still ongoing?	Auto	16928104	Closed	systemuser	11 Nov 2025 15:07:53:720	systemuser	11 Nov 2025 15:08:51:210	systemuser	11 Nov 2025 15:08:51:213		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251111 15:07:53.720	20251111 15:08:51.210	20251111 15:08:51.213	98	335	335	21	186	713	713
261	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 1	General Medical History	0/0/N	1	What is the verbatim term for the medical history condition/event?	Auto	16928103	Closed	systemuser	11 Nov 2025 15:07:53:703		11 Nov 2025 15:08:51:267	systemuser	11 Nov 2025 15:08:51:267		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251111 15:07:53.703	20251111 15:08:51.267	20251111 15:08:51.267	98	335	335	21	186	713	713
262	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 1	General Medical History	0/0/N	2	What is the verbatim term for the medical history condition/event?	DM	17009134	Closed	CoderImport	14 Nov 2025 11:52:09:027	BrezVe1	18 Nov 2025 09:12:45:677	systemuser	18 Nov 2025 09:12:45:813		4	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. BILATERAL DIAPHRAGMATIC HERNIA and 2. LAPAROSCOPICALLY BILATERAL DIAGPHRAGMATIC HERNIA REPAIR.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251114 11:52:09.027	20251118 09:12:45.677	20251118 09:12:45.813	98	335	335	21	186	713	713
263	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 1	General Medical History	0/0/N	3	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	17057574	Closed	kavya@1510	18 Nov 2025 08:10:32:457	BrezVe1	18 Nov 2025 09:12:19:873	kavya@1510	20 Nov 2025 08:04:43:933		0	2	Eligibility: Kindly clarify underlying etiology, other associated signs and symptoms and any investigations done to establish final diagnosis. Kindly also comment subject is clinically stable and meets inclusion criteria #8	etiology unknown, stable	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251118 08:10:32.457	20251118 09:12:19.873	20251120 08:04:43.933	98	335	335	21	186	713	713
264	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 1	General Medical History	0/0/N	3	What is the verbatim term for the medical history condition/event?	DM	19081322	Closed	SanchariDutta@025	19 Feb 2026 13:40:12:940	EHerman2	24 Feb 2026 07:20:16:300	SanchariDutta@025	10 Mar 2026 14:34:12:357		5	14	Medical Review I-1943314: Kindly mention the etiology for PAIN SYNDROME IN THE LUMBAR SPINE.	general non specific degenerative process of spine	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260219 13:40:12.940	20260224 07:20:16.300	20260310 14:34:12.357	98	335	335	21	186	713	713
265	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 1	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	18425988	Closed	systemuser	13 Jan 2026 17:01:29:430	systemuser	13 Jan 2026 17:01:57:267	systemuser	13 Jan 2026 17:01:57:270		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:01:29.430	20260113 17:01:57.267	20260113 17:01:57.270	98	335	335	21	186	713	713
266	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	16927931	Closed	systemuser	11 Nov 2025 15:00:54:780	systemuser	18 Nov 2025 09:11:21:737	systemuser	18 Nov 2025 09:11:21:737		7	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251111 15:00:54.780	20251118 09:11:21.737	20251118 09:11:21.737	98	335	335	21	186	713	713
267	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Screening Visit 2 (1)	Date of Visit	0/0/N		Did this visit occur?	DM	18246892	Closed	Ashwini201	30 Dec 2025 06:51:27:237	BrezVe1	05 Jan 2026 10:00:51:533	shyamaprasad972	06 Jan 2026 11:18:49:460		6	1	DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251230 06:51:27.237	20260105 10:00:51.533	20260106 11:18:49.460	98	335	335	21	186	713	713
268	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Maintenance	0/0/N	1	Start Date	Auto	20606593	Closed	systemuser	05 May 2026 06:43:09:783			systemuser	06 May 2026 07:32:04:917			1	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260505 06:43:09.783		20260506 07:32:04.917	98	335	335	21	186	713	713
269	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/N	1	Start Date	Auto	17647022	Closed	systemuser	05 Dec 2025 08:56:15:047			systemuser	08 Dec 2025 08:31:35:187			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:56:15.047		20251208 08:31:35.187	98	335	335	21	186	713	713
270	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/N	1	Start Date	Auto	18611564	Closed	systemuser	26 Jan 2026 06:45:00:110			systemuser	26 Jan 2026 07:35:26:850			0	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260126 06:45:00.110		20260126 07:35:26.850	98	335	335	21	186	713	713
271	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Stabilization	0/0/N	1	Start Date	Auto	19501352	Closed	systemuser	13 Mar 2026 07:38:48:580			systemuser	20 Mar 2026 11:35:45:327			7	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260313 07:38:48.580		20260320 11:35:45.327	98	335	335	21	186	713	713
272	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.4 Induction (1)	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		10. Suicidal Thoughts	Auto	18716026	Closed	systemuser	02 Feb 2026 08:36:25:027	systemuser	02 Feb 2026 08:36:39:623	systemuser	02 Feb 2026 08:36:39:627		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 08:36:25.027	20260202 08:36:39.623	20260202 08:36:39.627	98	335	335	21	186	713	713
273	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.4 Induction (1)	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		TOTAL MADRS SCALE SCORE	Auto	18716027	Closed	systemuser	02 Feb 2026 08:36:25:040	systemuser	02 Feb 2026 08:36:39:950	systemuser	02 Feb 2026 08:36:39:950		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 08:36:25.040	20260202 08:36:39.950	20260202 08:36:39.950	98	335	335	21	186	713	713
274	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.5 Induction (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	18974408	Closed	systemuser	16 Feb 2026 11:50:08:263	systemuser	16 Feb 2026 11:50:13:210	systemuser	16 Feb 2026 11:50:13:210		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260216 11:50:08.263	20260216 11:50:13.210	20260216 11:50:13.210	98	335	335	21	186	713	713
275	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		Over the last 2 weeks, how often have you been bothered by any of the following problems? 1. Little interest or pleasure in doing things.	Auto	19522818	Closed	systemuser	16 Mar 2026 07:58:42:147	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.147	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
276	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		2. Feeling down, depressed, or hopeless.	Auto	19522819	Closed	systemuser	16 Mar 2026 07:58:42:153	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.153	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
277	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		3. Trouble falling or staying asleep, or sleeping too much.	Auto	19522820	Closed	systemuser	16 Mar 2026 07:58:42:160	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.160	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
278	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		4. Feeling tired or having little energy.	Auto	19522821	Closed	systemuser	16 Mar 2026 07:58:42:163	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.163	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
279	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		5. Poor appetite or overeating.	Auto	19522822	Closed	systemuser	16 Mar 2026 07:58:42:170	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.170	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
280	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.	Auto	19522823	Closed	systemuser	16 Mar 2026 07:58:42:173	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.173	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
281	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		7. Trouble concentrating on things, such as reading the newspaper or watching television.	Auto	19522824	Closed	systemuser	16 Mar 2026 07:58:42:180	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.180	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
282	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		8. Moving or speaking so slowly that other people could have noticed? Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.	Auto	19522825	Closed	systemuser	16 Mar 2026 07:58:42:187	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.187	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
283	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		9. Thoughts that you would be better off dead or of hurting yourself in some way.	Auto	19522826	Closed	systemuser	16 Mar 2026 07:58:42:193	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.193	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
284	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?	Auto	19522827	Closed	systemuser	16 Mar 2026 07:58:42:200	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.200	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
285	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 1.7 Induction (1)	Patient Health Questionnaire - 9 Item	0/0/N		Was the collection date the same as the visit date?	Auto	19522817	Closed	systemuser	16 Mar 2026 07:58:42:137	systemuser	16 Mar 2026 07:59:24:143	systemuser	16 Mar 2026 07:59:24:143		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 07:58:42.137	20260316 07:59:24.143	20260316 07:59:24.143	98	335	335	21	186	713	713
286	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 2.3 Stabilization (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	20426536	Closed	systemuser	27 Apr 2026 07:19:30:220	systemuser	27 Apr 2026 07:19:35:360	systemuser	27 Apr 2026 07:19:35:363		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 07:19:30.220	20260427 07:19:35.360	20260427 07:19:35.363	98	335	335	21	186	713	713
287	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Clinical Global Impression - S (Depression)	0/0/N		Rater's Initials	Auto	18427405	Closed	systemuser	13 Jan 2026 18:55:45:367	systemuser	26 Jan 2026 07:34:05:540	systemuser	26 Jan 2026 07:34:05:540		13	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 18:55:45.367	20260126 07:34:05.540	20260126 07:34:05.540	98	335	335	21	186	713	713
288	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Date of Visit	0/0/N		Did this visit occur?	DM	18174712	Closed	Ashwini201	23 Dec 2025 08:33:14:420	BrezVe1	05 Jan 2026 10:01:40:950	Ashwini201	09 Jan 2026 08:30:35:950		13	4	DM: Please verify and update the data on all blank forms of Visit 3 Part 1 Baseline, else clarify.	will be done asap	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251223 08:33:14.420	20260105 10:01:40.950	20260109 08:30:35.950	98	335	335	21	186	713	713
289	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Date of Visit	0/0/N		Did this visit occur?	DM	18368243 (18174712)	Closed	Ashwini201	09 Jan 2026 08:30:36:120	BrezVe1	26 Jan 2026 07:33:56:660	shyamaprasad972	28 Jan 2026 10:40:07:423		17	2	RQ-DM1: Thank you for the response. Please verify and update the data on blanks form once available.	All V3 data entered	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260109 08:30:36.120	20260126 07:33:56.660	20260128 10:40:07.423	98	335	335	21	186	713	713
290	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		Was the collection date the same as the visit date?	Auto	18426122	Closed	systemuser	13 Jan 2026 17:13:47:840	systemuser	13 Jan 2026 17:14:38:893	systemuser	13 Jan 2026 17:14:38:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:47.840	20260113 17:14:38.893	20260113 17:14:38.893	98	335	335	21	186	713	713
291	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		1. Loss of appetite	Auto	18426123	Closed	systemuser	13 Jan 2026 17:13:47:907	systemuser	13 Jan 2026 17:14:38:887	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:47.907	20260113 17:14:38.887	20260113 17:14:38.890	98	335	335	21	186	713	713
292	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		2. Nausea - Vomiting	Auto	18426124	Closed	systemuser	13 Jan 2026 17:13:47:940	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:47.940	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
293	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		3. Diarrhea	Auto	18426125	Closed	systemuser	13 Jan 2026 17:13:48:003	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.003	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
294	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		4. Anxiety, Nervousness	Auto	18426126	Closed	systemuser	13 Jan 2026 17:13:48:050	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.050	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
295	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		5. Irritability	Auto	18426127	Closed	systemuser	13 Jan 2026 17:13:48:107	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.107	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
296	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		6. Dysphoric Mood, Depression	Auto	18426128	Closed	systemuser	13 Jan 2026 17:13:48:160	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.160	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
297	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		7. Insomnia	Auto	18426129	Closed	systemuser	13 Jan 2026 17:13:48:197	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.197	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
298	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		8. Fatigue, Lethargy Lack of energy	Auto	18426130	Closed	systemuser	13 Jan 2026 17:13:48:233	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.233	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
299	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		9. Poor Coordination	Auto	18426131	Closed	systemuser	13 Jan 2026 17:13:48:277	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.277	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
300	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		10. Restlessness, Agitation	Auto	18426132	Closed	systemuser	13 Jan 2026 17:13:48:313	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.313	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
301	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		11. Diaphoresis	Auto	18426133	Closed	systemuser	13 Jan 2026 17:13:48:360	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.360	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
302	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		12. Tremor - Tremulousness	Auto	18426134	Closed	systemuser	13 Jan 2026 17:13:48:390	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.390	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
303	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		13. Dizziness - Lightheadedness	Auto	18426135	Closed	systemuser	13 Jan 2026 17:13:48:430	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.430	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
304	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		14. Headaches	Auto	18426136	Closed	systemuser	13 Jan 2026 17:13:48:453	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:890		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.453	20260113 17:14:38.890	20260113 17:14:38.890	98	335	335	21	186	713	713
305	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		15. Muscle Aches or Stiffness	Auto	18426137	Closed	systemuser	13 Jan 2026 17:13:48:483	systemuser	13 Jan 2026 17:14:38:890	systemuser	13 Jan 2026 17:14:38:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.483	20260113 17:14:38.890	20260113 17:14:38.893	98	335	335	21	186	713	713
306	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		16. Weakness	Auto	18426138	Closed	systemuser	13 Jan 2026 17:13:48:537	systemuser	13 Jan 2026 17:14:38:893	systemuser	13 Jan 2026 17:14:38:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.537	20260113 17:14:38.893	20260113 17:14:38.893	98	335	335	21	186	713	713
307	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		17. Increased acuity for sound, smell, touch or pain	Auto	18426139	Closed	systemuser	13 Jan 2026 17:13:48:603	systemuser	13 Jan 2026 17:14:38:893	systemuser	13 Jan 2026 17:14:38:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.603	20260113 17:14:38.893	20260113 17:14:38.893	98	335	335	21	186	713	713
308	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		18. Paresthesias	Auto	18426140	Closed	systemuser	13 Jan 2026 17:13:48:643	systemuser	13 Jan 2026 17:14:38:893	systemuser	13 Jan 2026 17:14:38:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.643	20260113 17:14:38.893	20260113 17:14:38.893	98	335	335	21	186	713	713
309	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		19. Difficulty concentrating, remembering	Auto	18426141	Closed	systemuser	13 Jan 2026 17:13:48:650	systemuser	13 Jan 2026 17:14:38:893	systemuser	13 Jan 2026 17:14:38:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.650	20260113 17:14:38.893	20260113 17:14:38.893	98	335	335	21	186	713	713
310	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	Physician Withdrawal Checklist (PWC)	0/0/N		20. Depersonalization, Derealization	Auto	18426142	Closed	systemuser	13 Jan 2026 17:13:48:670	systemuser	13 Jan 2026 17:14:38:893	systemuser	13 Jan 2026 17:14:38:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260113 17:13:48.670	20260113 17:14:38.893	20260113 17:14:38.893	98	335	335	21	186	713	713
311	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		1. My sleep quality was	Auto	17646785	Closed	systemuser	05 Dec 2025 08:48:40:420	systemuser	05 Dec 2025 08:50:05:223	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.420	20251205 08:50:05.223	20251205 08:50:05.227	98	335	335	21	186	713	713
312	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		2. My sleep was refreshing	Auto	17646786	Closed	systemuser	05 Dec 2025 08:48:40:457	systemuser	05 Dec 2025 08:50:05:227	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.457	20251205 08:50:05.227	20251205 08:50:05.227	98	335	335	21	186	713	713
313	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		3. I had a problem with my sleep	Auto	17646787	Closed	systemuser	05 Dec 2025 08:48:40:483	systemuser	05 Dec 2025 08:50:05:227	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.483	20251205 08:50:05.227	20251205 08:50:05.227	98	335	335	21	186	713	713
314	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		4. I had difficulty falling asleep	Auto	17646788	Closed	systemuser	05 Dec 2025 08:48:40:540	systemuser	05 Dec 2025 08:50:05:227	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.540	20251205 08:50:05.227	20251205 08:50:05.227	98	335	335	21	186	713	713
315	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		5. My sleep was restless	Auto	17646789	Closed	systemuser	05 Dec 2025 08:48:40:580	systemuser	05 Dec 2025 08:50:05:227	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.580	20251205 08:50:05.227	20251205 08:50:05.227	98	335	335	21	186	713	713
316	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		6. I tried hard to get to sleep	Auto	17646790	Closed	systemuser	05 Dec 2025 08:48:40:610	systemuser	05 Dec 2025 08:50:05:227	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.610	20251205 08:50:05.227	20251205 08:50:05.227	98	335	335	21	186	713	713
317	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		7. I worried about not being able to fall asleep	Auto	17646791	Closed	systemuser	05 Dec 2025 08:48:40:617	systemuser	05 Dec 2025 08:50:05:227	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.617	20251205 08:50:05.227	20251205 08:50:05.227	98	335	335	21	186	713	713
318	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		8. I was satisfied with my sleep	Auto	17646792	Closed	systemuser	05 Dec 2025 08:48:40:620	systemuser	05 Dec 2025 08:50:05:227	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.620	20251205 08:50:05.227	20251205 08:50:05.227	98	335	335	21	186	713	713
319	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/N		Was the collection date the same as the visit date?	Auto	17646784	Closed	systemuser	05 Dec 2025 08:48:40:360	systemuser	05 Dec 2025 08:50:05:227	systemuser	05 Dec 2025 08:50:05:227		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251205 08:48:40.360	20251205 08:50:05.227	20251205 08:50:05.227	98	335	335	21	186	713	713
320	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040004	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	18359435	Closed	systemuser	08 Jan 2026 16:31:16:867	systemuser	26 Jan 2026 07:34:11:793	systemuser	26 Jan 2026 07:34:11:797		18	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260108 16:31:16.867	20260126 07:34:11.793	20260126 07:34:11.797	98	335	335	21	186	713	713
321	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/N	1	Is the adverse event still ongoing?	DM	19788571	Closed	JThoma858	01 Apr 2026 06:28:24:477	BrezVe1	01 Apr 2026 08:19:58:773	JThoma858	02 Apr 2026 06:47:14:017		0	1	Medical Review I-3115319: Please clarify if the event is still ongoing.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 06:28:24.477	20260401 08:19:58.773	20260402 06:47:14.017	98	335	335	30	186	713	713
322	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/N	1	Outcome	Auto	19224943	Closed	systemuser	02 Mar 2026 06:46:53:450	systemuser	02 Mar 2026 06:48:16:157	systemuser	02 Mar 2026 06:48:16:160		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260302 06:46:53.450	20260302 06:48:16.157	20260302 06:48:16.160	98	335	335	30	186	713	713
323	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/N	1	Relationship to Study Treatment	DM	19815411	Closed	Juhita@ksha4	02 Apr 2026 13:36:04:210	BrezVe1	20 Apr 2026 11:26:32:690	Juhita@ksha4	22 Apr 2026 08:18:25:260		18	2	Medical Review I-3115728: Kindly clarify rationality to consider AE to be related to study drug.	PI decision	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260402 13:36:04.210	20260420 11:26:32.690	20260422 08:18:25.260	98	335	335	30	186	713	713
324	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/N	1	Is the adverse event serious?	Auto	19224946	Closed	systemuser	02 Mar 2026 06:46:53:470	systemuser	02 Mar 2026 06:48:16:160	systemuser	02 Mar 2026 06:48:16:160		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260302 06:46:53.470	20260302 06:48:16.160	20260302 06:48:16.160	98	335	335	30	186	713	713
325	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/N	1	What is the adverse event term?	DM	19788504	Closed	JThoma858	01 Apr 2026 06:24:44:720	BrezVe1	01 Apr 2026 08:13:19:773	JThoma858	02 Apr 2026 05:48:57:250		0	1	Medical Review I-3115321 : Could you please confirm whether the psychomotor retardation was caused by increased somnolence? Kindly consider which term best describes the event. Otherwise, clarify.	Term PSYCHOMOTORIC RETARDATION DURING MORNING correct according to PI	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 06:24:44.720	20260401 08:13:19.773	20260402 05:48:57.250	98	335	335	30	186	713	713
326	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/N	1	What is the adverse event term?	DM	19788518	Closed	JThoma858	01 Apr 2026 06:26:50:533	BrezVe1	01 Apr 2026 08:12:47:600	JThoma858	02 Apr 2026 05:49:55:723		0	1	Medical Review I-3115320 : Could you please specify how long during the day the participant continued to experience retardation? Otherwise, clarify.	not specified	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 06:26:50.533	20260401 08:12:47.600	20260402 05:49:55.723	98	335	335	30	186	713	713
327	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	2	If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?	Auto	18655963	Closed	systemuser	28 Jan 2026 11:58:29:513	EHerman2	28 Jan 2026 11:59:19:170	Ashwini201	29 Jan 2026 08:00:36:347		0	1	Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 11:58:29.513	20260128 11:59:19.170	20260129 08:00:36.347	98	335	335	30	186	713	713
328	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	2	If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?	DM	18670013	Closed	Ashwini201	29 Jan 2026 08:00:50:960	EHerman2	03 Feb 2026 06:48:52:060	Ashwini201	04 Feb 2026 07:51:21:887		5	1	RQ-DM1: Thank you for the response. However, the field 'Was the medication/therapy taken prior to the study?' is still not updated. Kindly verify and update the data in the field.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260129 08:00:50.960	20260203 06:48:52.060	20260204 07:51:21.887	98	335	335	30	186	713	713
329	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	3	If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?	Auto	18655985	Closed	systemuser	28 Jan 2026 12:00:42:960	systemuser	28 Jan 2026 12:02:11:950	systemuser	28 Jan 2026 12:02:11:950		0	0	Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 12:00:42.960	20260128 12:02:11.950	20260128 12:02:11.950	98	335	335	30	186	713	713
330	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933321	Closed	systemuser	20 May 2026 12:10:02:133			systemuser	20 May 2026 12:10:14:603			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 12:10:02.133		20260520 12:10:14.603	98	335	335	30	186	713	713
331	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	19225539	Closed	systemuser	02 Mar 2026 07:24:56:597			systemuser	20 Apr 2026 11:25:05:500			49	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260302 07:24:56.597		20260420 11:25:05.500	98	335	335	30	186	713	713
332	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Suicidal Ideation1. Wish to be DeadLifetime	Auto	18654597	Closed	systemuser	28 Jan 2026 10:46:03:283	systemuser	28 Jan 2026 10:52:16:527	systemuser	28 Jan 2026 10:52:16:530		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.283	20260128 10:52:16.527	20260128 10:52:16.530	98	335	335	30	186	713	713
333	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 6 Months	Auto	18654598	Closed	systemuser	28 Jan 2026 10:46:03:290	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.290	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
334	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		2. Non-Specific Active Suicidal ThoughtsLifetime	Auto	18654599	Closed	systemuser	28 Jan 2026 10:46:03:300	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.300	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
335	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 6 Months	Auto	18654600	Closed	systemuser	28 Jan 2026 10:46:03:307	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.307	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
336	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Suicidal BehaviorActual AttemptLifetime	Auto	18654601	Closed	systemuser	28 Jan 2026 10:46:03:353	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.353	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
337	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	18654602	Closed	systemuser	28 Jan 2026 10:46:03:360	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.360	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
338	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Has subject engaged in Non-Suicidal Self-Injurious Behavior?Lifetime	Auto	18654603	Closed	systemuser	28 Jan 2026 10:46:03:380	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.380	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
339	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	18654604	Closed	systemuser	28 Jan 2026 10:46:03:390	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.390	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
340	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Interrupted AttemptLifetime	Auto	18654605	Closed	systemuser	28 Jan 2026 10:46:03:400	systemuser	28 Jan 2026 10:53:26:423	systemuser	28 Jan 2026 10:53:26:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.400	20260128 10:53:26.423	20260128 10:53:26.427	98	335	335	30	186	713	713
341	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	18654606	Closed	systemuser	28 Jan 2026 10:46:03:407	systemuser	28 Jan 2026 10:53:26:427	systemuser	28 Jan 2026 10:53:26:427		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.407	20260128 10:53:26.427	20260128 10:53:26.427	98	335	335	30	186	713	713
342	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Aborted AttemptLifetime	Auto	18654607	Closed	systemuser	28 Jan 2026 10:46:03:420	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.420	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
343	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	18654608	Closed	systemuser	28 Jan 2026 10:46:03:430	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.430	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
344	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Preparatory Acts or BehaviorLifetime	Auto	18654609	Closed	systemuser	28 Jan 2026 10:46:03:440	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.440	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
345	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	18654610	Closed	systemuser	28 Jan 2026 10:46:03:450	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.450	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
346	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Suicidal BehaviorLifetime	Auto	18654611	Closed	systemuser	28 Jan 2026 10:46:03:460	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.460	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
347	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	18654612	Closed	systemuser	28 Jan 2026 10:46:03:470	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.470	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
348	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Rater's Initials	Auto	18654596	Closed	systemuser	28 Jan 2026 10:46:03:280	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.280	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
349	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Was the collection date the same as the visit date?	Auto	18654595	Closed	systemuser	28 Jan 2026 10:46:03:263	systemuser	28 Jan 2026 10:52:16:563	systemuser	28 Jan 2026 10:52:16:563		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:46:03.263	20260128 10:52:16.563	20260128 10:52:16.563	98	335	335	30	186	713	713
350	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	Site from Medical Reviewer	18708650	Cancelled	Rajani_S_N1	31 Jan 2026 18:02:10:460			Rajani_S_N1	03 Feb 2026 13:39:13:473				ELigibility: Kindly update AE form with details Yes / no		42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260131 18:02:10.460		20260203 13:39:13.473	98	335	335	30	186	713	713
351	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	General Medical History	0/0/N	3	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	18708661	Closed	Rajani_S_N1	31 Jan 2026 18:11:22:683	EHerman2	03 Feb 2026 06:47:22:130	Rajani_S_N1	03 Feb 2026 13:38:11:480		3	0	Eligibility: Kindly comment on the clinical stability of the medical condition and severity	chronic condition with mild severity, not present all the time, present episodically	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260131 18:11:22.683	20260203 06:47:22.130	20260203 13:38:11.480	98	335	335	30	186	713	713
352	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Mini-Mental State Examination	0/0/N		Rater's Initials	Auto	18655622	Closed	systemuser	28 Jan 2026 11:40:20:817	systemuser	28 Jan 2026 11:44:36:897	systemuser	28 Jan 2026 11:44:36:900		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 11:40:20.817	20260128 11:44:36.897	20260128 11:44:36.900	98	335	335	30	186	713	713
353	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Mini-Mental State Examination	0/0/N		Total Score	Auto	18655623	Closed	systemuser	28 Jan 2026 11:40:20:823	systemuser	28 Jan 2026 11:44:36:900	systemuser	28 Jan 2026 11:44:36:900		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 11:40:20.823	20260128 11:44:36.900	20260128 11:44:36.900	98	335	335	30	186	713	713
354	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Mini-Mental State Examination	0/0/N		Was the collection date the same as the visit date?	Auto	18655621	Closed	systemuser	28 Jan 2026 11:40:20:803	systemuser	28 Jan 2026 11:44:36:900	systemuser	28 Jan 2026 11:44:36:900		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 11:40:20.803	20260128 11:44:36.900	20260128 11:44:36.900	98	335	335	30	186	713	713
355	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Neurologic Examination	0/0/N		Date of Assessment	Auto	19111043	Closed	systemuser	23 Feb 2026 07:47:55:310	systemuser	23 Feb 2026 07:49:10:937	systemuser	23 Feb 2026 07:49:10:937		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:47:55.310	20260223 07:49:10.937	20260223 07:49:10.937	98	335	335	30	186	713	713
356	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	19110929	Closed	systemuser	23 Feb 2026 07:37:44:573	systemuser	23 Feb 2026 07:38:02:840	systemuser	23 Feb 2026 07:38:02:840		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:37:44.573	20260223 07:38:02.840	20260223 07:38:02.840	98	335	335	30	186	713	713
357	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	SIGH-D-17	0/0/N		Collection Date	Auto	18703176	Closed	systemuser	30 Jan 2026 15:57:22:960	systemuser	30 Jan 2026 15:57:44:787	systemuser	30 Jan 2026 15:57:44:790		0	0	If Yes, was the collection date the same as the visit date? Is entered as "No". However the Collection date entered is same as the Date of visit. Please correct.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260130 15:57:22.960	20260130 15:57:44.787	20260130 15:57:44.790	98	335	335	30	186	713	713
358	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	18654047	Closed	systemuser	28 Jan 2026 10:24:37:333	systemuser	28 Jan 2026 10:25:24:680	systemuser	28 Jan 2026 10:25:24:683		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:24:37.333	20260128 10:25:24.680	20260128 10:25:24.683	98	335	335	30	186	713	713
359	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	18654076	Closed	systemuser	28 Jan 2026 10:25:25:290	systemuser	28 Jan 2026 10:25:50:847	systemuser	28 Jan 2026 10:25:50:850		0	0	The 'Diastolic Blood Pressure' is not within the range of '50' to '90'. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:25:25.290	20260128 10:25:50.847	20260128 10:25:50.850	98	335	335	30	186	713	713
360	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Pulse	Auto	18654045	Closed	systemuser	28 Jan 2026 10:24:37:313	systemuser	28 Jan 2026 10:25:24:730	systemuser	28 Jan 2026 10:25:24:730		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:24:37.313	20260128 10:25:24.730	20260128 10:25:24.730	98	335	335	30	186	713	713
361	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	18654046	Closed	systemuser	28 Jan 2026 10:24:37:323	systemuser	28 Jan 2026 10:25:24:750	systemuser	28 Jan 2026 10:25:24:750		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:24:37.323	20260128 10:25:24.750	20260128 10:25:24.750	98	335	335	30	186	713	713
362	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Temperature	Auto	18654044	Closed	systemuser	28 Jan 2026 10:24:37:300	systemuser	28 Jan 2026 10:25:24:750	systemuser	28 Jan 2026 10:25:24:750		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260128 10:24:37.300	20260128 10:25:24.750	20260128 10:25:24.750	98	335	335	30	186	713	713
363	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 2 (1)	CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS	0/0/N	2	Reason not done	Auto	19111069	Closed	systemuser	23 Feb 2026 07:50:15:153	systemuser	23 Feb 2026 07:50:51:857	systemuser	23 Feb 2026 07:50:51:860		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:50:15.153	20260223 07:50:51.857	20260223 07:50:51.860	98	335	335	30	186	713	713
364	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Screening Visit 2 (1)	CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS	0/0/N	2	Assessment Completed?	Auto	19111068	Closed	systemuser	23 Feb 2026 07:50:08:937	systemuser	23 Feb 2026 07:50:15:120	systemuser	23 Feb 2026 07:50:15:123		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:50:08.937	20260223 07:50:15.120	20260223 07:50:15.123	98	335	335	30	186	713	713
365	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/N	1	Start Date	Auto	19095586	Closed	systemuser	20 Feb 2026 11:11:16:217			systemuser	23 Feb 2026 08:35:56:117			3	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 11:11:16.217		20260223 08:35:56.117	98	335	335	30	186	713	713
366	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/N	1	Start Date	Auto	19866145	Closed	systemuser	08 Apr 2026 10:35:41:853			systemuser	20 Apr 2026 11:15:17:657			12	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:35:41.853		20260420 11:15:17.657	98	335	335	30	186	713	713
367	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Arizona Sexual Experiences Scale-Female	0/0/N		1. How strong is your sex drive?	Auto	19111322	Closed	systemuser	23 Feb 2026 08:09:35:117	systemuser	23 Feb 2026 08:10:01:447	systemuser	23 Feb 2026 08:10:01:447		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:09:35.117	20260223 08:10:01.447	20260223 08:10:01.447	98	335	335	30	186	713	713
368	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Arizona Sexual Experiences Scale-Female	0/0/N		2. How easily are you sexually aroused (turned on)?	Auto	19111323	Closed	systemuser	23 Feb 2026 08:09:35:123	systemuser	23 Feb 2026 08:10:01:447	systemuser	23 Feb 2026 08:10:01:447		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:09:35.123	20260223 08:10:01.447	20260223 08:10:01.447	98	335	335	30	186	713	713
369	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Arizona Sexual Experiences Scale-Female	0/0/N		3. How easily does your vagina become moist or wet during sex?	Auto	19111324	Closed	systemuser	23 Feb 2026 08:09:35:130	systemuser	23 Feb 2026 08:10:01:447	systemuser	23 Feb 2026 08:10:01:447		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:09:35.130	20260223 08:10:01.447	20260223 08:10:01.447	98	335	335	30	186	713	713
370	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Arizona Sexual Experiences Scale-Female	0/0/N		4. How easily can you reach an orgasm?	Auto	19111325	Closed	systemuser	23 Feb 2026 08:09:35:137	systemuser	23 Feb 2026 08:10:01:447	systemuser	23 Feb 2026 08:10:01:447		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:09:35.137	20260223 08:10:01.447	20260223 08:10:01.447	98	335	335	30	186	713	713
371	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Arizona Sexual Experiences Scale-Female	0/0/N		5. Are your orgasms satisfying?	Auto	19111326	Closed	systemuser	23 Feb 2026 08:09:35:143	systemuser	23 Feb 2026 08:10:01:450	systemuser	23 Feb 2026 08:10:01:450		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:09:35.143	20260223 08:10:01.450	20260223 08:10:01.450	98	335	335	30	186	713	713
372	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Arizona Sexual Experiences Scale-Female	0/0/N		Was the collection date the same as the visit date?	Auto	19111321	Closed	systemuser	23 Feb 2026 08:09:35:103	systemuser	23 Feb 2026 08:10:01:450	systemuser	23 Feb 2026 08:10:01:450		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:09:35.103	20260223 08:10:01.450	20260223 08:10:01.450	98	335	335	30	186	713	713
373	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Suicidal Ideation1. Wish to be Dead	Auto	19111468	Closed	systemuser	23 Feb 2026 08:15:37:320	systemuser	23 Feb 2026 08:16:43:813	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.320	20260223 08:16:43.813	20260223 08:16:43.817	98	335	335	30	186	713	713
374	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		2. Non-Specific Active Suicidal Thoughts	Auto	19111469	Closed	systemuser	23 Feb 2026 08:15:37:327	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.327	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
375	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Suicidal BehaviorActual Attempt	Auto	19111470	Closed	systemuser	23 Feb 2026 08:15:37:350	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.350	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
376	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Has subject engaged in Non-Suicidal Self-Injurious Behavior?	Auto	19111471	Closed	systemuser	23 Feb 2026 08:15:37:357	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.357	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
377	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Interrupted Attempt	Auto	19111472	Closed	systemuser	23 Feb 2026 08:15:37:360	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.360	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
378	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Aborted Attempt	Auto	19111473	Closed	systemuser	23 Feb 2026 08:15:37:370	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.370	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
379	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Preparatory Acts or Behavior	Auto	19111474	Closed	systemuser	23 Feb 2026 08:15:37:373	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.373	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
380	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Suicidal Behavior	Auto	19111475	Closed	systemuser	23 Feb 2026 08:15:37:380	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.380	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
381	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Suicide	Auto	19111476	Closed	systemuser	23 Feb 2026 08:15:37:390	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.390	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
382	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Rater's Initials	Auto	19111467	Closed	systemuser	23 Feb 2026 08:15:37:317	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.317	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
383	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Was the collection date the same as the visit date?	Auto	19111466	Closed	systemuser	23 Feb 2026 08:15:37:310	systemuser	23 Feb 2026 08:16:43:817	systemuser	23 Feb 2026 08:16:43:817		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:15:37.310	20260223 08:16:43.817	20260223 08:16:43.817	98	335	335	30	186	713	713
384	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Neurologic Examination	0/0/N		Date of Assessment	Auto	19111541	Closed	systemuser	23 Feb 2026 08:21:18:697	systemuser	23 Feb 2026 08:21:42:297	systemuser	23 Feb 2026 08:21:42:300		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:21:18.697	20260223 08:21:42.297	20260223 08:21:42.300	98	335	335	30	186	713	713
385	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Patient Global Impression of Severity - Insomnia	0/0/N		Thinking about the past 7 days, please choose the response below that best describes the problem of not feeling rested the next day.	Auto	19111292	Closed	systemuser	23 Feb 2026 08:08:27:373	systemuser	23 Feb 2026 08:08:41:683	systemuser	23 Feb 2026 08:08:41:687		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:08:27.373	20260223 08:08:41.683	20260223 08:08:41.687	98	335	335	30	186	713	713
386	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Patient Global Impression of Severity - Insomnia	0/0/N		In the past 7 days, how would you describe your difficulty falling asleep or staying asleep? Select one response.	Auto	19111291	Closed	systemuser	23 Feb 2026 08:08:27:370	systemuser	23 Feb 2026 08:08:41:687	systemuser	23 Feb 2026 08:08:41:687		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:08:27.370	20260223 08:08:41.687	20260223 08:08:41.687	98	335	335	30	186	713	713
387	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Patient Global Impression of Severity - Insomnia	0/0/N		In the past 7 days, how would you describe your sleep problems?	Auto	19111293	Closed	systemuser	23 Feb 2026 08:08:27:380	systemuser	23 Feb 2026 08:08:41:687	systemuser	23 Feb 2026 08:08:41:687		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:08:27.380	20260223 08:08:41.687	20260223 08:08:41.687	98	335	335	30	186	713	713
388	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Patient Global Impression of Severity - Insomnia	0/0/N		If Yes, was the collection date the same as the visit date?	Auto	19111290	Closed	systemuser	23 Feb 2026 08:08:27:360	systemuser	23 Feb 2026 08:08:41:687	systemuser	23 Feb 2026 08:08:41:687		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:08:27.360	20260223 08:08:41.687	20260223 08:08:41.687	98	335	335	30	186	713	713
389	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	19111238	Closed	systemuser	23 Feb 2026 08:05:32:270	systemuser	23 Feb 2026 08:05:41:303	systemuser	23 Feb 2026 08:05:41:307		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 08:05:32.270	20260223 08:05:41.303	20260223 08:05:41.307	98	335	335	30	186	713	713
390	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		1. Reported Sadness	Auto	19095216	Closed	systemuser	20 Feb 2026 10:42:08:240	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.240	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
391	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		2. Apparent Sadness	Auto	19095217	Closed	systemuser	20 Feb 2026 10:42:08:243	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.243	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
392	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		3. Inner Tension	Auto	19095218	Closed	systemuser	20 Feb 2026 10:42:08:250	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.250	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
393	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		4. Reduced Sleep	Auto	19095219	Closed	systemuser	20 Feb 2026 10:42:08:257	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.257	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
394	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		5. Reduced Appetite	Auto	19095220	Closed	systemuser	20 Feb 2026 10:42:08:260	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.260	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
395	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		6. Concentration Difficulties	Auto	19095221	Closed	systemuser	20 Feb 2026 10:42:08:267	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.267	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
396	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		7. Lassitude	Auto	19095222	Closed	systemuser	20 Feb 2026 10:42:08:270	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.270	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
397	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		8. Inability to Feel	Auto	19095223	Closed	systemuser	20 Feb 2026 10:42:08:277	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.277	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
398	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		9. Pessimistic Thoughts	Auto	19095224	Closed	systemuser	20 Feb 2026 10:42:08:280	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.280	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
399	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		10. Suicidal Thoughts	Auto	19095225	Closed	systemuser	20 Feb 2026 10:42:08:287	systemuser	20 Feb 2026 10:43:16:473	systemuser	20 Feb 2026 10:43:16:473		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.287	20260220 10:43:16.473	20260220 10:43:16.473	98	335	335	30	186	713	713
400	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		TOTAL MADRS SCALE SCORE	Auto	19095226	Closed	systemuser	20 Feb 2026 10:42:08:290	systemuser	20 Feb 2026 10:43:16:730	systemuser	20 Feb 2026 10:43:16:730		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.290	20260220 10:43:16.730	20260220 10:43:16.730	98	335	335	30	186	713	713
401	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		Rater's Initials	Auto	19095215	Closed	systemuser	20 Feb 2026 10:42:08:233	systemuser	20 Feb 2026 10:43:16:490	systemuser	20 Feb 2026 10:43:16:490		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.233	20260220 10:43:16.490	20260220 10:43:16.490	98	335	335	30	186	713	713
402	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		Was the collection date the same as the visit date?	Auto	19095214	Closed	systemuser	20 Feb 2026 10:42:08:223	systemuser	20 Feb 2026 10:43:16:490	systemuser	20 Feb 2026 10:43:16:490		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260220 10:42:08.223	20260220 10:43:16.490	20260220 10:43:16.490	98	335	335	30	186	713	713
403	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Body Mass Index	Auto	19111129	Closed	systemuser	23 Feb 2026 07:59:15:197	systemuser	23 Feb 2026 08:00:50:210	systemuser	23 Feb 2026 08:00:50:210		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:59:15.197	20260223 08:00:50.210	20260223 08:00:50.210	98	335	335	30	186	713	713
404	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	19111133	Closed	systemuser	23 Feb 2026 07:59:15:220	systemuser	23 Feb 2026 08:04:09:543	systemuser	23 Feb 2026 08:04:09:543		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:59:15.220	20260223 08:04:09.543	20260223 08:04:09.543	98	335	335	30	186	713	713
405	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Pulse	Auto	19111131	Closed	systemuser	23 Feb 2026 07:59:15:210	systemuser	23 Feb 2026 08:04:09:553	systemuser	23 Feb 2026 08:04:09:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:59:15.210	20260223 08:04:09.553	20260223 08:04:09.553	98	335	335	30	186	713	713
406	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	19111132	Closed	systemuser	23 Feb 2026 07:59:15:217	systemuser	23 Feb 2026 08:04:09:557	systemuser	23 Feb 2026 08:04:09:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:59:15.217	20260223 08:04:09.557	20260223 08:04:09.557	98	335	335	30	186	713	713
407	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	19111127	Closed	systemuser	23 Feb 2026 07:59:15:183	systemuser	23 Feb 2026 08:00:50:213	systemuser	23 Feb 2026 08:00:50:213		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:59:15.183	20260223 08:00:50.213	20260223 08:00:50.213	98	335	335	30	186	713	713
408	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Temperature	Auto	19111130	Closed	systemuser	23 Feb 2026 07:59:15:203	systemuser	23 Feb 2026 08:04:09:560	systemuser	23 Feb 2026 08:04:09:560		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:59:15.203	20260223 08:04:09.560	20260223 08:04:09.560	98	335	335	30	186	713	713
409	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Weight	Auto	19111128	Closed	systemuser	23 Feb 2026 07:59:15:193	systemuser	23 Feb 2026 08:00:50:213	systemuser	23 Feb 2026 08:00:50:213		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260223 07:59:15.193	20260223 08:00:50.213	20260223 08:00:50.213	98	335	335	30	186	713	713
410	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 7 Part 1 (1)	Date of Visit	0/0/N		Did this visit occur?	DM	19826791	Closed	Juhita@ksha4	03 Apr 2026 16:29:36:310	BrezVe1	20 Apr 2026 11:17:23:113	Juhita@ksha4	22 Apr 2026 08:47:01:863		17	2	DM: Please verify and updated the visit 8 part 1.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260403 16:29:36.310	20260420 11:17:23.113	20260422 08:47:01.863	98	335	335	30	186	713	713
411	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 7 Part 1 (1)	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	19758826	Closed	systemuser	30 Mar 2026 12:30:07:610	systemuser	30 Mar 2026 12:32:35:927	systemuser	30 Mar 2026 12:32:35:930		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260330 12:30:07.610	20260330 12:32:35.927	20260330 12:32:35.930	98	335	335	30	186	713	713
412	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 7 Part 1 (1)	Vital Signs	0/0/N		Pulse	Auto	19758823	Closed	systemuser	30 Mar 2026 12:30:07:593	systemuser	30 Mar 2026 12:32:35:937	systemuser	30 Mar 2026 12:32:35:937		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260330 12:30:07.593	20260330 12:32:35.937	20260330 12:32:35.937	98	335	335	30	186	713	713
413	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 7 Part 1 (1)	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	19758824	Closed	systemuser	30 Mar 2026 12:30:07:600	systemuser	30 Mar 2026 12:32:35:943	systemuser	30 Mar 2026 12:32:35:943		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260330 12:30:07.600	20260330 12:32:35.943	20260330 12:32:35.943	98	335	335	30	186	713	713
414	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 7 Part 1 (1)	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	19758820	Closed	systemuser	30 Mar 2026 12:30:07:570	systemuser	30 Mar 2026 12:32:35:943	systemuser	30 Mar 2026 12:32:35:943		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260330 12:30:07.570	20260330 12:32:35.943	20260330 12:32:35.943	98	335	335	30	186	713	713
415	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 7 Part 1 (1)	Vital Signs	0/0/N		Temperature	Auto	19758821	Closed	systemuser	30 Mar 2026 12:30:07:587	systemuser	30 Mar 2026 12:32:35:943	systemuser	30 Mar 2026 12:32:35:943		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260330 12:30:07.587	20260330 12:32:35.943	20260330 12:32:35.943	98	335	335	30	186	713	713
416	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Arizona Sexual Experiences Scale-Female	0/0/N		1. How strong is your sex drive?	Auto	19866306	Closed	systemuser	08 Apr 2026 10:39:35:260	systemuser	08 Apr 2026 10:41:00:107	systemuser	08 Apr 2026 10:41:00:107		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:39:35.260	20260408 10:41:00.107	20260408 10:41:00.107	98	335	335	30	186	713	713
417	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Arizona Sexual Experiences Scale-Female	0/0/N		2. How easily are you sexually aroused (turned on)?	Auto	19866307	Closed	systemuser	08 Apr 2026 10:39:35:270	systemuser	08 Apr 2026 10:41:00:107	systemuser	08 Apr 2026 10:41:00:107		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:39:35.270	20260408 10:41:00.107	20260408 10:41:00.107	98	335	335	30	186	713	713
418	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Arizona Sexual Experiences Scale-Female	0/0/N		3. How easily does your vagina become moist or wet during sex?	Auto	19866308	Closed	systemuser	08 Apr 2026 10:39:35:277	systemuser	08 Apr 2026 10:41:00:107	systemuser	08 Apr 2026 10:41:00:107		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:39:35.277	20260408 10:41:00.107	20260408 10:41:00.107	98	335	335	30	186	713	713
419	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Arizona Sexual Experiences Scale-Female	0/0/N		4. How easily can you reach an orgasm?	Auto	19866309	Closed	systemuser	08 Apr 2026 10:39:35:283	systemuser	08 Apr 2026 10:41:00:110	systemuser	08 Apr 2026 10:41:00:110		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:39:35.283	20260408 10:41:00.110	20260408 10:41:00.110	98	335	335	30	186	713	713
420	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Arizona Sexual Experiences Scale-Female	0/0/N		5. Are your orgasms satisfying?	Auto	19866310	Closed	systemuser	08 Apr 2026 10:39:35:293	systemuser	08 Apr 2026 10:41:00:110	systemuser	08 Apr 2026 10:41:00:110		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:39:35.293	20260408 10:41:00.110	20260408 10:41:00.110	98	335	335	30	186	713	713
421	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Arizona Sexual Experiences Scale-Female	0/0/N		Was the collection date the same as the visit date?	Auto	19866305	Closed	systemuser	08 Apr 2026 10:39:35:247	systemuser	08 Apr 2026 10:41:00:110	systemuser	08 Apr 2026 10:41:00:110		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:39:35.247	20260408 10:41:00.110	20260408 10:41:00.110	98	335	335	30	186	713	713
422	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	EQ-5D-5L	0/0/N		Mobility	Auto	19888919	Closed	systemuser	09 Apr 2026 10:43:01:103	systemuser	09 Apr 2026 10:44:05:370	systemuser	09 Apr 2026 10:44:05:370		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:43:01.103	20260409 10:44:05.370	20260409 10:44:05.370	98	335	335	30	186	713	713
423	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	EQ-5D-5L	0/0/N		Self-Care	Auto	19888920	Closed	systemuser	09 Apr 2026 10:43:01:113	systemuser	09 Apr 2026 10:44:05:370	systemuser	09 Apr 2026 10:44:05:370		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:43:01.113	20260409 10:44:05.370	20260409 10:44:05.370	98	335	335	30	186	713	713
424	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	EQ-5D-5L	0/0/N		Usual Activities	Auto	19888921	Closed	systemuser	09 Apr 2026 10:43:01:120	systemuser	09 Apr 2026 10:44:05:370	systemuser	09 Apr 2026 10:44:05:370		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:43:01.120	20260409 10:44:05.370	20260409 10:44:05.370	98	335	335	30	186	713	713
425	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	EQ-5D-5L	0/0/N		Pain/Discomfort	Auto	19888922	Closed	systemuser	09 Apr 2026 10:43:01:127	systemuser	09 Apr 2026 10:44:05:370	systemuser	09 Apr 2026 10:44:05:370		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:43:01.127	20260409 10:44:05.370	20260409 10:44:05.370	98	335	335	30	186	713	713
426	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	EQ-5D-5L	0/0/N		Anxiety/Depression	Auto	19888923	Closed	systemuser	09 Apr 2026 10:43:01:133	systemuser	09 Apr 2026 10:44:05:370	systemuser	09 Apr 2026 10:44:05:370		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:43:01.133	20260409 10:44:05.370	20260409 10:44:05.370	98	335	335	30	186	713	713
427	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	EQ-5D-5L	0/0/N		Your health today	Auto	19888924	Closed	systemuser	09 Apr 2026 10:43:01:140	systemuser	09 Apr 2026 10:44:05:370	systemuser	09 Apr 2026 10:44:05:370		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:43:01.140	20260409 10:44:05.370	20260409 10:44:05.370	98	335	335	30	186	713	713
428	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	EQ-5D-5L	0/0/N		Was the collection date the same as the visit date?	Auto	19888918	Closed	systemuser	09 Apr 2026 10:43:01:090	systemuser	09 Apr 2026 10:44:05:370	systemuser	09 Apr 2026 10:44:05:370		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:43:01.090	20260409 10:44:05.370	20260409 10:44:05.370	98	335	335	30	186	713	713
429	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Neurologic Examination	0/0/N		Date of Assessment	Auto	19889091	Closed	systemuser	09 Apr 2026 10:50:52:147	systemuser	20 Apr 2026 11:16:28:840	systemuser	20 Apr 2026 11:16:28:843		11	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:50:52.147	20260420 11:16:28.840	20260420 11:16:28.843	98	335	335	30	186	713	713
430	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Patient Global Impression of Severity - Insomnia	0/0/N		Thinking about the past 7 days, please choose the response below that best describes the problem of not feeling rested the next day.	Auto	19888942	Closed	systemuser	09 Apr 2026 10:45:16:040	systemuser	09 Apr 2026 10:46:10:640	systemuser	09 Apr 2026 10:46:10:643		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:45:16.040	20260409 10:46:10.640	20260409 10:46:10.643	98	335	335	30	186	713	713
431	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Patient Global Impression of Severity - Insomnia	0/0/N		In the past 7 days, how would you describe your difficulty falling asleep or staying asleep? Select one response.	Auto	19888941	Closed	systemuser	09 Apr 2026 10:45:16:030	systemuser	09 Apr 2026 10:46:10:643	systemuser	09 Apr 2026 10:46:10:643		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:45:16.030	20260409 10:46:10.643	20260409 10:46:10.643	98	335	335	30	186	713	713
432	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Patient Global Impression of Severity - Insomnia	0/0/N		In the past 7 days, how would you describe your sleep problems?	Auto	19888943	Closed	systemuser	09 Apr 2026 10:45:16:047	systemuser	09 Apr 2026 10:46:10:643	systemuser	09 Apr 2026 10:46:10:643		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:45:16.047	20260409 10:46:10.643	20260409 10:46:10.643	98	335	335	30	186	713	713
433	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Patient Global Impression of Severity - Insomnia	0/0/N		If Yes, was the collection date the same as the visit date?	Auto	19888940	Closed	systemuser	09 Apr 2026 10:45:16:020	systemuser	09 Apr 2026 10:46:10:643	systemuser	09 Apr 2026 10:46:10:643		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:45:16.020	20260409 10:46:10.643	20260409 10:46:10.643	98	335	335	30	186	713	713
434	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	19866258	Closed	systemuser	08 Apr 2026 10:38:23:520	systemuser	08 Apr 2026 10:38:33:053	systemuser	08 Apr 2026 10:38:33:057		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:38:23.520	20260408 10:38:33.053	20260408 10:38:33.057	98	335	335	30	186	713	713
435	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		1. Loss of appetite	Auto	19889270	Closed	systemuser	09 Apr 2026 10:53:38:547	systemuser	09 Apr 2026 10:54:51:480	systemuser	09 Apr 2026 10:54:51:480		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.547	20260409 10:54:51.480	20260409 10:54:51.480	98	335	335	30	186	713	713
436	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		2. Nausea - Vomiting	Auto	19889271	Closed	systemuser	09 Apr 2026 10:53:38:557	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.557	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
437	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		3. Diarrhea	Auto	19889272	Closed	systemuser	09 Apr 2026 10:53:38:567	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.567	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
438	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		4. Anxiety, Nervousness	Auto	19889273	Closed	systemuser	09 Apr 2026 10:53:38:573	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.573	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
439	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		5. Irritability	Auto	19889274	Closed	systemuser	09 Apr 2026 10:53:38:583	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.583	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
440	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		6. Dysphoric Mood, Depression	Auto	19889275	Closed	systemuser	09 Apr 2026 10:53:38:590	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.590	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
441	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		7. Insomnia	Auto	19889276	Closed	systemuser	09 Apr 2026 10:53:38:600	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.600	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
442	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		8. Fatigue, Lethargy Lack of energy	Auto	19889277	Closed	systemuser	09 Apr 2026 10:53:38:610	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.610	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
443	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		9. Poor Coordination	Auto	19889278	Closed	systemuser	09 Apr 2026 10:53:38:617	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.617	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
444	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		10. Restlessness, Agitation	Auto	19889279	Closed	systemuser	09 Apr 2026 10:53:38:627	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.627	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
445	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		11. Diaphoresis	Auto	19889280	Closed	systemuser	09 Apr 2026 10:53:38:633	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.633	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
446	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		12. Tremor - Tremulousness	Auto	19889281	Closed	systemuser	09 Apr 2026 10:53:38:640	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.640	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
447	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		13. Dizziness - Lightheadedness	Auto	19889282	Closed	systemuser	09 Apr 2026 10:53:38:650	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.650	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
448	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		14. Headaches	Auto	19889283	Closed	systemuser	09 Apr 2026 10:53:38:657	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.657	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
449	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		15. Muscle Aches or Stiffness	Auto	19889284	Closed	systemuser	09 Apr 2026 10:53:38:663	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.663	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
450	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		16. Weakness	Auto	19889285	Closed	systemuser	09 Apr 2026 10:53:38:673	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.673	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
451	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		17. Increased acuity for sound, smell, touch or pain	Auto	19889286	Closed	systemuser	09 Apr 2026 10:53:38:680	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.680	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
452	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		18. Paresthesias	Auto	19889287	Closed	systemuser	09 Apr 2026 10:53:38:683	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.683	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
453	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		19. Difficulty concentrating, remembering	Auto	19889288	Closed	systemuser	09 Apr 2026 10:53:38:690	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.690	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
454	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		20. Depersonalization, Derealization	Auto	19889289	Closed	systemuser	09 Apr 2026 10:53:38:700	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.700	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
455	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040005	Enrolled	Visit 8 Part 1 (1)	Physician Withdrawal Checklist (PWC)	0/0/N		Was the collection date the same as the visit date?	Auto	19889269	Closed	systemuser	09 Apr 2026 10:53:38:533	systemuser	09 Apr 2026 10:54:51:483	systemuser	09 Apr 2026 10:54:51:483		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 10:53:38.533	20260409 10:54:51.483	20260409 10:54:51.483	98	335	335	30	186	713	713
456	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?	Auto	18724963	Closed	systemuser	02 Feb 2026 15:30:16:610	systemuser	02 Feb 2026 15:30:57:317	systemuser	02 Feb 2026 15:30:57:320		0	0	Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 15:30:16.610	20260202 15:30:57.317	20260202 15:30:57.320	98	335	335	16	186	713	713
457	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	5	Dose Form	DM	19831711	Closed	Juhita@ksha4	06 Apr 2026 07:45:28:657	BrezVe1	20 Apr 2026 11:29:26:733	Juhita@ksha4	22 Apr 2026 08:20:01:520		14	2	Medical Review I-3115960: Kindly update dose form to implant	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260406 07:45:28.657	20260420 11:29:26.733	20260422 08:20:01.520	98	335	335	16	186	713	713
458	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933410	Closed	systemuser	20 May 2026 12:11:52:903			systemuser	20 May 2026 12:12:07:250			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 12:11:52.903		20260520 12:12:07.250	98	335	335	16	186	713	713
459	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	1	Ongoing	Site from Medical Reviewer	19780205	Closed	ewajs1	31 Mar 2026 14:58:18:067	BrezVe1	01 Apr 2026 08:17:44:593	ewajs1	22 Apr 2026 09:49:46:110		1	21	Did the participant had menstrual period after January?	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260331 14:58:18.067	20260401 08:17:44.593	20260422 09:49:46.110	98	335	335	16	186	713	713
460	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	1	Ongoing	Site from Medical Reviewer	19780237	Closed	ewajs1	31 Mar 2026 14:58:49:267	BrezVe1	01 Apr 2026 08:18:06:720	ewajs1	22 Apr 2026 09:49:49:640		1	21	Did the participant menstruated regularly prior to the study even if they had a hormonal IUD?	regular	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260331 14:58:49.267	20260401 08:18:06.720	20260422 09:49:49.640	98	335	335	16	186	713	713
461	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	19910694	Closed	systemuser	10 Apr 2026 11:11:31:410			systemuser	20 Apr 2026 11:38:19:350			10	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260410 11:11:31.410		20260420 11:38:19.350	98	335	335	16	186	713	713
462	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	19523574	Closed	Ashwini201	16 Mar 2026 08:23:15:543	BrezVe1	23 Mar 2026 13:24:51:430	Ashwini201	25 Mar 2026 08:23:19:487		7	2	DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 08:23:15.543	20260323 13:24:51.430	20260325 08:23:19.487	98	335	335	16	186	713	713
463	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 1	General Medical History	0/0/N	2	What is the verbatim term for the medical history condition/event?	DM	18899111	Closed	CoderImport	12 Feb 2026 06:28:18:150	BrezVe1	16 Feb 2026 12:32:13:037	systemuser	16 Feb 2026 12:32:13:243		4	0	CODING: The verbatim "APPENDECTOMIA" in the verbatim term "APPENDECTOMIA FOR APPENDICITIS" is not reported in English. Please translate it in English and update the Medical history name field accordingly.Thank you.	will be done but please unfreeze lgline 5 for data entry	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260212 06:28:18.150	20260216 12:32:13.037	20260216 12:32:13.243	98	335	335	16	186	713	713
464	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 1	General Medical History	0/0/N	3	What is the verbatim term for the medical history condition/event?	DM	18789150	Closed	CoderImport	05 Feb 2026 13:57:27:370	BrezVe1	09 Feb 2026 08:41:25:993	systemuser	09 Feb 2026 08:41:26:107		4	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. CYSTS ON THE LEFT OVARY and 2. UNILATERAL OOPHORECTOMY . Thank you.	please unfreeze logline 5 to enter the procedure	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260205 13:57:27.370	20260209 08:41:25.993	20260209 08:41:26.107	98	335	335	16	186	713	713
465	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 1	General Medical History	0/0/N	3	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	18804188	Closed	Rajani_S_N1	06 Feb 2026 09:12:57:993	BrezVe1	09 Feb 2026 08:41:43:683	Rajani_S_N1	09 Feb 2026 11:08:45:110		3	0	Eliibility: Kindly mention the etiology and clarify if malignant	not specified as malignant	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260206 09:12:57.993	20260209 08:41:43.683	20260209 11:08:45.110	98	335	335	16	186	713	713
466	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 1	Menstrual Cycle Tracking	0/0/N	1	If 'Estrogen/Gestagen', 'Hormonal IUD', or 'Non-hormonal IUD', choose the corresponding CM log line, start date, and term	Auto	18724469	Closed	systemuser	02 Feb 2026 15:06:41:680	systemuser	02 Feb 2026 15:40:34:157	systemuser	02 Feb 2026 15:40:34:157		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 15:06:41.680	20260202 15:40:34.157	20260202 15:40:34.157	98	335	335	16	186	713	713
467	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 1	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	18724356	Closed	systemuser	02 Feb 2026 15:00:08:523	systemuser	02 Feb 2026 15:00:25:190	systemuser	02 Feb 2026 15:00:25:197		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 15:00:08.523	20260202 15:00:25.190	20260202 15:00:25.197	98	335	335	16	186	713	713
468	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 2 (1)	CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS	0/0/N	1	Assessment Completed?	DM	19449854	Closed	Juhita@ksha4	10 Mar 2026 16:06:26:983	gnovotna@email.cz2	20 Mar 2026 11:37:45:100	Juhita@ksha4	20 Mar 2026 14:12:01:263		10	0	ECOA: Please verify and update the data for the field "Assessment Completed?"	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260310 16:06:26.983	20260320 11:37:45.100	20260320 14:12:01.263	98	335	335	16	186	713	713
469	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 2 (1)	CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS	0/0/N	2	Reason not done	Auto	19619883	Closed	systemuser	20 Mar 2026 11:38:02:817	systemuser	20 Mar 2026 11:39:25:677	systemuser	20 Mar 2026 11:39:25:677		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260320 11:38:02.817	20260320 11:39:25.677	20260320 11:39:25.677	98	335	335	16	186	713	713
470	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Screening Visit 2 (1)	Date of Visit	0/0/N		Did this visit occur?	DM	19501289	Closed	Ashwini201	13 Mar 2026 07:34:17:357	gnovotna@email.cz2	20 Mar 2026 11:41:06:517	shyamaprasad972	23 Mar 2026 08:47:54:080		7	3	DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260313 07:34:17.357	20260320 11:41:06.517	20260323 08:47:54.080	98	335	335	16	186	713	713
471	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	End Date	DM	20108885	Closed	Juhita@ksha4	22 Apr 2026 10:26:11:037	BrezVe1	22 Apr 2026 12:44:05:667	Juhita@ksha4	24 Apr 2026 08:54:53:213		0	2	Medical Review I-5159256: Please provide end date.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260422 10:26:11.037	20260422 12:44:05.667	20260424 08:54:53.213	98	335	335	16	186	713	713
472	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	Start Date	Auto	19214180	Closed	systemuser	27 Feb 2026 12:30:12:993			systemuser	09 Mar 2026 10:21:03:117			10	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260227 12:30:12.993		20260309 10:21:03.117	98	335	335	16	186	713	713
473	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	Start Date	Auto	19910693	Closed	systemuser	10 Apr 2026 11:11:31:393			systemuser	20 Apr 2026 11:19:18:147			10	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260410 11:11:31.393		20260420 11:19:18.147	98	335	335	16	186	713	713
474	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Visit 1.5 Induction (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	20632994	Closed	systemuser	06 May 2026 06:20:15:500	systemuser	06 May 2026 06:20:19:740	systemuser	06 May 2026 06:20:19:747		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260506 06:20:15.500	20260506 06:20:19.740	20260506 06:20:19.747	98	335	335	16	186	713	713
475	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Visit 3 Part 1 Baseline	Date of Visit	0/0/N		Did this visit occur?	DM	20050987	Closed	SanchariDutta@025	20 Apr 2026 06:37:50:523	BrezVe1	20 Apr 2026 11:28:45:643	SanchariDutta@025	06 May 2026 12:50:15:523		0	16	ECG: Please verify if the ECG was collected at Visit 3 Part 1 Baseline and sent to vendor, else clarify.	ecg sent	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260420 06:37:50.523	20260420 11:28:45.643	20260506 12:50:15.523	98	335	335	16	186	713	713
476	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Visit 3 Part 1 Baseline	Date of Visit	0/0/N		Did this visit occur?	DM	20742599	Closed	SanchariDutta@025	11 May 2026 07:54:04:230	BrezVe1	11 May 2026 08:52:31:163	SanchariDutta@025	12 May 2026 06:12:15:143		0	1	RQ-ECG1: In vendor file ECG collected for Visit 3 Part 1 Baseline (DOUBLE-BLIND DAY 1) is recorded with the date 25-Mar-2026. Kindly check and confirm the correct collection date and time along with provide the transmittal number in query response.	ECG under unscheduled, transmittal number is 153775953, DCF will be done in ERT Clario	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260511 07:54:04.230	20260511 08:52:31.163	20260512 06:12:15.143	98	335	335	16	186	713	713
477	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Visit 8 Part 1 (1)	Date of Visit	0/1/N		Did this visit occur?	DM	20915933	Answered	shyamaprasad972	19 May 2026 12:47:10:123	EHerman2	20 May 2026 12:02:23:567			2	1		Medical Review I-12758914: Kindly provide the clinical significance of high triglyceride as there is reported hypercholesterolemia in MH page. Kindly clarify if there is any worsening of existing MH.	not clinically significant	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260519 12:47:10.123	20260520 12:02:23.567		98	335	335	16	186	713	713
478	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040006	Enrolled	Visit 8 Part 1 (1)	Patient Global Impression of Change - Depression/Insomnia	0/0/N		Compared to when you started this study, how would you describe your sleep problems?	Auto	19937298	Closed	systemuser	13 Apr 2026 10:47:26:567	systemuser	20 Apr 2026 07:36:03:707	systemuser	20 Apr 2026 07:36:03:710		7	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260413 10:47:26.567	20260420 07:36:03.707	20260420 07:36:03.710	98	335	335	16	186	713	713
479	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933431	Closed	systemuser	20 May 2026 12:12:32:870			systemuser	20 May 2026 12:16:26:923			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 12:12:32.870		20260520 12:16:26.923	98	335	335	13	186	713	713
480	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	20607114	Closed	systemuser	05 May 2026 07:18:17:060			systemuser	06 May 2026 07:33:47:347			1	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260505 07:18:17.060		20260506 07:33:47.347	98	335	335	13	186	713	713
481	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	Site from Medical Reviewer	19433992	Closed	kavya@1510	10 Mar 2026 04:02:05:080	gnovotna@email.cz2	19 Mar 2026 13:14:29:967	kavya@1510	20 Mar 2026 05:38:11:860		9	1	Eligibility: Kindly update the AE page with appropriate details.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260310 04:02:05.080	20260319 13:14:29.967	20260320 05:38:11.860	98	335	335	13	186	713	713
482	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Screening Visit 1	General Medical History	0/0/N	1	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	19470782	Closed	kavya@1510	11 Mar 2026 15:08:54:607	gnovotna@email.cz2	19 Mar 2026 13:17:00:517	kavya@1510	20 Mar 2026 05:35:52:383		8	1	Eligibility: Kindly confirm if there is any plan for revision surgery and if participant is on any medication for this condition.	There is no plan for revision surgery and the participant is not taking any medications for this condition.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260311 15:08:54.607	20260319 13:17:00.517	20260320 05:35:52.383	98	335	335	13	186	713	713
483	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Screening Visit 1	General Medical History	0/0/N	1	What is the verbatim term for the medical history condition/event?	DM	20424991	Closed	Juhita@ksha4	27 Apr 2026 06:33:14:383	BrezVe1	27 Apr 2026 08:33:59:727	Juhita@ksha4	27 Apr 2026 13:05:15:177		0	0	Medical Review I-7088767: Kindly mention the indication for surgical procedure in a separate log line.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 06:33:14.383	20260427 08:33:59.727	20260427 13:05:15.177	98	335	335	13	186	713	713
484	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Screening Visit 1	General Medical History	0/0/N	2	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	19470677	Closed	kavya@1510	11 Mar 2026 14:57:32:933	gnovotna@email.cz2	19 Mar 2026 13:25:18:790	kavya@1510	20 Mar 2026 05:35:36:937		8	1	Eligibility: Kindly clarify the underlying cause for the recorded MH, also confirm clinical stability and functional impact during study period.	These are occasional, mild back pains that require the use of analgesics once every 1 to 2 months. They are most likely caused by age-related arthritic changes. These pains do not have a significant impact on the patient's functioning.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260311 14:57:32.933	20260319 13:25:18.790	20260320 05:35:36.937	98	335	335	13	186	713	713
485	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Screening Visit 1	MGH ATRQ, Geriatric, Section I and II	0/0/N	1	Generic Name	Auto	19240762	Closed	systemuser	02 Mar 2026 18:06:59:180	systemuser	02 Mar 2026 18:09:30:137	systemuser	02 Mar 2026 18:09:30:137		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260302 18:06:59.180	20260302 18:09:30.137	20260302 18:09:30.137	98	335	335	13	186	713	713
486	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Screening Visit 1	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	20115487	Closed	systemuser	22 Apr 2026 12:55:47:927	systemuser	22 Apr 2026 12:55:57:450	systemuser	22 Apr 2026 12:55:57:453		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260422 12:55:47.927	20260422 12:55:57.450	20260422 12:55:57.453	98	335	335	13	186	713	713
487	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Screening Visit 2 (1)	Date of Visit	0/0/N		Did this visit occur?	DM	19882661	Closed	Ashwini201	09 Apr 2026 07:12:20:510	BrezVe1	20 Apr 2026 11:21:04:493	Ashwini201	21 Apr 2026 15:12:26:987		11	1	DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 07:12:20.510	20260420 11:21:04.493	20260421 15:12:26.987	98	335	335	13	186	713	713
488	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/N	1	Start Date	Auto	19688496	Closed	systemuser	25 Mar 2026 07:41:23:090			systemuser	30 Mar 2026 09:19:41:233			5	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:41:23.090		20260330 09:19:41.233	98	335	335	13	186	713	713
489	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/N	1	Start Date	Auto	20607113	Closed	systemuser	05 May 2026 07:18:16:987			systemuser	06 May 2026 07:32:37:037			1	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260505 07:18:16.987		20260506 07:32:37.037	98	335	335	13	186	713	713
490	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Date of Visit	0/0/N		Did this visit occur?	DM	20744202	Closed	SanchariDutta@025	11 May 2026 08:53:37:857	BrezVe1	11 May 2026 10:10:50:913	SanchariDutta@025	12 May 2026 06:13:33:247		0	1	ECG: Please verify if the ECG was collected at Visit 3 Part 1 Baseline and sent to vendor. If collected, kindly provide the transmittal number in query response.	transmittal number is 154868756. DCF will be added to ERT Clario	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260511 08:53:37.857	20260511 10:10:50.913	20260512 06:13:33.247	98	335	335	13	186	713	713
491	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		1. Reported Sadness	Auto	19688384	Closed	systemuser	25 Mar 2026 07:38:29:087	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.087	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
492	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		2. Apparent Sadness	Auto	19688385	Closed	systemuser	25 Mar 2026 07:38:29:093	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.093	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
493	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		3. Inner Tension	Auto	19688386	Closed	systemuser	25 Mar 2026 07:38:29:103	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.103	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
494	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		4. Reduced Sleep	Auto	19688387	Closed	systemuser	25 Mar 2026 07:38:29:110	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.110	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
495	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		5. Reduced Appetite	Auto	19688388	Closed	systemuser	25 Mar 2026 07:38:29:113	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.113	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
496	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		6. Concentration Difficulties	Auto	19688389	Closed	systemuser	25 Mar 2026 07:38:29:120	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.120	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
497	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		7. Lassitude	Auto	19688390	Closed	systemuser	25 Mar 2026 07:38:29:127	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.127	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
498	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		8. Inability to Feel	Auto	19688391	Closed	systemuser	25 Mar 2026 07:38:29:133	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.133	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
499	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		9. Pessimistic Thoughts	Auto	19688392	Closed	systemuser	25 Mar 2026 07:38:29:140	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.140	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
500	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		10. Suicidal Thoughts	Auto	19688393	Closed	systemuser	25 Mar 2026 07:38:29:147	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.147	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
501	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		TOTAL MADRS SCALE SCORE	Auto	19688394	Closed	systemuser	25 Mar 2026 07:38:29:153	systemuser	25 Mar 2026 07:39:42:633	systemuser	25 Mar 2026 07:39:42:633		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.153	20260325 07:39:42.633	20260325 07:39:42.633	98	335	335	13	186	713	713
502	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		Rater's Initials	Auto	19688383	Closed	systemuser	25 Mar 2026 07:38:29:080	systemuser	25 Mar 2026 07:39:42:397	systemuser	25 Mar 2026 07:39:42:397		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.080	20260325 07:39:42.397	20260325 07:39:42.397	98	335	335	13	186	713	713
503	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 3 Part 1 Baseline	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/N		Was the collection date the same as the visit date?	Auto	19688382	Closed	systemuser	25 Mar 2026 07:38:29:073	systemuser	25 Mar 2026 07:39:42:380	systemuser	25 Mar 2026 07:39:42:380		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 07:38:29.073	20260325 07:39:42.380	20260325 07:39:42.380	98	335	335	13	186	713	713
504	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Suicidal Ideation1. Wish to be Dead	Auto	19868675	Closed	systemuser	08 Apr 2026 12:08:33:327	systemuser	08 Apr 2026 12:09:09:760	systemuser	08 Apr 2026 12:09:09:760		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.327	20260408 12:09:09.760	20260408 12:09:09.760	98	335	335	13	186	713	713
505	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		2. Non-Specific Active Suicidal Thoughts	Auto	19868676	Closed	systemuser	08 Apr 2026 12:08:33:337	systemuser	08 Apr 2026 12:09:09:760	systemuser	08 Apr 2026 12:09:09:760		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.337	20260408 12:09:09.760	20260408 12:09:09.760	98	335	335	13	186	713	713
506	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Suicidal BehaviorActual Attempt	Auto	19868677	Closed	systemuser	08 Apr 2026 12:08:33:373	systemuser	08 Apr 2026 12:09:09:777	systemuser	08 Apr 2026 12:09:09:777		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.373	20260408 12:09:09.777	20260408 12:09:09.777	98	335	335	13	186	713	713
507	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Has subject engaged in Non-Suicidal Self-Injurious Behavior?	Auto	19868678	Closed	systemuser	08 Apr 2026 12:08:33:383	systemuser	08 Apr 2026 12:09:09:777	systemuser	08 Apr 2026 12:09:09:777		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.383	20260408 12:09:09.777	20260408 12:09:09.777	98	335	335	13	186	713	713
508	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Interrupted Attempt	Auto	19868679	Closed	systemuser	08 Apr 2026 12:08:33:390	systemuser	08 Apr 2026 12:09:09:780	systemuser	08 Apr 2026 12:09:09:780		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.390	20260408 12:09:09.780	20260408 12:09:09.780	98	335	335	13	186	713	713
509	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Aborted Attempt	Auto	19868680	Closed	systemuser	08 Apr 2026 12:08:33:400	systemuser	08 Apr 2026 12:09:09:780	systemuser	08 Apr 2026 12:09:09:780		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.400	20260408 12:09:09.780	20260408 12:09:09.780	98	335	335	13	186	713	713
510	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Preparatory Acts or Behavior	Auto	19868681	Closed	systemuser	08 Apr 2026 12:08:33:410	systemuser	08 Apr 2026 12:09:09:780	systemuser	08 Apr 2026 12:09:09:780		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.410	20260408 12:09:09.780	20260408 12:09:09.780	98	335	335	13	186	713	713
511	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Suicidal Behavior	Auto	19868682	Closed	systemuser	08 Apr 2026 12:08:33:420	systemuser	08 Apr 2026 12:09:09:780	systemuser	08 Apr 2026 12:09:09:780		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.420	20260408 12:09:09.780	20260408 12:09:09.780	98	335	335	13	186	713	713
512	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Suicide	Auto	19868683	Closed	systemuser	08 Apr 2026 12:08:33:427	systemuser	08 Apr 2026 12:09:09:780	systemuser	08 Apr 2026 12:09:09:780		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.427	20260408 12:09:09.780	20260408 12:09:09.780	98	335	335	13	186	713	713
513	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Rater's Initials	Auto	19868674	Closed	systemuser	08 Apr 2026 12:08:33:320	systemuser	08 Apr 2026 12:09:09:780	systemuser	08 Apr 2026 12:09:09:780		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.320	20260408 12:09:09.780	20260408 12:09:09.780	98	335	335	13	186	713	713
514	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/N		Was the collection date the same as the visit date?	Auto	19868673	Closed	systemuser	08 Apr 2026 12:08:33:310	systemuser	08 Apr 2026 12:09:09:780	systemuser	08 Apr 2026 12:09:09:780		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 12:08:33.310	20260408 12:09:09.780	20260408 12:09:09.780	98	335	335	13	186	713	713
515	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040007	Enrolled	Visit 6 Part 1 (1)	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	19936534	Closed	systemuser	13 Apr 2026 10:08:41:383	systemuser	13 Apr 2026 10:08:56:837	systemuser	13 Apr 2026 10:08:56:840		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260413 10:08:41.383	20260413 10:08:56.837	20260413 10:08:56.840	98	335	335	13	186	713	713
516	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	1	End Date	Auto	20424960	Closed	systemuser	27 Apr 2026 06:32:21:070	systemuser	27 Apr 2026 06:33:01:427	systemuser	27 Apr 2026 06:33:01:450		0	0	If the Adverse Event is reported as 'Ongoing', an end date should not be present. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 06:32:21.070	20260427 06:33:01.427	20260427 06:33:01.450	98	335	335	15	186	713	713
517	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	1	Outcome	DM	20744052	Closed	Ashwini201	11 May 2026 08:46:50:330	BrezVe1	11 May 2026 09:00:58:680	Ashwini201	11 May 2026 12:39:44:350		0	0	DM: End date is updated as 08Apr2026 however outcome reported as Not Recovered or Not Resolved. Please verify and update the data as appropriate, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260511 08:46:50.330	20260511 09:00:58.680	20260511 12:39:44.350	98	335	335	15	186	713	713
518	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Adverse Events/Serious AEs	Adverse Events/Serious Aes	0/0/V	1	What is the adverse event term?	DM	20882876	Closed	Juhita@ksha4	18 May 2026 07:13:12:357	EHerman2	19 May 2026 08:45:55:507	Juhita@ksha4	19 May 2026 09:21:23:130		1	0	Medical Review I-12758848: Kindly clarify time of the day when AE occurs, if it is continuous or intermittent and if it affect daily routine activity.	cuntinuous, daily routine activity mildly affected	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260518 07:13:12.357	20260519 08:45:55.507	20260519 09:21:23.130	98	335	335	15	186	713	713
519	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	1	Frequency	Site from Medical Reviewer	19527250	Closed	Rajani_S_N1	16 Mar 2026 10:48:52:137	EHerman2	19 Mar 2026 07:16:54:707	Rajani_S_N1	19 Mar 2026 11:24:58:147		3	0	Eligibility: Kindly mention the frequency at which subject needs to take NIMESULIDE	approximately 2 times in month	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 10:48:52.137	20260319 07:16:54.707	20260319 11:24:58.147	98	335	335	15	186	713	713
520	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	1	If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?	Auto	19424767	Closed	systemuser	09 Mar 2026 13:19:10:440	systemuser	09 Mar 2026 13:20:23:663	systemuser	09 Mar 2026 13:20:23:667		0	0	Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260309 13:19:10.440	20260309 13:20:23.663	20260309 13:20:23.667	98	335	335	15	186	713	713
521	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	1	Start Date	Auto	19424784	Closed	systemuser	09 Mar 2026 13:20:23:787	systemuser	09 Mar 2026 13:20:51:017	systemuser	09 Mar 2026 13:20:51:037		0	0	Response to 'Was the medication/therapy taken prior to the study' is No, however, 'Start Date' is prior to the 'Informed Consent Date' ("<core:link text='datapoint.uservalue' formoid='DM_GL_900' folderoid='SCREEN' fieldoid='RFICDAT' />") on the "<core:link text='Demographics' formoid='DM_GL_900' folderoid='SCREEN' />" form. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260309 13:20:23.787	20260309 13:20:51.017	20260309 13:20:51.037	98	335	335	15	186	713	713
522	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	1	If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term	DM	20566175	Closed	shyamaprasad972	30 Apr 2026 11:50:39:370	BrezVe1	04 May 2026 09:28:45:500	Ashwini201	04 May 2026 11:08:02:073		4	0	DM: Please verify and update the correct spelling of the indication.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260430 11:50:39.370	20260504 09:28:45.500	20260504 11:08:02.073	98	335	335	15	186	713	713
523	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	1	If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term	Auto	20589161	Closed	systemuser	04 May 2026 09:28:17:163	BrezVe1	04 May 2026 09:28:39:377	Ashwini201	04 May 2026 11:07:19:253		0	0	The selected logline has been modified from '#001 > CARVICOBRACHIAL SYNDROME' to '#001 > CERVICOBRACHIAL SYNDROME' on 'General Medical History' form. Please either confirm by responding in the query answer box or re-select the correct General Medical History from the drop-down.#DSL#	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260504 09:28:17.163	20260504 09:28:39.377	20260504 11:07:19.253	98	335	335	15	186	713	713
524	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933457	Closed	systemuser	20 May 2026 12:13:25:987			systemuser	20 May 2026 12:13:41:363			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 12:13:25.987		20260520 12:13:41.363	98	335	335	15	186	713	713
525	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	20639879	Closed	systemuser	06 May 2026 07:45:41:780			systemuser	06 May 2026 08:44:50:400			0	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260506 07:45:41.780		20260506 08:44:50.400	98	335	335	15	186	713	713
526	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Screening Visit 1	Alcohol Test	0/0/N		Alcohol Test Result	Auto	19423582	Closed	systemuser	09 Mar 2026 12:54:59:050	systemuser	09 Mar 2026 12:55:14:493	systemuser	09 Mar 2026 12:55:14:497		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260309 12:54:59.050	20260309 12:55:14.493	20260309 12:55:14.497	98	335	335	15	186	713	713
527	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Screening Visit 1	Alcohol Test	0/0/N		Collection Date	Auto	19423581	Closed	systemuser	09 Mar 2026 12:54:59:040	systemuser	09 Mar 2026 12:55:14:497	systemuser	09 Mar 2026 12:55:14:497		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260309 12:54:59.040	20260309 12:55:14.497	20260309 12:55:14.497	98	335	335	15	186	713	713
528	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Screening Visit 1	General Medical History	0/0/N	1	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	19527423	Closed	Rajani_S_N1	16 Mar 2026 10:53:06:733	EHerman2	19 Mar 2026 07:18:22:820	Rajani_S_N1	19 Mar 2026 11:29:24:007		3	0	Eligibility: Kindly mention the severity and clinical stability of medical condition - Cervicobrachial syndrome	chronic relatively stabile condition, mild severity, approximately one times in month requires analgetic.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260316 10:53:06.733	20260319 07:18:22.820	20260319 11:29:24.007	98	335	335	15	186	713	713
529	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Screening Visit 2 (1)	Date of Visit	0/0/N		Did this visit occur?	DM	19882667	Closed	Ashwini201	09 Apr 2026 07:13:28:930	BrezVe1	20 Apr 2026 11:21:12:690	Ashwini201	21 Apr 2026 15:12:11:383		11	1	DM: Please verify and update the data on CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS form, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260409 07:13:28.930	20260420 11:21:12.690	20260421 15:12:11.383	98	335	335	15	186	713	713
530	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	Start Date	Auto	19693540	Closed	systemuser	25 Mar 2026 10:47:30:980			systemuser	30 Mar 2026 09:20:17:303			5	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:47:30.980		20260330 09:20:17.303	98	335	335	15	186	713	713
531	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	Start Date	Auto	20639878	Closed	systemuser	06 May 2026 07:45:41:737			systemuser	06 May 2026 07:54:01:297			0	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260506 07:45:41.737		20260506 07:54:01.297	98	335	335	15	186	713	713
532	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Insomnia Severity Index	0/0/N		1. Difficulty falling asleep:	Auto	19693474	Closed	systemuser	25 Mar 2026 10:45:23:383	systemuser	25 Mar 2026 10:46:21:547	systemuser	25 Mar 2026 10:46:21:550		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:45:23.383	20260325 10:46:21.547	20260325 10:46:21.550	98	335	335	15	186	713	713
533	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Insomnia Severity Index	0/0/N		2. Difficulty staying asleep:	Auto	19693475	Closed	systemuser	25 Mar 2026 10:45:23:393	systemuser	25 Mar 2026 10:46:21:550	systemuser	25 Mar 2026 10:46:21:550		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:45:23.393	20260325 10:46:21.550	20260325 10:46:21.550	98	335	335	15	186	713	713
534	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Insomnia Severity Index	0/0/N		3. Problem waking up too early in the morning:	Auto	19693476	Closed	systemuser	25 Mar 2026 10:45:23:400	systemuser	25 Mar 2026 10:46:21:550	systemuser	25 Mar 2026 10:46:21:550		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:45:23.400	20260325 10:46:21.550	20260325 10:46:21.550	98	335	335	15	186	713	713
535	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Insomnia Severity Index	0/0/N		4. How SATISFIED/dissatisfied are you with your current sleep pattern?	Auto	19693477	Closed	systemuser	25 Mar 2026 10:45:23:410	systemuser	25 Mar 2026 10:46:21:550	systemuser	25 Mar 2026 10:46:21:550		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:45:23.410	20260325 10:46:21.550	20260325 10:46:21.550	98	335	335	15	186	713	713
536	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Insomnia Severity Index	0/0/N		5. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (e.g.,daytime fatigue, ability to function at work/daily chores, concentration, memory, mood)?	Auto	19693478	Closed	systemuser	25 Mar 2026 10:45:23:417	systemuser	25 Mar 2026 10:46:21:550	systemuser	25 Mar 2026 10:46:21:550		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:45:23.417	20260325 10:46:21.550	20260325 10:46:21.550	98	335	335	15	186	713	713
537	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Insomnia Severity Index	0/0/N		6. How NOTICEABLE to others do you think your sleeping problem is in terms of impairing the quality ofyour life?	Auto	19693479	Closed	systemuser	25 Mar 2026 10:45:23:423	systemuser	25 Mar 2026 10:46:21:550	systemuser	25 Mar 2026 10:46:21:550		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:45:23.423	20260325 10:46:21.550	20260325 10:46:21.550	98	335	335	15	186	713	713
538	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Insomnia Severity Index	0/0/N		7. How WORRIED/distressed are you about your current sleep problem?	Auto	19693480	Closed	systemuser	25 Mar 2026 10:45:23:430	systemuser	25 Mar 2026 10:46:21:550	systemuser	25 Mar 2026 10:46:21:550		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:45:23.430	20260325 10:46:21.550	20260325 10:46:21.550	98	335	335	15	186	713	713
539	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Insomnia Severity Index	0/0/N		Was the collection date the same as the visit date?	Auto	19693473	Closed	systemuser	25 Mar 2026 10:45:23:370	systemuser	25 Mar 2026 10:46:21:550	systemuser	25 Mar 2026 10:46:21:550		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:45:23.370	20260325 10:46:21.550	20260325 10:46:21.550	98	335	335	15	186	713	713
540	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		1. My sleep quality was	Auto	19693435	Closed	systemuser	25 Mar 2026 10:43:14:070	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.070	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
541	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		2. My sleep was refreshing	Auto	19693436	Closed	systemuser	25 Mar 2026 10:43:14:080	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.080	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
542	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		3. I had a problem with my sleep	Auto	19693437	Closed	systemuser	25 Mar 2026 10:43:14:087	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.087	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
543	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		4. I had difficulty falling asleep	Auto	19693438	Closed	systemuser	25 Mar 2026 10:43:14:090	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.090	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
544	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		5. My sleep was restless	Auto	19693439	Closed	systemuser	25 Mar 2026 10:43:14:097	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.097	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
545	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		6. I tried hard to get to sleep	Auto	19693440	Closed	systemuser	25 Mar 2026 10:43:14:103	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.103	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
546	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		7. I worried about not being able to fall asleep	Auto	19693441	Closed	systemuser	25 Mar 2026 10:43:14:113	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.113	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
547	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		8. I was satisfied with my sleep	Auto	19693442	Closed	systemuser	25 Mar 2026 10:43:14:117	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.117	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
548	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	PROMIS - Sleep Disturbance	0/0/V		Was the collection date the same as the visit date?	Auto	19693434	Closed	systemuser	25 Mar 2026 10:43:14:060	systemuser	25 Mar 2026 10:44:56:527	systemuser	25 Mar 2026 10:44:56:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260325 10:43:14.060	20260325 10:44:56.527	20260325 10:44:56.527	98	335	335	15	186	713	713
549	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Body Mass Index	Auto	19790121	Closed	systemuser	01 Apr 2026 07:49:42:180	systemuser	01 Apr 2026 07:50:11:860	systemuser	01 Apr 2026 07:50:11:863		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 07:49:42.180	20260401 07:50:11.860	20260401 07:50:11.863	98	335	335	15	186	713	713
550	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Diastolic Blood Pressure	Auto	19790125	Closed	systemuser	01 Apr 2026 07:49:42:317	systemuser	01 Apr 2026 07:50:11:877	systemuser	01 Apr 2026 07:50:11:877		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 07:49:42.317	20260401 07:50:11.877	20260401 07:50:11.877	98	335	335	15	186	713	713
551	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Pulse	Auto	19790123	Closed	systemuser	01 Apr 2026 07:49:42:253	systemuser	01 Apr 2026 07:50:11:887	systemuser	01 Apr 2026 07:50:11:887		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 07:49:42.253	20260401 07:50:11.887	20260401 07:50:11.887	98	335	335	15	186	713	713
552	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Systolic Blood Pressure	Auto	19790124	Closed	systemuser	01 Apr 2026 07:49:42:283	systemuser	01 Apr 2026 07:50:11:893	systemuser	01 Apr 2026 07:50:11:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 07:49:42.283	20260401 07:50:11.893	20260401 07:50:11.893	98	335	335	15	186	713	713
553	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Was the collection date the same as the visit date?	Auto	19790119	Closed	systemuser	01 Apr 2026 07:49:42:117	systemuser	01 Apr 2026 07:50:11:893	systemuser	01 Apr 2026 07:50:11:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 07:49:42.117	20260401 07:50:11.893	20260401 07:50:11.893	98	335	335	15	186	713	713
554	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Temperature	Auto	19790122	Closed	systemuser	01 Apr 2026 07:49:42:213	systemuser	01 Apr 2026 07:50:11:893	systemuser	01 Apr 2026 07:50:11:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 07:49:42.213	20260401 07:50:11.893	20260401 07:50:11.893	98	335	335	15	186	713	713
555	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 3 Part 1 Baseline	Vital Signs	0/0/N		Weight	Auto	19790120	Closed	systemuser	01 Apr 2026 07:49:42:157	systemuser	01 Apr 2026 07:50:11:893	systemuser	01 Apr 2026 07:50:11:893		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260401 07:49:42.157	20260401 07:50:11.893	20260401 07:50:11.893	98	335	335	15	186	713	713
556	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal Ideation1. Wish to be Dead	Auto	19865696	Closed	systemuser	08 Apr 2026 10:13:48:173	systemuser	08 Apr 2026 10:14:19:817	systemuser	08 Apr 2026 10:14:19:820		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.173	20260408 10:14:19.817	20260408 10:14:19.820	98	335	335	15	186	713	713
557	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		2. Non-Specific Active Suicidal Thoughts	Auto	19865697	Closed	systemuser	08 Apr 2026 10:13:48:183	systemuser	08 Apr 2026 10:14:19:820	systemuser	08 Apr 2026 10:14:19:820		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.183	20260408 10:14:19.820	20260408 10:14:19.820	98	335	335	15	186	713	713
558	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal BehaviorActual Attempt	Auto	19865698	Closed	systemuser	08 Apr 2026 10:13:48:220	systemuser	08 Apr 2026 10:14:19:840	systemuser	08 Apr 2026 10:14:19:840		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.220	20260408 10:14:19.840	20260408 10:14:19.840	98	335	335	15	186	713	713
559	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Has subject engaged in Non-Suicidal Self-Injurious Behavior?	Auto	19865699	Closed	systemuser	08 Apr 2026 10:13:48:257	systemuser	08 Apr 2026 10:14:19:840	systemuser	08 Apr 2026 10:14:19:840		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.257	20260408 10:14:19.840	20260408 10:14:19.840	98	335	335	15	186	713	713
560	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Interrupted Attempt	Auto	19865700	Closed	systemuser	08 Apr 2026 10:13:48:267	systemuser	08 Apr 2026 10:14:19:840	systemuser	08 Apr 2026 10:14:19:840		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.267	20260408 10:14:19.840	20260408 10:14:19.840	98	335	335	15	186	713	713
561	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Aborted Attempt	Auto	19865701	Closed	systemuser	08 Apr 2026 10:13:48:277	systemuser	08 Apr 2026 10:14:19:840	systemuser	08 Apr 2026 10:14:19:843		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.277	20260408 10:14:19.840	20260408 10:14:19.843	98	335	335	15	186	713	713
562	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Preparatory Acts or Behavior	Auto	19865702	Closed	systemuser	08 Apr 2026 10:13:48:297	systemuser	08 Apr 2026 10:14:19:843	systemuser	08 Apr 2026 10:14:19:843		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.297	20260408 10:14:19.843	20260408 10:14:19.843	98	335	335	15	186	713	713
563	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal Behavior	Auto	19865703	Closed	systemuser	08 Apr 2026 10:13:48:313	systemuser	08 Apr 2026 10:14:19:843	systemuser	08 Apr 2026 10:14:19:843		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.313	20260408 10:14:19.843	20260408 10:14:19.843	98	335	335	15	186	713	713
564	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicide	Auto	19865704	Closed	systemuser	08 Apr 2026 10:13:48:327	systemuser	08 Apr 2026 10:14:19:843	systemuser	08 Apr 2026 10:14:19:843		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.327	20260408 10:14:19.843	20260408 10:14:19.843	98	335	335	15	186	713	713
565	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Rater's Initials	Auto	19865695	Closed	systemuser	08 Apr 2026 10:13:48:167	systemuser	08 Apr 2026 10:14:19:843	systemuser	08 Apr 2026 10:14:19:843		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.167	20260408 10:14:19.843	20260408 10:14:19.843	98	335	335	15	186	713	713
566	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 5 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Was the collection date the same as the visit date?	Auto	19865694	Closed	systemuser	08 Apr 2026 10:13:48:150	systemuser	08 Apr 2026 10:14:19:843	systemuser	08 Apr 2026 10:14:19:843		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260408 10:13:48.150	20260408 10:14:19.843	20260408 10:14:19.843	98	335	335	15	186	713	713
567	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal Ideation1. Wish to be Dead	Auto	20428553	Closed	systemuser	27 Apr 2026 08:26:06:767	systemuser	27 Apr 2026 08:26:27:517	systemuser	27 Apr 2026 08:26:27:523		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.767	20260427 08:26:27.517	20260427 08:26:27.523	98	335	335	15	186	713	713
568	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		2. Non-Specific Active Suicidal Thoughts	Auto	20428554	Closed	systemuser	27 Apr 2026 08:26:06:777	systemuser	27 Apr 2026 08:26:27:527	systemuser	27 Apr 2026 08:26:27:527		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.777	20260427 08:26:27.527	20260427 08:26:27.527	98	335	335	15	186	713	713
569	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal BehaviorActual Attempt	Auto	20428555	Closed	systemuser	27 Apr 2026 08:26:06:807	systemuser	27 Apr 2026 08:26:27:553	systemuser	27 Apr 2026 08:26:27:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.807	20260427 08:26:27.553	20260427 08:26:27.553	98	335	335	15	186	713	713
570	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Has subject engaged in Non-Suicidal Self-Injurious Behavior?	Auto	20428556	Closed	systemuser	27 Apr 2026 08:26:06:817	systemuser	27 Apr 2026 08:26:27:553	systemuser	27 Apr 2026 08:26:27:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.817	20260427 08:26:27.553	20260427 08:26:27.553	98	335	335	15	186	713	713
571	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Interrupted Attempt	Auto	20428557	Closed	systemuser	27 Apr 2026 08:26:06:827	systemuser	27 Apr 2026 08:26:27:553	systemuser	27 Apr 2026 08:26:27:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.827	20260427 08:26:27.553	20260427 08:26:27.553	98	335	335	15	186	713	713
572	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Aborted Attempt	Auto	20428558	Closed	systemuser	27 Apr 2026 08:26:06:837	systemuser	27 Apr 2026 08:26:27:553	systemuser	27 Apr 2026 08:26:27:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.837	20260427 08:26:27.553	20260427 08:26:27.553	98	335	335	15	186	713	713
573	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Preparatory Acts or Behavior	Auto	20428559	Closed	systemuser	27 Apr 2026 08:26:06:850	systemuser	27 Apr 2026 08:26:27:557	systemuser	27 Apr 2026 08:26:27:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.850	20260427 08:26:27.557	20260427 08:26:27.557	98	335	335	15	186	713	713
574	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicidal Behavior	Auto	20428560	Closed	systemuser	27 Apr 2026 08:26:06:860	systemuser	27 Apr 2026 08:26:27:557	systemuser	27 Apr 2026 08:26:27:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.860	20260427 08:26:27.557	20260427 08:26:27.557	98	335	335	15	186	713	713
575	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Suicide	Auto	20428561	Closed	systemuser	27 Apr 2026 08:26:06:870	systemuser	27 Apr 2026 08:26:27:557	systemuser	27 Apr 2026 08:26:27:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.870	20260427 08:26:27.557	20260427 08:26:27.557	98	335	335	15	186	713	713
576	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Rater's Initials	Auto	20428552	Closed	systemuser	27 Apr 2026 08:26:06:760	systemuser	27 Apr 2026 08:26:27:557	systemuser	27 Apr 2026 08:26:27:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.760	20260427 08:26:27.557	20260427 08:26:27.557	98	335	335	15	186	713	713
577	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040008	Enrolled	Visit 7 Part 1 (1)	Columbia-Suicide Severity Rating Scale - Since Last Visit	0/0/V		Was the collection date the same as the visit date?	Auto	20428551	Closed	systemuser	27 Apr 2026 08:26:06:733	systemuser	27 Apr 2026 08:26:27:557	systemuser	27 Apr 2026 08:26:27:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260427 08:26:06.733	20260427 08:26:27.557	20260427 08:26:27.557	98	335	335	15	186	713	713
578	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	3	Frequency	Site from Medical Reviewer	20021675	Closed	Mamatha.K1	17 Apr 2026 06:14:12:037	BrezVe1	20 Apr 2026 11:22:20:627	Mamatha.K1	21 Apr 2026 03:43:26:213		3	1	Eligibility : Kindly clarify if the &quot;as necessary&quot; usage has been stable for at least 12 weeks and is expected to remain stable during the course of the trial	stable	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260417 06:14:12.037	20260420 11:22:20.627	20260421 03:43:26.213	98	335	335	8	186	713	713
579	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933474	Closed	systemuser	20 May 2026 12:14:11:487			systemuser	20 May 2026 12:14:27:593			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 12:14:11.487		20260520 12:14:27.593	98	335	335	8	186	713	713
580	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	20841000	Closed	Ashwini201	14 May 2026 10:14:00:767	BrezVe1	18 May 2026 08:25:28:157	Ashwini201	18 May 2026 09:32:29:530		4	0	DM: Please verify and update the data on Physical Examination, Arizona Sexual Experiences Scale Summary, Educational Level, Local Labs for Background Antidepressant Compliance and Neurologic Examination forms, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260514 10:14:00.767	20260518 08:25:28.157	20260518 09:32:29.530	98	335	335	8	186	713	713
581	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 1	Demographics	0/0/V		What is the subject's childbearing potential?	Site from Medical Reviewer	20021790	Closed	Mamatha.K1	17 Apr 2026 06:16:21:937	BrezVe1	20 Apr 2026 11:54:40:870	Mamatha.K1	21 Apr 2026 03:45:24:690		3	1	Eligibility: Please clarify if the subject is permanently sterilized or postmenopausal. Update as applicable	data are correct	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260417 06:16:21.937	20260420 11:54:40.870	20260421 03:45:24.690	98	335	335	8	186	713	713
582	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 1	Demographics	0/0/V		What is the subject's childbearing potential?	Site from Medical Reviewer	20069479 (20021790)	Closed	Mamatha.K1	21 Apr 2026 03:45:24:867	BrezVe1	22 Apr 2026 12:50:23:640	Mamatha.K1	23 Apr 2026 05:10:12:783		1	1	Eligibility Re- Query : Thank you for the confirmation. Please provide when was the last menses or since when is the subject Menopausal	will be reviewed	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260421 03:45:24.867	20260422 12:50:23.640	20260423 05:10:12.783	98	335	335	8	186	713	713
583	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 1	Demographics	0/0/V		What is the subject's childbearing potential?	Site from Medical Reviewer	20128411 (20069479)	Closed	Mamatha.K1	23 Apr 2026 05:10:12:987	gnovotna@email.cz2	23 Apr 2026 14:15:54:603	Mamatha.K1	24 Apr 2026 04:33:50:053		0	1	Eligibility Re-Query: Kindly note, this information is needed for determining the subject eligibility because per protocol &quot;A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.&quot;.Please provide the details once available	pateint is permanently sterilized from 2005	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260423 05:10:12.987	20260423 14:15:54.603	20260424 04:33:50.053	98	335	335	8	186	713	713
584	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 1	Demographics	0/0/V		What is the subject's childbearing potential?	Site from Medical Reviewer	20163350 (20128411)	Closed	Mamatha.K1	24 Apr 2026 04:33:50:500	gnovotna@email.cz2	28 Apr 2026 13:15:48:793	Mamatha.K1	29 Apr 2026 04:06:52:567		4	1	Eligibility : thank you for the confirmation. Please select the appropriate child beraring potential as per your response	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260424 04:33:50.500	20260428 13:15:48.793	20260429 04:06:52.567	98	335	335	8	186	713	713
585	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 1	General Medical History	0/0/N	2	What is the verbatim term for the medical history condition/event?	DM	20078473	Closed	CoderImport	21 Apr 2026 10:39:43:553	BrezVe1	22 Apr 2026 12:47:59:660	systemuser	22 Apr 2026 12:48:00:813		1	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1.OSTEOTOMY FOR GRADE 3 OSTEOARTHRITIS OF THE KNEE OF THE RIGHT LOWER LIMB and 2. OSTEOTOMY. Thank you.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260421 10:39:43.553	20260422 12:47:59.660	20260422 12:48:00.813	98	335	335	8	186	713	713
586	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 1	General Medical History	0/0/N	4	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	20021686	Closed	Mamatha.K1	17 Apr 2026 06:14:59:720	BrezVe1	20 Apr 2026 11:55:00:603	Mamatha.K1	21 Apr 2026 03:45:52:650		3	1	Eligibility: Please clarify if this was total hysterectomy or partial	partial	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260417 06:14:59.720	20260420 11:55:00.603	20260421 03:45:52.650	98	335	335	8	186	713	713
587	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 1	General Medical History	0/0/N	4	What is the verbatim term for the medical history condition/event?	DM	20078470	Closed	CoderImport	21 Apr 2026 10:38:45:050	BrezVe1	22 Apr 2026 12:46:44:277	systemuser	22 Apr 2026 12:46:44:983		1	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. MYOMA and 2. HYSTERECTOMY AND OVARIECTOMY. Thank you.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260421 10:38:45.050	20260422 12:46:44.277	20260422 12:46:44.983	98	335	335	8	186	713	713
588	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Screening Visit 2 (1)	CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS	0/0/N	2	Reason not done	Auto	20625662	Closed	systemuser	05 May 2026 14:29:39:990	systemuser	05 May 2026 14:31:19:430	systemuser	05 May 2026 14:31:19:433		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260505 14:29:39.990	20260505 14:31:19.430	20260505 14:31:19.433	98	335	335	8	186	713	713
589	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	Start Date	Auto	20625655	Closed	systemuser	05 May 2026 14:29:04:153			systemuser	06 May 2026 07:35:33:563			1	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260505 14:29:04.153		20260506 07:35:33.563	98	335	335	8	186	713	713
590	CZE	S10-CZ10004	Medical Services Prague s.r.o.	CZ100040009	Enrolled	Visit 1.1 Induction Baseline (1)	Date of Visit	0/0/N		Visit Start Date	Auto	20633606	Closed	systemuser	06 May 2026 07:08:12:080	BrezVe1	06 May 2026 07:09:14:597	systemuser	06 May 2026 09:39:50:360		0	0	Date of visit should be greater than the last date of visit. Please reconcile.	data are correct	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260506 07:08:12.080	20260506 07:09:14.597	20260506 09:39:50.360	98	335	335	8	186	713	713
591	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	7	If Yes, Medication or Therapy	Site from Medical Reviewer	16041202	Closed	inayath1	19 Sep 2025 05:42:17:200	spinkova@email.cz2	03 Oct 2025 07:54:03:017	meghal.choksi@iqvia.com1	03 Oct 2025 10:19:26:423		14	0	Eligibility: Please justify updating Duloxetine in 2 loglines without change in dosage.	there is a change in dosage	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250919 05:42:17.200	20251003 07:54:03.017	20251003 10:19:26.423	6	335	335	6	11	713	713
592	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Investigator Periodic Review Acknowledgments/ Interim Signatures	20251003 - Periodic Investigator's EDC Review Acknowledgement	0/0/N		As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.	Auto	16252402	Closed	systemuser	03 Oct 2025 07:51:36:110	systemuser	03 Oct 2025 07:55:06:530	systemuser	03 Oct 2025 07:55:06:650		0	0	NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251003 07:51:36.110	20251003 07:55:06.530	20251003 07:55:06.650	6	335	335	6	11	713	713
593	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Suicidal Ideation1. Wish to be DeadLifetime	Auto	15875831	Closed	systemuser	09 Sep 2025 10:17:25:517	systemuser	09 Sep 2025 10:19:36:537	systemuser	09 Sep 2025 10:19:36:540		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.517	20250909 10:19:36.537	20250909 10:19:36.540	6	335	335	6	11	713	713
594	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 6 Months	Auto	15875832	Closed	systemuser	09 Sep 2025 10:17:25:530	systemuser	09 Sep 2025 10:19:36:553	systemuser	09 Sep 2025 10:19:36:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.530	20250909 10:19:36.553	20250909 10:19:36.553	6	335	335	6	11	713	713
595	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		2. Non-Specific Active Suicidal ThoughtsLifetime	Auto	15875833	Closed	systemuser	09 Sep 2025 10:17:25:543	systemuser	09 Sep 2025 10:19:36:553	systemuser	09 Sep 2025 10:19:36:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.543	20250909 10:19:36.553	20250909 10:19:36.553	6	335	335	6	11	713	713
596	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 6 Months	Auto	15875834	Closed	systemuser	09 Sep 2025 10:17:25:553	systemuser	09 Sep 2025 10:19:36:553	systemuser	09 Sep 2025 10:19:36:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.553	20250909 10:19:36.553	20250909 10:19:36.553	6	335	335	6	11	713	713
597	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Suicidal BehaviorActual AttemptLifetime	Auto	15875835	Closed	systemuser	09 Sep 2025 10:17:25:730	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.730	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
598	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	15875836	Closed	systemuser	09 Sep 2025 10:17:25:743	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.743	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
599	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Has subject engaged in Non-Suicidal Self-Injurious Behavior?Lifetime	Auto	15875837	Closed	systemuser	09 Sep 2025 10:17:25:777	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.777	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
600	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	15875838	Closed	systemuser	09 Sep 2025 10:17:25:787	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.787	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
601	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Interrupted AttemptLifetime	Auto	15875839	Closed	systemuser	09 Sep 2025 10:17:25:797	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.797	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
602	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	15875840	Closed	systemuser	09 Sep 2025 10:17:25:807	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.807	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
603	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Aborted AttemptLifetime	Auto	15875841	Closed	systemuser	09 Sep 2025 10:17:25:837	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.837	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
604	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	15875842	Closed	systemuser	09 Sep 2025 10:17:25:853	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.853	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
605	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Preparatory Acts or BehaviorLifetime	Auto	15875843	Closed	systemuser	09 Sep 2025 10:17:25:880	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.880	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
606	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	15875844	Closed	systemuser	09 Sep 2025 10:17:25:890	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.890	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
607	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Suicidal BehaviorLifetime	Auto	15875845	Closed	systemuser	09 Sep 2025 10:17:25:907	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.907	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
608	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Past 1 Years	Auto	15875846	Closed	systemuser	09 Sep 2025 10:17:25:917	systemuser	09 Sep 2025 10:19:36:557	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.917	20250909 10:19:36.557	20250909 10:19:36.557	6	335	335	6	11	713	713
609	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Rater's Initials	Auto	15875830	Closed	systemuser	09 Sep 2025 10:17:25:507	systemuser	09 Sep 2025 10:19:36:553	systemuser	09 Sep 2025 10:19:36:557		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.507	20250909 10:19:36.553	20250909 10:19:36.557	6	335	335	6	11	713	713
610	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Columbia-Suicide Severity Rating Scale - Baseline/Screening Version	0/0/N		Was the collection date the same as the visit date?	Auto	15875829	Closed	systemuser	09 Sep 2025 10:17:25:480	systemuser	09 Sep 2025 10:19:36:553	systemuser	09 Sep 2025 10:19:36:553		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 10:17:25.480	20250909 10:19:36.553	20250909 10:19:36.553	6	335	335	6	11	713	713
611	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Date of Visit	0/0/N		Subject's Status	Auto	16252400	Closed	systemuser	03 Oct 2025 07:50:57:867	spinkova@email.cz2	03 Oct 2025 07:54:47:593	shyamaprasad972	06 Oct 2025 06:17:53:703		0	3	Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.	I confirm	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251003 07:50:57.867	20251003 07:54:47.593	20251006 06:17:53.703	6	335	335	6	11	713	713
612	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	General Medical History	0/0/N	1	What is the verbatim term for the medical history condition/event?	DM	15953427	Closed	CoderImport	14 Sep 2025 06:07:02:803	spinkova@email.cz2	03 Oct 2025 07:46:34:010	systemuser	03 Oct 2025 07:46:34:190		19	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. MYOMA and 2. HYSTERECTOMY.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250914 06:07:02.803	20251003 07:46:34.010	20251003 07:46:34.190	6	335	335	6	11	713	713
613	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	General Medical History	0/0/N	1	What is the verbatim term for the medical history condition/event?	Site from Medical Reviewer	16041221	Closed	inayath1	19 Sep 2025 05:47:10:473	spinkova@email.cz2	03 Oct 2025 07:46:39:603	meghal.choksi@iqvia.com1	03 Oct 2025 10:19:26:497		14	0	Eligibility: Please confirm whether hysterectomy was partial or complete.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250919 05:47:10.473	20251003 07:46:39.603	20251003 10:19:26.497	6	335	335	6	11	713	713
614	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	General Medical History	0/0/N	7	What is the verbatim term for the medical history condition/event?	DM	16340823	Closed	CoderImport	09 Oct 2025 14:12:18:973	spinkova@email.cz2	19 Nov 2025 16:16:49:787	systemuser	19 Nov 2025 16:16:49:940		41	0	CODING: Reported term contains a medical condition as well as a procedure. Please split the term and record the diagnosis and procedure separately. Example: 1. UTERINE MYOMA and 2. HYSTERECTOMY.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251009 14:12:18.973	20251119 16:16:49.787	20251119 16:16:49.940	6	335	335	6	11	713	713
615	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	General Medical History	0/0/N	7	Start Date	Auto	17104107	Closed	systemuser	19 Nov 2025 16:15:24:390			systemuser	19 Nov 2025 16:15:35:890			0	Data is not in the expected format. Please Correct.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251119 16:15:24.390		20251119 16:15:35.890	6	335	335	6	11	713	713
616	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050001	Screen Failed	Screening Visit 1	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	15886841	Closed	systemuser	09 Sep 2025 18:01:13:100	systemuser	09 Sep 2025 18:01:29:863	systemuser	09 Sep 2025 18:01:29:863		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250909 18:01:13.100	20250909 18:01:29.863	20250909 18:01:29.863	6	335	335	6	11	713	713
617	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	3	If Start Date is entirely or partially unknown:Was the medication/therapy taken prior to the study?	Auto	16773754	Closed	systemuser	04 Nov 2025 13:15:44:733	systemuser	04 Nov 2025 13:18:27:157	systemuser	04 Nov 2025 13:18:27:160		0	0	Start Date' is entirely or partially unknown. However, response for 'Was the medication/therapy taken prior to the study?' is missing. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251104 13:15:44.733	20251104 13:18:27.157	20251104 13:18:27.160	6	335	335	5	11	713	713
618	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	3	If indication is 'Medical History,' choose the primary corresponding MH log line(s) and term(s)MH log line, and term	Auto	18723689	Closed	systemuser	02 Feb 2026 14:26:22:177	systemuser	02 Feb 2026 14:29:31:210	systemuser	02 Feb 2026 14:29:31:210		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 14:26:22.177	20260202 14:29:31.210	20260202 14:29:31.210	6	335	335	5	11	713	713
619	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	3	Indication	Site from Medical Reviewer	16932878	Closed	joetrombello1	11 Nov 2025 20:20:46:790	spinkova@email.cz2	19 Nov 2025 16:19:43:590	MAhmad203	19 Nov 2025 19:13:29:000		8	0	medical reviewer: Pls clarify if the primary indication was major depression or related conditions like insomnia or anxiety. Please review and revise here and in MH if deemed clinically necessary.	insomnia in depressive disorder	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251111 20:20:46.790	20251119 16:19:43.590	20251119 19:13:29.000	6	335	335	5	11	713	713
620	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	3	Indication	Site from Medical Reviewer	17108322 (16932878)	Closed	MAhmad203	19 Nov 2025 19:13:29:220	spinkova@email.cz2	02 Feb 2026 14:26:30:617	ewajs1	12 Feb 2026 13:59:09:793		75	10	Since Trazodone was given for insomnia, please update indication to insomnia, and add insomnia to Medical History page	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251119 19:13:29.220	20260202 14:26:30.617	20260212 13:59:09.793	6	335	335	5	11	713	713
621	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	3	Indication	Site from Medical Reviewer	18037493	Closed	MAhmad203	17 Dec 2025 03:25:01:397	spinkova@email.cz2	02 Feb 2026 14:26:42:047	ewajs1	12 Feb 2026 13:59:15:613		47	10	Since Trazodone was given for insomnia, please update indication to insomnia, and add insomnia to Medical History page. Insomnia is a comorbidity of MDD.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251217 03:25:01.397	20260202 14:26:42.047	20260212 13:59:15.613	6	335	335	5	11	713	713
622	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	3	Indication	Auto	18723688	Closed	systemuser	02 Feb 2026 14:26:22:163	spinkova@email.cz2	02 Feb 2026 14:26:35:477	Ashwini201	05 Feb 2026 09:53:06:330		0	3	"Is this a medication/therapy taken for current episode of depression?" is 'Yes', however, Indication is not selected as 'Trial Indication'. Please resolve.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 14:26:22.163	20260202 14:26:35.477	20260205 09:53:06.330	6	335	335	5	11	713	713
623	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	4	Indication	Site from Medical Reviewer	16932856	Closed	joetrombello1	11 Nov 2025 20:20:24:310	spinkova@email.cz2	19 Nov 2025 16:20:04:587	MAhmad203	19 Nov 2025 19:15:31:997		8	0	medical reviewer: Pls clarify if the primary indication was major depression or related conditions like insomnia or anxiety. Please review and revise here and in MH if deemed clinically necessary.	insomnia in depressive disorder	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251111 20:20:24.310	20251119 16:20:04.587	20251119 19:15:31.997	6	335	335	5	11	713	713
624	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	4	Indication	Site from Medical Reviewer	17108379 (16932856)	Closed	MAhmad203	19 Nov 2025 19:15:32:157	spinkova@email.cz2	02 Feb 2026 14:30:23:670	ewajs1	12 Feb 2026 14:00:46:317		75	10	Since quetiapine was given for insomnia, please update indication to insomnia, and add insomnia to Medical History page	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251119 19:15:32.157	20260202 14:30:23.670	20260212 14:00:46.317	6	335	335	5	11	713	713
625	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	4	Indication	Site from Medical Reviewer	18037500	Closed	MAhmad203	17 Dec 2025 03:25:47:727	spinkova@email.cz2	02 Feb 2026 14:30:38:450	ewajs1	12 Feb 2026 14:00:49:960		47	10	Since quetiapine was given for insomnia, please update indication to insomnia, and add insomnia to Medical History page Insomnia is a comorbidity of MDD	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251217 03:25:47.727	20260202 14:30:38.450	20260212 14:00:49.960	6	335	335	5	11	713	713
626	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	4	Indication	Auto	18723777	Closed	systemuser	02 Feb 2026 14:29:56:473	spinkova@email.cz2	02 Feb 2026 14:30:31:563	Ashwini201	05 Feb 2026 09:53:16:663		0	3	"Is this a medication/therapy taken for current episode of depression?" is 'Yes', however, Indication is not selected as 'Trial Indication'. Please resolve.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260202 14:29:56.473	20260202 14:30:31.563	20260205 09:53:16.663	6	335	335	5	11	713	713
627	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/N	4	End Date	Site from Medical Reviewer	17004570	Cancelled	kavya@1510	14 Nov 2025 09:07:50:083			kavya@1510	20 Nov 2025 20:21:36:950				Eligibility: Please note, ongoing Antipsychotics are prohibited at least 14 days prior to Day 1 until the Follow-up visit. Kindly comment if the subject agrees to discontinue drug &amp; PI consider Clinically indicated to discontinue. If so, Can PI confirm whether drug can be safely tapered off with washout of 14 days as per exclusion #29 &amp; prohibited medication section 6.9.2.		42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251114 09:07:50.083		20251120 20:21:36.950	6	335	335	5	11	713	713
628	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260211 - Periodic Investigator's EDC Review Acknowledgement	0/0/N		As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.	Auto	17104258	Closed	systemuser	19 Nov 2025 16:23:30:060	systemuser	11 Feb 2026 12:26:55:840	systemuser	11 Feb 2026 12:26:55:997		84	0	NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251119 16:23:30.060	20260211 12:26:55.840	20260211 12:26:55.997	6	335	335	5	11	713	713
629	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Screening Visit 1	Date of Visit	0/0/N		Subject's Status	Auto	17104254	Closed	systemuser	19 Nov 2025 16:22:36:277	spinkova@email.cz2	19 Nov 2025 16:25:32:903	Ashwini201	21 Nov 2025 09:08:28:397		0	2	Were all eligibility criteria met?’ was answered as ‘No’, the subject’s status got updated to ‘Discontinuing Study’. Please confirm by responding in the query answer box.	I confirm	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251119 16:22:36.277	20251119 16:25:32.903	20251121 09:08:28.397	6	335	335	5	11	713	713
630	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	Site from Medical Reviewer	16996619	Closed	kavya@1510	13 Nov 2025 20:10:53:490	spinkova@email.cz2	19 Nov 2025 16:18:15:230	kavya@1510	20 Nov 2025 20:21:03:403		6	1	Eligibility: Kindly update details in the AE page with Yes or No.	the page is complete	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251113 20:10:53.490	20251119 16:18:15.230	20251120 20:21:03.403	6	335	335	5	11	713	713
631	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	18173132	Closed	Ashwini201	23 Dec 2025 07:08:45:840	spinkova@email.cz2	02 Feb 2026 14:31:28:140	shyamaprasad972	03 Feb 2026 08:38:05:610		41	1	DM: Please verify and update the field 'Were any adverse events experienced?' on Adverse event form.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251223 07:08:45.840	20260202 14:31:28.140	20260203 08:38:05.610	6	335	335	5	11	713	713
632	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Screening Visit 1	Demographics	0/0/N		Sex reported at birth	Auto	16765790	Closed	systemuser	04 Nov 2025 09:43:51:270	systemuser	04 Nov 2025 09:44:15:627	systemuser	04 Nov 2025 09:44:15:640		0	0	Sex reported at birth is 'Male. However, What is the subject's childbearing potential? is selected other than 'Not Applicable'. Please review.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251104 09:43:51.270	20251104 09:44:15.627	20251104 09:44:15.640	6	335	335	5	11	713	713
633	CZE	S10-CZ10005	A-Shine s.r.o.	CZ100050002	Screen Failed	Screening Visit 1	Psychiatric History for Major Depressive Disorder	0/0/N	1	Psychiatric Disorder	Auto	16770588	Closed	systemuser	04 Nov 2025 11:48:48:333	systemuser	04 Nov 2025 11:49:22:097	systemuser	04 Nov 2025 11:49:22:100		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251104 11:48:48.333	20251104 11:49:22.097	20251104 11:49:22.100	6	335	335	5	11	713	713
634	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	2	Is the medication/therapy still ongoing?	DM	19723934	Closed	JThoma858	26 Mar 2026 11:48:28:717	v.smidkova1	09 Apr 2026 06:31:57:270	JThoma858	13 Apr 2026 07:22:23:443		14	4	DM: Please note the drug is given for current episode of depression and recorded in MGH ATRQ-Non Geriatric Section I and II , however the drug is not ongoing in CM form. As per guidance &quot; End Date should be blank (if there are multiple records, then previous record may have end date/dose change, but current record should match MGH-ATRQ&quot;'. Kindly recheck and verify. Else clarify	The subject used dose 300 mg of Venlafaxine from 22Feb2023 (150 mg twice daily) and then the dose 75 mg was added on 18Sep2024. The total dose from 18 Sep2024 was 375 mg (this dose is mentioned in MGH-ATRQ)	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260326 11:48:28.717	20260409 06:31:57.270	20260413 07:22:23.443	94	335	335	37	231	713	713
635	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	2	Start Date	DM	18628769	Closed	Lisa232	27 Jan 2026 08:11:58:273	v.smidkova1	29 Jan 2026 07:31:11:753	Lisa232	12 Feb 2026 11:01:21:600		2	14	DM: The start date 18 Sep 2024 of the logline#2 is overlapping with the end date 30 Jan 2025 of logline #1. Please verify and update the dates accordingly.	The patient was taking 150 mg from 22.2.2023, on 18.9.2024 the dose was increased from 75 mg to 225 mg daily.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260127 08:11:58.273	20260129 07:31:11.753	20260212 11:01:21.600	94	335	335	37	231	713	713
636	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	2	Start Date	DM	18906071	Cancelled	Lisa232	12 Feb 2026 11:03:13:677			Lisa232	12 Feb 2026 11:04:45:677				RQ-DM1: Response noted, however the start date of logline 6 cannot be the same as the end date of logline 3. Please verify and update the dates accordingly.		42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260212 11:03:13.677		20260212 11:04:45.677	94	335	335	37	231	713	713
637	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	2	Start Date	DM	18906145	Closed	Lisa232	12 Feb 2026 11:05:02:080	v.smidkova1	17 Feb 2026 07:38:36:860	Lisa232	23 Feb 2026 07:58:54:970		5	6	RQ-DM1: As per query response, CM dose was increased on 18 Sep 2024, however, start date of logline 2 is overlapping with logline 1. Please review and amend or clarify.	ADT does not overlap, as 150mg was increased by 75mg for a total daily intake of 225mg. 150mg was taken twice daily 75mg was taken once daily	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260212 11:05:02.080	20260217 07:38:36.860	20260223 07:58:54.970	94	335	335	37	231	713	713
638	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Concomitant Therapy	Concomitant Therapy / Medication	0/0/V	7	If Prophylaxis or Other, Specify	Auto	14468174	Closed	systemuser	17 Jul 2025 09:43:16:880	systemuser	17 Jul 2025 09:47:02:313	systemuser	17 Jul 2025 09:47:02:313		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250717 09:43:16.880	20250717 09:47:02.313	20250717 09:47:02.313	94	335	335	37	231	713	713
639	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Follow-up 7-14 Days After (1)	Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale	0/0/V		Was the collection date the same as the visit date?	Auto	17207779	Closed	systemuser	24 Nov 2025 07:14:28:817	systemuser	24 Nov 2025 07:14:35:507	systemuser	24 Nov 2025 07:14:35:510		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251124 07:14:28.817	20251124 07:14:35.507	20251124 07:14:35.510	94	335	335	37	231	713	713
640	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Investigator Periodic Review Acknowledgments/ Interim Signatures	20251211 - Periodic Investigator's EDC Review Acknowledgement	0/0/N		As the investigator, I have ensured the accuracy, completeness, and timeliness of the data reported to the sponsor in the CRFs.	Auto	17891908	Closed	systemuser	10 Dec 2025 11:17:04:190	systemuser	11 Dec 2025 07:42:01:720	systemuser	11 Dec 2025 07:42:01:833		1	0	NOTIFICATION: Date of discontinuation/completion has been completed for the subject. To ensure compliance with regulatory requirements for data oversight, please mark the tick box after you have reviewed the subject’s data in EDC.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251210 11:17:04.190	20251211 07:42:01.720	20251211 07:42:01.833	94	335	335	37	231	713	713
641	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Investigator Periodic Review Acknowledgments/ Interim Signatures	20260520 - PART1 - Interim Investigator Signature	0/0/N		I have verified that all data in this case book were completed up to the cutoff and I am ready to proceed with sign-off for interim closure.	Auto	20933069	Closed	systemuser	20 May 2026 11:56:48:300			systemuser	20 May 2026 11:57:37:753			0	Notification : Please click 'Sign' to sign the page then click 'Save'. (query will automatically close when page is saved).	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260520 11:56:48.300		20260520 11:57:37.753	94	335	335	37	231	713	713
642	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Drug Expiry Information	0/0/N		Did the subject take all investigational medication within the expiry timeframe?	Auto	18571810	Closed	systemuser	22 Jan 2026 06:46:38:950	systemuser	22 Jan 2026 06:46:52:907	systemuser	22 Jan 2026 06:46:52:907		0	0	There are no active logline in this form. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260122 06:46:38.950	20260122 06:46:52.907	20260122 06:46:52.907	94	335	335	37	231	713	713
643	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	1	Start date of menstrual period	DM	15765188	Closed	Ashwini201	02 Sep 2025 15:44:45:360	v.smidkova1	11 Sep 2025 11:14:35:773	Ashwini201	14 Oct 2025 13:35:32:047		9	33	DM: Please verify and update the menstrual cycle data for month of Jul and Aug 2025, else clarify.	added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250902 15:44:45.360	20250911 11:14:35.773	20251014 13:35:32.047	94	335	335	37	231	713	713
644	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	2	Stop date of menstrual period	DM	16398884	Closed	Ashwini201	14 Oct 2025 13:37:27:723	m.deif2	16 Oct 2025 07:55:08:213	Ashwini201	16 Oct 2025 08:34:20:310		2	0	DM: Please verify and update the end date as appropriate, else clarify.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251014 13:37:27.723	20251016 07:55:08.213	20251016 08:34:20.310	94	335	335	37	231	713	713
645	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	3	Stop date of menstrual period	DM	19445871	Cancelled	JThoma858	10 Mar 2026 13:43:33:933			JThoma858	10 Mar 2026 13:43:43:343				DM: Please update the Menstrual Cycle Tracking Log for the month of Sep and Oct c 2025. else clarify.		42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260310 13:43:33.933		20260310 13:43:43.343	94	335	335	37	231	713	713
646	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	3	Stop date of menstrual period	DM	19445879	Closed	JThoma858	10 Mar 2026 13:44:03:500	v.smidkova1	12 Mar 2026 07:42:30:470	JThoma858	16 Mar 2026 05:43:02:297		2	4	DM: Please update the Menstrual Cycle Tracking Log for the month of Sep and Oct 2025. else clarify	added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260310 13:44:03.500	20260312 07:42:30.470	20260316 05:43:02.297	94	335	335	37	231	713	713
647	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Menstrual Cycle Tracking Log	0/0/N	5	Stop date of menstrual period	DM	20567074	Closed	JThoma858	30 Apr 2026 12:45:34:723	v.smidkova1	06 May 2026 09:02:07:683	JThoma858	07 May 2026 08:28:31:273		6	1	DM: Kindly update the menstrual cycle data for the month of Nov 2025.	the last menstrual cycle record is 9.10-14.10.2025	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260430 12:45:34.723	20260506 09:02:07.683	20260507 08:28:31.273	94	335	335	37	231	713	713
648	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Perceived Treatment Group Assignment	0/0/N		Questionnaire completed?	Auto	15895070	Closed	systemuser	10 Sep 2025 08:51:06:850			systemuser	11 Sep 2025 11:18:02:913			1	Please enter Yes or No if questionnaire was completed.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 08:51:06.850		20250911 11:18:02.913	94	335	335	37	231	713	713
649	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Treatment Disposition - Induction	0/0/V		Treatment Disposition Date	DM	19612747	Closed	Juhita@ksha4	20 Mar 2026 07:38:16:723	v.smidkova1	25 Mar 2026 12:15:18:540	Juhita@ksha4	25 Mar 2026 15:05:41:027		5	0	Medical Review I-3085490: Please revise the date to align with the date of in-clinic visit where the decision to discontinue treatment occurred.	done	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260320 07:38:16.723	20260325 12:15:18.540	20260325 15:05:41.027	94	335	335	37	231	713	713
650	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Trial Disposition Completion/ Discontinuation	0/0/V		Disposition Date	Auto	17891929	Closed	systemuser	10 Dec 2025 11:18:12:573	systemuser	11 Dec 2025 07:27:53:967	systemuser	11 Dec 2025 07:27:53:967		1	0	The 'Disposition Date' is not equal to or after the 'Treatment Disposition Date' "<core:link text='datapoint.uservalue' formoid='DS_GL_908' folderoid='SCRDS' fieldoid='DSSTDAT_TDD' />" on the "<core:link text='Treatment Disposition' formoid='DS_GL_908' folderoid='SCRDS' />" form. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251210 11:18:12.573	20251211 07:27:53.967	20251211 07:27:53.967	94	335	335	37	231	713	713
651	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening to end of study	Trial Disposition Completion/ Discontinuation	0/0/V		Disposition Date	DM	18460679	Closed	Ashwini201	15 Jan 2026 13:04:54:990	v.smidkova1	22 Jan 2026 06:48:07:680	shyamaprasad972	22 Jan 2026 14:46:51:627		7	0	DM: Please verify and update the data on all blank forms of Screening to end of study, else clarify.	added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260115 13:04:54.990	20260122 06:48:07.680	20260122 14:46:51.627	94	335	335	37	231	713	713
652	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Arizona Sexual Experiences Scale Summary	0/0/N		Which version of the Arizona Sexual Experiences Scale will be used?	DM	15661544	Closed	shyamaprasad972	28 Aug 2025 08:45:42:283	v.smidkova1	08 Sep 2025 11:30:37:463	shyamaprasad972	10 Sep 2025 13:52:22:177		11	2	DM: This form is asking which ASEX will be used for this subject, not if it was completed during this visit. Please update to generate form for V3 assessment.	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250828 08:45:42.283	20250908 11:30:37.463	20250910 13:52:22.177	94	335	335	37	231	713	713
653	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Date of Visit	0/0/N		Subject's Status	Site from Medical Reviewer	14344059	Closed	inayath1	15 Jul 2025 13:17:12:307	v.smidkova1	16 Jul 2025 12:15:29:003	inayath1	16 Jul 2025 13:08:23:063		1	0	Eligibility: Please update the AE form. In case subject did not experience any Adverse event, please updates the response to datapoint 'Were any adverse events experienced?' as 'No'.	added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250715 13:17:12.307	20250716 12:15:29.003	20250716 13:08:23.063	94	335	335	37	231	713	713
654	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	Site from Medical Reviewer	14344053	Closed	inayath1	15 Jul 2025 13:16:36:503	v.smidkova1	16 Jul 2025 12:14:45:160	inayath1	16 Jul 2025 13:08:43:073		1	0	Eligibility: Please fill Drug Testing and alcohol testing forms.	added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250715 13:16:36.503	20250716 12:14:45.160	20250716 13:08:43.073	94	335	335	37	231	713	713
655	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	15552688	Closed	Ashwini201	25 Aug 2025 10:00:38:473	v.smidkova1	25 Aug 2025 11:54:55:840	Ashwini201	26 Aug 2025 07:47:00:980		0	1	DM: Please verify and update the data on Educational Level form, else clarify.	added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250825 10:00:38.473	20250825 11:54:55.840	20250826 07:47:00.980	94	335	335	37	231	713	713
656	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	15582050	Closed	Ashwini201	26 Aug 2025 07:53:39:833	v.smidkova1	28 Aug 2025 06:10:09:490	shyamaprasad972	28 Aug 2025 08:45:19:577		2	0	DM: Please reactivate the Arizona Sexual Experiences Scale Summary form and update the data as appropriate, else clarify.	added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250826 07:53:39.833	20250828 06:10:09.490	20250828 08:45:19.577	94	335	335	37	231	713	713
657	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Date of Visit	0/0/N		Did this visit occur?	DM	18460722	Closed	Ashwini201	15 Jan 2026 13:06:53:950	v.smidkova1	22 Jan 2026 06:45:23:157	shyamaprasad972	22 Jan 2026 14:47:56:300		7	0	DM: Please verify and update the field 'Has the subject undergone any procedure?' on Procedures form.	Procedures were added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20260115 13:06:53.950	20260122 06:45:23.157	20260122 14:47:56.300	94	335	335	37	231	713	713
658	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Demographics	0/0/V		What is the subject's childbearing potential?	Site from Medical Reviewer	14343775	Closed	inayath1	15 Jul 2025 13:08:54:143	v.smidkova1	17 Jul 2025 08:06:12:990	meghal.choksi@iqvia.com1	18 Sep 2025 11:12:11:967		2	63	Eligibility: As per updates the subject is of childbearing potential. Please update the contraceptive method being used by the subject.	ADDED	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250715 13:08:54.143	20250717 08:06:12.990	20250918 11:12:11.967	94	335	335	37	231	713	713
659	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Demographics	0/0/V		What was the date of the signature on informed consent?	Auto	13950832	Closed	systemuser	07 Jul 2025 08:45:48:930	systemuser	08 Jul 2025 09:26:05:607	systemuser	08 Jul 2025 09:26:05:607		1	0	Date of the signature on informed consent is before or equal to the 'What is the protocol date the subject consented to at study start'. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250707 08:45:48.930	20250708 09:26:05.607	20250708 09:26:05.607	94	335	335	37	231	713	713
660	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Demographics	0/0/V		Sex reported at birth	Site from Medical Reviewer	14344103	Closed	inayath1	15 Jul 2025 13:18:27:210	v.smidkova1	16 Jul 2025 12:15:45:830	inayath1	16 Jul 2025 13:11:22:427		1	0	Eligibility: Please fill Menstrual Cycle Tracking form as per completion guidelines.	added	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250715 13:18:27.210	20250716 12:15:45.830	20250716 13:11:22.427	94	335	335	37	231	713	713
661	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Demographics	0/0/V		What is the protocol date the subject consented to at study start?	Auto	13950833	Closed	systemuser	07 Jul 2025 08:45:48:990	systemuser	08 Jul 2025 09:26:05:610	systemuser	08 Jul 2025 09:26:05:610		1	0	The 'Date of the protocol the subject consented to at study enrollment' is equal to or after the 'Date of the signature on informed consent'. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250707 08:45:48.990	20250708 09:26:05.610	20250708 09:26:05.610	94	335	335	37	231	713	713
662	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Menstrual Cycle Tracking	0/0/N	1	Start Date	Auto	14446782	Closed	systemuser	16 Jul 2025 12:06:35:770	systemuser	17 Jul 2025 08:05:29:590	systemuser	17 Jul 2025 08:05:29:593		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250716 12:06:35.770	20250717 08:05:29.590	20250717 08:05:29.593	94	335	335	37	231	713	713
663	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Menstrual Cycle Tracking	0/0/N	1	Is it ongoing?	Auto	14446783	Closed	systemuser	16 Jul 2025 12:06:35:787	systemuser	17 Jul 2025 08:05:29:593	systemuser	17 Jul 2025 08:05:29:593		1	0	Please enter the response for 'End Date' or 'Is it ongoing'.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250716 12:06:35.787	20250717 08:05:29.593	20250717 08:05:29.593	94	335	335	37	231	713	713
664	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Physical Examination	0/0/N		Was the collection date the same as the visit date?	Auto	15089446	Closed	systemuser	01 Aug 2025 08:49:42:567	systemuser	01 Aug 2025 08:51:11:300	systemuser	01 Aug 2025 08:51:11:307		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250801 08:49:42.567	20250801 08:51:11.300	20250801 08:51:11.307	94	335	335	37	231	713	713
665	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Pregnancy Test	0/0/N		Pregnancy Test Result	Auto	13950840	Closed	systemuser	07 Jul 2025 08:46:54:727	systemuser	10 Jul 2025 10:51:20:600	systemuser	10 Jul 2025 10:51:20:603		3	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250707 08:46:54.727	20250710 10:51:20.600	20250710 10:51:20.603	94	335	335	37	231	713	713
666	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 1	Vital Signs	0/0/N		Temperature Anatomical Location	Auto	13964535	Closed	systemuser	07 Jul 2025 13:19:49:323	systemuser	08 Jul 2025 09:24:07:583	systemuser	08 Jul 2025 09:24:07:583		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250707 13:19:49.323	20250708 09:24:07.583	20250708 09:24:07.583	94	335	335	37	231	713	713
667	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 2 (1)	CLINICAL OUTCOME ASSESSMENTS COMPLETION STATUS	0/0/N	2	Reason not done	Auto	15605971	Closed	systemuser	27 Aug 2025 10:08:18:913	systemuser	27 Aug 2025 10:08:37:743	systemuser	27 Aug 2025 10:08:37:743		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250827 10:08:18.913	20250827 10:08:37.743	20250827 10:08:37.743	94	335	335	37	231	713	713
668	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 2 (1)	Date of Visit	0/0/N		Subject's Status	Auto	15016522	Closed	systemuser	29 Jul 2025 05:43:27:960	systemuser	29 Jul 2025 05:43:42:423	systemuser	29 Jul 2025 05:43:42:423		0	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250729 05:43:27.960	20250729 05:43:42.423	20250729 05:43:42.423	94	335	335	37	231	713	713
669	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 2 (1)	Date of Visit	0/0/N		Visit Start Date	Auto	15020947	Closed	systemuser	29 Jul 2025 09:12:54:567			systemuser	29 Jul 2025 09:13:03:663			0	Data is not in the expected format. Please Correct.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250729 09:12:54.567		20250729 09:13:03.663	94	335	335	37	231	713	713
670	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Screening Visit 2 (1)	Date of Visit	0/0/N		Visit Start Date	Auto	15020952	Closed	systemuser	29 Jul 2025 09:13:06:183			systemuser	29 Jul 2025 09:20:17:777			0	Date of visit should be greater than the last date of visit. Please reconcile.	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250729 09:13:06.183		20250729 09:20:17.777	94	335	335	37	231	713	713
671	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Study Drug Administration (1)	Study Drug Administration Double Blind Part 1	0/0/V	1	End Date	Site from Medical Reviewer	16801433	Closed	ewajs1	05 Nov 2025 11:25:40:117	v.smidkova1	12 Nov 2025 12:56:21:550	ewajs1	26 Nov 2025 09:18:08:570		7	14	Please verify the end date and correct all the end dates on this page. The participant had last visit (V.8) in the Double Blind Part 1 on 10 Sep25, the last dose would be 09 Sep25 Sep25	updated	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251105 11:25:40.117	20251112 12:56:21.550	20251126 09:18:08.570	94	335	335	37	231	713	713
672	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	1	Start Date	Auto	15895069	Closed	systemuser	10 Sep 2025 08:51:06:807			systemuser	11 Sep 2025 11:15:04:767			1	Please enter study drug administration start date as soon as it's available	QueryCloseBySystem	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20250910 08:51:06.807		20250911 11:15:04.767	94	335	335	37	231	713	713
673	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Study Drug Administration (1)	Study Drug Administration Open Label Part 2 - Induction	0/0/V	5	End Date	Auto	16956037	Closed	systemuser	12 Nov 2025 12:59:56:273	systemuser	12 Nov 2025 13:01:40:553	systemuser	12 Nov 2025 13:01:40:557		0	0	The End Date must be equal to or after the Start Date. Please resolve.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251112 12:59:56.273	20251112 13:01:40.553	20251112 13:01:40.557	94	335	335	37	231	713	713
674	CZE	S10-CZ10008	Clintrial s r o	CZ100080001	Completed	Visit 1.5 Induction (1)	Clinical Global Impression - S (Depression)	0/0/V		Rater's Initials	Auto	16317799	Closed	systemuser	08 Oct 2025 10:37:10:350	systemuser	09 Oct 2025 09:24:35:773	systemuser	09 Oct 2025 09:24:35:783		1	0	Required field. Please complete or provide a response.	Value changed.	42847922MDD3003 [Prod]	CZE	All	All	All	None	All	All	All	All	All	No	None	None	None	None	None	Final	With Text	5.6 - 1.0	5/21/2026 4:26:25 AM	GMT	Vladimir Buzalka [Site Manager]		20251008 10:37:10.350	20251009 09:24:35.773	20251009 09:24:35.783	94	335	335	37	231	713	713

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