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vladimir.buzalka
2026-06-12 15:29:57 +02:00
parent 39e578af2d
commit 35e6310dac
79 changed files with 27428 additions and 0 deletions
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Clario/Downloads/Zpracovano/2026-06-12_08-10-42 77242113UCO3001 Clario MayoScore.csv
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"Protocol","Study Population","Country","Site","Principal Investigator","Participant ID","Baseline Stool Frequency","Visit","Visit Date","Endoscopy Completed?","Endoscopy Date","Bowel Preparation Start Date 1","Bowel Preparation End Date 1","Bowel Preparation Start Date 2","Bowel Preparation End Date 2","Central Endoscopy Score","Local Endoscopy Score","PGA Score","Eligible Day (-1)","Day (-1) Excluded Reason(s)","Eligible Day (-2)","Day (-2) Excluded Reason(s)","Eligible Day (-3)","Day (-3) Excluded Reason(s)","Eligible Day (-4)","Day (-4) Excluded Reason(s)","Eligible Day (-5)","Day (-5) Excluded Reason(s)","Eligible Day (-6)","Day (-6) Excluded Reason(s)","Eligible Day (-7)","Day (-7) Excluded Reason(s)","Eligible Day (-8)","Day (-8) Excluded Reason(s)","Eligible Day (-9)","Day (-9) Excluded Reason(s)","Eligible Day (-10)","Day (-10) Excluded Reason(s)","Eligible Day (-1) Stool Count","Eligible Day (-2) Stool Count","Eligible Day (-3) Stool Count","Eligible Day (-4) Stool Count","Eligible Day (-5) Stool Count","Eligible Day (-6) Stool Count","Eligible Day (-7) Stool Count","Eligible Day (-8) Stool Count","Eligible Day (-9) Stool Count","Eligible Day (-10) Stool Count","Stool Frequency Sub-score","Eligible Day (-1) Rectal Bleeding Score","Eligible Day (-2) Rectal Bleeding Score","Eligible Day (-3) Rectal Bleeding Score","Eligible Day (-4) Rectal Bleeding Score","Eligible Day (-5) Rectal Bleeding Score","Eligible Day (-6) Rectal Bleeding Score","Eligible Day (-7) Rectal Bleeding Score","Eligible Day (-8) Rectal Bleeding Score","Eligible Day (-9) Rectal Bleeding Score","Eligible Day (-10) Rectal Bleeding Score","Rectal Bleeding Sub-score","Partial Mayo Score","Modified Mayo Score","Full Mayo Score","Site Action","Last Mayo Score Submission","Week I-12 Clinical Responder","Week I-12 Clinical Remission","Clinical Flare","Loss of Response","Partial Mayo Response Post Loss of Response","Partial Mayo Response for Clinical Non-Responders"
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"77242113UCO3001","Adult","Czech Republic","DD5-CZ10013","David Stepek","CZ100132001","1","I-2","08 Apr 2026","-","-","-","-","-","-","-","-","2","07 Apr 2026","-","06 Apr 2026","-","05 Apr 2026","-","04 Apr 2026","-","03 Apr 2026","-","02 Apr 2026","-","01 Apr 2026","-","31 Mar 2026","Day Not Applicable for Calculation","30 Mar 2026","Day Not Applicable for Calculation","29 Mar 2026","Day Not Applicable for Calculation","5","2","3","6","5","5","5","-","-","-","2","0","0","0","0","1","1","0","-","-","-","0","4","","","-","27 May 2026 12:53:52","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10013","David Stepek","CZ100132001","1","I-4","21 Apr 2026","-","-","-","-","-","-","-","-","0","20 Apr 2026","-","19 Apr 2026","-","18 Apr 2026","-","17 Apr 2026","-","16 Apr 2026","-","15 Apr 2026","-","14 Apr 2026","-","13 Apr 2026","Day Not Applicable for Calculation","12 Apr 2026","Day Not Applicable for Calculation","11 Apr 2026","Day Not Applicable for Calculation","4","3","4","3","3","4","4","-","-","-","2","0","0","0","0","0","0","0","-","-","-","0","2","","","-","27 May 2026 12:54:41","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10013","David Stepek","CZ100132002","1","I-0","12 May 2026","Yes","21 Apr 2026","20 Apr 2026","21 Apr 2026","-","-","2","-","2","11 May 2026","-","10 May 2026","-","09 May 2026","-","08 May 2026","-","07 May 2026","-","06 May 2026","-","05 May 2026","Missing Diary","04 May 2026","Day Not Applicable for Calculation","03 May 2026","Day Not Applicable for Calculation","02 May 2026","Day Not Applicable for Calculation","2","1","1","1","1","2","-","-","-","-","0","0","0","0","0","0","0","-","-","-","-","0","2","2","4","-","28 May 2026 23:19:30","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10013","David Stepek","CZ100132002","1","I-2","26 May 2026","-","-","-","-","-","-","-","-","1","25 May 2026","-","24 May 2026","Missing Diary","23 May 2026","-","22 May 2026","-","21 May 2026","-","20 May 2026","-","19 May 2026","-","18 May 2026","Missing Diary;Day Not Applicable for Calculation","17 May 2026","Day Not Applicable for Calculation","16 May 2026","Day Not Applicable for Calculation","1","-","1","2","1","2","2","-","-","-","1","0","-","0","0","0","0","0","-","-","-","0","2","","","-","28 May 2026 23:19:51","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10013","David Stepek","CZ100132002","1","I-4","10 Jun 2026","-","-","-","-","-","-","-","-","2","09 Jun 2026","-","08 Jun 2026","Missing Diary","07 Jun 2026","-","06 Jun 2026","-","05 Jun 2026","-","04 Jun 2026","-","03 Jun 2026","-","02 Jun 2026","Missing Diary;Day Not Applicable for Calculation","01 Jun 2026","Day Not Applicable for Calculation","31 May 2026","Day Not Applicable for Calculation","4","-","1","1","2","2","1","-","-","-","1","0","-","0","0","0","0","0","-","-","-","0","3","","","-","-","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10013","David Stepek","CZ100132003","1","I-0","02 Jun 2026","Yes","25 May 2026","24 May 2026","24 May 2026","-","-","2","-","2","01 Jun 2026","-","31 May 2026","-","30 May 2026","-","29 May 2026","-","28 May 2026","-","27 May 2026","-","26 May 2026","-","25 May 2026","Endoscopy;Missing Diary;Day Not Applicable for Calculation","24 May 2026","Bowel Preparation for Procedure;Missing Diary;Day Not Applicable for Calculation","23 May 2026","Missing Diary;Day Not Applicable for Calculation","8","8","11","10","10","11","6","-","-","-","3","2","2","1","2","1","2","2","-","-","-","2","7","7","9","-","02 Jun 2026 08:17:40","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10013","David Stepek","CZ100132003","1","I-2","10 Jun 2026","-","-","-","-","-","-","-","-","2","09 Jun 2026","-","08 Jun 2026","-","07 Jun 2026","-","06 Jun 2026","-","05 Jun 2026","-","04 Jun 2026","-","03 Jun 2026","-","02 Jun 2026","Day Not Applicable for Calculation","01 Jun 2026","Day Not Applicable for Calculation","31 May 2026","Day Not Applicable for Calculation","9","2","1","4","2","4","2","-","-","-","1","1","1","0","1","1","1","0","-","-","-","1","4","","","-","-","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10016","Robert Mudr","CZ100162001","1","I-0","28 May 2026","Yes","19 May 2026","18 May 2026","19 May 2026","-","-","3","-","3","27 May 2026","-","26 May 2026","-","25 May 2026","-","24 May 2026","-","23 May 2026","-","22 May 2026","-","21 May 2026","-","20 May 2026","Day Not Applicable for Calculation","19 May 2026","Endoscopy;Bowel Preparation for Procedure;Day Not Applicable for Calculation","18 May 2026","Bowel Preparation for Procedure;Day Not Applicable for Calculation","14","15","15","15","15","15","15","-","-","-","3","2","3","3","2","2","3","3","-","-","-","3","9","9","12","-","28 May 2026 10:22:48","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10016","Robert Mudr","CZ100162001","1","I-2","11 Jun 2026","-","-","-","-","-","-","-","-","3","10 Jun 2026","-","09 Jun 2026","-","08 Jun 2026","-","07 Jun 2026","-","06 Jun 2026","-","05 Jun 2026","-","04 Jun 2026","-","03 Jun 2026","Day Not Applicable for Calculation","02 Jun 2026","Day Not Applicable for Calculation","01 Jun 2026","Day Not Applicable for Calculation","10","9","9","8","13","9","8","-","-","-","3","2","1","1","1","2","1","1","-","-","-","1","7","","","-","-","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adolescent","Czech Republic","DD5-CZ10020","Lucie Gonsorcikova","CZ100201001","1","Unscheduled 1","04 May 2026","Yes","20 Apr 2026","12 Apr 2026","15 Apr 2026","-","-","2","-","3","03 May 2026","-","02 May 2026","-","01 May 2026","-","30 Apr 2026","-","29 Apr 2026","-","28 Apr 2026","-","27 Apr 2026","-","26 Apr 2026","Day Not Applicable for Calculation","25 Apr 2026","Day Not Applicable for Calculation","24 Apr 2026","Day Not Applicable for Calculation","5","6","6","7","6","3","3","-","-","-","2","0","0","0","0","0","0","0","-","-","-","0","5","4","7","-","-","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adolescent","Czech Republic","DD5-CZ10020","Lucie Gonsorcikova","CZ100201001","1","I-0","18 May 2026","Yes","01 May 2026","01 May 2026","01 May 2026","-","-","2","-","3","17 May 2026","-","16 May 2026","-","15 May 2026","-","14 May 2026","-","13 May 2026","-","12 May 2026","-","11 May 2026","-","10 May 2026","Day Not Applicable for Calculation","09 May 2026","Day Not Applicable for Calculation","08 May 2026","Day Not Applicable for Calculation","6","6","6","6","6","6","6","-","-","-","3","0","0","0","0","0","0","0","-","-","-","0","6","5","8","-","18 May 2026 08:36:37","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adolescent","Czech Republic","DD5-CZ10020","Lucie Gonsorcikova","CZ100201001","1","I-2","01 Jun 2026","-","-","-","-","-","-","-","-","3","31 May 2026","-","30 May 2026","Missing Diary","29 May 2026","Missing Diary","28 May 2026","Missing Diary","27 May 2026","-","26 May 2026","-","25 May 2026","-","24 May 2026","Day Not Applicable for Calculation","23 May 2026","Day Not Applicable for Calculation","22 May 2026","Day Not Applicable for Calculation","6","-","-","-","6","6","6","-","-","-","3","0","-","-","-","0","0","0","-","-","-","0","6","","","-","-","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10021","Martin Bortlik","CZ100212001","1","I-0","07 Apr 2026","Yes","16 Mar 2026","15 Mar 2026","16 Mar 2026","-","-","3","-","3","06 Apr 2026","-","05 Apr 2026","-","04 Apr 2026","-","03 Apr 2026","-","02 Apr 2026","-","01 Apr 2026","-","31 Mar 2026","-","30 Mar 2026","Day Not Applicable for Calculation","29 Mar 2026","Day Not Applicable for Calculation","28 Mar 2026","Day Not Applicable for Calculation","11","11","10","11","11","10","9","-","-","-","3","2","2","2","2","2","2","2","-","-","-","2","8","8","11","-","20 Apr 2026 09:27:58","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10021","Martin Bortlik","CZ100212001","1","I-2","20 Apr 2026","-","-","-","-","-","-","-","-","3","19 Apr 2026","-","18 Apr 2026","-","17 Apr 2026","-","16 Apr 2026","-","15 Apr 2026","-","14 Apr 2026","-","13 Apr 2026","-","12 Apr 2026","Day Not Applicable for Calculation","11 Apr 2026","Day Not Applicable for Calculation","10 Apr 2026","Day Not Applicable for Calculation","8","7","9","8","8","7","8","-","-","-","3","2","2","1","1","1","2","1","-","-","-","1","7","","","-","20 Apr 2026 09:29:01","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10021","Martin Bortlik","CZ100212001","1","I-4","05 May 2026","-","-","-","-","-","-","-","-","1","04 May 2026","-","03 May 2026","-","02 May 2026","-","01 May 2026","-","30 Apr 2026","-","29 Apr 2026","-","28 Apr 2026","-","27 Apr 2026","Day Not Applicable for Calculation","26 Apr 2026","Day Not Applicable for Calculation","25 Apr 2026","Day Not Applicable for Calculation","6","6","6","6","7","7","6","-","-","-","3","0","0","1","1","1","1","1","-","-","-","1","5","","","-","-","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10021","Martin Bortlik","CZ100212001","1","I-8","02 Jun 2026","-","-","-","-","-","-","-","-","1","01 Jun 2026","-","31 May 2026","-","30 May 2026","-","29 May 2026","-","28 May 2026","-","27 May 2026","-","26 May 2026","-","25 May 2026","Day Not Applicable for Calculation","24 May 2026","Day Not Applicable for Calculation","23 May 2026","Day Not Applicable for Calculation","3","4","4","4","5","5","5","-","-","-","2","0","0","0","0","0","1","1","-","-","-","0","3","","","-","02 Jun 2026 14:44:34","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222002","1","I-0","19 Feb 2026","Yes","11 Feb 2026","10 Feb 2026","11 Feb 2026","-","-","2","-","2","18 Feb 2026","-","17 Feb 2026","-","16 Feb 2026","-","15 Feb 2026","-","14 Feb 2026","-","13 Feb 2026","-","12 Feb 2026","-","11 Feb 2026","Endoscopy;Bowel Preparation for Procedure;Day Not Applicable for Calculation","10 Feb 2026","Bowel Preparation for Procedure;Day Not Applicable for Calculation","09 Feb 2026","Day Not Applicable for Calculation","3","2","2","3","4","3","2","-","-","-","1","1","1","0","0","0","2","2","-","-","-","1","4","4","6","-","19 Feb 2026 15:24:43","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222003","1","I-0","09 Mar 2026","Yes","11 Feb 2026","10 Feb 2026","11 Feb 2026","-","-","2","-","2","08 Mar 2026","-","07 Mar 2026","-","06 Mar 2026","-","05 Mar 2026","-","04 Mar 2026","-","03 Mar 2026","Missing Diary","02 Mar 2026","Missing Diary","01 Mar 2026","Missing Diary;Day Not Applicable for Calculation","28 Feb 2026","Missing Diary;Day Not Applicable for Calculation","27 Feb 2026","Missing Diary;Day Not Applicable for Calculation","7","7","6","6","7","-","-","-","-","-","3","2","2","2","2","2","-","-","-","-","-","2","7","7","9","-","27 Mar 2026 07:27:49","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222003","1","I-2","27 Mar 2026","-","-","-","-","-","-","-","-","2","26 Mar 2026","-","25 Mar 2026","-","24 Mar 2026","-","23 Mar 2026","-","22 Mar 2026","-","21 Mar 2026","-","20 Mar 2026","-","19 Mar 2026","Day Not Applicable for Calculation","18 Mar 2026","Day Not Applicable for Calculation","17 Mar 2026","Day Not Applicable for Calculation","7","3","3","3","5","5","5","-","-","-","2","0","0","1","1","1","1","2","-","-","-","1","5","","","-","08 Apr 2026 07:36:56","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222003","1","I-4","08 Apr 2026","-","-","-","-","-","-","-","-","2","07 Apr 2026","-","06 Apr 2026","-","05 Apr 2026","-","04 Apr 2026","-","03 Apr 2026","-","02 Apr 2026","-","01 Apr 2026","-","31 Mar 2026","Day Not Applicable for Calculation","30 Mar 2026","Day Not Applicable for Calculation","29 Mar 2026","Day Not Applicable for Calculation","3","3","4","4","5","4","3","-","-","-","2","1","0","0","2","1","1","2","-","-","-","1","5","","","-","08 Apr 2026 07:59:35","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222003","1","I-8","04 May 2026","-","-","-","-","-","-","-","-","2","03 May 2026","-","02 May 2026","-","01 May 2026","-","30 Apr 2026","-","29 Apr 2026","-","28 Apr 2026","-","27 Apr 2026","-","26 Apr 2026","Day Not Applicable for Calculation","25 Apr 2026","Day Not Applicable for Calculation","24 Apr 2026","Missing Diary;Day Not Applicable for Calculation","3","5","3","3","3","2","3","-","-","-","1","0","0","0","0","0","0","0","-","-","-","0","3","","","-","04 May 2026 07:52:47","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222003","1","I-12","01 Jun 2026","Yes","20 May 2026","19 May 2026","20 May 2026","-","-","3","-","2","31 May 2026","-","30 May 2026","-","29 May 2026","-","28 May 2026","-","27 May 2026","-","26 May 2026","-","25 May 2026","-","24 May 2026","Day Not Applicable for Calculation","23 May 2026","Day Not Applicable for Calculation","22 May 2026","Day Not Applicable for Calculation","4","4","6","3","3","3","3","-","-","-","2","1","1","2","1","1","1","2","-","-","-","1","5","6","8","-","01 Jun 2026 14:25:57","Clinical Nonresponder","No","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222005","1","I-0","09 Apr 2026","Yes","08 Apr 2026","31 Mar 2026","01 Apr 2026","-","-","2","-","2","08 Apr 2026","Endoscopy","07 Apr 2026","-","06 Apr 2026","-","05 Apr 2026","-","04 Apr 2026","-","03 Apr 2026","-","02 Apr 2026","-","01 Apr 2026","Bowel Preparation for Procedure;Day Not Applicable for Calculation","31 Mar 2026","Bowel Preparation for Procedure;Day Not Applicable for Calculation","30 Mar 2026","-","-","3","3","4","3","4","3","-","-","3","1","-","2","2","2","2","2","2","-","-","2","2","5","5","7","-","29 May 2026 11:07:08","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222005","1","I-2","22 Apr 2026","-","-","-","-","-","-","-","-","2","21 Apr 2026","-","20 Apr 2026","-","19 Apr 2026","-","18 Apr 2026","-","17 Apr 2026","-","16 Apr 2026","-","15 Apr 2026","-","14 Apr 2026","Day Not Applicable for Calculation","13 Apr 2026","Day Not Applicable for Calculation","12 Apr 2026","Day Not Applicable for Calculation","3","3","5","3","2","3","2","-","-","-","1","1","2","2","1","1","1","2","-","-","-","1","4","","","-","22 Apr 2026 14:12:15","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222005","1","I-4","05 May 2026","-","-","-","-","-","-","-","-","2","04 May 2026","-","03 May 2026","-","02 May 2026","-","01 May 2026","-","30 Apr 2026","-","29 Apr 2026","-","28 Apr 2026","-","27 Apr 2026","Day Not Applicable for Calculation","26 Apr 2026","Day Not Applicable for Calculation","25 Apr 2026","Day Not Applicable for Calculation","4","2","2","2","2","2","2","-","-","-","1","1","1","1","1","2","1","1","-","-","-","1","4","","","-","05 May 2026 07:30:02","N/A","N/A","N/A","N/A","N/A","N/A"
"77242113UCO3001","Adult","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222005","1","I-8","02 Jun 2026","-","-","-","-","-","-","-","-","2","01 Jun 2026","-","31 May 2026","-","30 May 2026","-","29 May 2026","-","28 May 2026","-","27 May 2026","-","26 May 2026","-","25 May 2026","Day Not Applicable for Calculation","24 May 2026","Day Not Applicable for Calculation","23 May 2026","Day Not Applicable for Calculation","2","2","2","2","2","4","10","-","-","-","1","2","1","2","1","2","2","2","-","-","-","2","5","","","-","02 Jun 2026 08:19:16","N/A","N/A","N/A","N/A","N/A","N/A"
1 Protocol Study Population Country Site Principal Investigator Participant ID Baseline Stool Frequency Visit Visit Date Endoscopy Completed? Endoscopy Date Bowel Preparation Start Date 1 Bowel Preparation End Date 1 Bowel Preparation Start Date 2 Bowel Preparation End Date 2 Central Endoscopy Score Local Endoscopy Score PGA Score Eligible Day (-1) Day (-1) Excluded Reason(s) Eligible Day (-2) Day (-2) Excluded Reason(s) Eligible Day (-3) Day (-3) Excluded Reason(s) Eligible Day (-4) Day (-4) Excluded Reason(s) Eligible Day (-5) Day (-5) Excluded Reason(s) Eligible Day (-6) Day (-6) Excluded Reason(s) Eligible Day (-7) Day (-7) Excluded Reason(s) Eligible Day (-8) Day (-8) Excluded Reason(s) Eligible Day (-9) Day (-9) Excluded Reason(s) Eligible Day (-10) Day (-10) Excluded Reason(s) Eligible Day (-1) Stool Count Eligible Day (-2) Stool Count Eligible Day (-3) Stool Count Eligible Day (-4) Stool Count Eligible Day (-5) Stool Count Eligible Day (-6) Stool Count Eligible Day (-7) Stool Count Eligible Day (-8) Stool Count Eligible Day (-9) Stool Count Eligible Day (-10) Stool Count Stool Frequency Sub-score Eligible Day (-1) Rectal Bleeding Score Eligible Day (-2) Rectal Bleeding Score Eligible Day (-3) Rectal Bleeding Score Eligible Day (-4) Rectal Bleeding Score Eligible Day (-5) Rectal Bleeding Score Eligible Day (-6) Rectal Bleeding Score Eligible Day (-7) Rectal Bleeding Score Eligible Day (-8) Rectal Bleeding Score Eligible Day (-9) Rectal Bleeding Score Eligible Day (-10) Rectal Bleeding Score Rectal Bleeding Sub-score Partial Mayo Score Modified Mayo Score Full Mayo Score Site Action Last Mayo Score Submission Week I-12 Clinical Responder Week I-12 Clinical Remission Clinical Flare Loss of Response Partial Mayo Response Post Loss of Response Partial Mayo Response for Clinical Non-Responders
2 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012001 1 I-0 19 Feb 2026 Yes 05 Feb 2026 04 Feb 2026 04 Feb 2026 - - 2 - 3 18 Feb 2026 - 17 Feb 2026 - 16 Feb 2026 - 15 Feb 2026 - 14 Feb 2026 - 13 Feb 2026 - 12 Feb 2026 - 11 Feb 2026 Day Not Applicable for Calculation 10 Feb 2026 Day Not Applicable for Calculation 09 Feb 2026 Day Not Applicable for Calculation 10 8 7 5 7 8 8 - - - 3 1 1 1 0 1 1 1 - - - 1 7 6 9 - 08 Apr 2026 07:11:25 N/A N/A N/A N/A N/A N/A
3 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012001 1 I-2 04 Mar 2026 - - - - - - - - 3 03 Mar 2026 - 02 Mar 2026 - 01 Mar 2026 - 28 Feb 2026 - 27 Feb 2026 - 26 Feb 2026 - 25 Feb 2026 - 24 Feb 2026 Day Not Applicable for Calculation 23 Feb 2026 Day Not Applicable for Calculation 22 Feb 2026 Day Not Applicable for Calculation 5 4 5 4 5 6 6 - - - 2 1 0 1 0 1 0 1 - - - 1 6 - 28 May 2026 10:04:05 N/A N/A N/A N/A N/A N/A
4 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012001 1 I-4 18 Mar 2026 - - - - - - - - 2 17 Mar 2026 - 16 Mar 2026 - 15 Mar 2026 - 14 Mar 2026 - 13 Mar 2026 - 12 Mar 2026 - 11 Mar 2026 - 10 Mar 2026 Day Not Applicable for Calculation 09 Mar 2026 Day Not Applicable for Calculation 08 Mar 2026 Day Not Applicable for Calculation 5 5 5 4 5 4 5 - - - 2 1 0 0 1 1 1 0 - - - 1 5 - 08 Apr 2026 07:11:43 N/A N/A N/A N/A N/A N/A
5 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012001 1 I-8 05 May 2026 - - - - - - - - 1 04 May 2026 - 03 May 2026 - 02 May 2026 - 01 May 2026 - 30 Apr 2026 - 29 Apr 2026 - 28 Apr 2026 - 27 Apr 2026 Day Not Applicable for Calculation 26 Apr 2026 Day Not Applicable for Calculation 25 Apr 2026 Day Not Applicable for Calculation 3 3 4 4 5 4 4 - - - 2 1 1 1 1 1 1 1 - - - 1 4 - 28 May 2026 14:42:53 N/A N/A N/A N/A N/A N/A
6 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012001 1 I-12 13 May 2026 Yes 06 May 2026 05 May 2026 05 May 2026 - - 1 - 1 12 May 2026 - 11 May 2026 - 10 May 2026 - 09 May 2026 - 08 May 2026 - 07 May 2026 - 06 May 2026 Endoscopy 05 May 2026 Bowel Preparation for Procedure;Day Not Applicable for Calculation 04 May 2026 - 03 May 2026 Day Not Applicable for Calculation 5 4 6 5 5 5 - - 3 - 2 1 0 1 1 1 1 - - 1 - 1 4 4 5 - 28 May 2026 14:43:11 Clinical Responder No N/A N/A N/A N/A
7 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012001 1 M-4 10 Jun 2026 - - - - - - - - 1 09 Jun 2026 - 08 Jun 2026 - 07 Jun 2026 - 06 Jun 2026 - 05 Jun 2026 - 04 Jun 2026 - 03 Jun 2026 - 02 Jun 2026 Day Not Applicable for Calculation 01 Jun 2026 Day Not Applicable for Calculation 31 May 2026 Day Not Applicable for Calculation 4 5 3 4 5 4 5 - - - 2 0 0 0 0 1 0 1 - - - 0 3 - 10 Jun 2026 07:15:50 N/A N/A No N/A N/A N/A
8 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012002 1 I-0 08 Apr 2026 Yes 18 Mar 2026 17 Mar 2026 18 Mar 2026 - - 2 - 2 07 Apr 2026 - 06 Apr 2026 - 05 Apr 2026 - 04 Apr 2026 Missing Diary 03 Apr 2026 - 02 Apr 2026 - 01 Apr 2026 - 31 Mar 2026 Day Not Applicable for Calculation 30 Mar 2026 Day Not Applicable for Calculation 29 Mar 2026 Day Not Applicable for Calculation 3 3 4 - 3 3 4 - - - 1 0 0 0 - 0 0 1 - - - 0 3 3 5 - 10 Jun 2026 08:42:08 N/A N/A N/A N/A N/A N/A
9 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012002 1 I-2 23 Apr 2026 - - - - - - - - 2 22 Apr 2026 Missing Diary 21 Apr 2026 - 20 Apr 2026 - 19 Apr 2026 - 18 Apr 2026 - 17 Apr 2026 - 16 Apr 2026 - 15 Apr 2026 Day Not Applicable for Calculation 14 Apr 2026 Day Not Applicable for Calculation 13 Apr 2026 Day Not Applicable for Calculation - 3 3 6 5 5 4 - - - 2 - 0 0 1 1 1 1 - - - 1 5 - 10 Jun 2026 08:42:33 N/A N/A N/A N/A N/A N/A
10 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012002 1 I-4 06 May 2026 - - - - - - - - 1 05 May 2026 - 04 May 2026 - 03 May 2026 - 02 May 2026 - 01 May 2026 - 30 Apr 2026 - 29 Apr 2026 - 28 Apr 2026 Day Not Applicable for Calculation 27 Apr 2026 Day Not Applicable for Calculation 26 Apr 2026 Day Not Applicable for Calculation 6 3 2 3 3 3 3 - - - 1 1 0 0 0 1 1 0 - - - 0 2 - 04 Jun 2026 07:39:06 N/A N/A N/A N/A N/A N/A
11 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012002 1 I-8 04 Jun 2026 - - - - - - - - 1 03 Jun 2026 - 02 Jun 2026 - 01 Jun 2026 - 31 May 2026 - 30 May 2026 - 29 May 2026 - 28 May 2026 - 27 May 2026 Day Not Applicable for Calculation 26 May 2026 Day Not Applicable for Calculation 25 May 2026 Day Not Applicable for Calculation 3 4 3 3 3 3 4 - - - 1 0 0 0 0 0 0 1 - - - 0 2 - - N/A N/A N/A N/A N/A N/A
12 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012003 1 I-0 27 May 2026 Yes 13 May 2026 12 May 2026 12 May 2026 - - 3 - 2 26 May 2026 - 25 May 2026 - 24 May 2026 - 23 May 2026 - 22 May 2026 - 21 May 2026 - 20 May 2026 - 19 May 2026 Day Not Applicable for Calculation 18 May 2026 Day Not Applicable for Calculation 17 May 2026 Day Not Applicable for Calculation 6 9 7 8 9 7 8 - - - 3 2 2 2 2 1 1 1 - - - 2 7 8 10 - 27 May 2026 07:24:39 N/A N/A N/A N/A N/A N/A
13 77242113UCO3001 Adult Czech Republic DD5-CZ10001 Matej Falc CZ100012003 1 I-2 10 Jun 2026 - - - - - - - - 2 09 Jun 2026 - 08 Jun 2026 - 07 Jun 2026 - 06 Jun 2026 - 05 Jun 2026 - 04 Jun 2026 - 03 Jun 2026 - 02 Jun 2026 Day Not Applicable for Calculation 01 Jun 2026 Day Not Applicable for Calculation 31 May 2026 Day Not Applicable for Calculation 7 8 8 7 6 8 6 - - - 3 2 2 1 2 2 2 1 - - - 2 7 - 10 Jun 2026 07:30:18 N/A N/A N/A N/A N/A N/A
14 77242113UCO3001 Adult Czech Republic DD5-CZ10003 Leksa Vaclav CZ100032001 2 I-0 10 Jun 2026 Yes 27 May 2026 26 May 2026 26 May 2026 - - 2 - 2 09 Jun 2026 - 08 Jun 2026 - 07 Jun 2026 - 06 Jun 2026 - 05 Jun 2026 - 04 Jun 2026 - 03 Jun 2026 - 02 Jun 2026 Day Not Applicable for Calculation 01 Jun 2026 Day Not Applicable for Calculation 31 May 2026 Day Not Applicable for Calculation 4 4 4 4 5 4 5 - - - 1 2 2 2 2 2 2 2 - - - 2 5 5 7 - 10 Jun 2026 08:48:09 N/A N/A N/A N/A N/A N/A
15 77242113UCO3001 Adult Czech Republic DD5-CZ10006 Michal Konecny CZ100062001 1 I-0 20 Mar 2026 Yes 19 Feb 2026 - - - - 3 - 3 19 Mar 2026 - 18 Mar 2026 - 17 Mar 2026 - 16 Mar 2026 - 15 Mar 2026 - 14 Mar 2026 - 13 Mar 2026 - 12 Mar 2026 Day Not Applicable for Calculation 11 Mar 2026 Day Not Applicable for Calculation 10 Mar 2026 Day Not Applicable for Calculation 7 7 8 8 7 8 5 - - - 3 2 1 1 1 1 1 0 - - - 1 7 7 10 - 20 Mar 2026 07:02:44 N/A N/A N/A N/A N/A N/A
16 77242113UCO3001 Adult Czech Republic DD5-CZ10006 Michal Konecny CZ100062001 1 I-2 08 Apr 2026 - - - - - - - - 2 07 Apr 2026 Medication For Diarrhea 06 Apr 2026 Medication For Diarrhea 05 Apr 2026 Medication For Diarrhea 04 Apr 2026 Medication For Diarrhea 03 Apr 2026 Medication For Diarrhea 02 Apr 2026 Medication For Diarrhea 01 Apr 2026 Medication For Diarrhea 31 Mar 2026 Medication For Diarrhea;Day Not Applicable for Calculation 30 Mar 2026 Medication For Diarrhea;Day Not Applicable for Calculation 29 Mar 2026 Day Not Applicable for Calculation - - - - - - - - - - Non-Evaluable - - - - - - - - - - Non-Evaluable Non-Evaluable Non-Evaluable Non-Evaluable - - N/A N/A N/A N/A N/A N/A
17 77242113UCO3001 Adult Czech Republic DD5-CZ10006 Michal Konecny CZ100062001 1 I-4 15 Apr 2026 - - - - - - - - 3 14 Apr 2026 - 13 Apr 2026 - 12 Apr 2026 - 11 Apr 2026 - 10 Apr 2026 - 09 Apr 2026 - 08 Apr 2026 - 07 Apr 2026 Medication For Diarrhea;Day Not Applicable for Calculation 06 Apr 2026 Medication For Diarrhea;Day Not Applicable for Calculation 05 Apr 2026 Medication For Diarrhea;Day Not Applicable for Calculation 9 22 20 19 17 18 18 - - - 3 1 3 2 2 2 2 2 - - - 2 8 - 04 May 2026 22:06:03 N/A N/A N/A N/A N/A N/A
18 77242113UCO3001 Adult Czech Republic DD5-CZ10006 Michal Konecny CZ100062001 1 I-8 18 May 2026 - - - - - - - - 2 17 May 2026 - 16 May 2026 - 15 May 2026 - 14 May 2026 - 13 May 2026 - 12 May 2026 - 11 May 2026 - 10 May 2026 Day Not Applicable for Calculation 09 May 2026 Day Not Applicable for Calculation 08 May 2026 Day Not Applicable for Calculation 7 5 9 7 7 8 8 - - - 3 1 1 1 1 1 1 1 - - - 1 6 - 04 Jun 2026 21:41:47 N/A N/A N/A N/A N/A N/A
19 77242113UCO3001 Adult Czech Republic DD5-CZ10006 Michal Konecny CZ100062001 1 I-12 08 Jun 2026 Yes 28 May 2026 - - - - 3 - 3 07 Jun 2026 - 06 Jun 2026 - 05 Jun 2026 - 04 Jun 2026 - 03 Jun 2026 - 02 Jun 2026 - 01 Jun 2026 Missing Diary 31 May 2026 Day Not Applicable for Calculation 30 May 2026 Day Not Applicable for Calculation 29 May 2026 Day Not Applicable for Calculation 6 5 5 5 7 6 - - - - 3 1 1 0 0 1 0 - - - - 1 7 7 10 - 11 Jun 2026 22:12:05 Clinical Nonresponder No N/A N/A N/A N/A
20 77242113UCO3001 Adult Czech Republic DD5-CZ10006 Michal Konecny CZ100062002 1 I-0 26 May 2026 Yes 14 May 2026 13 May 2026 13 May 2026 - - 2 - 2 25 May 2026 - 24 May 2026 - 23 May 2026 - 22 May 2026 - 21 May 2026 - 20 May 2026 - 19 May 2026 - 18 May 2026 Day Not Applicable for Calculation 17 May 2026 Day Not Applicable for Calculation 16 May 2026 Day Not Applicable for Calculation 8 8 6 7 7 6 7 - - - 3 2 2 2 2 2 2 2 - - - 2 7 7 9 - 29 May 2026 15:45:00 N/A N/A N/A N/A N/A N/A
21 77242113UCO3001 Adult Czech Republic DD5-CZ10006 Michal Konecny CZ100062002 1 I-2 09 Jun 2026 - - - - - - - - 2 08 Jun 2026 - 07 Jun 2026 - 06 Jun 2026 - 05 Jun 2026 - 04 Jun 2026 - 03 Jun 2026 - 02 Jun 2026 - 01 Jun 2026 Day Not Applicable for Calculation 31 May 2026 Day Not Applicable for Calculation 30 May 2026 Day Not Applicable for Calculation 7 8 7 7 7 5 7 - - - 3 2 1 1 1 2 2 2 - - - 2 7 - 11 Jun 2026 22:12:40 N/A N/A N/A N/A N/A N/A
22 77242113UCO3001 Adult Czech Republic DD5-CZ10009 Jiri Pumprla CZ100092001 1 I-0 05 May 2026 Yes 24 Apr 2026 23 Apr 2026 23 Apr 2026 - - 2 - 2 04 May 2026 - 03 May 2026 - 02 May 2026 - 01 May 2026 - 30 Apr 2026 - 29 Apr 2026 - 28 Apr 2026 - 27 Apr 2026 Day Not Applicable for Calculation 26 Apr 2026 Day Not Applicable for Calculation 25 Apr 2026 Day Not Applicable for Calculation 5 5 5 5 5 5 5 - - - 2 1 1 1 1 1 1 1 - - - 1 5 5 7 - 05 May 2026 11:19:40 N/A N/A N/A N/A N/A N/A
23 77242113UCO3001 Adult Czech Republic DD5-CZ10009 Jiri Pumprla CZ100092001 1 I-2 19 May 2026 - - - - - - - - 1 18 May 2026 - 17 May 2026 - 16 May 2026 - 15 May 2026 - 14 May 2026 - 13 May 2026 - 12 May 2026 - 11 May 2026 Day Not Applicable for Calculation 10 May 2026 Day Not Applicable for Calculation 09 May 2026 Day Not Applicable for Calculation 5 4 5 5 5 4 6 - - - 2 1 1 1 1 1 1 1 - - - 1 4 - 19 May 2026 10:38:25 N/A N/A N/A N/A N/A N/A
24 77242113UCO3001 Adult Czech Republic DD5-CZ10009 Jiri Pumprla CZ100092001 1 I-4 04 Jun 2026 - - - - - - - - 1 03 Jun 2026 - 02 Jun 2026 - 01 Jun 2026 - 31 May 2026 - 30 May 2026 - 29 May 2026 - 28 May 2026 - 27 May 2026 Day Not Applicable for Calculation 26 May 2026 Day Not Applicable for Calculation 25 May 2026 Day Not Applicable for Calculation 2 3 2 3 3 2 3 - - - 1 0 0 0 0 0 0 0 - - - 0 2 - 04 Jun 2026 09:24:54 N/A N/A N/A N/A N/A N/A
25 77242113UCO3001 Adult Czech Republic DD5-CZ10012 Stefan Konecny CZ100122001 5 I-0 07 Apr 2026 Yes 24 Mar 2026 22 Mar 2026 22 Mar 2026 - - 2 - 2 06 Apr 2026 - 05 Apr 2026 - 04 Apr 2026 - 03 Apr 2026 - 02 Apr 2026 - 01 Apr 2026 - 31 Mar 2026 - 30 Mar 2026 Day Not Applicable for Calculation 29 Mar 2026 Day Not Applicable for Calculation 28 Mar 2026 Day Not Applicable for Calculation 8 11 5 9 11 10 13 - - - 3 1 2 2 2 2 2 2 - - - 2 7 7 9 - 04 May 2026 08:44:52 N/A N/A N/A N/A N/A N/A
26 77242113UCO3001 Adult Czech Republic DD5-CZ10012 Stefan Konecny CZ100122001 5 I-2 22 Apr 2026 - - - - - - - - 2 21 Apr 2026 - 20 Apr 2026 - 19 Apr 2026 - 18 Apr 2026 - 17 Apr 2026 - 16 Apr 2026 - 15 Apr 2026 - 14 Apr 2026 Day Not Applicable for Calculation 13 Apr 2026 Day Not Applicable for Calculation 12 Apr 2026 Day Not Applicable for Calculation 7 5 6 6 7 8 2 - - - 1 1 0 1 1 1 2 0 - - - 1 4 - 04 May 2026 08:45:07 N/A N/A N/A N/A N/A N/A
27 77242113UCO3001 Adult Czech Republic DD5-CZ10012 Stefan Konecny CZ100122001 5 I-4 07 May 2026 - - - - - - - - 1 06 May 2026 - 05 May 2026 - 04 May 2026 - 03 May 2026 - 02 May 2026 - 01 May 2026 - 30 Apr 2026 - 29 Apr 2026 Day Not Applicable for Calculation 28 Apr 2026 Day Not Applicable for Calculation 27 Apr 2026 Day Not Applicable for Calculation 8 7 7 8 4 11 7 - - - 1 2 1 1 1 0 1 1 - - - 1 3 - 01 Jun 2026 00:57:35 N/A N/A N/A N/A N/A N/A
28 77242113UCO3001 Adult Czech Republic DD5-CZ10012 Stefan Konecny CZ100122001 5 I-8 03 Jun 2026 - - - - - - - - 2 02 Jun 2026 - 01 Jun 2026 - 31 May 2026 - 30 May 2026 - 29 May 2026 - 28 May 2026 - 27 May 2026 - 26 May 2026 Day Not Applicable for Calculation 25 May 2026 Day Not Applicable for Calculation 24 May 2026 Day Not Applicable for Calculation 5 9 7 5 5 9 7 - - - 1 1 1 1 0 3 0 1 - - - 1 4 - 03 Jun 2026 17:47:25 N/A N/A N/A N/A N/A N/A
29 77242113UCO3001 Adult Czech Republic DD5-CZ10013 David Stepek CZ100132001 1 I-0 24 Mar 2026 Yes 12 Mar 2026 11 Mar 2026 11 Mar 2026 - - 2 - 2 23 Mar 2026 - 22 Mar 2026 - 21 Mar 2026 - 20 Mar 2026 - 19 Mar 2026 - 18 Mar 2026 - 17 Mar 2026 - 16 Mar 2026 Day Not Applicable for Calculation 15 Mar 2026 Day Not Applicable for Calculation 14 Mar 2026 Day Not Applicable for Calculation 8 6 5 7 6 7 6 - - - 3 1 1 1 0 1 1 1 - - - 1 6 6 8 - 05 Apr 2026 22:41:27 N/A N/A N/A N/A N/A N/A
30 77242113UCO3001 Adult Czech Republic DD5-CZ10013 David Stepek CZ100132001 1 I-2 08 Apr 2026 - - - - - - - - 2 07 Apr 2026 - 06 Apr 2026 - 05 Apr 2026 - 04 Apr 2026 - 03 Apr 2026 - 02 Apr 2026 - 01 Apr 2026 - 31 Mar 2026 Day Not Applicable for Calculation 30 Mar 2026 Day Not Applicable for Calculation 29 Mar 2026 Day Not Applicable for Calculation 5 2 3 6 5 5 5 - - - 2 0 0 0 0 1 1 0 - - - 0 4 - 27 May 2026 12:53:52 N/A N/A N/A N/A N/A N/A
31 77242113UCO3001 Adult Czech Republic DD5-CZ10013 David Stepek CZ100132001 1 I-4 21 Apr 2026 - - - - - - - - 0 20 Apr 2026 - 19 Apr 2026 - 18 Apr 2026 - 17 Apr 2026 - 16 Apr 2026 - 15 Apr 2026 - 14 Apr 2026 - 13 Apr 2026 Day Not Applicable for Calculation 12 Apr 2026 Day Not Applicable for Calculation 11 Apr 2026 Day Not Applicable for Calculation 4 3 4 3 3 4 4 - - - 2 0 0 0 0 0 0 0 - - - 0 2 - 27 May 2026 12:54:41 N/A N/A N/A N/A N/A N/A
32 77242113UCO3001 Adult Czech Republic DD5-CZ10013 David Stepek CZ100132002 1 I-0 12 May 2026 Yes 21 Apr 2026 20 Apr 2026 21 Apr 2026 - - 2 - 2 11 May 2026 - 10 May 2026 - 09 May 2026 - 08 May 2026 - 07 May 2026 - 06 May 2026 - 05 May 2026 Missing Diary 04 May 2026 Day Not Applicable for Calculation 03 May 2026 Day Not Applicable for Calculation 02 May 2026 Day Not Applicable for Calculation 2 1 1 1 1 2 - - - - 0 0 0 0 0 0 0 - - - - 0 2 2 4 - 28 May 2026 23:19:30 N/A N/A N/A N/A N/A N/A
33 77242113UCO3001 Adult Czech Republic DD5-CZ10013 David Stepek CZ100132002 1 I-2 26 May 2026 - - - - - - - - 1 25 May 2026 - 24 May 2026 Missing Diary 23 May 2026 - 22 May 2026 - 21 May 2026 - 20 May 2026 - 19 May 2026 - 18 May 2026 Missing Diary;Day Not Applicable for Calculation 17 May 2026 Day Not Applicable for Calculation 16 May 2026 Day Not Applicable for Calculation 1 - 1 2 1 2 2 - - - 1 0 - 0 0 0 0 0 - - - 0 2 - 28 May 2026 23:19:51 N/A N/A N/A N/A N/A N/A
34 77242113UCO3001 Adult Czech Republic DD5-CZ10013 David Stepek CZ100132002 1 I-4 10 Jun 2026 - - - - - - - - 2 09 Jun 2026 - 08 Jun 2026 Missing Diary 07 Jun 2026 - 06 Jun 2026 - 05 Jun 2026 - 04 Jun 2026 - 03 Jun 2026 - 02 Jun 2026 Missing Diary;Day Not Applicable for Calculation 01 Jun 2026 Day Not Applicable for Calculation 31 May 2026 Day Not Applicable for Calculation 4 - 1 1 2 2 1 - - - 1 0 - 0 0 0 0 0 - - - 0 3 - - N/A N/A N/A N/A N/A N/A
35 77242113UCO3001 Adult Czech Republic DD5-CZ10013 David Stepek CZ100132003 1 I-0 02 Jun 2026 Yes 25 May 2026 24 May 2026 24 May 2026 - - 2 - 2 01 Jun 2026 - 31 May 2026 - 30 May 2026 - 29 May 2026 - 28 May 2026 - 27 May 2026 - 26 May 2026 - 25 May 2026 Endoscopy;Missing Diary;Day Not Applicable for Calculation 24 May 2026 Bowel Preparation for Procedure;Missing Diary;Day Not Applicable for Calculation 23 May 2026 Missing Diary;Day Not Applicable for Calculation 8 8 11 10 10 11 6 - - - 3 2 2 1 2 1 2 2 - - - 2 7 7 9 - 02 Jun 2026 08:17:40 N/A N/A N/A N/A N/A N/A
36 77242113UCO3001 Adult Czech Republic DD5-CZ10013 David Stepek CZ100132003 1 I-2 10 Jun 2026 - - - - - - - - 2 09 Jun 2026 - 08 Jun 2026 - 07 Jun 2026 - 06 Jun 2026 - 05 Jun 2026 - 04 Jun 2026 - 03 Jun 2026 - 02 Jun 2026 Day Not Applicable for Calculation 01 Jun 2026 Day Not Applicable for Calculation 31 May 2026 Day Not Applicable for Calculation 9 2 1 4 2 4 2 - - - 1 1 1 0 1 1 1 0 - - - 1 4 - - N/A N/A N/A N/A N/A N/A
37 77242113UCO3001 Adult Czech Republic DD5-CZ10016 Robert Mudr CZ100162001 1 I-0 28 May 2026 Yes 19 May 2026 18 May 2026 19 May 2026 - - 3 - 3 27 May 2026 - 26 May 2026 - 25 May 2026 - 24 May 2026 - 23 May 2026 - 22 May 2026 - 21 May 2026 - 20 May 2026 Day Not Applicable for Calculation 19 May 2026 Endoscopy;Bowel Preparation for Procedure;Day Not Applicable for Calculation 18 May 2026 Bowel Preparation for Procedure;Day Not Applicable for Calculation 14 15 15 15 15 15 15 - - - 3 2 3 3 2 2 3 3 - - - 3 9 9 12 - 28 May 2026 10:22:48 N/A N/A N/A N/A N/A N/A
38 77242113UCO3001 Adult Czech Republic DD5-CZ10016 Robert Mudr CZ100162001 1 I-2 11 Jun 2026 - - - - - - - - 3 10 Jun 2026 - 09 Jun 2026 - 08 Jun 2026 - 07 Jun 2026 - 06 Jun 2026 - 05 Jun 2026 - 04 Jun 2026 - 03 Jun 2026 Day Not Applicable for Calculation 02 Jun 2026 Day Not Applicable for Calculation 01 Jun 2026 Day Not Applicable for Calculation 10 9 9 8 13 9 8 - - - 3 2 1 1 1 2 1 1 - - - 1 7 - - N/A N/A N/A N/A N/A N/A
39 77242113UCO3001 Adolescent Czech Republic DD5-CZ10020 Lucie Gonsorcikova CZ100201001 1 Unscheduled 1 04 May 2026 Yes 20 Apr 2026 12 Apr 2026 15 Apr 2026 - - 2 - 3 03 May 2026 - 02 May 2026 - 01 May 2026 - 30 Apr 2026 - 29 Apr 2026 - 28 Apr 2026 - 27 Apr 2026 - 26 Apr 2026 Day Not Applicable for Calculation 25 Apr 2026 Day Not Applicable for Calculation 24 Apr 2026 Day Not Applicable for Calculation 5 6 6 7 6 3 3 - - - 2 0 0 0 0 0 0 0 - - - 0 5 4 7 - - N/A N/A N/A N/A N/A N/A
40 77242113UCO3001 Adolescent Czech Republic DD5-CZ10020 Lucie Gonsorcikova CZ100201001 1 I-0 18 May 2026 Yes 01 May 2026 01 May 2026 01 May 2026 - - 2 - 3 17 May 2026 - 16 May 2026 - 15 May 2026 - 14 May 2026 - 13 May 2026 - 12 May 2026 - 11 May 2026 - 10 May 2026 Day Not Applicable for Calculation 09 May 2026 Day Not Applicable for Calculation 08 May 2026 Day Not Applicable for Calculation 6 6 6 6 6 6 6 - - - 3 0 0 0 0 0 0 0 - - - 0 6 5 8 - 18 May 2026 08:36:37 N/A N/A N/A N/A N/A N/A
41 77242113UCO3001 Adolescent Czech Republic DD5-CZ10020 Lucie Gonsorcikova CZ100201001 1 I-2 01 Jun 2026 - - - - - - - - 3 31 May 2026 - 30 May 2026 Missing Diary 29 May 2026 Missing Diary 28 May 2026 Missing Diary 27 May 2026 - 26 May 2026 - 25 May 2026 - 24 May 2026 Day Not Applicable for Calculation 23 May 2026 Day Not Applicable for Calculation 22 May 2026 Day Not Applicable for Calculation 6 - - - 6 6 6 - - - 3 0 - - - 0 0 0 - - - 0 6 - - N/A N/A N/A N/A N/A N/A
42 77242113UCO3001 Adult Czech Republic DD5-CZ10021 Martin Bortlik CZ100212001 1 I-0 07 Apr 2026 Yes 16 Mar 2026 15 Mar 2026 16 Mar 2026 - - 3 - 3 06 Apr 2026 - 05 Apr 2026 - 04 Apr 2026 - 03 Apr 2026 - 02 Apr 2026 - 01 Apr 2026 - 31 Mar 2026 - 30 Mar 2026 Day Not Applicable for Calculation 29 Mar 2026 Day Not Applicable for Calculation 28 Mar 2026 Day Not Applicable for Calculation 11 11 10 11 11 10 9 - - - 3 2 2 2 2 2 2 2 - - - 2 8 8 11 - 20 Apr 2026 09:27:58 N/A N/A N/A N/A N/A N/A
43 77242113UCO3001 Adult Czech Republic DD5-CZ10021 Martin Bortlik CZ100212001 1 I-2 20 Apr 2026 - - - - - - - - 3 19 Apr 2026 - 18 Apr 2026 - 17 Apr 2026 - 16 Apr 2026 - 15 Apr 2026 - 14 Apr 2026 - 13 Apr 2026 - 12 Apr 2026 Day Not Applicable for Calculation 11 Apr 2026 Day Not Applicable for Calculation 10 Apr 2026 Day Not Applicable for Calculation 8 7 9 8 8 7 8 - - - 3 2 2 1 1 1 2 1 - - - 1 7 - 20 Apr 2026 09:29:01 N/A N/A N/A N/A N/A N/A
44 77242113UCO3001 Adult Czech Republic DD5-CZ10021 Martin Bortlik CZ100212001 1 I-4 05 May 2026 - - - - - - - - 1 04 May 2026 - 03 May 2026 - 02 May 2026 - 01 May 2026 - 30 Apr 2026 - 29 Apr 2026 - 28 Apr 2026 - 27 Apr 2026 Day Not Applicable for Calculation 26 Apr 2026 Day Not Applicable for Calculation 25 Apr 2026 Day Not Applicable for Calculation 6 6 6 6 7 7 6 - - - 3 0 0 1 1 1 1 1 - - - 1 5 - - N/A N/A N/A N/A N/A N/A
45 77242113UCO3001 Adult Czech Republic DD5-CZ10021 Martin Bortlik CZ100212001 1 I-8 02 Jun 2026 - - - - - - - - 1 01 Jun 2026 - 31 May 2026 - 30 May 2026 - 29 May 2026 - 28 May 2026 - 27 May 2026 - 26 May 2026 - 25 May 2026 Day Not Applicable for Calculation 24 May 2026 Day Not Applicable for Calculation 23 May 2026 Day Not Applicable for Calculation 3 4 4 4 5 5 5 - - - 2 0 0 0 0 0 1 1 - - - 0 3 - 02 Jun 2026 14:44:34 N/A N/A N/A N/A N/A N/A
46 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222002 1 I-0 19 Feb 2026 Yes 11 Feb 2026 10 Feb 2026 11 Feb 2026 - - 2 - 2 18 Feb 2026 - 17 Feb 2026 - 16 Feb 2026 - 15 Feb 2026 - 14 Feb 2026 - 13 Feb 2026 - 12 Feb 2026 - 11 Feb 2026 Endoscopy;Bowel Preparation for Procedure;Day Not Applicable for Calculation 10 Feb 2026 Bowel Preparation for Procedure;Day Not Applicable for Calculation 09 Feb 2026 Day Not Applicable for Calculation 3 2 2 3 4 3 2 - - - 1 1 1 0 0 0 2 2 - - - 1 4 4 6 - 19 Feb 2026 15:24:43 N/A N/A N/A N/A N/A N/A
47 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222003 1 I-0 09 Mar 2026 Yes 11 Feb 2026 10 Feb 2026 11 Feb 2026 - - 2 - 2 08 Mar 2026 - 07 Mar 2026 - 06 Mar 2026 - 05 Mar 2026 - 04 Mar 2026 - 03 Mar 2026 Missing Diary 02 Mar 2026 Missing Diary 01 Mar 2026 Missing Diary;Day Not Applicable for Calculation 28 Feb 2026 Missing Diary;Day Not Applicable for Calculation 27 Feb 2026 Missing Diary;Day Not Applicable for Calculation 7 7 6 6 7 - - - - - 3 2 2 2 2 2 - - - - - 2 7 7 9 - 27 Mar 2026 07:27:49 N/A N/A N/A N/A N/A N/A
48 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222003 1 I-2 27 Mar 2026 - - - - - - - - 2 26 Mar 2026 - 25 Mar 2026 - 24 Mar 2026 - 23 Mar 2026 - 22 Mar 2026 - 21 Mar 2026 - 20 Mar 2026 - 19 Mar 2026 Day Not Applicable for Calculation 18 Mar 2026 Day Not Applicable for Calculation 17 Mar 2026 Day Not Applicable for Calculation 7 3 3 3 5 5 5 - - - 2 0 0 1 1 1 1 2 - - - 1 5 - 08 Apr 2026 07:36:56 N/A N/A N/A N/A N/A N/A
49 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222003 1 I-4 08 Apr 2026 - - - - - - - - 2 07 Apr 2026 - 06 Apr 2026 - 05 Apr 2026 - 04 Apr 2026 - 03 Apr 2026 - 02 Apr 2026 - 01 Apr 2026 - 31 Mar 2026 Day Not Applicable for Calculation 30 Mar 2026 Day Not Applicable for Calculation 29 Mar 2026 Day Not Applicable for Calculation 3 3 4 4 5 4 3 - - - 2 1 0 0 2 1 1 2 - - - 1 5 - 08 Apr 2026 07:59:35 N/A N/A N/A N/A N/A N/A
50 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222003 1 I-8 04 May 2026 - - - - - - - - 2 03 May 2026 - 02 May 2026 - 01 May 2026 - 30 Apr 2026 - 29 Apr 2026 - 28 Apr 2026 - 27 Apr 2026 - 26 Apr 2026 Day Not Applicable for Calculation 25 Apr 2026 Day Not Applicable for Calculation 24 Apr 2026 Missing Diary;Day Not Applicable for Calculation 3 5 3 3 3 2 3 - - - 1 0 0 0 0 0 0 0 - - - 0 3 - 04 May 2026 07:52:47 N/A N/A N/A N/A N/A N/A
51 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222003 1 I-12 01 Jun 2026 Yes 20 May 2026 19 May 2026 20 May 2026 - - 3 - 2 31 May 2026 - 30 May 2026 - 29 May 2026 - 28 May 2026 - 27 May 2026 - 26 May 2026 - 25 May 2026 - 24 May 2026 Day Not Applicable for Calculation 23 May 2026 Day Not Applicable for Calculation 22 May 2026 Day Not Applicable for Calculation 4 4 6 3 3 3 3 - - - 2 1 1 2 1 1 1 2 - - - 1 5 6 8 - 01 Jun 2026 14:25:57 Clinical Nonresponder No N/A N/A N/A N/A
52 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222005 1 I-0 09 Apr 2026 Yes 08 Apr 2026 31 Mar 2026 01 Apr 2026 - - 2 - 2 08 Apr 2026 Endoscopy 07 Apr 2026 - 06 Apr 2026 - 05 Apr 2026 - 04 Apr 2026 - 03 Apr 2026 - 02 Apr 2026 - 01 Apr 2026 Bowel Preparation for Procedure;Day Not Applicable for Calculation 31 Mar 2026 Bowel Preparation for Procedure;Day Not Applicable for Calculation 30 Mar 2026 - - 3 3 4 3 4 3 - - 3 1 - 2 2 2 2 2 2 - - 2 2 5 5 7 - 29 May 2026 11:07:08 N/A N/A N/A N/A N/A N/A
53 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222005 1 I-2 22 Apr 2026 - - - - - - - - 2 21 Apr 2026 - 20 Apr 2026 - 19 Apr 2026 - 18 Apr 2026 - 17 Apr 2026 - 16 Apr 2026 - 15 Apr 2026 - 14 Apr 2026 Day Not Applicable for Calculation 13 Apr 2026 Day Not Applicable for Calculation 12 Apr 2026 Day Not Applicable for Calculation 3 3 5 3 2 3 2 - - - 1 1 2 2 1 1 1 2 - - - 1 4 - 22 Apr 2026 14:12:15 N/A N/A N/A N/A N/A N/A
54 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222005 1 I-4 05 May 2026 - - - - - - - - 2 04 May 2026 - 03 May 2026 - 02 May 2026 - 01 May 2026 - 30 Apr 2026 - 29 Apr 2026 - 28 Apr 2026 - 27 Apr 2026 Day Not Applicable for Calculation 26 Apr 2026 Day Not Applicable for Calculation 25 Apr 2026 Day Not Applicable for Calculation 4 2 2 2 2 2 2 - - - 1 1 1 1 1 2 1 1 - - - 1 4 - 05 May 2026 07:30:02 N/A N/A N/A N/A N/A N/A
55 77242113UCO3001 Adult Czech Republic DD5-CZ10022 Petr Hrabak CZ100222005 1 I-8 02 Jun 2026 - - - - - - - - 2 01 Jun 2026 - 31 May 2026 - 30 May 2026 - 29 May 2026 - 28 May 2026 - 27 May 2026 - 26 May 2026 - 25 May 2026 Day Not Applicable for Calculation 24 May 2026 Day Not Applicable for Calculation 23 May 2026 Day Not Applicable for Calculation 2 2 2 2 2 4 10 - - - 1 2 1 2 1 2 2 2 - - - 2 5 - 02 Jun 2026 08:19:16 N/A N/A N/A N/A N/A N/A
Clario/Downloads/Zpracovano/2026-06-12_08-15-18 77242113UCO3001 Clario MayoDiary.csv
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Clario/Downloads/Zpracovano/2026-06-12_08-50-33 77242113UCO3001 Clario eCOA DCRs.csv
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"Protocol","Country","Site","PI Name","Subject ID","Age at Informed Consent","Baseline Stool Count","Confirm Baseline Stool Count","Data Correction ID","Creation Date UTC","Status","Description","Date of Last Action UTC","Total Open Period","Total Open Time (Days)","Current Status Time (Days)","Type","Next Action Required","Category","Query History","Reason for Change","Resolution"
"77242113UCO3001","Czech Republic","DD5-CZ10001","Matej Falc","CZ100012001","48","1","","SW00703544","13-May-2026","Submitted","Please change answer to clinical remision from no to YES (week 12). Entry erros ","20-May-2026","15-21 Days","21","16","Query Active ","Site","New","(1) 20 May 2026 msullivan (Clario): Please confirm your request
Dear Site. Thank you for submitting this Data Clarification Request.
For us to process your request, please let us know the name of the form (with date) with question.
Thank you. ERT/CLARIO Data Coordination Team
","Entry Error",""
"77242113UCO3001","Czech Republic","DD5-CZ10001","Matej Falc","CZ100012002","79","1","","SW00696586","09-Apr-2026","ReadyForQC","Please correct date of endoscopy to date: 18 March 2026 (from 25 March 2026)","15-Apr-2026","Over 28 Days","43","39","Query Active ","Site","Site-Entered Data","","Entry Error","CLARIO RESOLUTION:
Part 1: In Mayo Subscore (1) dated 08 Apr 2026 for I-0 visit, CLARIO to make the following changes:
- What was the date of endoscopy? (ENDODT1D): from 25 Mar 2026 to 18 Mar 2026
- Data Flag (QSDFLG1B): from blank to check
"
"77242113UCO3001","Czech Republic","DD5-CZ10006","Michal Konecny","CZ100062001","19","1","","SW00704536","19-May-2026","ReadyForQC","Please change the endoscopy date to 19-FEB-2026. 06-MAR-2026 was entered in error. ","26-May-2026","15-21 Days","17","12","Query Active ","Site","Site-Entered Data","","Entry Error","CLARIO RESOLUTION:
Part 1: In Mayo Subscore (1) dated 20 Mar 2026 for I-0 visit, CLARIO to make the following changes:
-What was the date of endoscopy? (ENDODT1D): from 06 Mar 2026 to 19 Feb 2026
- Data Flag (QSDFLG1B): from blank to check
"
"77242113UCO3001","Czech Republic","DD5-CZ10012","Stefan Konecny","CZ100122001","22","5","Yes, I confirm this is the correct stool count.","SW00706684","01-Jun-2026","Submitted","The right endoscopy date is 23MAR2026, please change the date","05-Jun-2026","8-14 Days","9","4","Query Active ","Site","New","(1) 05 Jun 2026 msullivan (Clario): Please confirm your request
Dear Site. Thank you for submitting this Data Clarification.
Please confirm that if you are requesting following.
Mayo Subscore (1) dated 07 Apr 2026 for I-0
What was the date of endoscopy? (ENDODT1D): from 24 Mar 2026 to 23 Mar 2026
Thank you. ERT/CLARIO Data Coordination Team.
","Entry Error",""
"77242113UCO3001","Czech Republic","DD5-CZ10013","David Stepek","CZ100132002","29","1","","SW00705646","26-May-2026","ReadyForQC","Correct visit date I-O is 12-May-2026. All questionaries were filled on paper and entered in tablet later.
Log-in issue. ","09-Jun-2026","8-14 Days","12","3","","Clario DM","Visit Data","(1) 01 Jun 2026 msullivan (Clario): Please confirm your request
Dear Site. Thank you for submitting this Data Clarification.
Please provide the timestamps for each of the assessments if you used paper forms and transcribed into the device.
If unknown, ERT will use a dummy timestamp.
Thank you. ERT/CLARIO Data Coordination Team.
(2) 01 Jun 2026 dstepek@vnbrno.cz (Site User): time is unknown
","Changed Information","CLARIO RESOLUTION:
Part 1: In the following forms for I-0, CLARIO to make the following changes:
-Report Date: from 26May 2026 to 12 May 2026
-Report Start Date and time: from 26 May 2026 to 12 May 2026 23:59:59
-Event End Date: from 26 May 2026 08:27:57 to 12 May 2026 23:59:59
+Tablet Training Module (1)
+Participant Start Instructions (1)
+IBDQ (1)
+PROMIS Fatigue – Short Form 7a (1)
+BASDAI (1)
+Participant End Instructions (1)
+Visit End (122)
"
"77242113UCO3001","Czech Republic","DD5-CZ10013","David Stepek","CZ100132003","49","1","","SW00708623","10-Jun-2026","Cancelled","Correct date of I-2 is 26.5.2026. all questionaries were entered on paper at 07,45 and transmited later. ","10-Jun-2026","1 Day","1","","","","New","","yes, subject mishmasch",""
"77242113UCO3001","Czech Republic","DD5-CZ10013","David Stepek","CZ100132003","49","1","","SW00706581","29-May-2026","Completed","baseline stool count reported by subject is 0, please change to 1 as per CRA request (subject has 1 stool in 2-3 days if in remission)","10-Jun-2026","4-7 Days","7","","","","Demographic","","Changed Information","CLARIO RESOLUTION:
Part 1: In System Variables form, CLARIO to make the following changes:
- Baseline Stool Count (PT.Custom4): from 0 to 1
"
"77242113UCO3001","Czech Republic","DD5-CZ10016","Robert Mudr","CZ100162001","48","1","","SW00705916","27-May-2026","Completed","As per ATS investigation (ATS26040111), please remove the below form which was entered as a duplicate
- MAYO Diary (5) 24 Apr 2026","10-Jun-2026","8-14 Days","9","","","","Technical Revision","","Technical Revision - Other","CLARIO RESOLUTION:
Part 1: CLARIO to delete MAYO Diary (5) dated 24 Apr 2026
"
"77242113UCO3001","Czech Republic","DD5-CZ10020","Lucie Gonsorcikova","CZ100201001","15","1","","SW00701729","06-May-2026","Completed","Dears, please delete data from visit I-0 (reported as 4th of May 2026) as this visit had to be postponed - see the previous DCR of this patient and change data request that was corrected. Patient has left the site before it was resolved and and new date of I-0 was planned. Patient continues to fill in his diary and patient is coming to I=0 visit within allowed window. We need the system and tablet to be ready to run new Mayo Score Report with updated and recent data (e.g. reflect new I-0 visit date, new eligible days -1 to -7.).
thank you, Jiri Skopek","19-May-2026","8-14 Days","8","","","","Visit Data","(1) 11 May 2026 msullivan (Clario): Please confirm your request
Dear Site. Thank you for submitting this Data Clarification.
Please note that the delete forms are allowed if the reason is one of the following.
If not, forms will move to unscheduled visit.
Data collected by the wrong patient.
Data collected by someone other than the patient.
Data collected prior to informed consent, or after withdrawal from the study.
Duplicate data erroneously entered at an Unscheduled visit via paper transcription.
Data collected that is not expected per protocol.
Also, I-0 visit is still ongoing. Please close the visit.
Once the visit was closed, we will process accoridngly.
Thank you. ERT/CLARIO Data Coordination Team
(2) 11 May 2026 jskopek (Site User): Dears,
I do not see any option that is adequate -from the list. Data are not needed to be deleted fully, they reflect the situation at May4th. Please mark it as unscheduled visit - as exactly that is the case. We need the system to be ready for I-0 visit planned for next week.
I will close the visit tomorrow - do you mean in tablet/ipad?
Thank you very much for your help! Jiri
(3) 12 May 2026 venkata.ramana (Clario): Thank you for your response.
Please note that the visit I-0 was still ongoing but not closed yet.
So please close the visit.
Kind Regards, Clario Data Coordination Team.
(4) 12 May 2026 jskopek (Site User): If I try to close the I-O visit in TABLET, it asks me if patient fulfils eligibility criteria to proceed to next visit based on these old data – if I answer NO, it asks me to DEACTIVATE patient. I do not want to DEACTIVATE patient – can you help WHERE and HOW to close this visit for you to change it to UNSCHEDULED and not to de-activate patient?
Thank you Jiri
","Other-delete visit I-0","CLARIO RESOLUTION:
Part 1: In the following forms dated 04 May 2026, CLARIO to make the following changes:
-Event ID: from I-0 to Unscheduled Visit 1
-Event At Entry: from I-0 to Unscheduled Visit 1
+Visit Start (49)
+ePRO Availability (1)
+Mayo Subscore (1)
+PGA (1)
Part 2: CLARIO to delete the following forms dated 04 May 2026 for I-0 visit.
+C-SSRS Since Last Visit (1)
+C-SSRS Since Last Visit Findings Report (1)
Part 3: CLARIO to manually enter Visit End form for Unscheduled visit 1 with the following information:
-Protocol: 77242113UCO3001
-Report Date: 04 May 2026
-Report Start Date and Time: 04 May 2026 23:59:59
-Event ID: Unscheduled Visit 1
-Event End Date: 04 May 2026 23:59:59
-Visit Status: Incomplete
-Phase At Entry: Screening
-Phase At Entry Timestamp: 13 Apr 2026 12:32:20
-Event At Entry: Unscheduled visit 1
-Event Start Date: 04 May 2026 23:59:59
-Event Time Zone Offset in Milliseconds: 7200000
-Session Repeat Number (SESREP1N): 0
-Session Instance Id (SESINST1S): 3f1214f0-4788-11f1-a0cf-bb403212adce
"
"77242113UCO3001","Czech Republic","DD5-CZ10020","Lucie Gonsorcikova","CZ100201001","15","1","","SW00701226","04-May-2026","Completed","Dears, we would like ask you to change the information I read on assignment form given by patient on April 13, 2026 (Visit 1), Baseline Stool Count (PT.Custom4) as 3 that should be reported as 1.
Patient has entered wrong number as he did not understood it should be number of stools when illness is in remission or absent. He is a child and did not reflected this question correctly. Therefore, please change Baseline Stool Count = 1.
Thank you, Jiri Skopek ","04-May-2026","1 Day","1","","","","Demographic","","Changed Information","(Clario instructions)
1. Please make below changes in the assignment form:
Baseline Stool Count (PT. Custom4): 03 to 01."
"77242113UCO3001","Czech Republic","DD5-CZ10021","Martin Bortlik","CZ100212001","61","1","","SW00699492","23-Apr-2026","ReadyForQC","Please correct the date of endoscopy done during screening visit of patient CZ100212001 to correct date 16-MAR-2026.","29-Apr-2026","Over 28 Days","34","30","Query Active ","Site","Site-Entered Data","","Changed Information","CLARIO RESOLUTION:
Part 1: In the Mayo Subscore (1) dated 07 Apr 2026 for I-0 visit, CLARIO to make the following changes:
-What was the date of endoscopy? (ENDODT1D): from 24 Mar 2026 to 16 Mar 2026
- Data Flag (QSDFLG1B): from blank to check
"
"77242113UCO3001","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222003","39","1","","SW00703322","12-May-2026","Completed","As per ATS investigation (ATS26040111), please remove the below form that's been entered as a duplicate
- MAYO Diary (16) - 18 Mar 2026
","20-May-2026","4-7 Days","6","","","","Technical Revision","","Technical Revision - Other","CLARIO RESOLUTION:
Part 1: CLARIO to delete the MAYO Diary (16) dated 18 Mar 2026.
"
"77242113UCO3001","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222003","39","1","","SW00689748","09-Mar-2026","Completed","Dear all,
Patient CZ 100222003 was randomized on 9 Mar 2026. Kindly correct the colonoscopy date to 11 Feb 2025.
The date was initially entered as 21 Feb 2025 because the earlier date could not be entered in the system. The patient was rescreened.","02-Apr-2026","15-21 Days","17","","","","Site-Entered Data","(1) 13 Mar 2026 msullivan (Clario): Please confirm your request
Dear Site. Thank you for submitting this Data Clarification.
Could you please conform that if you are requesting following?
Mayo Subscore (1) dated 09 Mar 2026 for I-0 visit
-What was the date of endoscopy? (ENDODT1D): from 23 Feb 2026 to 11 Feb 2025
Could you please confirm the year? This subject was assigned on 02 Mar 2026, you are providing that correct date is 11 Feb 2025 which a year ago.
If you are not requesting above, please provide us the name of the form with question.
Thank you. ERT/CLARIO Data Coordination Team
(2) 13 Mar 2026 katerina.havlikova@clinoxus.com (Site User): confirm date of colonoscopy 11Feb2026
(3) 21 Mar 2026 msullivan (Clario): Dear Site,
The requested changes to the Mayo data have been updated. Please navigate to the Mayo Score Report and resubmit the form for visit to log the updated Mayo Score form. Once done, please respond to this query confirming that the Mayo Score has been resubmitted.
Thank you. ERT/CLARIO Data Coordination Team
(4) 24 Mar 2026 jana.pomahacova@clinoxus.com (Site User): Thank you and sent
","New Information","CLARIO RESOLUTION:
Part 1: In the Mayo Subscore (1) dated 09 Mar 2026 for I-0 visit, CLARIO to make the following changes:
-What was the date of endoscopy? (ENDODT1D): from 23 Feb 2026 to 11 Feb 2025
-Data Flag (QSDFLG1B): from blank to check"
"77242113UCO3001","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222005","33","1","","SW00705372","22-May-2026","Submitted","Dear all, please change Colonoscopz date from 8April2026 to date 01Apr2026 Thank you in advance","02-Jun-2026","8-14 Days","14","7","","Clario DM","New","(1) 29 May 2026 msullivan (Clario): Please confirm your request
Dear Site. Thank you for submitting this Data Clarification.
Please provide us the name of the form for this request.
Thank you. ERT/CLARIO Data Coordination Team
(2) 02 Jun 2026 katerina.havlikova@clinoxus.com (Site User): Dear all, please change Colonoscopy for Week I-12 date from 8April2026 to date 01Apr2026 Thank you in advance
","Changed Information",""
"77242113UCO3001","Czech Republic","DD5-CZ10022","Petr Hrabak","CZ100222005","33","1","","SW00702538","08-May-2026","Completed","This TRR is to document the correction to the Mayo Subscore (1) form, where the following variables were populated with NULL values, due to a known core defect:
Event At Entry, Event Start Date, Event Time Zone Offset in Milliseconds.","12-May-2026","2-3 Days","2","","","","Technical Revision","","Technical Revision - Other","Please make the below changes in Mayo Subscore (1) dated 22 Apr 2026:
-Event At Entry: I-0
-Event Start Date: 09 Apr 2026 08:09:19
-Event Time Zone Offset in Milliseconds: 7200000"
1 Protocol Country Site PI Name Subject ID Age at Informed Consent Baseline Stool Count Confirm Baseline Stool Count Data Correction ID Creation Date UTC Status Description Date of Last Action UTC Total Open Period Total Open Time (Days) Current Status Time (Days) Type Next Action Required Category Query History Reason for Change Resolution
2 77242113UCO3001 Czech Republic DD5-CZ10001 Matej Falc CZ100012001 48 1 SW00703544 13-May-2026 Submitted Please change answer to clinical remision from no to YES (week 12). Entry erros 20-May-2026 15-21 Days 21 16 Query Active Site New (1) 20 May 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification Request. For us to process your request, please let us know the name of the form (with date) with question. Thank you. ERT/CLARIO Data Coordination Team Entry Error
3 77242113UCO3001 Czech Republic DD5-CZ10001 Matej Falc CZ100012002 79 1 SW00696586 09-Apr-2026 ReadyForQC Please correct date of endoscopy to date: 18 March 2026 (from 25 March 2026) 15-Apr-2026 Over 28 Days 43 39 Query Active Site Site-Entered Data Entry Error CLARIO RESOLUTION: Part 1: In Mayo Subscore (1) dated 08 Apr 2026 for I-0 visit, CLARIO to make the following changes: - What was the date of endoscopy? (ENDODT1D): from 25 Mar 2026 to 18 Mar 2026 - Data Flag (QSDFLG1B): from blank to check
4 77242113UCO3001 Czech Republic DD5-CZ10006 Michal Konecny CZ100062001 19 1 SW00704536 19-May-2026 ReadyForQC Please change the endoscopy date to 19-FEB-2026. 06-MAR-2026 was entered in error. 26-May-2026 15-21 Days 17 12 Query Active Site Site-Entered Data Entry Error CLARIO RESOLUTION: Part 1: In Mayo Subscore (1) dated 20 Mar 2026 for I-0 visit, CLARIO to make the following changes: -What was the date of endoscopy? (ENDODT1D): from 06 Mar 2026 to 19 Feb 2026 - Data Flag (QSDFLG1B): from blank to check
5 77242113UCO3001 Czech Republic DD5-CZ10012 Stefan Konecny CZ100122001 22 5 Yes, I confirm this is the correct stool count. SW00706684 01-Jun-2026 Submitted The right endoscopy date is 23MAR2026, please change the date 05-Jun-2026 8-14 Days 9 4 Query Active Site New (1) 05 Jun 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Please confirm that if you are requesting following. Mayo Subscore (1) dated 07 Apr 2026 for I-0 What was the date of endoscopy? (ENDODT1D): from 24 Mar 2026 to 23 Mar 2026 Thank you. ERT/CLARIO Data Coordination Team. Entry Error
6 77242113UCO3001 Czech Republic DD5-CZ10013 David Stepek CZ100132002 29 1 SW00705646 26-May-2026 ReadyForQC Correct visit date I-O is 12-May-2026. All questionaries were filled on paper and entered in tablet later. Log-in issue. 09-Jun-2026 8-14 Days 12 3 Clario DM Visit Data (1) 01 Jun 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Please provide the timestamps for each of the assessments if you used paper forms and transcribed into the device. If unknown, ERT will use a dummy timestamp. Thank you. ERT/CLARIO Data Coordination Team. (2) 01 Jun 2026 dstepek@vnbrno.cz (Site User): time is unknown Changed Information CLARIO RESOLUTION: Part 1: In the following forms for I-0, CLARIO to make the following changes: -Report Date: from 26May 2026 to 12 May 2026 -Report Start Date and time: from 26 May 2026 to 12 May 2026 23:59:59 -Event End Date: from 26 May 2026 08:27:57 to 12 May 2026 23:59:59 +Tablet Training Module (1) +Participant Start Instructions (1) +IBDQ (1) +PROMIS Fatigue – Short Form 7a (1) +BASDAI (1) +Participant End Instructions (1) +Visit End (122)
7 77242113UCO3001 Czech Republic DD5-CZ10013 David Stepek CZ100132003 49 1 SW00708623 10-Jun-2026 Cancelled Correct date of I-2 is 26.5.2026. all questionaries were entered on paper at 07,45 and transmited later. 10-Jun-2026 1 Day 1 New yes, subject mishmasch
8 77242113UCO3001 Czech Republic DD5-CZ10013 David Stepek CZ100132003 49 1 SW00706581 29-May-2026 Completed baseline stool count reported by subject is 0, please change to 1 as per CRA request (subject has 1 stool in 2-3 days if in remission) 10-Jun-2026 4-7 Days 7 Demographic Changed Information CLARIO RESOLUTION: Part 1: In System Variables form, CLARIO to make the following changes: - Baseline Stool Count (PT.Custom4): from 0 to 1
9 77242113UCO3001 Czech Republic DD5-CZ10016 Robert Mudr CZ100162001 48 1 SW00705916 27-May-2026 Completed As per ATS investigation (ATS26040111), please remove the below form which was entered as a duplicate - MAYO Diary (5) 24 Apr 2026 10-Jun-2026 8-14 Days 9 Technical Revision Technical Revision - Other CLARIO RESOLUTION: Part 1: CLARIO to delete MAYO Diary (5) dated 24 Apr 2026
10 77242113UCO3001 Czech Republic DD5-CZ10020 Lucie Gonsorcikova CZ100201001 15 1 SW00701729 06-May-2026 Completed Dears, please delete data from visit I-0 (reported as 4th of May 2026) as this visit had to be postponed - see the previous DCR of this patient and change data request that was corrected. Patient has left the site before it was resolved and and new date of I-0 was planned. Patient continues to fill in his diary and patient is coming to I=0 visit within allowed window. We need the system and tablet to be ready to run new Mayo Score Report with updated and recent data (e.g. reflect new I-0 visit date, new eligible days -1 to -7.). thank you, Jiri Skopek 19-May-2026 8-14 Days 8 Visit Data (1) 11 May 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Please note that the delete forms are allowed if the reason is one of the following. If not, forms will move to unscheduled visit. Data collected by the wrong patient. Data collected by someone other than the patient. Data collected prior to informed consent, or after withdrawal from the study. Duplicate data erroneously entered at an Unscheduled visit via paper transcription. Data collected that is not expected per protocol. Also, I-0 visit is still ongoing. Please close the visit. Once the visit was closed, we will process accoridngly. Thank you. ERT/CLARIO Data Coordination Team (2) 11 May 2026 jskopek (Site User): Dears, I do not see any option that is adequate -from the list. Data are not needed to be deleted fully, they reflect the situation at May4th. Please mark it as unscheduled visit - as exactly that is the case. We need the system to be ready for I-0 visit planned for next week. I will close the visit tomorrow - do you mean in tablet/ipad? Thank you very much for your help! Jiri (3) 12 May 2026 venkata.ramana (Clario): Thank you for your response. Please note that the visit I-0 was still ongoing but not closed yet. So please close the visit. Kind Regards, Clario Data Coordination Team. (4) 12 May 2026 jskopek (Site User): If I try to close the I-O visit in TABLET, it asks me if patient fulfils eligibility criteria to proceed to next visit based on these old data – if I answer NO, it asks me to DEACTIVATE patient. I do not want to DEACTIVATE patient – can you help WHERE and HOW to close this visit for you to change it to UNSCHEDULED and not to de-activate patient? Thank you Jiri Other-delete visit I-0 CLARIO RESOLUTION: Part 1: In the following forms dated 04 May 2026, CLARIO to make the following changes: -Event ID: from I-0 to Unscheduled Visit 1 -Event At Entry: from I-0 to Unscheduled Visit 1 +Visit Start (49) +ePRO Availability (1) +Mayo Subscore (1) +PGA (1) Part 2: CLARIO to delete the following forms dated 04 May 2026 for I-0 visit. +C-SSRS Since Last Visit (1) +C-SSRS Since Last Visit Findings Report (1) Part 3: CLARIO to manually enter Visit End form for Unscheduled visit 1 with the following information: -Protocol: 77242113UCO3001 -Report Date: 04 May 2026 -Report Start Date and Time: 04 May 2026 23:59:59 -Event ID: Unscheduled Visit 1 -Event End Date: 04 May 2026 23:59:59 -Visit Status: Incomplete -Phase At Entry: Screening -Phase At Entry Timestamp: 13 Apr 2026 12:32:20 -Event At Entry: Unscheduled visit 1 -Event Start Date: 04 May 2026 23:59:59 -Event Time Zone Offset in Milliseconds: 7200000 -Session Repeat Number (SESREP1N): 0 -Session Instance Id (SESINST1S): 3f1214f0-4788-11f1-a0cf-bb403212adce
11 77242113UCO3001 Czech Republic DD5-CZ10020 Lucie Gonsorcikova CZ100201001 15 1 SW00701226 04-May-2026 Completed Dears, we would like ask you to change the information I read on assignment form given by patient on April 13, 2026 (Visit 1), Baseline Stool Count (PT.Custom4) as 3 that should be reported as 1. Patient has entered wrong number as he did not understood it should be number of stools when illness is in remission or absent. He is a child and did not reflected this question correctly. Therefore, please change Baseline Stool Count = 1. Thank you, Jiri Skopek 04-May-2026 1 Day 1 Demographic Changed Information (Clario instructions) 1. Please make below changes in the assignment form: Baseline Stool Count (PT. Custom4): 03 to 01.
12 77242113UCO3001 Czech Republic DD5-CZ10021 Martin Bortlik CZ100212001 61 1 SW00699492 23-Apr-2026 ReadyForQC Please correct the date of endoscopy done during screening visit of patient CZ100212001 to correct date 16-MAR-2026. 29-Apr-2026 Over 28 Days 34 30 Query Active Site Site-Entered Data Changed Information CLARIO RESOLUTION: Part 1: In the Mayo Subscore (1) dated 07 Apr 2026 for I-0 visit, CLARIO to make the following changes: -What was the date of endoscopy? (ENDODT1D): from 24 Mar 2026 to 16 Mar 2026 - Data Flag (QSDFLG1B): from blank to check
13 77242113UCO3001 Czech Republic DD5-CZ10022 Petr Hrabak CZ100222003 39 1 SW00703322 12-May-2026 Completed As per ATS investigation (ATS26040111), please remove the below form that's been entered as a duplicate - MAYO Diary (16) - 18 Mar 2026 20-May-2026 4-7 Days 6 Technical Revision Technical Revision - Other CLARIO RESOLUTION: Part 1: CLARIO to delete the MAYO Diary (16) dated 18 Mar 2026.
14 77242113UCO3001 Czech Republic DD5-CZ10022 Petr Hrabak CZ100222003 39 1 SW00689748 09-Mar-2026 Completed Dear all, Patient CZ 100222003 was randomized on 9 Mar 2026. Kindly correct the colonoscopy date to 11 Feb 2025. The date was initially entered as 21 Feb 2025 because the earlier date could not be entered in the system. The patient was rescreened. 02-Apr-2026 15-21 Days 17 Site-Entered Data (1) 13 Mar 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Could you please conform that if you are requesting following? Mayo Subscore (1) dated 09 Mar 2026 for I-0 visit -What was the date of endoscopy? (ENDODT1D): from 23 Feb 2026 to 11 Feb 2025 Could you please confirm the year? This subject was assigned on 02 Mar 2026, you are providing that correct date is 11 Feb 2025 which a year ago. If you are not requesting above, please provide us the name of the form with question. Thank you. ERT/CLARIO Data Coordination Team (2) 13 Mar 2026 katerina.havlikova@clinoxus.com (Site User): confirm date of colonoscopy 11Feb2026 (3) 21 Mar 2026 msullivan (Clario): Dear Site, The requested changes to the Mayo data have been updated. Please navigate to the Mayo Score Report and resubmit the form for visit to log the updated Mayo Score form. Once done, please respond to this query confirming that the Mayo Score has been resubmitted. Thank you. ERT/CLARIO Data Coordination Team (4) 24 Mar 2026 jana.pomahacova@clinoxus.com (Site User): Thank you and sent New Information CLARIO RESOLUTION: Part 1: In the Mayo Subscore (1) dated 09 Mar 2026 for I-0 visit, CLARIO to make the following changes: -What was the date of endoscopy? (ENDODT1D): from 23 Feb 2026 to 11 Feb 2025 -Data Flag (QSDFLG1B): from blank to check
15 77242113UCO3001 Czech Republic DD5-CZ10022 Petr Hrabak CZ100222005 33 1 SW00705372 22-May-2026 Submitted Dear all, please change Colonoscopz date from 8April2026 to date 01Apr2026 Thank you in advance 02-Jun-2026 8-14 Days 14 7 Clario DM New (1) 29 May 2026 msullivan (Clario): Please confirm your request Dear Site. Thank you for submitting this Data Clarification. Please provide us the name of the form for this request. Thank you. ERT/CLARIO Data Coordination Team (2) 02 Jun 2026 katerina.havlikova@clinoxus.com (Site User): Dear all, please change Colonoscopy for Week I-12 date from 8April2026 to date 01Apr2026 Thank you in advance Changed Information
16 77242113UCO3001 Czech Republic DD5-CZ10022 Petr Hrabak CZ100222005 33 1 SW00702538 08-May-2026 Completed This TRR is to document the correction to the Mayo Subscore (1) form, where the following variables were populated with NULL values, due to a known core defect: Event At Entry, Event Start Date, Event Time Zone Offset in Milliseconds. 12-May-2026 2-3 Days 2 Technical Revision Technical Revision - Other Please make the below changes in Mayo Subscore (1) dated 22 Apr 2026: -Event At Entry: I-0 -Event Start Date: 09 Apr 2026 08:09:19 -Event Time Zone Offset in Milliseconds: 7200000