This commit is contained in:
2026-06-01 16:50:50 +02:00
parent d017203644
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{
"pk": 340,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100222001 has been created in IRT at site DD5-CZ10022",
"event": "Create",
"actual_date": "2026-01-15",
"subject": "CZ100222001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 15-Jan-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 15-Jan-2026\n\nTransaction Date/Time (site local): 15-Jan-2026 16:07:14\n\nTransaction Date/Time (system local): 15-Jan-2026 15:07:14\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 403,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100012001 has been created in IRT at site DD5-CZ10001",
"event": "Create",
"actual_date": "2026-01-22",
"subject": "CZ100012001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 22-Jan-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 22-Jan-2026\n\nTransaction Date/Time (site local): 22-Jan-2026 07:43:26\n\nTransaction Date/Time (system local): 22-Jan-2026 06:43:26\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 420,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100222002 has been created in IRT at site DD5-CZ10022",
"event": "Create",
"actual_date": "2026-01-23",
"subject": "CZ100222002",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 23-Jan-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 23-Jan-2026\n\nTransaction Date/Time (site local): 23-Jan-2026 09:14:45\n\nTransaction Date/Time (system local): 23-Jan-2026 08:14:45\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 752,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100062001 has been created in IRT at site DD5-CZ10006",
"event": "Create",
"actual_date": "2026-02-13",
"subject": "CZ100062001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 13-Feb-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 13-Feb-2026\n\nTransaction Date/Time (site local): 13-Feb-2026 06:43:53\n\nTransaction Date/Time (system local): 13-Feb-2026 05:43:53\n\nTransaction performed by: konecnymi@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 861,
"title": "Screenfail",
"label": "Janssen 77242113UCO3001 Subject CZ100222002 has been screen failed at site DD5-CZ10022",
"event": "uv_screen_fail",
"actual_date": "2026-02-19",
"subject": "CZ100222002",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222002\n\nIRT Subject Status: Screen Failed\n\nScreenfail Date: 19-Feb-2026\n\nTransaction Date/Time (site local): 19-Feb-2026 15:39:37\n\nTransaction Date/Time (system local): 19-Feb-2026 14:39:37\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 852,
"title": "Randomized",
"label": "Janssen 77242113UCO3001 Subject randomized CZ100012001 at site DD5-CZ10001",
"event": "I0",
"actual_date": "2026-02-19",
"subject": "CZ100012001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1136793\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 19-Feb-2026 07:50:32\n\nTransaction Date/Time (system local): 19-Feb-2026 06:50:32\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1090,
"title": "Screenfail",
"label": "Janssen 77242113UCO3001 Subject CZ100222001 has been screen failed at site DD5-CZ10022",
"event": "uv_screen_fail",
"actual_date": "2026-02-20",
"subject": "CZ100222001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222001\n\nIRT Subject Status: Screen Failed\n\nScreenfail Date: 20-Feb-2026\n\nTransaction Date/Time (site local): 03-Mar-2026 08:51:04\n\nTransaction Date/Time (system local): 03-Mar-2026 07:51:04\n\nTransaction performed by: katerina.havlikova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 972,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100012002 has been created in IRT at site DD5-CZ10001",
"event": "Create",
"actual_date": "2026-02-25",
"subject": "CZ100012002",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 25-Feb-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: Yes\n\nDate of Subject Creation in IRT: 25-Feb-2026\n\nTransaction Date/Time (site local): 25-Feb-2026 12:27:20\n\nTransaction Date/Time (system local): 25-Feb-2026 11:27:20\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 971,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100212001 has been created in IRT at site DD5-CZ10021",
"event": "Create",
"actual_date": "2026-02-25",
"subject": "CZ100212001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100212001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10021\n\nInvestigator: Martin Bortlik\n\nSubject Details\n\nSubject: CZ100212001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 25-Feb-2026\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 25-Feb-2026\n\nTransaction Date/Time (site local): 25-Feb-2026 11:32:00\n\nTransaction Date/Time (system local): 25-Feb-2026 10:32:00\n\nTransaction performed by: dvorakova.zdenka@nemcb.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1001,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100132001 has been created in IRT at site DD5-CZ10013",
"event": "Create",
"actual_date": "2026-02-26",
"subject": "CZ100132001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 26-Feb-2026\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 26-Feb-2026\n\nTransaction Date/Time (site local): 26-Feb-2026 13:09:10\n\nTransaction Date/Time (system local): 26-Feb-2026 12:09:10\n\nTransaction performed by: dstepek@vnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1054,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100222003 has been created in IRT at site DD5-CZ10022",
"event": "Create",
"actual_date": "2026-03-02",
"subject": "CZ100222003",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222003 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Screened\n\nRescreened Subject: Yes\n\n Prior Subject : CZ100222002\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 02-Mar-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 02-Mar-2026\n\nTransaction Date/Time (site local): 02-Mar-2026 10:10:20\n\nTransaction Date/Time (system local): 02-Mar-2026 09:10:20\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1103,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100222004 has been created in IRT at site DD5-CZ10022",
"event": "Create",
"actual_date": "2026-03-03",
"subject": "CZ100222004",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222004 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222004\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 03-Mar-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 03-Mar-2026\n\nTransaction Date/Time (site local): 03-Mar-2026 11:02:56\n\nTransaction Date/Time (system local): 03-Mar-2026 10:02:56\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1147,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100222005 has been created in IRT at site DD5-CZ10022",
"event": "Create",
"actual_date": "2026-03-04",
"subject": "CZ100222005",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222005 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222005\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 04-Mar-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: Yes\n\nDate of Subject Creation in IRT: 04-Mar-2026\n\nTransaction Date/Time (site local): 04-Mar-2026 08:11:16\n\nTransaction Date/Time (system local): 04-Mar-2026 07:11:16\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1266,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100222003 dispensing confirmation has occurred at site DD5-CZ10022",
"event": "uv_disp_conf",
"actual_date": "2026-03-09",
"subject": "CZ100222003",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100222003 has been performed for the following medication IDs:\n\n Medication id: 1168110\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 09-Mar-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 09-Mar-2026 08:57:02\n\nTransaction Date/Time (system local): 09-Mar-2026 07:57:02\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1265,
"title": "Randomized",
"label": "Janssen 77242113UCO3001 Subject randomized CZ100222003 at site DD5-CZ10022",
"event": "I0",
"actual_date": "2026-03-09",
"subject": "CZ100222003",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222003 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1168110\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 09-Mar-2026 08:55:24\n\nTransaction Date/Time (system local): 09-Mar-2026 07:55:24\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1334,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100122001 has been created in IRT at site DD5-CZ10012",
"event": "Create",
"actual_date": "2026-03-10",
"subject": "CZ100122001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100122001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10012\n\nInvestigator: Stefan Konecny\n\nSubject Details\n\nSubject: CZ100122001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 10-Mar-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 10-Mar-2026\n\nTransaction Date/Time (site local): 10-Mar-2026 14:15:44\n\nTransaction Date/Time (system local): 10-Mar-2026 13:15:44\n\nTransaction performed by: hosova.kristyna@fnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1461,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100012001 dispensing confirmation has occurred at site DD5-CZ10001",
"event": "uv_disp_conf",
"actual_date": "2026-03-16",
"subject": "CZ100012001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100012001 has been performed for the following medication IDs:\n\n Medication id: 1136793\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 19-Feb-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 16-Mar-2026 10:25:59\n\nTransaction Date/Time (system local): 16-Mar-2026 09:25:59\n\nTransaction performed by: matesfalc@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1548,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100012001 dispensing confirmation has occurred at site DD5-CZ10001",
"event": "uv_disp_conf",
"actual_date": "2026-03-18",
"subject": "CZ100012001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100012001 has been performed for the following medication IDs:\n\n Medication id: 1136793\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 19-Feb-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 18-Mar-2026 07:25:24\n\nTransaction Date/Time (system local): 18-Mar-2026 06:25:24\n\nTransaction performed by: matesfalc@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1557,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100012001 dispensing confirmation has occurred at site DD5-CZ10001",
"event": "uv_disp_conf",
"actual_date": "2026-03-18",
"subject": "CZ100012001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100012001 has been performed for the following medication IDs:\n\n Medication id: 1068485\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 18-Mar-2026\n\n Medication id: 1171236\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 18-Mar-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 18-Mar-2026 09:52:54\n\nTransaction Date/Time (system local): 18-Mar-2026 08:52:54\n\nTransaction performed by: matesfalc@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1550,
"title": "Assignment",
"label": "Janssen 77242113UCO3001 Subject CZ100012001 has been assigned medication for visit Week I-4 at site DD5-CZ10001",
"event": "I4",
"actual_date": "2026-03-18",
"subject": "CZ100012001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012001 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1068485\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1171236\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 18-Mar-2026 07:27:34\n\nTransaction Date/Time (system local): 18-Mar-2026 06:27:34\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1549,
"title": "Medication_Return",
"label": "Janssen 77242113UCO3001 Subject CZ100012001 has returned a medication at site DD5-CZ10001",
"event": "uv_return",
"actual_date": "2026-03-18",
"subject": "CZ100012001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) for Subject CZ100012001 has been performed.\n\n \n\n Medication id: 1136793\n Medication status: Returned by Subject\n\nReturned Inner Qty: 0\n Returned Date: 18-Mar-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n Transaction Date/Time (site local): 18-Mar-2026 07:27:02\n\n Transaction Date/Time (system local): 18-Mar-2026 06:27:02\n\n Transaction performed by: matesfalc@seznam.cz\n\n If you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1618,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100062001 dispensing confirmation has occurred at site DD5-CZ10006",
"event": "uv_disp_conf",
"actual_date": "2026-03-20",
"subject": "CZ100062001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100062001 has been performed for the following medication IDs:\n\n Medication id: 1058454\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 20-Mar-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 20-Mar-2026 17:49:52\n\nTransaction Date/Time (system local): 20-Mar-2026 16:49:52\n\nTransaction performed by: konecnymi@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1605,
"title": "Randomized",
"label": "Janssen 77242113UCO3001 Subject randomized CZ100062001 at site DD5-CZ10006",
"event": "I0",
"actual_date": "2026-03-20",
"subject": "CZ100062001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1058454\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 20-Mar-2026 07:35:02\n\nTransaction Date/Time (system local): 20-Mar-2026 06:35:02\n\nTransaction performed by: konecnymi@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1666,
"title": "Screenfail",
"label": "Janssen 77242113UCO3001 Subject CZ100222004 has been screen failed at site DD5-CZ10022",
"event": "uv_screen_fail",
"actual_date": "2026-03-24",
"subject": "CZ100222004",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222004\n\nIRT Subject Status: Screen Failed\n\nScreenfail Date: 24-Mar-2026\n\nTransaction Date/Time (site local): 24-Mar-2026 10:23:59\n\nTransaction Date/Time (system local): 24-Mar-2026 09:23:59\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1659,
"title": "Randomized",
"label": "Janssen 77242113UCO3001 Subject randomized CZ100132001 at site DD5-CZ10013",
"event": "I0",
"actual_date": "2026-03-24",
"subject": "CZ100132001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1086141\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 24-Mar-2026 08:09:58\n\nTransaction Date/Time (system local): 24-Mar-2026 07:09:58\n\nTransaction performed by: dstepek@vnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1844,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100132001 dispensing confirmation has occurred at site DD5-CZ10013",
"event": "uv_disp_conf",
"actual_date": "2026-03-30",
"subject": "CZ100132001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100132001 has been performed for the following medication IDs:\n\n Medication id: 1086141\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 24-Mar-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 30-Mar-2026 10:05:21\n\nTransaction Date/Time (system local): 30-Mar-2026 08:05:21\n\nTransaction performed by: studycoordinator@vnbrno.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1884,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100092001 has been created in IRT at site DD5-CZ10009",
"event": "Create",
"actual_date": "2026-03-31",
"subject": "CZ100092001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100092001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10009\n\nInvestigator: Jiri Pumprla\n\nSubject Details\n\nSubject: CZ100092001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 31-Mar-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 31-Mar-2026\n\nTransaction Date/Time (site local): 31-Mar-2026 08:39:04\n\nTransaction Date/Time (system local): 31-Mar-2026 06:39:04\n\nTransaction performed by: kolackova@vilazdravi.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 1953,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100132002 has been created in IRT at site DD5-CZ10013",
"event": "Create",
"actual_date": "2026-04-01",
"subject": "CZ100132002",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 01-Apr-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 01-Apr-2026\n\nTransaction Date/Time (site local): 01-Apr-2026 07:47:19\n\nTransaction Date/Time (system local): 01-Apr-2026 05:47:19\n\nTransaction performed by: dstepek@vnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2139,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100122001 dispensing confirmation has occurred at site DD5-CZ10012",
"event": "uv_disp_conf",
"actual_date": "2026-04-07",
"subject": "CZ100122001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100122001 has been performed for the following medication IDs:\n\n Medication id: 1114893\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 07-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10012\n\nInvestigator: Stefan Konecny\n\nSubject Details\n\nSubject: CZ100122001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 07-Apr-2026 13:59:16\n\nTransaction Date/Time (system local): 07-Apr-2026 11:59:16\n\nTransaction performed by: laznickova.edita@fnbrno.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2134,
"title": "Randomized",
"label": "Janssen 77242113UCO3001 Subject randomized CZ100122001 at site DD5-CZ10012",
"event": "I0",
"actual_date": "2026-04-07",
"subject": "CZ100122001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100122001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1114893\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10012\n\nInvestigator: Stefan Konecny\n\nSubject Details\n\nSubject: CZ100122001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 07-Apr-2026 11:55:52\n\nTransaction Date/Time (system local): 07-Apr-2026 09:55:52\n\nTransaction performed by: konecny.stefan@fnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2110,
"title": "Randomized",
"label": "Janssen 77242113UCO3001 Subject randomized CZ100212001 at site DD5-CZ10021",
"event": "I0",
"actual_date": "2026-04-07",
"subject": "CZ100212001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100212001 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1075956\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10021\n\nInvestigator: Martin Bortlik\n\nSubject Details\n\nSubject: CZ100212001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 07-Apr-2026 09:36:22\n\nTransaction Date/Time (system local): 07-Apr-2026 07:36:22\n\nTransaction performed by: dvorakova.zdenka@nemcb.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2165,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100012002 dispensing confirmation has occurred at site DD5-CZ10001",
"event": "uv_disp_conf",
"actual_date": "2026-04-08",
"subject": "CZ100012002",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100012002 has been performed for the following medication IDs:\n\n Medication id: 1185466\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 08-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012002\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 08-Apr-2026 07:35:25\n\nTransaction Date/Time (system local): 08-Apr-2026 05:35:25\n\nTransaction performed by: matesfalc@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2169,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100222003 dispensing confirmation has occurred at site DD5-CZ10022",
"event": "uv_disp_conf",
"actual_date": "2026-04-08",
"subject": "CZ100222003",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100222003 has been performed for the following medication IDs:\n\n Medication id: 1072571\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 08-Apr-2026\n\n Medication id: 1086416\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 08-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 08-Apr-2026 08:06:31\n\nTransaction Date/Time (system local): 08-Apr-2026 06:06:31\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2167,
"title": "Assignment",
"label": "Janssen 77242113UCO3001 Subject CZ100222003 has been assigned medication for visit Week I-4 at site DD5-CZ10022",
"event": "I4",
"actual_date": "2026-04-08",
"subject": "CZ100222003",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222003 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1072571\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1086416\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 08-Apr-2026 08:02:11\n\nTransaction Date/Time (system local): 08-Apr-2026 06:02:11\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2168,
"title": "Medication_Return",
"label": "Janssen 77242113UCO3001 Subject CZ100222003 has returned a medication at site DD5-CZ10022",
"event": "uv_return",
"actual_date": "2026-04-08",
"subject": "CZ100222003",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) for Subject CZ100222003 has been performed.\n\n \n\n Medication id: 1168110\n Medication status: Returned by Subject\n\nReturned Inner Qty: 2\n Returned Date: 08-Apr-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222003\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n Transaction Date/Time (site local): 08-Apr-2026 08:05:54\n\n Transaction Date/Time (system local): 08-Apr-2026 06:05:54\n\n Transaction performed by: jana.pomahacova@clinoxus.com\n\n If you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2164,
"title": "Randomized",
"label": "Janssen 77242113UCO3001 Subject randomized CZ100012002 at site DD5-CZ10001",
"event": "I0",
"actual_date": "2026-04-08",
"subject": "CZ100012002",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012002 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1185466\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012002\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: Yes\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 08-Apr-2026 07:13:02\n\nTransaction Date/Time (system local): 08-Apr-2026 05:13:02\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2222,
"title": "Randomized",
"label": "Janssen 77242113UCO3001 Subject randomized CZ100222005 at site DD5-CZ10022",
"event": "I0",
"actual_date": "2026-04-09",
"subject": "CZ100222005",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100222005 has been randomized.\n\n The following medication(s) has been assigned to the subject:\n\n \n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1037862\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222005\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n \n Isolated Proctitis: No\n\nTransaction Date/Time (site local): 09-Apr-2026 10:16:00\n\nTransaction Date/Time (system local): 09-Apr-2026 08:16:00\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2340,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100201001 has been created in IRT at site DD5-CZ10020",
"event": "Create",
"actual_date": "2026-04-13",
"subject": "CZ100201001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100201001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10020\n\nInvestigator: Lucie Gonsorcikova\n\nSubject Details\n\nSubject: CZ100201001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adolescent subjects (under 18 years)\n\nInformed Consent Date at Subject Creation: 13-Apr-2026\n\n Adolescent Assent Date: 13-Apr-2026\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 13-Apr-2026\n\nTransaction Date/Time (site local): 13-Apr-2026 11:58:29\n\nTransaction Date/Time (system local): 13-Apr-2026 09:58:29\n\nTransaction performed by: zuzana.zahradnikova@ftn.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2387,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100212001 dispensing confirmation has occurred at site DD5-CZ10021",
"event": "uv_disp_conf",
"actual_date": "2026-04-14",
"subject": "CZ100212001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100212001 has been performed for the following medication IDs:\n\n Medication id: 1075956\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 07-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10021\n\nInvestigator: Martin Bortlik\n\nSubject Details\n\nSubject: CZ100212001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 14-Apr-2026 11:54:08\n\nTransaction Date/Time (system local): 14-Apr-2026 09:54:08\n\nTransaction performed by: dvorakova.zdenka@nemcb.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2478,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100062001 dispensing confirmation has occurred at site DD5-CZ10006",
"event": "uv_disp_conf",
"actual_date": "2026-04-15",
"subject": "CZ100062001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100062001 has been performed for the following medication IDs:\n\n Medication id: 1009513\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 15-Apr-2026\n\n Medication id: 1194467\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 15-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 15-Apr-2026 22:07:00\n\nTransaction Date/Time (system local): 15-Apr-2026 20:07:00\n\nTransaction performed by: konecnymi@seznam.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2427,
"title": "Assignment",
"label": "Janssen 77242113UCO3001 Subject CZ100062001 has been assigned medication for visit Week I-4 at site DD5-CZ10006",
"event": "I4",
"actual_date": "2026-04-15",
"subject": "CZ100062001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062001 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1009513\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n \n 1194467\n Icotrokinra 320mg / placebo\n 4392802\n 30-Oct-2026\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 15-Apr-2026 06:41:16\n\nTransaction Date/Time (system local): 15-Apr-2026 04:41:16\n\nTransaction performed by: konecnymi@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2516,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100092002 has been created in IRT at site DD5-CZ10009",
"event": "Create",
"actual_date": "2026-04-16",
"subject": "CZ100092002",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100092002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10009\n\nInvestigator: Jiri Pumprla\n\nSubject Details\n\nSubject: CZ100092002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 16-Apr-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 16-Apr-2026\n\nTransaction Date/Time (site local): 16-Apr-2026 11:13:20\n\nTransaction Date/Time (system local): 16-Apr-2026 09:13:20\n\nTransaction performed by: kolackova@vilazdravi.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2574,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100062002 has been created in IRT at site DD5-CZ10006",
"event": "Create",
"actual_date": "2026-04-20",
"subject": "CZ100062002",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100062002 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10006\n\nInvestigator: Michal Konecny\n\nSubject Details\n\nSubject: CZ100062002\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 20-Apr-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: Yes\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 20-Apr-2026\n\nTransaction Date/Time (site local): 20-Apr-2026 06:50:59\n\nTransaction Date/Time (system local): 20-Apr-2026 04:50:59\n\nTransaction performed by: konecnymi@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2622,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100132001 dispensing confirmation has occurred at site DD5-CZ10013",
"event": "uv_disp_conf",
"actual_date": "2026-04-21",
"subject": "CZ100132001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100132001 has been performed for the following medication IDs:\n\n Medication id: 1056051\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 21-Apr-2026\n\n Medication id: 1172586\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 21-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 21-Apr-2026 07:55:26\n\nTransaction Date/Time (system local): 21-Apr-2026 05:55:26\n\nTransaction performed by: dstepek@vnbrno.cz\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2621,
"title": "Assignment",
"label": "Janssen 77242113UCO3001 Subject CZ100132001 has been assigned medication for visit Week I-4 at site DD5-CZ10013",
"event": "I4",
"actual_date": "2026-04-21",
"subject": "CZ100132001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100132001 has been assigned the following medication(s) for visit Week I-4:\n\nThe following medication(s) has been assigned to the subject:\n\n \n Medication No\n Medication Type\n Packaged Lot No\n Expiration Date\n \n \n \n 1056051\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n \n 1172586\n Icotrokinra 320mg / placebo\n 4393030\n 19-Jan-2027\n \n \n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 21-Apr-2026 07:54:13\n\nTransaction Date/Time (system local): 21-Apr-2026 05:54:13\n\nTransaction performed by: dstepek@vnbrno.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2627,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100162001 has been created in IRT at site DD5-CZ10016",
"event": "Create",
"actual_date": "2026-04-21",
"subject": "CZ100162001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100162001 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10016\n\nInvestigator: Robert Mudr\n\nSubject Details\n\nSubject: CZ100162001\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 21-Apr-2026\n\n ADT-IR: Yes\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 21-Apr-2026\n\nTransaction Date/Time (site local): 21-Apr-2026 09:31:12\n\nTransaction Date/Time (system local): 21-Apr-2026 07:31:12\n\nTransaction performed by: petr.pekny@nmskb.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2647,
"title": "Dispensation_Confirmation",
"label": "Janssen 77242113UCO3001 Subject CZ100222005 dispensing confirmation has occurred at site DD5-CZ10022",
"event": "uv_disp_conf",
"actual_date": "2026-04-21",
"subject": "CZ100222005",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nConfirmation of dispensing medication(s) for Subject: CZ100222005 has been performed for the following medication IDs:\n\n Medication id: 1037862\nProduct Label Type: Icotrokinra 320mg / placebo\n Medication status: Dispensed\n Dispensation date: 09-Apr-2026\n\n \nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10022\n\nInvestigator: Petr Hrabak\n\nSubject Details\n\nSubject: CZ100222005\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\nTransaction Date/Time (site local): 21-Apr-2026 11:39:52\n\nTransaction Date/Time (system local): 21-Apr-2026 09:39:52\n\nTransaction performed by: jana.pomahacova@clinoxus.com\n\n \nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2791,
"title": "Medication_Return",
"label": "Janssen 77242113UCO3001 Subject CZ100132001 has returned a medication at site DD5-CZ10013",
"event": "uv_return",
"actual_date": "2026-04-24",
"subject": "CZ100132001",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nAction to return medication(s) for Subject CZ100132001 has been performed.\n\n \n\n Medication id: 1086141\n Medication status: Returned by Subject\n\nReturned Inner Qty: 3\n Returned Date: 21-Apr-2026\n \n\nSite Details\n\nLocation: CZE\n\n Site: DD5-CZ10013\n\nInvestigator: David Stepek\n\nSubject Details\n\nSubject: CZ100132001\n\nIRT Subject Status: Randomized\n\nCohort: Adult subjects (18 years or older)\n\n Transaction Date/Time (site local): 24-Apr-2026 10:55:03\n\n Transaction Date/Time (system local): 24-Apr-2026 08:55:03\n\n Transaction performed by: studycoordinator@vnbrno.cz\n\n If you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}
@@ -0,0 +1,10 @@
{
"pk": 2983,
"title": "Subject_Number_Creation",
"label": "Janssen 77242113UCO3001 Subject CZ100012003 has been created in IRT at site DD5-CZ10001",
"event": "Create",
"actual_date": "2026-04-29",
"subject": "CZ100012003",
"study": "77242113UCO3001",
"text": "77242113UCO3001\n\nJanssen Pharmaceuticals\nhttps://janssen.4gclinical.com\n\nSubject CZ100012003 has been created in IRT.\n\nSite Details\n\nLocation: CZE\n\nSite: DD5-CZ10001\n\nInvestigator: Matej Falc\n\nSubject Details\n\nSubject: CZ100012003\n\nIRT Subject Status: Screened\n\nRescreened Subject: No\n\nCohort: Adult subjects (18 years or older)\n\nInformed Consent Date at Subject Creation: 29-Apr-2026\n\n ADT-IR: No\n\n 3 or More Advanced Therapies: No\n\n Ustekinumab: No\n\n Only Oral 5-ASA Compounds: No\n\nDate of Subject Creation in IRT: 29-Apr-2026\n\nTransaction Date/Time (site local): 29-Apr-2026 07:12:54\n\nTransaction Date/Time (system local): 29-Apr-2026 05:12:54\n\nTransaction performed by: matesfalc@seznam.cz\n\nIf you have questions about this notification, please contact 4G Clinical Support at http://support.4gclinical.com"
}

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