Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT01647516
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2012-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607776', 'term': 'ozanimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@Celgene.com', 'phone': '908-673-9100', 'title': 'Anne McClain, Senior Manager', 'organization': 'Celgene Corporation'}, 'certainAgreement': {'otherDetails': 'Results from a center cannot be submitted for publication before results of multicenter study are published unless it is \\> 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo during the induction period.', 'description': 'The mean total duration of study drug exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo during the maintenance period and 2.42 years during the open label treatment period, The safety population includes all participants who received at least dose of study treatment; maintenance phase data includes all participants who entered the maintenance phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Induction Period: Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9).', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 9, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Induction Period: Ozanimod HCL 0.5 mg', 'description': 'Participants received 0.5 mg ozanimod capsules daily during the induction period (weeks 0 to 9).', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 8, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Induction Period: Ozanimod HCL 1 mg', 'description': 'Participants received 1 mg ozanimod capsules daily during the induction period (weeks 0 to 9).', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 8, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Maintenance Period: Placebo', 'description': 'Participants originally assigned to placebo who completed the induction period and were responders at week 8 continued to receive placebo in the maintenance period. Participants received identically matching placebo capsules daily during the maintenance period (weeks 9-32).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 3, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Maintenance Period: Ozanimod HCL 0.5 mg', 'description': 'Participants originally assigned to ozanimod 0.5 mg who completed the induction period and were responders at week 8 continued to receive ozanimod 0.5 mg daily in the maintenance period. Participants received 0.5 mg ozanimod capsules daily during the maintenance period (weeks 9 to 32).', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 2, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Maintenance Period: Ozanimod HCL 1 mg', 'description': 'Participants originally assigned to ozanimod 1 mg who completed the induction period and were responders at week 8 continued to receive ozanimod 0.5 mg daily in the maintenance period. Participants received 1 mg ozanimod capsules daily during the maintenance period (weeks 9 to 32).', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 2, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Open-Label Treatment Period (OLP): Placebo/Ozanimod', 'description': 'Participants who received placebo capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and receive 1 mg ozanimod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 19, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG007', 'title': 'OLP: Ozanimod 0.5 mg/Ozanimod 1 mg', 'description': 'Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 17, 'seriousNumAtRisk': 56, 'deathsNumAffected': 1, 'seriousNumAffected': 14}, {'id': 'EG008', 'title': 'OLP: Ozanimod 1mg/Ozanimod 1 mg', 'description': 'Participants who received 1 mg ozanimod capsules and completed the induction period and were non-responders at Week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and continue to receive 1 mg ozaninod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 22, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperpyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary bulla', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary microemboli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0482', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.262', 'ciLowerLimit': '0.969', 'ciUpperLimit': '10.984', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).'}, {'pValue': '0.1422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.500', 'ciLowerLimit': '0.722', 'ciUpperLimit': '8.661', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': "Clinical Remission was defined as: Mayo score of \\<2 points and with no individual subscore of \\> 1 point.\n\nThe Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\n* Stool Frequency Subscore (SFS)\n* Rectal bleeding Subscore (RBS)\n* Endoscopy Subscore\n* Physician's Global Assessment (PGA)\n\nClinical Remission was based on the 4-component Mayo definition.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat ( ITT) population consisted of all randomized participants who received at least one dose of study treatment, with treatment. Participants with missing Mayo scores were classified as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '56.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0207', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.158', 'ciLowerLimit': '1.093', 'ciUpperLimit': '4.263', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).'}, {'pValue': '0.0648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.947', 'ciLowerLimit': '0.961', 'ciUpperLimit': '3.946', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': "Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.\n\nThe Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\nClinical Respone was based on the 4-component Mayo definition.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Participants with missing Mayo score were considered non-responders. Non responder imputation (NRI).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mayo Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '2.79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0042', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).'}, {'pValue': '0.1415', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 8', 'description': "The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\n* Stool Frequency Subscore (SFS)\n* Rectal bleeding Subscore (RBS)\n* Endoscopy Subscore\n* Physician's Global Assessment (PGA)", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Includes participants with available data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mucosal Healing at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}, {'value': '34.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.861', 'ciLowerLimit': '1.572', 'ciUpperLimit': '9.484', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-TNF therapy experience, (yes or no).'}, {'pValue': '0.0348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.647', 'ciLowerLimit': '1.058', 'ciUpperLimit': '6.621', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-TNF therapy experience, (yes or no).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.\n\nThe endoscopy scale:\n\n0 = Normal or inactive disease\n\n1. = Mild disease (erythema, decreased vascular pattern, mild friability)\n2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)\n3. = Severe disease (spontaneous bleeding, ulceration)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Non-responder imputation (NRI).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '26.2', 'groupId': 'OG001'}, {'value': '20.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0108', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.332', 'ciLowerLimit': '1.323', 'ciUpperLimit': '14.186', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-TNF therapy experience, (yes or no).'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.443', 'ciLowerLimit': '1.706', 'ciUpperLimit': '17.365', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-TNF therapy experience, (yes or no).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 32', 'description': "Clinical Remission was defined as: Mayo score of \\<2 points and with no individual subscore of \\> 1 point.\n\nThe Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\n* Stool Frequency Subscore (SFS)\n* Rectal bleeding Subscore (RBS)\n* Endoscopy Subscore\n* Physician's Global Assessment (PGA)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Participants with missing Mayo score were considered non-responders. Non responder imputation (NRI).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Clinical Response at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '50.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.030', 'ciLowerLimit': '1.871', 'ciUpperLimit': '8.678', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified by prior anti-TNF therapy experience, (yes or no).'}, {'pValue': '0.0571', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.154', 'ciLowerLimit': '0.974', 'ciUpperLimit': '4.763', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-TNF therapy experience, (yes or no).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 32', 'description': "Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.\n\nThe Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\n* Stool Frequency Subscore (SFS)\n* Rectal bleeding Subscore (RBS)\n* Endoscopy Subscore\n* Physician's Global Assessment (PGA)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Participants with missing Mayo score were considered non-responders. Non responder imputation (NRI).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mucosal Healing at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}, {'value': '32.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.557', 'ciLowerLimit': '1.444', 'ciUpperLimit': '8.762', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-TNF therapy experience, (yes or no).'}, {'pValue': '0.0064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.428', 'ciLowerLimit': '1.384', 'ciUpperLimit': '8.494', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by prior anti-TNF therapy experience, (yes or no).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 32', 'description': 'Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.\n\nThe endoscopy scale:\n\n0 = Normal or inactive disease\n\n1. = Mild disease (erythema, decreased vascular pattern, mild friability)\n2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)\n3. = Severe disease (spontaneous bleeding, ulceration)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment. Non-responder imputation (NRI).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'title': '≥ 1 TEAE', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Moderate or Severe TEAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Severe TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Possibly, Probably or Definitely Related TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Serious SAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Possibly, Probably or Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 TEAE Leading to Withdrawal From Study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo', 'description': 'A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of investigational product (IP).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'OG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'OG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}], 'classes': [{'title': '≥ 1 TEAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Moderate or Severe TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Severe TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Possibly, Probably or Definitely Related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 Possibly, Probably or Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 TEAE Leading to Withdrawal From Study', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.', 'description': 'A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of investigational product (IP) and who entered the maintenance period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAE During the Open-Label Treatment Period (OLP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants who completed the induction period and were non-responders at Week 8 and those who completed the maintenance period or experienced a disease relapse entered the open label treatment period (OLP) and received 1 mg ozaninod daily up to 6 years. Participants who did not show clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.'}], 'classes': [{'title': '≥ 1 TEAE', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 Moderate or Severe TEAE', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 Severe TEAE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 Possible, Probable or Related TEAE', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 Related TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 Serious TEAE', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 Possible, Probable or Related Serious TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 TEAE Leading to Discontinuation of IP', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': '≥ 1 TEAE Leading to Withdrawal from Study', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '1 Death Possible, Probable or Related to IP', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years', 'description': 'A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were enrolled and received at least 1 dose of investigational product (IP). All participants in the OLE safety population received 1 mg capsules ozanimod as noted in the description.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'FG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'FG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'FG003', 'title': 'Open-Label Treatment Period (OLP): Placebo/Ozanimod', 'description': 'Participants who received placebo capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and receive 1 mg ozanimod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.'}, {'id': 'FG004', 'title': 'OLP: Ozanimod 0.5 mg/Ozanimod 1 mg', 'description': 'Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.'}, {'id': 'FG005', 'title': 'OLP: Ozanimod 1 mg/Ozanimod 1 mg', 'description': 'Participants who received 1 mg ozanimod capsules and completed the induction period and were non-responders at week 8 and those who completed the maintenance period or experienced a disease relapse, were given the option to enter the open label treatment period (OLP) and continue to receive 1 mg ozaninod daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.'}], 'periods': [{'title': 'Induction Period (IP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant Choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'No study drug received', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Period (MP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The MP includes participants who were responders at week 8.', 'groupId': 'FG000', 'numSubjects': '25'}, {'comment': 'The MP includes participants who were responders at week 8.', 'groupId': 'FG001', 'numSubjects': '36'}, {'comment': 'The MP includes participants who were responders at week 8.', 'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'The participants were:\n\nnon-responders at Week 8,completed the MP or had disease relapse during MP', 'groupId': 'FG003', 'numSubjects': '55'}, {'comment': 'The participants were:\n\nnon-responders at Week 8,completed the MP or had disease relapse during MP', 'groupId': 'FG004', 'numSubjects': '56'}, {'comment': 'The participants were:\n\nnon-responders at Week 8,completed the MP or had disease relapse during MP', 'groupId': 'FG005', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Sponsor Termination; moved to 3102 study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '23'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'Participant Choice to Stop Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'No completion / discontinuation visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 57 sites from 13 countries located in Europe, North America, and the Asia-Pacific region.', 'preAssignmentDetails': 'Participants were randomly assigned in a 1:1:1 ratio on Day 1 to placebo, ozanimod 0.5 mg, or ozanimod 1 mg capsules and were stratified by whether they had received anti-tumor necrosis factor class of therapy (yes vs no).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received identically matching placebo capsules daily for 9 weeks during the induction period (weeks 0 to 9). Participants who completed the induction period and were responders, continued to receive identically matching placebo tablets during the maintenance period (weeks 9-32).'}, {'id': 'BG001', 'title': 'Ozanimod Hydrochloride 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'BG002', 'title': 'Ozanimod Hydrochloride 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '12.30', 'groupId': 'BG000'}, {'value': '38.8', 'spread': '12.06', 'groupId': 'BG001'}, {'value': '41.8', 'spread': '11.01', 'groupId': 'BG002'}, {'value': '40.8', 'spread': '11.82', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years Since Ulcerative Colitis Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '5.46', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '5.44', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '6.76', 'groupId': 'BG002'}, {'value': '6.2', 'spread': '5.91', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Any Prior Ulcerative Colitis Medication Use', 'classes': [{'title': 'Aminosalycylates', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}]}, {'title': 'Systemic Corticosteroids', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}, {'title': 'Azathioprine', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}, {'title': 'Anti-Tumor Necrosis Factors (Anti-TNF)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': '6-Mercaptopurine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Other Immunomodulators', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Topical Medication', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Methotrexate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mayo Score', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.51', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '1.45', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '1.61', 'groupId': 'BG002'}, {'value': '8.5', 'spread': '1.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The intent to treat ( ITT) population consisted of all randomized patients who received at least one dose of study treatment, with treatment assignment designated according to randomized treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-03', 'size': 872936, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-28T09:30', 'hasProtocol': True}, {'date': '2014-09-23', 'size': 672972, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-28T09:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2016-05-26', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2012-07-19', 'dispFirstSubmitQcDate': '2016-05-26', 'resultsFirstSubmitDate': '2020-08-30', 'studyFirstSubmitQcDate': '2012-07-19', 'dispFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-21', 'studyFirstPostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8', 'timeFrame': 'Week 8', 'description': "Clinical Remission was defined as: Mayo score of \\<2 points and with no individual subscore of \\> 1 point.\n\nThe Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\n* Stool Frequency Subscore (SFS)\n* Rectal bleeding Subscore (RBS)\n* Endoscopy Subscore\n* Physician's Global Assessment (PGA)\n\nClinical Remission was based on the 4-component Mayo definition."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved a Clinical Response in the Mayo Score (MS) at Week 8', 'timeFrame': 'Week 8', 'description': "Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.\n\nThe Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\nClinical Respone was based on the 4-component Mayo definition."}, {'measure': 'Change From Baseline in Mayo Score at Week 8', 'timeFrame': 'Baseline to Week 8', 'description': "The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\n* Stool Frequency Subscore (SFS)\n* Rectal bleeding Subscore (RBS)\n* Endoscopy Subscore\n* Physician's Global Assessment (PGA)"}, {'measure': 'Percentage of Participants With Mucosal Healing at Week 8', 'timeFrame': 'Week 8', 'description': 'Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.\n\nThe endoscopy scale:\n\n0 = Normal or inactive disease\n\n1. = Mild disease (erythema, decreased vascular pattern, mild friability)\n2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)\n3. = Severe disease (spontaneous bleeding, ulceration)'}, {'measure': 'Percentage of Participants Who Achieved Clinical Remission in the Mayo Score at Week 32', 'timeFrame': 'Week 32', 'description': "Clinical Remission was defined as: Mayo score of \\<2 points and with no individual subscore of \\> 1 point.\n\nThe Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\n* Stool Frequency Subscore (SFS)\n* Rectal bleeding Subscore (RBS)\n* Endoscopy Subscore\n* Physician's Global Assessment (PGA)"}, {'measure': 'Percentage of Participants Who Achieved Clinical Response at Week 32', 'timeFrame': 'Week 32', 'description': "Clinical response was defined as a reduction from baseline in Mayo score ≥3 points and ≥30%, and a decrease from baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point.\n\nThe Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.\n\n* Stool Frequency Subscore (SFS)\n* Rectal bleeding Subscore (RBS)\n* Endoscopy Subscore\n* Physician's Global Assessment (PGA)"}, {'measure': 'Percentage of Participants With Mucosal Healing at Week 32', 'timeFrame': 'Week 32', 'description': 'Mucosal healing is defined as an endoscopy subscore ≤ 1 point. Endoscopy subscores were calculated based on central endoscopy reading.\n\nThe endoscopy scale:\n\n0 = Normal or inactive disease\n\n1. = Mild disease (erythema, decreased vascular pattern, mild friability)\n2. = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions)\n3. = Severe disease (spontaneous bleeding, ulceration)'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Induction Period', 'timeFrame': 'From the first dose of investigational product (IP) up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 52.8 days, 56.1 days and 50.8 days respectively for 0.5 mg, 1 mg ozanimod and placebo', 'description': 'A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Maintenance Period', 'timeFrame': 'From the first dose of IP up to 90 days after the last dose of IP or at follow-up visit; the mean total duration of IP exposure was 156.3 days, 171.1 days and 154.5 days respectively for 0.5 mg, 1 mg ozanimod and placebo.', 'description': 'A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.'}, {'measure': 'Number of Participants With TEAE During the Open-Label Treatment Period (OLP)', 'timeFrame': 'From the first dose of IP until 90 days after the last dose of IP or at follow-up visit; the mean total duration of study drug exposure in the OLP was 2.42 years', 'description': 'A TEAE was defined as any event with an onset date on or after first dose date or any ongoing event on the first dose date that worsens in severity after first dose date and until 90 days following the last dose of treatment with the study drug. earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = an AE usually transient in nature and generally not interfering with normal activities; Moderate = an AE that is sufficiently discomforting to interfere with normal activities; Severe = an AE that is incapacitating and prevents normal activities.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '27144850', 'type': 'BACKGROUND', 'citation': "Sandborn WJ, Feagan BG, Wolf DC, D'Haens G, Vermeire S, Hanauer SB, Ghosh S, Smith H, Cravets M, Frohna PA, Aranda R, Gujrathi S, Olson A; TOUCHSTONE Study Group. Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis. N Engl J Med. 2016 May 5;374(18):1754-62. doi: 10.1056/NEJMoa1513248."}, {'pmid': '39018016', 'type': 'DERIVED', 'citation': "Regueiro M, Siegmund B, Horst S, Moslin R, Charles L, Petersen A, Tatosian D, Wu H, Lawlor G, Fischer M, D'Haens G, Colombel JF. Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis. Inflamm Bowel Dis. 2025 Apr 10;31(4):1010-1017. doi: 10.1093/ibd/izae136."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ulcerative colitis (UC) confirmed on endoscopy\n* Moderately to severely active UC (Mayo score 6-12)\n\nExclusion Criteria:\n\n* Current use of anti-TNF agents'}, 'identificationModule': {'nctId': 'NCT01647516', 'acronym': 'Touchstone', 'briefTitle': 'Efficacy and Safety Study of Ozanimod in Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'RPC01-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ozanimod 0.5 mg', 'description': 'Participants received 0.5 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 0.5 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. Participants who had not shown clinical improvement 8 weeks after initiation of the OLP were discontinued from the study.', 'interventionNames': ['Drug: Ozanimod']}, {'type': 'EXPERIMENTAL', 'label': 'Ozanimod 1 mg', 'description': 'Participants received 1 mg capsules of ozanimod hydrochloride daily during the induction period weeks 0-9 (an initial 8-day dose escalation regimen in the induction period that consisted of 4 days of ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg), followed by 3 days of ozanimod HCl 0.5 mg, (equivalent to ozanimod 0.46 mg) followed by the assigned treatment level for at least 8 weeks. Participants who completed the induction period and were responders at week 8, continued to receive the same dose of ozanimod during the maintenance period up to week 32. Participants who received ozanimod 1 mg capsules and completed the induction period and were non-responders at Week 8 and who completed the maintenance period or experienced a disease relapse, were given the option to enter the OLP and receive 1 mg ozaninod capsules daily up to 6 years. 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