Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT03467958
Status:
TERMINATED
Last Update Posted:
2025-09-17
First Post:
2018-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Norway']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607776', 'term': 'ozanimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email:', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).', 'eventGroups': [{'id': 'EG000', 'title': 'RPC01-3201/3202 Placebo', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 179, 'deathsNumAtRisk': 179, 'otherNumAffected': 104, 'seriousNumAtRisk': 179, 'deathsNumAffected': 0, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'RPC01-3201/3202 Ozanimod 0.92 mg', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 329, 'deathsNumAtRisk': 329, 'otherNumAffected': 181, 'seriousNumAtRisk': 329, 'deathsNumAffected': 0, 'seriousNumAffected': 59}, {'id': 'EG002', 'title': 'RPC01-3203 Placebo-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 24, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 44, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 38, 'seriousNumAtRisk': 91, 'deathsNumAffected': 1, 'seriousNumAffected': 11}, {'id': 'EG005', 'title': 'RPC01-3203 Placebo-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 22, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 15, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'RPC01-2201 Ozanimod 0.92 mg', 'description': 'Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Epiretinal membrane', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haemorrhoids thrombosed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG007', 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{'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC01-3201/3202 Placebo', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG001', 'title': 'RPC01-3201/3202 Ozanimod 0.92 mg', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG002', 'title': 'RPC01-3203 Placebo-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG003', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG004', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG005', 'title': 'RPC01-3203 Placebo-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG006', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG007', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG008', 'title': 'RPC01-2201 Ozanimod 0.92 mg', 'description': 'Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}, {'value': '21.0', 'groupId': 'OG001'}, {'value': '60.6', 'groupId': 'OG002'}, {'value': '58.8', 'groupId': 'OG003'}, {'value': '56.0', 'groupId': 'OG004'}, {'value': '34.2', 'groupId': 'OG005'}, {'value': '27.3', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG007'}, {'value': '84.6', 'groupId': 'OG008'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '37.9', 'groupId': 'OG002'}, {'value': '41.2', 'groupId': 'OG003'}, {'value': '38.5', 'groupId': 'OG004'}, {'value': '18.4', 'groupId': 'OG005'}, {'value': '15.2', 'groupId': 'OG006'}, {'value': '15.0', 'groupId': 'OG007'}, {'value': '84.6', 'groupId': 'OG008'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}, {'value': '22.7', 'groupId': 'OG002'}, {'value': '23.5', 'groupId': 'OG003'}, {'value': '18.7', 'groupId': 'OG004'}, {'value': '13.2', 'groupId': 'OG005'}, {'value': '12.1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '61.5', 'groupId': 'OG008'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}, {'value': '11.8', 'groupId': 'OG003'}, {'value': '9.9', 'groupId': 'OG004'}, {'value': '2.6', 'groupId': 'OG005'}, {'value': '3.0', 'groupId': 'OG006'}, {'value': '5.0', 'groupId': 'OG007'}, {'value': '30.8', 'groupId': 'OG008'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '3.5', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}, {'value': '2.6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5.0', 'groupId': 'OG007'}, {'value': '38.5', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 48, 96, 144, 192, 240', 'description': "Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \\< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\\\\[none\\\\\\] to 3 \\\\\\[Severe\\\\\\]), general well-being (0 \\\\\\[well\\\\\\] to 4 \\\\\\[terrible\\\\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC01-3201/3202 Placebo', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG001', 'title': 'RPC01-3201/3202 Ozanimod 0.92 mg', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG002', 'title': 'RPC01-3203 Placebo-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG003', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG004', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG005', 'title': 'RPC01-3203 Placebo-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG006', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG007', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG008', 'title': 'RPC01-2201 Ozanimod 0.92 mg', 'description': 'Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'TEAE leading to discontinuation to study drug', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)', 'description': 'A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC01-3201/3202 Placebo', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG001', 'title': 'RPC01-3201/3202 Ozanimod 0.92 mg', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG002', 'title': 'RPC01-3203 Placebo-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG003', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG004', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG005', 'title': 'RPC01-3203 Placebo-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG006', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG007', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG008', 'title': 'RPC01-2201 Ozanimod 0.92 mg', 'description': 'Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}, {'value': '53.0', 'groupId': 'OG002'}, {'value': '52.9', 'groupId': 'OG003'}, {'value': '45.1', 'groupId': 'OG004'}, {'value': '34.2', 'groupId': 'OG005'}, {'value': '18.2', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}, {'value': '37.9', 'groupId': 'OG002'}, {'value': '36.5', 'groupId': 'OG003'}, {'value': '36.3', 'groupId': 'OG004'}, {'value': '18.4', 'groupId': 'OG005'}, {'value': '12.1', 'groupId': 'OG006'}, {'value': '15.0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}, {'value': '24.7', 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}, {'value': '13.2', 'groupId': 'OG005'}, {'value': '12.1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}, {'value': '10.6', 'groupId': 'OG003'}, {'value': '7.7', 'groupId': 'OG004'}, {'value': '2.6', 'groupId': 'OG005'}, {'value': '3.0', 'groupId': 'OG006'}, {'value': '5.0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '1.2', 'groupId': 'OG003'}, {'value': '1.1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5.0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 48, 96, 144, 192, 240', 'description': 'Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. Higher scores indicated worse outcomes.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC01-3201/3202 Placebo', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG001', 'title': 'RPC01-3201/3202 Ozanimod 0.92 mg', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG002', 'title': 'RPC01-3203 Placebo-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG003', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG004', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG005', 'title': 'RPC01-3203 Placebo-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG006', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG007', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'OG008', 'title': 'RPC01-2201 Ozanimod 0.92 mg', 'description': 'Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}, {'value': '62.1', 'groupId': 'OG002'}, {'value': '64.7', 'groupId': 'OG003'}, {'value': '61.5', 'groupId': 'OG004'}, {'value': '36.8', 'groupId': 'OG005'}, {'value': '30.3', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG007'}, {'value': '84.6', 'groupId': 'OG008'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}, {'value': '43.9', 'groupId': 'OG002'}, {'value': '44.7', 'groupId': 'OG003'}, {'value': '45.1', 'groupId': 'OG004'}, {'value': '18.4', 'groupId': 'OG005'}, {'value': '15.2', 'groupId': 'OG006'}, {'value': '15.0', 'groupId': 'OG007'}, {'value': '84.6', 'groupId': 'OG008'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}, {'value': '22.7', 'groupId': 'OG002'}, {'value': '28.2', 'groupId': 'OG003'}, {'value': '19.8', 'groupId': 'OG004'}, {'value': '13.2', 'groupId': 'OG005'}, {'value': '12.1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '61.5', 'groupId': 'OG008'}]}]}, {'title': 'Week 192', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}, {'value': '12.9', 'groupId': 'OG003'}, {'value': '11.0', 'groupId': 'OG004'}, {'value': '2.6', 'groupId': 'OG005'}, {'value': '3.0', 'groupId': 'OG006'}, {'value': '5.0', 'groupId': 'OG007'}, {'value': '30.8', 'groupId': 'OG008'}]}]}, {'title': 'Week 240', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '3.5', 'groupId': 'OG003'}, {'value': '2.2', 'groupId': 'OG004'}, {'value': '2.6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5.0', 'groupId': 'OG007'}, {'value': '38.5', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At weeks 48, 96, 144, 192, 240', 'description': "Clinical response is defined as a Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of \\< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\\\\[none\\\\\\] to 3 \\\\\\[Severe\\\\\\]), general well-being (0 \\\\\\[well\\\\\\] to 4 \\\\\\[terrible\\\\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RPC01-3201/3202 Placebo', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'FG001', 'title': 'RPC01-3201/3202 Ozanimod 0.92 mg', 'description': 'Responders from the induction study entered the maintenance study. Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'FG002', 'title': 'RPC01-3203 Placebo-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'FG003', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'FG004', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'FG005', 'title': 'RPC01-3203 Placebo-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'FG006', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'FG007', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'FG008', 'title': 'RPC01-2201 Ozanimod 0.92 mg', 'description': 'Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '329'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '85'}, {'groupId': 'FG004', 'numSubjects': '91'}, {'groupId': 'FG005', 'numSubjects': '38'}, {'groupId': 'FG006', 'numSubjects': '33'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '329'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '85'}, {'groupId': 'FG004', 'numSubjects': '91'}, {'groupId': 'FG005', 'numSubjects': '38'}, {'groupId': 'FG006', 'numSubjects': '33'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, 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Non-responders had the option to enter the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'BG002', 'title': 'RPC01-3203 Placebo-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'BG003', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'BG004', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers', 'description': 'Participants who completed the 52 weeks maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'BG005', 'title': 'RPC01-3203 Placebo-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'BG006', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'BG007', 'title': 'RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse', 'description': 'Participants who relapsed in the maintenance study entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'BG008', 'title': 'RPC01-2201 Ozanimod 0.92 mg', 'description': 'Participants who completed at least 1 year of RPC01-2201 entered the open-label extension 3204 study and took Ozanimod 0.92 mg oral daily.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.93', 'spread': '13.147', 'groupId': 'BG000'}, {'value': '39.21', 'spread': '13.508', 'groupId': 'BG001'}, 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'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '70', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, 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'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-16', 'size': 3434985, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-27T16:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 854}}, 'statusModule': {'whyStopped': 'Business objectives have changed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2018-03-12', 'resultsFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-29', 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Remission', 'timeFrame': 'At weeks 48, 96, 144, 192, 240', 'description': "Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \\< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\\\\[none\\\\\\] to 3 \\\\\\[Severe\\\\\\]), general well-being (0 \\\\\\[well\\\\\\] to 4 \\\\\\[terrible\\\\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)', 'description': 'A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission', 'timeFrame': 'At weeks 48, 96, 144, 192, 240', 'description': 'Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. Higher scores indicated worse outcomes.'}, {'measure': 'Percentage of Participants With Clinical Response', 'timeFrame': 'At weeks 48, 96, 144, 192, 240', 'description': "Clinical response is defined as a Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of \\< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\\\\[none\\\\\\] to 3 \\\\\\[Severe\\\\\\]), general well-being (0 \\\\\\[well\\\\\\] to 4 \\\\\\[terrible\\\\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Crohn's Disease", 'Crohn Disease', 'Oral', 'Ozanimod', 'Moderately active', 'Severely active', 'RPC01', 'RPC01-3204'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '36208720', 'type': 'DERIVED', 'citation': "Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5."}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': "This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies\n* Experience relapse or who complete the Maintenance Study\n* Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation\n\nExclusion Criteria:\n\n* Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study\n* Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated\n* Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors\n\nOther protocol-defined inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT03467958', 'briefTitle': "An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': "A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease", 'orgStudyIdInfo': {'id': 'RPC01-3204'}, 'secondaryIdInfos': [{'id': 'U1111-1203-8203', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': '2017-004295-55', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of oral Ozanimod', 'interventionNames': ['Drug: Ozanimod']}], 'interventions': [{'name': 'Ozanimod', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Administration of oral Ozanimod']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Holland Center for Family Health', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution - 202', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution - 026', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '93012', 'city': 'Camarillo', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 284', 'geoPoint': {'lat': 34.21639, 'lon': -119.0376}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Chula Vista Medical Center', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 039', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Ucsd Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Clinical Trials', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 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