Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT04706793
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}}}}, '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': 'C000656249', 'term': 'etrasimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, non-serious treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected during the 40-week continuous treatment period, followed by a 4-week follow-up period up to Week 44 of C5041013 (APD334-308).', 'description': 'Safety set population included all randomized participants who received at least 1 dose of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 16, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'OG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.86', 'ciLowerLimit': '-3.10', 'ciUpperLimit': '38.82', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \\[\\>=\\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population (All randomized participants who received at least 1 dose of study intervention). Only those participants with data available at the specified time points were analyzed. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure".'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'OG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.57', 'ciLowerLimit': '6.28', 'ciUpperLimit': '50.86', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Endoscopic improvement was defined as an ES \\<=1 (excluding friability) at Week 40 of APD334-308 compared with Week 12 of APD334-302. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure".'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'OG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '39.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.14', 'ciLowerLimit': '9.58', 'ciUpperLimit': '54.71', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a \\>= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'OG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.43', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '42.92', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Mucosal healing was defined as an ES \\<= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than \\[\\<\\] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'OG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.86', 'ciLowerLimit': '-3.10', 'ciUpperLimit': '38.82', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \\[\\>=\\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Sustained Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'OG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.14', 'ciLowerLimit': '-2.40', 'ciUpperLimit': '16.68', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \\[\\>=\\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. A subject with sustained clinical remission is defined as someone who achieved clinical remission at both Week 12 of APD334-302 and Week 40 of APD334-308.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population. "Overall number of participants analyzed" signifies participants evaluable for this outcome measure". Only those participants with data available at the specified time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'FG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308'}], 'periods': [{'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Disease worsening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease worsening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Comparator: Placebo', 'description': 'Participants received etrasimod matching placebo 1 tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'BG001', 'title': 'Experimental: Etrasimod 2 mg', 'description': 'Participants received etrasimod 2 mg tablet by mouth, once daily up to 40 weeks in APD334-308'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '14.12', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '14.29', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '14.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 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[{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set: All randomized participants who received at least 1 dose of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-15', 'size': 1528397, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-14T10:06', 'hasProtocol': True}, {'date': '2022-09-26', 'size': 725561, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-22T08:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2021-01-11', 'resultsFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-22', 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \\[\\>=\\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Endoscopic improvement was defined as an ES \\<=1 (excluding friability) at Week 40 of APD334-308 compared with Week 12 of APD334-302. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease); higher score indicated more severe disease.'}, {'measure': 'Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Symptomatic remission was defined as an SF sub-score = 0 (or = 1 with a \\>= 1 point decrease from Baseline) and RB sub-score = 0. The SF sub-score ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB sub-score ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicated more severe disease.'}, {'measure': 'Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Mucosal healing was defined as an ES \\<= 1 (excluding friability) with histologic remission measured by a Geboes Index score less than \\[\\<\\] 2.0). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease.'}, {'measure': 'Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \\[\\>=\\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.'}, {'measure': 'Percentage of Participants Achieving Sustained Clinical Remission', 'timeFrame': 'Week 40 of APD334-308', 'description': 'Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \\[\\>=\\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease. A subject with sustained clinical remission is defined as someone who achieved clinical remission at both Week 12 of APD334-302 and Week 40 of APD334-308.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Etrasimod', 'APD334', 'UC'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=APD334-308', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will continue with the same blinded treatment assigned in Study APD334-302 for a total treatment duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants with moderately to severely active ulcerative colitis (UC) are eligible to enroll into this study if they fulfill all of the following:\n\n* Must have completed the Week 12 visit of Study APD334-302\n* Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a participant \\< 20 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of participants \\< 20 years should be conducted only if acceptable according to local laws and regulations.\n* Both men and women subjects agree to use a highly effective method of birth control if the possibility of conception exists\n\nExclusion Criteria:\n\nParticipants who meet any of the following exclusion criteria will not be eligible for enrollment into the study:\n\n* If the Investigator considers the participant to be unsuitable for any reason to participate in the study\n* Participants requiring partial or total colectomy during the APD334-302 study\n* Participants requiring treatment with prohibited concomitant medications'}, 'identificationModule': {'nctId': 'NCT04706793', 'briefTitle': 'Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'APD334-308'}, 'secondaryIdInfos': [{'id': 'C5041013', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etrasimod 2 mg', 'interventionNames': ['Drug: Etrasimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Etrasimod', 'type': 'DRUG', 'otherNames': ['APD334'], 'description': 'Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks', 'armGroupLabels': ['Etrasimod 2 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '457-8511', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Kojunkai Daido Clinic', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '457-8511', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Kojunkai Daido Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '441-8570', 'city': 'Toyohashi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Toyohashi Municipal Hospital', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'zip': '277-0871', 'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Tsujinaka Hospital Kashiwanoha'}, {'zip': '270-0116', 'city': 'Nagareyama-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Ishii Eye Clinic'}, {'zip': '814-0180', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 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{'zip': '302-0014', 'city': 'Toride-shi', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Matsumoto Eye Clinic'}, {'zip': '920-8650', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'NHO Kanazawa Medical Center', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '760-0017', 'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Takamatsu Red Cross Hospital', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'zip': '760-8557', 'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Kagawa Prefectural Central Hospital', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'zip': '890-0062', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'JA- Kagoshima Koseiren Hospital (PET/DLCO)', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '890-0062', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Kagoshima Kouseiren Hospital', 'geoPoint': {'lat': 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'Japan', 'facility': 'National Hospital Organization Kyoto Medical Center', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '514-8507', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Mie University Hospital', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '510-8561', 'city': 'Yokkaichi-shi', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Mie Prefectural General Medical Center'}, {'zip': '981-8563', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'JOHAS Tohoku Rokai Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '981-8563', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'JOHAS Tohoku Rosai Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '982-8502', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Sendai City Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '553-0003', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Japan Community Health care Organization Osaka Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '849-8501', 'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'facility': 'Saga University Hospital', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '104-8560', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': "St. Luke's International Hospital"}, {'zip': '187-8510', 'city': 'Kodaira-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Showa General Hospital'}, {'zip': '108-8642', 'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kitasato University Kitasato Institute Hospital'}, {'zip': '169-0073', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'JCHO Tokyo Yamate Medical Center'}, {'zip': '641-8510', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Wakayama Medical University Hospital', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Arena is a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}