Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-31 @ 2:13 AM
Study NCT ID:
NCT03178669
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2017-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711771', 'term': 'cobitolimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karin.arnesson@indexpharma.com', 'phone': '+46 8 122 038 57', 'title': 'Karin Arnesson, Clinical Trial Manager', 'organization': 'InDex Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)', 'eventGroups': [{'id': 'EG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 12, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 8, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 10, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 11, 'seriousNumAtRisk': 44, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Ulcerative colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Viral upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Faecal calprotectin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Ulcerative colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1806', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.0', 'ciLowerLimit': '0.75', 'ciUpperLimit': '5.47', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6649', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.7', 'ciLowerLimit': '0.20', 'ciUpperLimit': '2.24', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0247', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '3.8', 'ciLowerLimit': '1.53', 'ciUpperLimit': '9.47', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3279', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.4', 'ciLowerLimit': '0.52', 'ciUpperLimit': '3.88', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks after first treatment', 'description': 'Patients with clinical remission at Week 6 (yes=1, no=0), defined by Modified Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Non Responder Imputation (NRI). Number of observed data is presented.'}, {'type': 'SECONDARY', 'title': 'Modified Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2115', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.9', 'ciLowerLimit': '0.69', 'ciUpperLimit': '4.99', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8498', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.3', 'ciLowerLimit': '0.06', 'ciUpperLimit': '1.34', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0977', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.6', 'ciLowerLimit': '1.01', 'ciUpperLimit': '6.62', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5220', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.0', 'ciLowerLimit': '0.32', 'ciUpperLimit': '2.84', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'Patients with modified clinical remission at Week 6 (yes=1, no=0), defined by the Modified Mayo score ≤ 2 and sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), iii) endoscopy score of 0 or 1 (excluding friability ) and iiii) physician´s global assessment (PGA) of 0 or 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented in the table.'}, {'type': 'SECONDARY', 'title': 'Symptomatic Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2335', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.5', 'ciLowerLimit': '0.74', 'ciUpperLimit': '2.94', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2511', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.4', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.69', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1162', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.8', 'ciLowerLimit': '0.96', 'ciUpperLimit': '3.52', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3467', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.2', 'ciLowerLimit': '0.63', 'ciUpperLimit': '2.40', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'Patients with symptomatic remission at Week 6 (yes=1, no=0), defined by the Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), (patient reported outcome)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented.'}, {'type': 'SECONDARY', 'title': 'Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.6326', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.9', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.50', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7127', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.8', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.37', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2658', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.3', 'ciLowerLimit': '0.75', 'ciUpperLimit': '2.34', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8301', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.6', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.16', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'Patients with clinical response at Week 6 (yes=1, no=0), defined as clinical remission or a three point and ≥30 % decrease from Baseline, Week 0 in the sum of the Modified Mayo score, i) rectal bleeding, ii) stool frequency and iii) endoscopy score (excluding friability), iiii) physicians global assessment (PGA)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented.'}, {'type': 'SECONDARY', 'title': 'Endoscopic Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.7994', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.6', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.27', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9665', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.3', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.72', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2049', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.5', 'ciLowerLimit': '0.80', 'ciUpperLimit': '2.82', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6504', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.8', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.60', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'Patients with endoscopic remission at Week 6 (yes=1, no=0), defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented.'}, {'type': 'SECONDARY', 'title': 'Histological Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.9207', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.4', 'ciLowerLimit': '0.18', 'ciUpperLimit': '0.93', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9228', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.4', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.92', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6636', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.8', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.61', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7449', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.7', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.41', 'pValueComment': 'one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS), was based on the intention-to-treat (ITT) principles, which consists of all randomised patients who meet the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and receive at least one dose of the study drug (active or placebo). Missing data was replaced using Placebo Multiple Imputation (PMI). Number of observed data is presented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'FG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'FG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'FG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '44'}]}, {'type': 'Completed Week 6', 'comment': 'Completed Week 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 10', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1 patient in the 2x31 mg and one patient in the 4x125 mg was never treated with study drug and excluded from analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Cobitolimod Dose 2x31 mg', 'description': 'Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'BG001', 'title': 'Cobitolimod Dose 2x125 mg', 'description': 'Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'BG002', 'title': 'Cobitolimod Dose 2x250 mg', 'description': 'Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'BG003', 'title': 'Cobitolimod Dose 4x125 mg', 'description': 'Dose 125 mg of cobitolimod, at 4 occasions\n\ncobitolimod: Rectal administration'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Placebo at four occasions\n\nPlacebo: Solution manufactured to mimic cobitolimod'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '47.4', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '47.0', 'spread': '16.9', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '14.0', 'groupId': 'BG002'}, {'value': '47.2', 'spread': '14.9', 'groupId': 'BG003'}, {'value': '45.5', 'spread': '15.2', 'groupId': 'BG004'}, {'value': '46.6', 'spread': '15.4', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '82', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '129', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity : Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'Ethnicity : White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '202', 'groupId': 'BG005'}]}]}, {'title': 'Ethnicity : Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '75.5', 'spread': '16.70', 'groupId': 'BG000'}, {'value': '71.5', 'spread': '14.85', 'groupId': 'BG001'}, {'value': '73.3', 'spread': '13.15', 'groupId': 'BG002'}, {'value': '73.1', 'spread': '17.53', 'groupId': 'BG003'}, {'value': '78.1', 'spread': '12.89', 'groupId': 'BG004'}, {'value': '74.3', 'spread': '15.14', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '4.54', 'groupId': 'BG000'}, {'value': '24.7', 'spread': '4.65', 'groupId': 'BG001'}, {'value': '24.5', 'spread': '3.70', 'groupId': 'BG002'}, {'value': '24.7', 'spread': '5.06', 'groupId': 'BG003'}, {'value': '25.9', 'spread': '4.80', 'groupId': 'BG004'}, {'value': '25.0', 'spread': '4.56', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tobacco use at screening', 'classes': [{'title': 'Never smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '149', 'groupId': 'BG005'}]}]}, {'title': 'Current smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}, {'title': 'Former smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total inflammatory Bowel Disease Questionnaire score (IBDQ)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '131.9', 'spread': '28.11', 'groupId': 'BG000'}, {'value': '140.1', 'spread': '32.46', 'groupId': 'BG001'}, {'value': '131.5', 'spread': '36.64', 'groupId': 'BG002'}, {'value': '120.9', 'spread': '34.81', 'groupId': 'BG003'}, {'value': '133.9', 'spread': '28.58', 'groupId': 'BG004'}, {'value': '131.7', 'spread': '32.59', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'The IBDQ is an instrument used to assess quality of life in participants. It includes 32 questions on 4 domains : Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse health.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Ulcerative Colitis (UC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7.88', 'spread': '6.480', 'groupId': 'BG000'}, {'value': '8.46', 'spread': '7.431', 'groupId': 'BG001'}, {'value': '7.89', 'spread': '6.830', 'groupId': 'BG002'}, {'value': '8.14', 'spread': '6.772', 'groupId': 'BG003'}, {'value': '7.36', 'spread': '7.277', 'groupId': 'BG004'}, {'value': '7.94', 'spread': '6.920', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stool frequency per day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.93', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '1.83', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '2.73', 'groupId': 'BG002'}, {'value': '5.7', 'spread': '2.56', 'groupId': 'BG003'}, {'value': '5.9', 'spread': '3.04', 'groupId': 'BG004'}, {'value': '5.7', 'spread': '2.62', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Stools per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mayo score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '8.3', 'spread': '1.7', 'groupId': 'BG003'}, {'value': '8.3', 'spread': '1.6', 'groupId': 'BG004'}, {'value': '8.3', 'spread': '1.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': "The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings (excluding friability at grade 1), and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. Higher values represent worse disease.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mayo stool frequency subscore', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}]}, {'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}]}]}, {'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '70', 'groupId': 'BG005'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mayo stool frequency subscore: 0=normal, 1=one to two stools per day more than normal, 2=three to four stools per day more than normal, 3=more than four stools per day more than normal.', 'unitOfMeasure': 'Participants'}, {'title': 'Mayo rectal bleeding subscore', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}, {'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}]}, {'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mayo rectal bleeding sub-score: 0=none, 1=visible blood with stool less than half the time, 2=visible blood with stool half the time or more, 3=passing blood alone.', 'unitOfMeasure': 'Participants'}, {'title': 'Mayo endoscopic subscore', 'classes': [{'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '91', 'groupId': 'BG005'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '120', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mayo endoscopic subscore: 2=moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'Participants'}, {'title': 'Mayo Physicians Global Assessment (PGA) subscore', 'classes': [{'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}]}, {'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '160', 'groupId': 'BG005'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mayo PGA subscore:1=mild disease, 2=moderate disease, 3=severe disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Disease extent', 'classes': [{'title': 'Rectosigmoid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '108', 'groupId': 'BG005'}]}]}, {'title': 'Descending colon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '103', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Nancy Histological Index (NHI) score', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '209', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '209', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '209', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}, {'title': '3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '209', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '209', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '105', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Nancy Histological Index (NHI) classifies histologic status, a score from 0 to 4. Grade 0= no histological findings, grade 1= no acute acute inflammatory infiltrate, grade 2= acute inflammatory cells infiltrate and no ulceration 3= acute inflammatory cells infiltrate and no ulceration 4= ulceration. The most severe observation across all segments is used for the final NHI score. A higher score indicates more severe disease.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing NHI score for 2 patients'}, {'title': 'Faecal calprotectin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '3563', 'spread': '6256', 'groupId': 'BG000'}, {'value': '3389', 'spread': '5669', 'groupId': 'BG001'}, {'value': '2654', 'spread': '4294', 'groupId': 'BG002'}, {'value': '3730', 'spread': '4954', 'groupId': 'BG003'}, {'value': '3263', 'spread': '5379', 'groupId': 'BG004'}, {'value': '3313', 'spread': '5292', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'C-reactive protein (CRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '9.7', 'spread': '16.9', 'groupId': 'BG003'}, {'value': '8.1', 'spread': '12.1', 'groupId': 'BG004'}, {'value': '7.5', 'spread': '11.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Concomitant Ulcerative Colitis(UC) medication', 'classes': [{'title': '5-aminosalicylic acid (5-ASA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '178', 'groupId': 'BG005'}]}]}, {'title': 'Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '79', 'groupId': 'BG005'}]}]}, {'title': 'Thiopurines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous UC therapy', 'classes': [{'title': 'Thiopurines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '203', 'groupId': 'BG005'}]}]}, {'title': 'Anti-TNF Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '211', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}]}]}, {'title': 'Vedolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, 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'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-12', 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Remission', 'timeFrame': '6 weeks after first treatment', 'description': 'Patients with clinical remission at Week 6 (yes=1, no=0), defined by Modified Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).'}], 'secondaryOutcomes': [{'measure': 'Modified Clinical Remission', 'timeFrame': 'Week 6', 'description': 'Patients with modified clinical remission at Week 6 (yes=1, no=0), defined by the Modified Mayo score ≤ 2 and sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), iii) endoscopy score of 0 or 1 (excluding friability ) and iiii) physician´s global assessment (PGA) of 0 or 1'}, {'measure': 'Symptomatic Remission', 'timeFrame': 'Week 6', 'description': 'Patients with symptomatic remission at Week 6 (yes=1, no=0), defined by the Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), (patient reported outcome)'}, {'measure': 'Clinical Response', 'timeFrame': 'Week 6', 'description': 'Patients with clinical response at Week 6 (yes=1, no=0), defined as clinical remission or a three point and ≥30 % decrease from Baseline, Week 0 in the sum of the Modified Mayo score, i) rectal bleeding, ii) stool frequency and iii) endoscopy score (excluding friability), iiii) physicians global assessment (PGA)'}, {'measure': 'Endoscopic Remission', 'timeFrame': 'Week 6', 'description': 'Patients with endoscopic remission at Week 6 (yes=1, no=0), defined by the Modified Mayo endoscopic sub score of 0 or 1 (excluding friability)'}, {'measure': 'Histological Remission', 'timeFrame': 'Week 6', 'description': 'Patients with histological remission at Week 6 (yes=1, no=0), defined by the Nancy histological index of grade 0 or 1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colitis, Ulcerative', 'Gastrointestinal Diseases', 'Inflammatory Bowel Disease', 'Immunomodulator Therapy', 'Glucocorticoids', 'Anti-Inflammatory Agents', 'Therapeutic uses', 'Kappaproct', 'IDX0150', 'DIMS0150'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '33031757', 'type': 'DERIVED', 'citation': 'Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hebuterne X, Arnesson K, Knittel T, Kowalski J, Neurath MF, Sandborn WJ, Reinisch W; CONDUCT study group. Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial. Lancet Gastroenterol Hepatol. 2020 Dec;5(12):1063-1075. doi: 10.1016/S2468-1253(20)30301-0. Epub 2020 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.', 'detailedDescription': 'This was a Phase IIb study in patients with moderate to severe left-sided ulcerative colitis. Patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. To ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. Blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. Primary endpoint was evaluated at week 6.\n\nDuration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Established diagnosis of Ulcerative Colitis (UC)\n* Moderately to severely active left sided UC assessed by central reading\n* Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use\n* Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:\n\n * Immunomodulators\n * Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins\n\nExclusion Criteria:\n\n* Suspicion of differential diagnosis\n* Acute fulminant UC and/or signs of 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