Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-28 @ 7:28 AM
Study NCT ID:
NCT03198767
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709456', 'term': 'licogliflozin'}, {'id': 'D011620', 'term': 'Psyllium'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: LIK066 + 50% CHO', 'description': 'Part A: LIK066 + 50% carbohydrate CHO', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 21, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: LIK066 + 25% CHO', 'description': 'Part A: LIK066 + 25% carbohydrate CHO', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 19, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: LIK066 + 0% CHO', 'description': 'Part A: LIK066 + 0% carbohydrate CHO', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 19, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A: LIK066 + 8% CHO', 'description': 'Part A: LIK066 + 8% carbohydrate CHO', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part B: LIK066 + 50% CHO + NS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 21, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part B: LIK066 + 50% CHO + PS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 19, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: LIK066 + 50% CHO CC', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 22, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Episodes of Diarrhea (Part A and Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: LIK066 + 50% CHO', 'description': 'Part A: LIK066 + 50% carbohydrate CHO'}, {'id': 'OG001', 'title': 'Part A: LIK066 + 25% CHO', 'description': 'Part A: LIK066 + 25% carbohydrate CHO'}, {'id': 'OG002', 'title': 'Part A: LIK066 + 0% CHO', 'description': 'Part A: LIK066 + 0% carbohydrate CHO'}, {'id': 'OG003', 'title': 'Part B: LIK066 + 50% CHO + NS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)'}, {'id': 'OG004', 'title': 'Part B: LIK066 + 50% CHO + PS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)'}, {'id': 'OG005', 'title': 'Part B: LIK066 + 50% CHO CC', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '1.88', 'spread': '1.51', 'groupId': 'OG003'}, {'value': '1.46', 'spread': '1.41', 'groupId': 'OG004'}, {'value': '1.46', 'spread': '1.67', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.71', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.00', 'groupDescription': 'Day 3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.21', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.32', 'groupDescription': 'Day 3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.30', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.46', 'groupDescription': 'Day 3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.275', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.79', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.04', 'groupDescription': 'Day 3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.234', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.78', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.02', 'groupDescription': 'Day 3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.921', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.98', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.30', 'groupDescription': 'Day 3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours on Day 3 of each treatment period', 'description': 'Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.', 'unitOfMeasure': 'Number of stools', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set. All subjects with any available pharmacodynamic (PD) data and no major protocol deviations with impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Three-day Total Number of Episodes of Diarrhea (Part A and Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: LIK066 + 50% CHO', 'description': 'Part A: LIK066 + 50% carbohydrate CHO'}, {'id': 'OG001', 'title': 'Part A: LIK066 + 25% CHO', 'description': 'Part A: LIK066 + 25% carbohydrate CHO'}, {'id': 'OG002', 'title': 'Part A: LIK066 + 0% CHO', 'description': 'Part A: LIK066 + 0% carbohydrate CHO'}, {'id': 'OG003', 'title': 'Part B: LIK066 + 50% CHO + NS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)'}, {'id': 'OG004', 'title': 'Part B: LIK066 + 50% CHO + PS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)'}, {'id': 'OG005', 'title': 'Part B: LIK066 + 50% CHO CC', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.96', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '2.97', 'groupId': 'OG001'}, {'value': '1.50', 'spread': '2.02', 'groupId': 'OG002'}, {'value': '4.42', 'spread': '3.41', 'groupId': 'OG003'}, {'value': '3.46', 'spread': '3.24', 'groupId': 'OG004'}, {'value': '4.00', 'spread': '3.11', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.68', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.86', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.37', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.49', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.008', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.54', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.72', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.141', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.79', 'ciLowerLimit': '0.65', 'ciUpperLimit': '0.97', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.510', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.90', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.401', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of number of events', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.14', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.41', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to 3 of each treatment period', 'description': 'Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on days 1 to 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.', 'unitOfMeasure': 'Number of stools', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set. All subjects with any available pharmacodynamic (PD) data and no major protocol deviations with impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Average Consistency With Bristol Stool Chart (Part A and Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: LIK066 + 50% CHO', 'description': 'Part A: LIK066 + 50% carbohydrate CHO'}, {'id': 'OG001', 'title': 'Part A: LIK066 + 25% CHO', 'description': 'Part A: LIK066 + 25% carbohydrate CHO'}, {'id': 'OG002', 'title': 'Part A: LIK066 + 0% CHO', 'description': 'Part A: LIK066 + 0% carbohydrate CHO'}, {'id': 'OG003', 'title': 'Part B: LIK066 + 50% CHO + NS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)'}, {'id': 'OG004', 'title': 'Part B: LIK066 + 50% CHO + PS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)'}, {'id': 'OG005', 'title': 'Part B: LIK066 + 50% CHO CC', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.45', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '5.42', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '4.71', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '5.81', 'spread': '1.07', 'groupId': 'OG003'}, {'value': '5.52', 'spread': '0.99', 'groupId': 'OG004'}, {'value': '5.62', 'spread': '1.02', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.426', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.21', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.06', 'ciLowerLimit': '-1.46', 'ciUpperLimit': '-0.67', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.009', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.85', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '-0.45', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.135', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.37', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.436', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.19', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.452', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.18', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.49', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours on Day 3 of each treatment period', 'description': 'BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool).', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Average Stool pH (Part A and Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: LIK066 + 50% CHO', 'description': 'Part A: LIK066 + 50% carbohydrate CHO'}, {'id': 'OG001', 'title': 'Part A: LIK066 + 25% CHO', 'description': 'Part A: LIK066 + 25% carbohydrate CHO'}, {'id': 'OG002', 'title': 'Part A: LIK066 + 0% CHO', 'description': 'Part A: LIK066 + 0% carbohydrate CHO'}, {'id': 'OG003', 'title': 'Part B: LIK066 + 50% CHO + NS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)'}, {'id': 'OG004', 'title': 'Part B: LIK066 + 50% CHO + PS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)'}, {'id': 'OG005', 'title': 'Part B: LIK066 + 50% CHO CC', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.35', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '6.29', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '6.52', 'spread': '0.59', 'groupId': 'OG003'}, {'value': '6.79', 'spread': '0.67', 'groupId': 'OG004'}, {'value': '6.66', 'spread': '0.50', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours on Day 3 of each treatment period', 'description': 'Average PH of Stool at day 3', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set'}, {'type': 'SECONDARY', 'title': 'Average Stool Weight (Part A and Part B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: LIK066 + 50% CHO', 'description': 'Part A: LIK066 + 50% carbohydrate CHO'}, {'id': 'OG001', 'title': 'Part A: LIK066 + 25% CHO', 'description': 'Part A: LIK066 + 25% carbohydrate CHO'}, {'id': 'OG002', 'title': 'Part A: LIK066 + 0% CHO', 'description': 'Part A: LIK066 + 0% carbohydrate CHO'}, {'id': 'OG003', 'title': 'Part B: LIK066 + 50% CHO + NS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)'}, {'id': 'OG004', 'title': 'Part B: LIK066 + 50% CHO + PS', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)'}, {'id': 'OG005', 'title': 'Part B: LIK066 + 50% CHO CC', 'description': 'Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)'}], 'classes': [{'categories': [{'measurements': [{'value': '136.5', 'spread': '88.99', 'groupId': 'OG000'}, {'value': '154.5', 'spread': '87.11', 'groupId': 'OG001'}, {'value': '116.7', 'spread': '65.57', 'groupId': 'OG002'}, {'value': '145.5', 'spread': '75.21', 'groupId': 'OG003'}, {'value': '177.1', 'spread': '138.1', 'groupId': 'OG004'}, {'value': '164.3', 'spread': '108.5', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours on Day 3 of each treatment period', 'description': '24 hour average stool weight on day 3', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate'}, {'id': 'FG001', 'title': 'Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate'}, {'id': 'FG002', 'title': 'Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate'}, {'id': 'FG003', 'title': 'Part A: LIK066 + P1: 8% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.'}, {'id': 'FG004', 'title': 'Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)'}, {'id': 'FG005', 'title': 'Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)'}, {'id': 'FG006', 'title': 'Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 116 subjects were screened and 54 subjects were enrolled and randomized, with 48 completing the study. 6 subjects in Part A were discontinued due to a protocol deviation after day 3 dosing (the protein drink provided to subjects was incorrect and included 8% carbohydrate).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '54', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate'}, {'id': 'BG001', 'title': 'Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate'}, {'id': 'BG002', 'title': 'Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate'}, {'id': 'BG003', 'title': 'Part A: LIK066 + P1: 8% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.'}, {'id': 'BG004', 'title': 'Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)'}, {'id': 'BG005', 'title': 'Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)'}, {'id': 'BG006', 'title': 'Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '46'}, {'value': '45.5', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '61'}, {'value': '43.9', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '63'}, {'value': '53.3', 'groupId': 'BG003', 'lowerLimit': '51', 'upperLimit': '57'}, {'value': '43.8', 'groupId': 'BG004', 'lowerLimit': '27', 'upperLimit': '56'}, {'value': '50.1', 'groupId': 'BG005', 'lowerLimit': '36', 'upperLimit': '62'}, {'value': '43.3', 'groupId': 'BG006', 'lowerLimit': '29', 'upperLimit': '58'}, {'value': '44.3', 'groupId': 'BG007', 'lowerLimit': '21', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Safety Analysis Set'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '37', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Analysis Set'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '46', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Analysis Set'}], 'populationDescription': 'Safety Analysis Set. All subjects that received any study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-08', 'size': 591889, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-27T10:10', 'hasProtocol': True}, {'date': '2017-09-27', 'size': 320605, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-27T10:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2017-06-16', 'resultsFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-27', 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Episodes of Diarrhea (Part A and Part B)', 'timeFrame': '24 hours on Day 3 of each treatment period', 'description': 'Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.'}], 'secondaryOutcomes': [{'measure': 'Three-day Total Number of Episodes of Diarrhea (Part A and Part B)', 'timeFrame': 'Day 1 to 3 of each treatment period', 'description': 'Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on days 1 to 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.'}, {'measure': 'Average Consistency With Bristol Stool Chart (Part A and Part B)', 'timeFrame': '24 hours on Day 3 of each treatment period', 'description': 'BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool).'}, {'measure': 'Average Stool pH (Part A and Part B)', 'timeFrame': '24 hours on Day 3 of each treatment period', 'description': 'Average PH of Stool at day 3'}, {'measure': 'Average Stool Weight (Part A and Part B)', 'timeFrame': '24 hours on Day 3 of each treatment period', 'description': '24 hour average stool weight on day 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'overweight', 'body mass index', 'BMI', 'diarrhea'], 'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=453', 'label': 'A Plain Language Trial Summary is available on novartisclinicatrials.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with LIK066.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese and overweight, BMI 25-50, HbA1C \\<10%\n\nExclusion Criteria:\n\n* Preexisting, clinically significant cardiovascular, liver, renal, or GI disease that is considered unstable; pregnancy, Type 1 diabetes; Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03198767', 'briefTitle': 'Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Open Label, Two-part, Three-period, Cross Over Study to Investigate the Effects of Carbohydrate in Diet and to Evaluate Supplements on the Gastrointestinal Tolerability of LIK066 in Overweight or Obese Subjects', 'orgStudyIdInfo': {'id': 'CLIK066B2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate', 'interventionNames': ['Drug: LIK066', 'Dietary Supplement: Carbohydrate 50%', 'Dietary Supplement: Carbohydrate 25%', 'Dietary Supplement: Carbohydrate 0%']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate', 'interventionNames': ['Drug: LIK066', 'Dietary Supplement: Carbohydrate 50%', 'Dietary Supplement: Carbohydrate 25%', 'Dietary Supplement: Carbohydrate 0%']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate', 'interventionNames': ['Drug: LIK066', 'Dietary Supplement: Carbohydrate 50%', 'Dietary Supplement: Carbohydrate 25%', 'Dietary Supplement: Carbohydrate 0%']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: LIK066 + P1: 8% CHO', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.', 'interventionNames': ['Drug: LIK066', 'Dietary Supplement: Carbohydrate 8%']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)', 'interventionNames': ['Drug: LIK066', 'Dietary Supplement: Carbohydrate 50%', 'Dietary Supplement: Psyllium', 'Dietary Supplement: Calcium carbonate']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)', 'interventionNames': ['Drug: LIK066', 'Dietary Supplement: Carbohydrate 50%', 'Dietary Supplement: Psyllium', 'Dietary Supplement: Calcium carbonate']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS', 'description': 'Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)', 'interventionNames': ['Drug: LIK066', 'Dietary Supplement: Carbohydrate 50%', 'Dietary Supplement: Psyllium', 'Dietary Supplement: Calcium carbonate']}], 'interventions': [{'name': 'LIK066', 'type': 'DRUG', 'description': 'LIK066 50 mg tablets. Open-label, bulk, blister-pack.', 'armGroupLabels': ['Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO', 'Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO', 'Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO', 'Part A: LIK066 + P1: 8% CHO', 'Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS', 'Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC', 'Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS']}, {'name': 'Carbohydrate 50%', 'type': 'DIETARY_SUPPLEMENT', 'description': '50% carbohydrate in breakfast meal', 'armGroupLabels': ['Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO', 'Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO', 'Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO', 'Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS', 'Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC', 'Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS']}, {'name': 'Carbohydrate 25%', 'type': 'DIETARY_SUPPLEMENT', 'description': '25% carbohydrate in breakfast meal', 'armGroupLabels': ['Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO', 'Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO', 'Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO']}, {'name': 'Carbohydrate 8%', 'type': 'DIETARY_SUPPLEMENT', 'description': '8% carbohydrate in breakfast meal', 'armGroupLabels': ['Part A: LIK066 + P1: 8% CHO']}, {'name': 'Carbohydrate 0%', 'type': 'DIETARY_SUPPLEMENT', 'description': '0% carbohydrate in breakfast meal', 'armGroupLabels': ['Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO', 'Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO', 'Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO']}, {'name': 'Psyllium', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['MetaMucil®'], 'description': 'Powder 6 grams', 'armGroupLabels': ['Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS', 'Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC', 'Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS']}, {'name': 'Calcium carbonate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Quality Value®'], 'description': 'Liquid 1 gram (4 mL equivalent sugar free)', 'armGroupLabels': ['Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS', 'Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC', 'Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}