Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-28 @ 8:41 PM
Study NCT ID:
NCT04096560
Status:
TERMINATED
Last Update Posted:
2024-10-29
First Post:
2019-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'A safety signal had emerged in the phase 2 studies of firazorexton causing early termination of Part C and Part D of the study.'}}, 'adverseEventsModule': {'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 13, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 17, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 14, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Ex-tobacco user', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Faeces hard', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Glutamate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hypervigilance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Middle insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Puncture site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Urinary tract pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vaccination complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vulvovaginal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Pleomorphic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood pressure diastolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacterial disease carrier', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35) in Part A', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'title': 'Calcium (mmol/L): <1.92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sodium (mmol/L): <130', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Potassium (mmol/L): >5.3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35) in Part A', 'description': 'Standard safety laboratory values (hematology, serum chemistry, urinalysis) were collected and compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: Erythrocytes(10\\^12/L:\\<0.8xlower limit of normal(LLN), \\>1.2xupper limit of normal(ULN); Hemoglobin grams per litre(g/L):\\<0.8xLLN, \\>1.2xULN; Hematocrit voltage/volts(V/V):\\<0.8xLLN, \\>1.2xULN; Platelets(10\\^9/L):\\<75, \\>600; Leukocytes(10\\^9/L):\\<0.5xLLN, \\>1.5xULN; Alanine Aminotransferase units/litre(U/L):\\>3xULN, Aspartate Aminotransferase(U/L):\\>3xULN; Bilirubin micromoles/litre (umol/L):\\>1.5xULN; Alkaline Phosphatase(U/L):\\>3xULN; Gamma Glutamyl Transferase(U/L):\\>3 x ULN; Albumin(g/L):\\<25; Protein Total(g/L):\\<0.8xLLN, \\>1.2xULN;Glucose millimoles/litre(mmol/L):\\<2.8, \\>19.4; Calcium(mmol/L):\\<1.92, \\>2.77; Creatinine(umol/L):\\>1.5xULN; Urea(mmol/L):\\>10.7; Sodium(mmol/L):\\<130, \\>150; Potassium(mmol/L):\\<3.0, \\>5.3. Only categories with at least one participant with event are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'title': 'Systolic Blood Pressure (mmHg) <90', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure (mmHg): Change from Pre-Dose >20', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure (mmHg): Change from Pre-Dose >30', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure (mmHg): Time-matched Change from Baseline > 20', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure (mmHg): Time-matched Change from Baseline > 30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure (mmHg): Change from Pre-Dose >20', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure (mmHg): Time-matched Change from Baseline > 20', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Temperature (C): >38.5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35) in Part A', 'description': 'Vital signs (body temperature and sitting blood pressure) were collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Markedly abnormal values criteria: Heart Rate (beats/min): \\<40, \\>115; Systolic Blood Pressure millimeters of mercury (mmHg): \\<90, ≥160, Change from Pre-Dose \\>20, Change from Pre-Dose \\>30, Time-matched Change from Baseline \\> 20, Time-matched Change from Baseline \\> 30; Diastolic Blood Pressure (mmHg): \\<50, ≥100, Change from Pre-Dose \\>20, Change from Pre-Dose \\>30, Time-matched Change from Baseline \\> 20, Time-matched Change from Baseline \\> 30; Respiratory Rate (breaths/min): \\>21; Temperature Celsius (C): \\>38.5. Only categories with at least one participant with event are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'title': 'PR Interval (msec): ≥200', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval (msec): ≥30 change from baseline and >450', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QRS Duration (msec): ≤80', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35) in Part A', 'description': 'A 12 lead ECG was performed, the ECG values were compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: ECG Mean Heart Rate (beats/min): \\<40, \\>115; PR Interval milliseconds (msec): ≤80, ≥200; corrected QT interval by Fredericia (QTcF) Interval (msec): ≤300, \\>500, ≥30 change from baseline and \\>450; QRS Duration (msec): ≤80, ≥180. Only categories with at least one participant with event are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Parts B and C: Change From Baseline in Average Sleep Latency as Assessed by the Maintenance of Wakefulness Test (MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG003', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG004', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '2.27', 'groupId': 'OG001'}, {'value': '27.4', 'spread': '2.17', 'groupId': 'OG002'}, {'value': '32.6', 'spread': '2.25', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.4', 'ciLowerLimit': '20.07', 'ciUpperLimit': '32.73', 'pValueComment': 'The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.15', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The unstructured covariance structure was used for the repeated statement.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.9', 'ciLowerLimit': '23.68', 'ciUpperLimit': '36.07', 'pValueComment': 'The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.08', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The unstructured covariance structure was used for the repeated statement.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.0', 'ciLowerLimit': '28.73', 'ciUpperLimit': '41.34', 'pValueComment': 'The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.14', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The unstructured covariance structure was used for the repeated statement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8 (Day 56) in Parts B and C', 'description': "MWT: validated, objective measure that evaluates person's ability to remain awake under soporific conditions for defined period. During each MWT session (1 session=40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on electroencephalography (EEG). If no sleep had been observed according to these rules, then latency= 40 minutes. Mixed-effect model for repeated measures (MMRM) was used for analysis. Due to early termination of the study, no post-baseline efficacy data for this outcome measure was collected and analyzed for participants in Part C: TAK-994 180 mg.", 'unitOfMeasure': 'minutes (min)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included participants who received at least 1 dose of study drug, had baseline measure and at least 1 evaluable post-dose value. Overall number of participants analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Part A: Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-994 at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'title': 'Cmax (ng/mL); Following First (AM) Dose at Day 1', 'categories': [{'measurements': [{'value': '305.5', 'spread': '68.3', 'groupId': 'OG000'}, {'value': '679.1', 'spread': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'Cmax (ng/mL); Following Second (PM) Dose at Day 1', 'categories': [{'measurements': [{'value': '437.1', 'spread': '46.9', 'groupId': 'OG000'}, {'value': '1127', 'spread': '26.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 1 in Part A', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration. Overall number of participants analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Part A: Tmax: Time of First Occurrence of Cmax After Single Dose of TAK-994 at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg tablets, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'title': 'Tmax (h): Following First (AM) Dose at Day 1', 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.03'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '5.00'}]}]}, {'title': 'Tmax (h): Following Second (PM) Dose at Day 1', 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '4.00'}, {'value': '1.75', 'groupId': 'OG001', 'lowerLimit': '1.42', 'upperLimit': '2.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and at multiple time points (Up to 14 hours) post-dose at Day 1 in Part A', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration. Overall number of participants analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Part A: AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration After Single Dose of TAK-994 at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg tablets, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3700', 'spread': '63.0', 'groupId': 'OG000'}, {'value': '8559', 'spread': '26.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at multiple time points (up to 24 hours) post-dose at Day 1 in Part A', 'unitOfMeasure': 'nanograms*hour per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Part A: Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-994 at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'title': 'Cmax (ng/mL); Following First (AM) Dose at Day 28', 'categories': [{'measurements': [{'value': '377.5', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '856.9', 'spread': '31.6', 'groupId': 'OG001'}]}]}, {'title': 'Cmax (ng/mL); Following Second (PM) Dose at Day 28', 'categories': [{'measurements': [{'value': '416.0', 'spread': '40.9', 'groupId': 'OG000'}, {'value': '829.4', 'spread': '28.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 28 in Part A', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Part A: Tmax: Time of First Occurrence of Cmax After Multiple Doses of TAK-994 at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'title': 'Tmax (h): Following First (AM) Dose at Day 28', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '3.10'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '1.00'}]}]}, {'title': 'Tmax (h): Following Second (PM) Dose at Day 28', 'categories': [{'measurements': [{'value': '2.15', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.05'}, {'value': '3.46', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '7.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 28 in Part A', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Part A: AUC(0-t): Area Under the Concentration-time Curve From Time 0 to Time Tau Over a Dosing Interval of TAK-994 at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2968', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '6438', 'spread': '22.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at multiple time points (Up to 12 hours) post-dose at Day 28 in Part A', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Parts B and C: Change From Baseline in the Epworth Sleepiness Scale (ESS) Total Score to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG003', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG004', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-12.2', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '-13.5', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '-15.1', 'spread': '1.41', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.1', 'ciLowerLimit': '-14.07', 'ciUpperLimit': '-6.16', 'pValueComment': 'The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.96', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The unstructured covariance structure was used for the repeated statement.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.4', 'ciLowerLimit': '-15.20', 'ciUpperLimit': '-7.56', 'pValueComment': 'The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.89', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The unstructured covariance structure was used for the repeated statement.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.0', 'ciLowerLimit': '-16.96', 'ciUpperLimit': '-9.09', 'pValueComment': 'The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.95', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The unstructured covariance structure was used for the repeated statement.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8 (Day 56) in Parts B and C', 'description': 'The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. MMRM was used for analysis. Due to early termination of the study, no post-baseline secondary efficacy data for this outcome measure was collected and analyzed for participants in Part C: TAK-994 180 mg.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included participants who received at least 1 dose of study drug, had baseline measure and at least 1 evaluable post-dose value. Overall number of participants analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Parts B and C: Change From Baseline in Weekly Cataplexy Rate (WCR) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG003', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG004', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.58', 'spread': '7.433', 'groupId': 'OG000'}, {'value': '-16.17', 'spread': '20.979', 'groupId': 'OG001'}, {'value': '-11.91', 'spread': '10.174', 'groupId': 'OG002'}, {'value': '-15.74', 'spread': '9.978', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '=0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'IRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '0.007', 'ciUpperLimit': '0.317', 'pValueComment': 'The incidence rate was the exponentiated LS means and the incidence rate ratio (IRR) was the exponentiated LS mean differences from the generalized estimating equation (GEE) Poisson regression model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The Poisson regression with natural log link was on the count of cataplexy per week.'}, {'pValue': '=0.019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'IRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.050', 'ciUpperLimit': '0.767', 'pValueComment': 'The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The Poisson regression with natural log link was on the count of cataplexy per week.'}, {'pValue': '=0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'IRR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '0.047', 'ciUpperLimit': '0.482', 'pValueComment': 'The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The Poisson regression with natural log link was on the count of cataplexy per week.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 (Day 56) in Parts B and C', 'description': 'Participants will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary. The total number of events averaged for a week will be reported. WCR = (Total number of cataplexy over a number of non-missing diary days for a given duration/number of Non-missing diary days in that duration)\\*7. MMRM was used for the analysis. Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.', 'unitOfMeasure': 'cataplexy attacks per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included participants who received at least 1 dose of study drug, had baseline measure and at least 1 evaluable post-dose value. Overall number of participants analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Parts B and C: Number of Participants Who Experience at Least 1 TEAE During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part B: FTAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG003', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG004', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study drug to end of study follow-up (up to Day 63) in Parts B and C', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG003', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG004', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}], 'classes': [{'title': 'Alanine Aminotransferase (ALT) [U/L)]: >3 × Upper limit normal (ULN)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Aspartate Aminotransferase (AST) [(U/L)]: >3 × ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Bilirubin (µmol/L): >1.5 × ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Calcium (mmol/L): <1.92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Potassium (mmol/L): <3.0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Potassium (mmol/L): >5.3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 63 in Parts B and C', 'description': 'Standard safety laboratory values (serum chemistry, hematology, and urine analysis) were collected and compared to pre-specified criteria for Markedly Abnormal Values throughout the study. Markedly abnormal values criteria: Alanine Aminotransferase (U/L):\\>3xULN, Aspartate Aminotransferase(U/L):\\>3xULN; Bilirubin micromoles/litre (umol/L):\\>1.5xULN; Calcium(mmol/L):\\<1.92, \\>2.77; Potassium(mmol/L):\\<3.0, \\>5.3. Only categories with at least one participant with event are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG003', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG004', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}], 'classes': [{'title': 'Systolic blood pressure (mmHg): <90', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Systolic blood pressure (mmHg):>=160', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Systolic blood pressure (mmHg): Change from Predose >20', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Systolic blood pressure (mmHg): Change from Predose >30', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Systolic blood pressure (mmHg): Time-matched Change from Baseline >20', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Systolic blood pressure (mmHg): Time-matched Change from Baseline >30', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Diastolic blood pressure (mmHg): <50', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Diastolic blood pressure (mmHg): >=100', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Diastolic blood pressure (mmHg): Change from Predose >20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Diastolic blood pressure (mmHg): Change from Predose >30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Diastolic blood pressure (mmHg): Time-matched Change from Baseline >20', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Diastolic blood pressure (mmHg): Time-matched Change from Baseline >30', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Respiratory Rate [Breaths per minute (breaths/min)]: >21', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 63 in Parts B and C', 'description': 'Vital signs (body temperature and sitting blood pressure) were collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Markedly abnormal values criteria: Systolic Blood Pressure millimeters of mercury (mmHg): \\<90, ≥160, Change from Pre-Dose \\>20, Change from Pre-Dose \\>30, Time-matched Change from Baseline \\> 20, Time-matched Change from Baseline \\> 30; Diastolic Blood Pressure (mmHg): \\<50, ≥100, Change from Pre-Dose \\>20, Change from Pre-Dose \\>30, Time-matched Change from Baseline \\> 20, Time-matched Change from Baseline \\> 30; Respiratory Rate (breaths/min): \\>21.Only categories with at least one participant with event are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for ECG Parameters at Least Once Postdose During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG001', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG002', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG003', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'OG004', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}], 'classes': [{'title': 'PR Interval (msec): >=200', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'QRS Duration (msec):<=80', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 63 in Parts B and C', 'description': 'A 12 lead ECG was performed, the ECG values were compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: PR Interval (msec): ≤80, ≥200; QRS Duration (msec): ≤80, ≥180. Only categories with at least one participant with event are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of the study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, twice daily (BID) for 28 days, in participants with NT1.'}, {'id': 'FG001', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'FG002', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'FG003', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'FG004', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'FG005', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'FG006', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'FG007', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in Chinese participants with NT1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Pretreatment Event, Serious Adverse Event, or Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Met the Discontinuation Criteria of the Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 35 investigative sites in Canada, China, France, Hungary, Italy, Japan, South Korea, Spain and United States from 27 May 2020 to 05 November 2021. The study was early terminated due to a safety signal that had emerged in the phase 2 studies of firazorexton.', 'preAssignmentDetails': 'Participants with Narcolepsy Type 1 or Type 2 were planned to be enrolled in study in Parts A, B, C and D to receive TAK-994 or placebo. Due to the early termination of the study, data was not collected for Part C: placebo and was insufficient for Part C: TAK-994 180 mg to allow the pre-planned analyses. Similarly, for Part D, the prespecified sample size at Week 4 was not reached and therefore the pre-planned analyses cannot be adequately interpreted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.'}, {'id': 'BG001', 'title': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.'}, {'id': 'BG002', 'title': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1'}, {'id': 'BG003', 'title': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'BG004', 'title': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'BG005', 'title': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'BG006', 'title': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.'}, {'id': 'BG007', 'title': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in Chinese participants with NT1.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '36'}, {'value': '38.0', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '53'}, {'value': '33.4', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '45'}, {'value': '32.6', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '47'}, {'value': '33.4', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '55'}, {'value': '28.8', 'groupId': 'BG005', 'lowerLimit': '18', 'upperLimit': '48'}, {'value': '29.2', 'groupId': 'BG006', 'lowerLimit': '19', 'upperLimit': '43'}, {'value': '38.5', 'groupId': 'BG007', 'lowerLimit': '25', 'upperLimit': '52'}, {'value': '33.16', 'groupId': 'BG008', 'lowerLimit': '18', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '54', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '43', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '92', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'title': 'American Indian or Alaska Native', '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'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', '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'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '52', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '168.07', 'groupId': 'BG000', 'lowerLimit': '157.5', 'upperLimit': '177.8'}, {'value': '176.61', 'groupId': 'BG001', 'lowerLimit': '162.0', 'upperLimit': '187.9'}, {'value': '164.01', 'groupId': 'BG002', 'lowerLimit': '152.8', 'upperLimit': '177.8'}, {'value': '171.00', 'groupId': 'BG003', 'lowerLimit': '150.4', 'upperLimit': '187.0'}, {'value': '164.24', 'groupId': 'BG004', 'lowerLimit': '151.0', 'upperLimit': '177.8'}, {'value': '168.38', 'groupId': 'BG005', 'lowerLimit': '151.9', 'upperLimit': '182.0'}, {'value': '171.66', 'groupId': 'BG006', 'lowerLimit': '160.0', 'upperLimit': '185.4'}, {'value': '169', 'groupId': 'BG007', 'lowerLimit': '163.0', 'upperLimit': '175.0'}, {'value': '169.12', 'groupId': 'BG008', 'lowerLimit': '150.4', 'upperLimit': '187.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '85.77', 'groupId': 'BG000', 'lowerLimit': '74.2', 'upperLimit': '92.7'}, {'value': '80.07', 'groupId': 'BG001', 'lowerLimit': '56.7', 'upperLimit': '102.5'}, {'value': '74.33', 'groupId': 'BG002', 'lowerLimit': '60.0', 'upperLimit': '91.9'}, {'value': '80.75', 'groupId': 'BG003', 'lowerLimit': '46.3', 'upperLimit': '126.5'}, {'value': '71.97', 'groupId': 'BG004', 'lowerLimit': '48.0', 'upperLimit': '108.0'}, {'value': '77.68', 'groupId': 'BG005', 'lowerLimit': '52.3', 'upperLimit': '102.0'}, {'value': '80.33', 'groupId': 'BG006', 'lowerLimit': '56.7', 'upperLimit': '102.0'}, {'value': '77', 'groupId': 'BG007', 'lowerLimit': '66.0', 'upperLimit': '88.0'}, {'value': '78.48', 'groupId': 'BG008', 'lowerLimit': '46.3', 'upperLimit': '126.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '30.529', 'groupId': 'BG000', 'lowerLimit': '25.3', 'upperLimit': '37.4'}, {'value': '25.629', 'groupId': 'BG001', 'lowerLimit': '20.5', 'upperLimit': '33.2'}, {'value': '27.575', 'groupId': 'BG002', 'lowerLimit': '23.2', 'upperLimit': '33.8'}, {'value': '27.48', 'groupId': 'BG003', 'lowerLimit': '20.5', 'upperLimit': '38.9'}, {'value': '26.56', 'groupId': 'BG004', 'lowerLimit': '18.2', 'upperLimit': '38.3'}, {'value': '27.29', 'groupId': 'BG005', 'lowerLimit': '19.7', 'upperLimit': '35.3'}, {'value': '27.21', 'groupId': 'BG006', 'lowerLimit': '19.2', 'upperLimit': '34.0'}, {'value': '26.75', 'groupId': 'BG007', 'lowerLimit': '24.8', 'upperLimit': '28.7'}, {'value': '27.37', 'groupId': 'BG008', 'lowerLimit': '18.2', 'upperLimit': '38.9'}]}]}], 'paramType': 'MEAN', 'description': 'BMI= Weight (kg)/\\[height(m)\\^2\\]', 'unitOfMeasure': 'kilogram per square meter (kg/m^2)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Average Sleep Latency (MWT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '3.30', 'groupId': 'BG000', 'lowerLimit': '1.1', 'upperLimit': '8.6'}, {'value': '4.41', 'groupId': 'BG001', 'lowerLimit': '0.3', 'upperLimit': '13.4'}, {'value': '2.75', 'groupId': 'BG002', 'lowerLimit': '1.0', 'upperLimit': '6.9'}, {'value': '6.0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '31'}, {'value': '6.1', 'groupId': 'BG004', 'lowerLimit': '1', 'upperLimit': '21'}, {'value': '6.1', 'groupId': 'BG005', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '4.9', 'groupId': 'BG006', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '17.87', 'groupId': 'BG007', 'lowerLimit': '4.5', 'upperLimit': '40'}, {'value': '6.43', 'groupId': 'BG008', 'lowerLimit': '0', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'description': "The Maintenance of Wakefulness Test (MWT) is a validated, objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on electroencephalography (EEG). If no sleep was observed according to these rules, then the latency was defined as 40 minutes.", 'unitOfMeasure': 'minutes', 'dispersionType': 'FULL_RANGE'}, {'title': 'Epworth Sleepiness Scale (ESS) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '97', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '21'}, {'value': '17.4', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '18.0', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '23'}, {'value': '16.6', 'groupId': 'BG003', 'lowerLimit': '8', 'upperLimit': '21'}, {'value': '18.5', 'groupId': 'BG004', 'lowerLimit': '12', 'upperLimit': '23'}, {'value': '17.5', 'groupId': 'BG005', 'lowerLimit': '10', 'upperLimit': '23'}, {'value': '17.4', 'groupId': 'BG006', 'lowerLimit': '11', 'upperLimit': '23'}, {'value': '20', 'groupId': 'BG007', 'lowerLimit': '16', 'upperLimit': '24'}, {'value': '18', 'groupId': 'BG008', 'lowerLimit': '8', 'upperLimit': '24'}]}]}], 'paramType': 'MEAN', 'description': 'The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks them how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weekly Cataplexy Rate (WCR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '95', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '49'}, {'value': '19.1', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '41'}, {'value': '12.0', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '28'}, {'value': '15.94', 'groupId': 'BG003', 'lowerLimit': '0.0', 'upperLimit': '50.0'}, {'value': '14.98', 'groupId': 'BG004', 'lowerLimit': '3.5', 'upperLimit': '72.5'}, {'value': '11.68', 'groupId': 'BG005', 'lowerLimit': '4.3', 'upperLimit': '36.5'}, {'value': '15.37', 'groupId': 'BG006', 'lowerLimit': '3.0', 'upperLimit': '47.5'}, {'value': '13.62', 'groupId': 'BG008', 'lowerLimit': '0.0', 'upperLimit': '72.5'}]}]}], 'paramType': 'MEAN', 'description': 'WCR = (Total number of cataplexy over a number of non-missing diary days for a given duration/number of Non-missing diary days in that duration)\\*7.', 'unitOfMeasure': 'cataplexy attacks per week', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.'}], 'populationDescription': 'Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-15', 'size': 9202354, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-03T09:27', 'hasProtocol': True}, {'date': '2021-05-12', 'size': 3370092, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-03T09:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'whyStopped': 'A safety signal has emerged in Phase 2 studies of TAK-994. As an immediate precautionary measure, Takeda has suspended dosing of patients and has decided to stop Phase 2 studies early.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2022-10-05', 'completionDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2019-09-18', 'dispFirstSubmitQcDate': '2022-10-05', 'resultsFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2019-09-18', 'dispFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-04', 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) During the Study', 'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35) in Part A', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.'}, {'measure': 'Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study', 'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35) in Part A', 'description': 'Standard safety laboratory values (hematology, serum chemistry, urinalysis) were collected and compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: Erythrocytes(10\\^12/L:\\<0.8xlower limit of normal(LLN), \\>1.2xupper limit of normal(ULN); Hemoglobin grams per litre(g/L):\\<0.8xLLN, \\>1.2xULN; Hematocrit voltage/volts(V/V):\\<0.8xLLN, \\>1.2xULN; Platelets(10\\^9/L):\\<75, \\>600; Leukocytes(10\\^9/L):\\<0.5xLLN, \\>1.5xULN; Alanine Aminotransferase units/litre(U/L):\\>3xULN, Aspartate Aminotransferase(U/L):\\>3xULN; Bilirubin micromoles/litre (umol/L):\\>1.5xULN; Alkaline Phosphatase(U/L):\\>3xULN; Gamma Glutamyl Transferase(U/L):\\>3 x ULN; Albumin(g/L):\\<25; Protein Total(g/L):\\<0.8xLLN, \\>1.2xULN;Glucose millimoles/litre(mmol/L):\\<2.8, \\>19.4; Calcium(mmol/L):\\<1.92, \\>2.77; Creatinine(umol/L):\\>1.5xULN; Urea(mmol/L):\\>10.7; Sodium(mmol/L):\\<130, \\>150; Potassium(mmol/L):\\<3.0, \\>5.3. Only categories with at least one participant with event are reported.'}, {'measure': 'Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study', 'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35) in Part A', 'description': 'Vital signs (body temperature and sitting blood pressure) were collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Markedly abnormal values criteria: Heart Rate (beats/min): \\<40, \\>115; Systolic Blood Pressure millimeters of mercury (mmHg): \\<90, ≥160, Change from Pre-Dose \\>20, Change from Pre-Dose \\>30, Time-matched Change from Baseline \\> 20, Time-matched Change from Baseline \\> 30; Diastolic Blood Pressure (mmHg): \\<50, ≥100, Change from Pre-Dose \\>20, Change from Pre-Dose \\>30, Time-matched Change from Baseline \\> 20, Time-matched Change from Baseline \\> 30; Respiratory Rate (breaths/min): \\>21; Temperature Celsius (C): \\>38.5. Only categories with at least one participant with event are reported.'}, {'measure': 'Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose During the Study', 'timeFrame': 'First dose of study treatment to end of study follow-up (up to Day 35) in Part A', 'description': 'A 12 lead ECG was performed, the ECG values were compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: ECG Mean Heart Rate (beats/min): \\<40, \\>115; PR Interval milliseconds (msec): ≤80, ≥200; corrected QT interval by Fredericia (QTcF) Interval (msec): ≤300, \\>500, ≥30 change from baseline and \\>450; QRS Duration (msec): ≤80, ≥180. Only categories with at least one participant with event are reported.'}, {'measure': 'Parts B and C: Change From Baseline in Average Sleep Latency as Assessed by the Maintenance of Wakefulness Test (MWT)', 'timeFrame': 'Baseline and Week 8 (Day 56) in Parts B and C', 'description': "MWT: validated, objective measure that evaluates person's ability to remain awake under soporific conditions for defined period. During each MWT session (1 session=40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on electroencephalography (EEG). If no sleep had been observed according to these rules, then latency= 40 minutes. Mixed-effect model for repeated measures (MMRM) was used for analysis. Due to early termination of the study, no post-baseline efficacy data for this outcome measure was collected and analyzed for participants in Part C: TAK-994 180 mg."}], 'secondaryOutcomes': [{'measure': 'Part A: Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-994 at Day 1', 'timeFrame': 'Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 1 in Part A'}, {'measure': 'Part A: Tmax: Time of First Occurrence of Cmax After Single Dose of TAK-994 at Day 1', 'timeFrame': 'Pre-dose and at multiple time points (Up to 14 hours) post-dose at Day 1 in Part A'}, {'measure': 'Part A: AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration After Single Dose of TAK-994 at Day 1', 'timeFrame': 'Pre-dose and at multiple time points (up to 24 hours) post-dose at Day 1 in Part A'}, {'measure': 'Part A: Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-994 at Day 28', 'timeFrame': 'Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 28 in Part A'}, {'measure': 'Part A: Tmax: Time of First Occurrence of Cmax After Multiple Doses of TAK-994 at Day 28', 'timeFrame': 'Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 28 in Part A'}, {'measure': 'Part A: AUC(0-t): Area Under the Concentration-time Curve From Time 0 to Time Tau Over a Dosing Interval of TAK-994 at Day 28', 'timeFrame': 'Pre-dose and at multiple time points (Up to 12 hours) post-dose at Day 28 in Part A'}, {'measure': 'Parts B and C: Change From Baseline in the Epworth Sleepiness Scale (ESS) Total Score to Week 8', 'timeFrame': 'Baseline and Week 8 (Day 56) in Parts B and C', 'description': 'The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. MMRM was used for analysis. Due to early termination of the study, no post-baseline secondary efficacy data for this outcome measure was collected and analyzed for participants in Part C: TAK-994 180 mg.'}, {'measure': 'Parts B and C: Change From Baseline in Weekly Cataplexy Rate (WCR) at Week 8', 'timeFrame': 'Baseline and Week 8 (Day 56) in Parts B and C', 'description': 'Participants will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary. The total number of events averaged for a week will be reported. WCR = (Total number of cataplexy over a number of non-missing diary days for a given duration/number of Non-missing diary days in that duration)\\*7. MMRM was used for the analysis. Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.'}, {'measure': 'Parts B and C: Number of Participants Who Experience at Least 1 TEAE During the Study', 'timeFrame': 'First dose of study drug to end of study follow-up (up to Day 63) in Parts B and C', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.'}, {'measure': 'Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study', 'timeFrame': 'Up to Day 63 in Parts B and C', 'description': 'Standard safety laboratory values (serum chemistry, hematology, and urine analysis) were collected and compared to pre-specified criteria for Markedly Abnormal Values throughout the study. Markedly abnormal values criteria: Alanine Aminotransferase (U/L):\\>3xULN, Aspartate Aminotransferase(U/L):\\>3xULN; Bilirubin micromoles/litre (umol/L):\\>1.5xULN; Calcium(mmol/L):\\<1.92, \\>2.77; Potassium(mmol/L):\\<3.0, \\>5.3. Only categories with at least one participant with event are reported.'}, {'measure': 'Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study', 'timeFrame': 'Up to Day 63 in Parts B and C', 'description': 'Vital signs (body temperature and sitting blood pressure) were collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Markedly abnormal values criteria: Systolic Blood Pressure millimeters of mercury (mmHg): \\<90, ≥160, Change from Pre-Dose \\>20, Change from Pre-Dose \\>30, Time-matched Change from Baseline \\> 20, Time-matched Change from Baseline \\> 30; Diastolic Blood Pressure (mmHg): \\<50, ≥100, Change from Pre-Dose \\>20, Change from Pre-Dose \\>30, Time-matched Change from Baseline \\> 20, Time-matched Change from Baseline \\> 30; Respiratory Rate (breaths/min): \\>21.Only categories with at least one participant with event are reported.'}, {'measure': 'Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for ECG Parameters at Least Once Postdose During the Study', 'timeFrame': 'Up to Day 63 in Parts B and C', 'description': 'A 12 lead ECG was performed, the ECG values were compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: PR Interval (msec): ≤80, ≥200; QRS Duration (msec): ≤80, ≥180. Only categories with at least one participant with event are reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Narcolepsy Type 1 (NT1)', 'Narcolepsy Type 2 (NT2)']}, 'referencesModule': {'references': [{'pmid': '37494485', 'type': 'DERIVED', 'citation': 'Dauvilliers Y, Mignot E, Del Rio Villegas R, Du Y, Hanson E, Inoue Y, Kadali H, Koundourakis E, Meyer S, Rogers R, Scammell TE, Sheikh SI, Swick T, Szakacs Z, von Rosenstiel P, Wu J, Zeitz H, Murthy NV, Plazzi G, von Hehn C. Oral Orexin Receptor 2 Agonist in Narcolepsy Type 1. N Engl J Med. 2023 Jul 27;389(4):309-321. doi: 10.1056/NEJMoa2301940.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b603c4db2bf003ab4a34e', 'label': ': To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'The main aims of the study are:\n\n* To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate.\n* To check what dose range provides adequate relief of narcolepsy symptoms.\n* To check how much TAK-994 stays in the blood of participants, over time.\n\nThe study will have 4 parts. Participants can only join 1 of the parts.\n\nA. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it.\n\nB. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days.\n\nC. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days.\n\nD. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.', 'detailedDescription': 'The drug being tested in this study is called TAK-994. TAK-994 is being tested in participants with NT1 and NT2.\n\nThe study will enroll up to approximately 202 participants. The study has 4 Parts: Parts A, B, C (China only) and D. Part A - Part A has 2 cohorts \\[Cohorts (A1a and A1b) A2\\] In both of these Cohorts, participants will be randomly assigned (by chance, like flipping a coin) in a 2:1 ratio to receive TAK-994 or placebo up to 28 days:\n\n* Part B: In Part B, participants will be randomized in 1:1:1:1 ratio in four parallel arms to receive TAK-994 Dose 1, 2 or 3 or placebo for 56 days. Depending upon their eligibility participants completing Part B of the study treatment will be enrolled to participate in an Extension study.\n* Part C: In Part C, participants only from China will be enrolled and randomized in a 2:1 ratio to receive TAK-994 and placebo for 56 days.\n* Part D: Participants will be included in two cohorts \\[Cohorts (D1a and D1b) and D2\\] and will be randomized in 2:1 ratio to receive TAK-994 or placebo for 28 days. The dose will be selected based on the safety and tolerability in Part A.\n\nThis multi-center trial will be conducted in the United States, Japan, China, Italy, France, and European Union. The overall duration of the study is 63 days. Participants will be followed up for 7 days after the last dose of study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has a diagnosis of narcolepsy type 1 (NT1) (Parts A-C) or NT2 (Part D) by polysomnography (PSG)/ multiple sleep latency test (MSLT) performed within the past 10 years meeting the minimal acceptable criteria for the proper performance of the PSG/MSLT as outlined by the International Classification of Sleep Disorders, 3rd edition criteria.\n2. The participant\'s Epworth Sleepiness Scale (ESS) score must be greater than or equal to (\\>=) 10 at Day -1.\n3. Must be willing to discontinue all medications used for the treatment of NT1/NT2.\n4. The human leukocyte antigen (HLA) genotype: Part A: should test positive for human leukocyte antigen (HLADQB1)\\* 06:02 (PARTs A-C)- (positive results for either homozygous or heterozygous alleles will be considered "positive" and acceptable). However, if the HLA test is negative (i.e. negative for the heterozygous allele) and the PI feels strongly that the participant has narcolepsy with cataplexy (NT1) then a discussion should be initiated between the PI and the sponsor or designee about the advisability of doing a spinal tap to determine the participant\'s cerebrospinal fluid (CSF) orexin-1 (OX-1) level. If the CSF result shows the orexin 1 (OX-1) concentration is either less than or equal to\\<110 pg/mL, or less than one-third of mean values obtained in normal participants with the same standardized assay, then the diagnosis of NT1 is established allowing the participant to be enrolled and randomized, If the CSF OX-1 concentration is \\>110 pg/mL then the participant will not be allowed to continue in the study .\n5. For Parts A, B, and C, during the screening period, participant, must have \\>=4 partial or complete episodes of cataplexy/week (WCR), and \\>=4 partial or complete episodes of cataplexy/week during the screening period when off of anticataplexy medications, averaged over 2 weeks (14 consecutive days) minimum. WCR recording taken during following period will be considered for study eligibility: after the participant has stopped taking anticataplexy medications for at least 7 days (minimum 7-day washout) and study Day -2.\n\nExclusion Criteria:\n\n1. Has a risk of suicide according to endorsement of Item 4 or 5 of the screening/baseline visit Columbia suicide severity rating scale (C-SSRS) or has made a suicide attempt in the previous 12 months.\n2. Is an excessive (\\>600 mg/day) caffeine user 1 week before to the study screening.\n3. Has a history of cancer (except carcinoma in situ that has been resolved without further treatment or basal cell skin cancer); past or current epilepsy, seizure; a lifetime history of major psychiatric disorder other than depression or anxiety; a clinically significant history of head injury or head trauma; a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation; known coronary artery disease, a history of myocardial infarction, angina, cardiac rhythm abnormality, or heart failure; or current or recent (within 6 months) gastrointestinal disease expected to influence the absorption of drugs. Any history of Roux-en-Y gastric bypass is considered exclusionary and any other surgical intervention that may influence the absorption of drugs should be discussed and approved by the sponsor or designee before enrolling the participants.\n4. Has a medical disorder, other than narcolepsy, associated with EDS. This includes clinically significant moderate to severe obstructive sleep apnea and/or with or without treatment with mandibular advanced device hypoglossal nerve stimulation and/or positive airway pressure (PAP) therapy) and/or restless legs syndrome (RLS)/periodic limb movement disorder that has a significant impact on daytime sleepiness. This is evidenced by a clinical history of sleep apnea syndrome (loud snoring with observed respiratory pauses in the absence of nPSG) and/or RLS causing historical sleep onset/maintenance insomnia with resultant insufficient sleep. Or any as evaluated during the clinical interview at screening. pPast PSG data demonstrating any of the following sleep disturbances: apnea Hypopnea Index ≥15 or apnea index ≥10, an oxygen saturation of \\<80 for \\>10 seconds, periodic leg movement arousal index of ≥15/h) or as evaluated on interview at the time of screening. Asshould be considered exclusionary unless, based on a clinical evaluation by the investigator, a meaningful change in clinical status has occurred that would impact the results. Because nPSG data is obtained on Day -2, subjects may fail screening if criteria are not meet on the Day -2 nPSG.\n5. Has a usual bedtime later than 2400 (12:00 AM, midnight) or an occupation requiring nighttime shift work or variable shift work within the past 6 months or travel within more than 3 time zones, within 14 days before Study Day -2.\n6. Has a nicotine dependence that is likely to have an effect on sleep (e.g., a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portions of the study. Participants undergoing optional CSF collection.\n7. Has a local infection at the puncture site.\n8. Has developed signs of lumbar radiculopathy, including lower extremity pain and paresthesia.\n9. Has any known focal neurological deficit that might suggest an increase in intracranial pressure.'}, 'identificationModule': {'nctId': 'NCT04096560', 'briefTitle': 'A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)', 'orgStudyIdInfo': {'id': 'TAK-994-1501'}, 'secondaryIdInfos': [{'id': 'JapicCTI-205178', 'type': 'REGISTRY', 'domain': 'JapicCTI'}, {'id': '2020-000777-24', 'type': 'REGISTRY', 'domain': 'EudraCT'}, {'id': 'U1111-1240-0346', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, twice daily (BID) for 28 days, in participants with NT1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: TAK-994 120 mg', 'description': 'TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.', 'interventionNames': ['Drug: TAK-994']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: TAK-994 180 mg', 'description': 'TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.', 'interventionNames': ['Drug: TAK-994']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: TAK-994 30 mg', 'description': 'TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.', 'interventionNames': ['Drug: TAK-994']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: TAK-994 90 mg', 'description': 'TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.', 'interventionNames': ['Drug: TAK-994']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.', 'interventionNames': ['Drug: TAK-994']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: TAK-994 180 mg', 'description': 'TAK-994 180 mg tablets, orally, BID for 56 days, in Chinese participants with NT1.', 'interventionNames': ['Drug: TAK-994']}], 'interventions': [{'name': 'TAK-994', 'type': 'DRUG', 'otherNames': ['Firazorexton'], 'description': 'TAK-994 tablets.', 'armGroupLabels': ['Part A: TAK-994 120 mg', 'Part A: TAK-994 180 mg', 'Part B: TAK-994 180 mg', 'Part B: TAK-994 30 mg', 'Part B: TAK-994 90 mg', 'Part C: TAK-994 180 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'TAK-994 placebo-matching tablets.', 'armGroupLabels': ['Part A: Placebo', 'Part B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35007', 'city': 'Alabaster', 'state': 'Alabama', 'country': 'United States', 'facility': 'Wright Clinical Research', 'geoPoint': {'lat': 33.24428, 'lon': -86.81638}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'CITrials - Bellflower', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford School of Medicine', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '92128', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network, Inc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'SDS Clinical Trials, Inc.', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Alpine Clinical Research Center', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80918', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Delta Waves Sleep Disorders and Research Center', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Francis Medical Institute', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sleep Medicine Specialists of South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Trials of Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33624', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'JSV Clinical Research Study, Inc', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Pulmonary Research Institute, LLC', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'iResearch Atlanta, LLC', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sleep Practitioners, LLC', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Global Research Associates', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Pacific Neuroscience', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Lutheran Sleep Disorder Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center Research Institute, Inc.', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02459', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Neurocare, Inc., dba Neurocare Center for Research', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '28037', 'city': 'Denver', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Carolina Elite LLC', 'geoPoint': {'lat': 35.53125, 'lon': -81.0298}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Research of Gastonia', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CTI Clinical Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Intrepid Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine and Neuroscience Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Respiratory Specialists', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina (MUSC)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Bogan Sleep Consultants, LLC', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy & Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Comprehensive Sleep Medicine Associates', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': 'K2A3Z8', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'West Ottawa Sleep Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4P 1P2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sleep Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 3A3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Jodha Tishon Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510630', 'city': 'Tianhe', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Jinan University'}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '50333', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '708 52', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '128 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Vseobecna fakultni nemocnice v Praze', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '380', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Terveystalo Helsinki Uniklinikka', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '34295', 'city': 'Montpellier', 'state': 'Herault', 'country': 'France', 'facility': 'Hopital Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '59037', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Hopital Roger Salengro - CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '1012', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'SomnoCenter Budapest', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '94018', 'city': 'Troina', 'state': 'Enna', 'country': 'Italy', 'facility': 'IRCCS Oasi Maria SS', 'geoPoint': {'lat': 37.78437, 'lon': 14.59605}}, {'zip': '40123', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '20127', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele (San Raffaele Turro)', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '133', 'city': 'Roma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Policlinico Tor Vergata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '812-0025', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'SOUSEIKAI PS Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '802-0084', 'city': 'Kitakyushu-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'You Ariyoshi Sleep Clinic'}, {'zip': '830-0011', 'city': 'Kurume-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kurume University Hospital'}, {'zip': '223-0059', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kaiseikai Kita Shin Yokohama Internal Medicine Clinic', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '862-0954', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Howakai Kuwamizu Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '854-0081', 'city': 'Isahaya-shi', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Jinyukai Kotorii Isahaya Hospital'}, {'zip': '850-0045', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Shunkaikai Inoue Hospital', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '532-0003', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Gokeikai Osaka Kaisei Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '599-8263', 'city': 'Sakai-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Kyowakai Hannan Hospital'}, {'zip': '112-0012', 'city': 'Bunkyō City', 'state': 'Tokyo-To', 'country': 'Japan', 'facility': 'Koishikawa Tokyo Hospital', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'zip': '173-8610', 'city': 'Itabashi-ku', 'state': 'Tokyo-To', 'country': 'Japan', 'facility': 'Nihon University Itabashi Hospital'}, {'zip': '151-0053', 'city': 'Shibuya-ku', 'state': 'Tokyo-To', 'country': 'Japan', 'facility': 'Yoyogi Sleep Disorder Center'}, {'zip': '140-0011', 'city': 'Shinagawa-ku', 'state': 'Tokyo-To', 'country': 'Japan', 'facility': 'Sleep Support Clinic'}, {'zip': '141-6003', 'city': 'Shinagawa-ku', 'state': 'Tokyo-To', 'country': 'Japan', 'facility': 'Sleep & Stress Clinic'}, {'zip': '130-0004', 'city': 'Sumida-ku', 'state': 'Tokyo-To', 'country': 'Japan', 'facility': 'Sumida Hospital'}, {'zip': '2103 SW', 'city': 'Heemstede', 'country': 'Netherlands', 'facility': 'Stichting Epilepsie Instelling Nederland, Heemstede', 'geoPoint': {'lat': 52.34992, 'lon': 4.62301}}, {'zip': '5591 VE', 'city': 'Heeze', 'country': 'Netherlands', 'facility': 'Kempenhaeghe, Heeze', 'geoPoint': {'lat': 51.3828, 'lon': 5.57145}}, {'zip': '16247', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "The Catholic University of Korea, St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '42601', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '1004', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'facility': 'Hospital Universitario Araba Sede Santiago', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '12004', 'city': 'Castellon', 'state': 'Castellon', 'country': 'Spain', 'facility': 'Hospital General de Castellon', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '8036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28043', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Vithas Nuestra Senora de America', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}