Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-28 @ 9:09 PM
Study NCT ID:
NCT02706834
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
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': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Per an audit performed at the study site that enrolled Cohort 3, noncompliance to Good Clinical Practice (GCP) was identified and prevented confirmed reliability of the data collected. Data was still analyzed and results are reported in this posting.'}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 up to 30 days after last dose of study drug (up to 85 days).', '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': 'Cohort 1: Placebo', 'description': 'Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: TAK-828 0.1 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.', 'otherNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cohort 1: TAK-828 0.5 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 1: TAK-828 15 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.', 'otherNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 1: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 1: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.', 'otherNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 2: Placebo', 'description': 'Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 2: TAK-828 3 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort 2: TAK-828 50 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort 2: TAK-828 200 mg/ Fasted', 'description': 'Cohort 2: TAK-828 200 mg/ Fasted Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Cohort 2: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.', 'otherNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Cohort 2: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Cohort 3: Placebo', 'description': 'Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Cohort 3: TAK-828 15 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'Cohort 3: TAK-828 100 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Cohort 3: TAK-828 150 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 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0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Placebo', 'description': 'Non-Japanese participants in Cohort 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Period 1.'}, {'id': 'OG014', 'title': 'Cohort 3: TAK-828 100 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG015', 'title': 'Cohort 3: TAK-828 150 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}, {'value': '37.5', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '12.5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '11.1', 'groupId': 'OG007'}, {'value': '11.1', 'groupId': 'OG008'}, {'value': '11.1', 'groupId': 'OG009'}, {'value': '22.2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '25.0', 'groupId': 'OG013'}, {'value': '75.0', 'groupId': 'OG014'}, {'value': '66.7', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after last dose of study drug (up to 85 days)', '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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for TAK-828F (Free Base of TAK-828)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-828 0.1 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'TAK-828 0.5 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG002', 'title': 'TAK-828 3 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG003', 'title': 'TAK-828 15 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG004', 'title': 'TAK-828 50 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG005', 'title': 'TAK-828 100 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG006', 'title': 'TAK-828 100 mg/ Fed in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG007', 'title': 'TAK-828 200 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG008', 'title': 'TAK-828 15 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG009', 'title': 'TAK-828 100 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG010', 'title': 'TAK-828 150 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.96', 'spread': '0.982', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '3.56', 'groupId': 'OG001'}, {'value': '247', 'spread': '28.7', 'groupId': 'OG002'}, {'value': '1150', 'spread': '201', 'groupId': 'OG003'}, {'value': '4820', 'spread': '1090', 'groupId': 'OG004'}, {'value': '8900', 'spread': '1870', 'groupId': 'OG005'}, {'value': '3730', 'spread': '850', 'groupId': 'OG006'}, {'value': '18400', 'spread': '2950', 'groupId': 'OG007'}, {'value': '1400', 'spread': '114', 'groupId': 'OG008'}, {'value': '9530', 'spread': '1030', 'groupId': 'OG009'}, {'value': '14300', 'spread': '2470', 'groupId': 'OG010'}]}]}], 'analyses': [{'groupIds': ['OG005', 'OG006'], 'paramType': 'Point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.430', 'ciLowerLimit': '0.380', 'ciUpperLimit': '0.487', 'estimateComment': 'Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted', 'groupDescription': 'Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means on the original scale.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence interval of 0.80 to 1.25'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F. Food effect statistical analysis is based on 10 participants who received TAK-828 100 mg under fasted and fed conditions.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Placebo', 'description': 'Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-828 0.1 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG002', 'title': 'Cohort 1: TAK-828 0.5 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG003', 'title': 'Cohort 1: TAK-828 15 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG004', 'title': 'Cohort 1: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG005', 'title': 'Cohort 1: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.'}, {'id': 'OG007', 'title': 'Cohort 2: TAK-828 3 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG008', 'title': 'Cohort 2: TAK-828 50 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG009', 'title': 'Cohort 2: TAK-828 200 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG010', 'title': 'Cohort 2: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG011', 'title': 'Cohort 2: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG012', 'title': 'Cohort 3: Placebo', 'description': 'Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.'}, {'id': 'OG013', 'title': 'Cohort 3: TAK-828 15 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG014', 'title': 'Cohort 3: TAK-828 100 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG015', 'title': 'Cohort 3: TAK-828 150 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '12.5', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after last dose of study drug (up to 85 days)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Placebo', 'description': 'Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-828 0.1 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG002', 'title': 'Cohort 1: TAK-828 0.5 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG003', 'title': 'Cohort 1: TAK-828 15 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG004', 'title': 'Cohort 1: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG005', 'title': 'Cohort 1: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.'}, {'id': 'OG007', 'title': 'Cohort 2: TAK-828 3 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG008', 'title': 'Cohort 2: TAK-828 50 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG009', 'title': 'Cohort 2: TAK-828 200 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG010', 'title': 'Cohort 2: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG011', 'title': 'Cohort 2: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG012', 'title': 'Cohort 3: Placebo', 'description': 'Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.'}, {'id': 'OG013', 'title': 'Cohort 3: TAK-828 15 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG014', 'title': 'Cohort 3: TAK-828 100 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG015', 'title': 'Cohort 3: TAK-828 150 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 7 days after last dose of study drug (up to 52 days)', 'description': 'Hematology and Chemistry values that met the following criteria were considered to be markedly abnormal:\n\nErythrocytes, Hematocrit and Hemoglobin \\<0.8\\*Lower Limit of Normal (LLN) or \\>1.2\\*Upper Limit of Normal ULN.; Leukocytes \\<0.5\\*LLN or \\>1.5\\*ULN; Platelet \\<75 or \\>600 10\\^9/liter (L).\n\nAlanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase \\>3\\*ULN; Albumin \\<25 g/L; Bilirubin \\> 34.2 umol/L; Blood Urea Nitrogen \\>10.7 mmol/L; Chloride \\<75 or \\>126 mmol/L; Creatinine \\>177 umol/L; Direct Bilirubin \\>2\\*ULN; Glucose \\<2.8 or \\>19.4 mmol/L; Potassium \\<3.0 or \\>6.0 mmol/L; Protein \\<0.8\\*LLN or \\>1.2\\*ULN; Sodium \\<130 or \\>150 mmol/L.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Placebo', 'description': 'Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-828 0.1 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG002', 'title': 'Cohort 1: TAK-828 0.5 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG003', 'title': 'Cohort 1: TAK-828 15 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG004', 'title': 'Cohort 1: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG005', 'title': 'Cohort 1: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.'}, {'id': 'OG007', 'title': 'Cohort 2: TAK-828 3 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG008', 'title': 'Cohort 2: TAK-828 50 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG009', 'title': 'Cohort 2: TAK-828 200 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG010', 'title': 'Cohort 2: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG011', 'title': 'Cohort 2: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG012', 'title': 'Cohort 3: Placebo', 'description': 'Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.'}, {'id': 'OG013', 'title': 'Cohort 3: TAK-828 15 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG014', 'title': 'Cohort 3: TAK-828 100 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG015', 'title': 'Cohort 3: TAK-828 150 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'title': 'SBP <85 mmHg: standing, after 1 minute', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '12.5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '11.1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '8.3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'SBP <85 mmHg: standing, after 3 minutes', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '11.1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '11.1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'DBP <50 mmHg: supine, after 5 minutes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '11.1', 'groupId': 'OG007'}, {'value': '11.1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '8.3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '12.5', 'groupId': 'OG014'}, {'value': '16.7', 'groupId': 'OG015'}]}]}, {'title': 'DBP <50 mmHg: standing, after 3 minutes', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '11.1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '8.3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '12.5', 'groupId': 'OG014'}, {'value': '16.7', 'groupId': 'OG015'}]}]}, {'title': 'PR <50 bpm: supine, after 5 minutes', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '25.0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '22.2', 'groupId': 'OG007'}, {'value': '22.2', 'groupId': 'OG008'}, {'value': '22.2', 'groupId': 'OG009'}, {'value': '22.2', 'groupId': 'OG010'}, {'value': '50.0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '16.7', 'groupId': 'OG015'}]}]}, {'title': 'PR <50 bpm: standing, after 1 minute', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '11.1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'PR >120 bpm: standing, after 1 minute', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '28.6', 'groupId': 'OG004'}, {'value': '12.5', 'groupId': 'OG005'}, {'value': '11.1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '11.1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'PR <50 bpm: standing, after 3 minutes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '11.1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'PR >120 bpm: standing, after 3 minutes', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}, {'value': '12.5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Temperature: <35.6 C', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}, {'value': '12.5', 'groupId': 'OG005'}, {'value': '11.1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '16.7', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '16.7', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 7 days after last dose of study drug (up to 52 days)', 'description': 'Vital signs measurements that met the following criteria were considered to be markedly abnormal:\n\nSystolic Blood Pressure (SBP) \\<85 mmHg or \\>180 mmHg supine laying face upward) or standing; Diastolic Blood Pressure (DBP) \\<50 mmHg or \\>110 mmHg supine or standing; Pulse Rate (PR) \\<50 beats/minute (bpm) or \\>120 bpm supine or standing; Temperature \\<35.6 degrees Celsius (C) or \\>37.7 degrees C.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Measurements at Least Once Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '12', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}, {'value': '8', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Placebo', 'description': 'Non-Japanese participants in Cohort 1 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.'}, {'id': 'OG001', 'title': 'Cohort 1: TAK-828 0.1 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG002', 'title': 'Cohort 1: TAK-828 0.5 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG003', 'title': 'Cohort 1: TAK-828 15 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG004', 'title': 'Cohort 1: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG005', 'title': 'Cohort 1: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG006', 'title': 'Cohort 2: Placebo', 'description': 'Non-Japanese participants in Cohort 2 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2, 3 or 4.'}, {'id': 'OG007', 'title': 'Cohort 2: TAK-828 3 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG008', 'title': 'Cohort 2: TAK-828 50 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG009', 'title': 'Cohort 2: TAK-828 200 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG010', 'title': 'Cohort 2: TAK-828 100 mg/ Fasted', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG011', 'title': 'Cohort 2: TAK-828 100 mg/ Fed', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG012', 'title': 'Cohort 3: Placebo', 'description': 'Japanese participants in Cohort 3 who received placebo-matching TAK-828 oral solution, fasted (after an 8 hour fast), on Day 1 of Periods 1, 2 or 3.'}, {'id': 'OG013', 'title': 'Cohort 3: TAK-828 15 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG014', 'title': 'Cohort 3: TAK-828 100 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG015', 'title': 'Cohort 3: TAK-828 150 mg/ Fasted', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'title': 'Heart Rate <50 bpm', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '25.0', 'groupId': 'OG005'}, {'value': '44.4', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '33.3', 'groupId': 'OG009'}, {'value': '55.6', 'groupId': 'OG010'}, {'value': '50.0', 'groupId': 'OG011'}, {'value': '8.3', 'groupId': 'OG012'}, {'value': '12.5', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'QTcB: ≥500 msec OR ≥30 msec CFB and ≥450 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '25.0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '8.3', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '12.5', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 7 days after last dose of study drug (up to 52 days)', 'description': "Heart Rate \\<50 beats per minute (bpm) \\>120 bpm; QTcB (Bazett's Correction Formula) ≤50 milliseconds (msec) or ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec; QTcF (Fridericia's Correction Formula) ≤50 msec or ≥500 msec OR ≥30 msec change from Baseline (CFB) and ≥450 msec.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time of First Occurrence of Cmax for TAK-828F (Free Base of TAK-828)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-828 0.1 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'TAK-828 0.5 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG002', 'title': 'TAK-828 3 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG003', 'title': 'TAK-828 15 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG004', 'title': 'TAK-828 50 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG005', 'title': 'TAK-828 100 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG006', 'title': 'TAK-828 100 mg/ Fed in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG007', 'title': 'TAK-828 200 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG008', 'title': 'TAK-828 15 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG009', 'title': 'TAK-828 100 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG010', 'title': 'TAK-828 150 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '1.13'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.517', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '0.500', 'upperLimit': '1.50'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '0.500', 'upperLimit': '1.02'}, {'value': '3.50', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG007', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG008', 'lowerLimit': '0.500', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG009', 'lowerLimit': '0.500', 'upperLimit': '1.50'}, {'value': '1.00', 'groupId': 'OG010', 'lowerLimit': '0.500', 'upperLimit': '1.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F.'}, {'type': 'SECONDARY', 'title': 't1/2z: Terminal Disposition Phase Half-Life for TAK-828F (Free Base of TAK-828)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-828 0.1 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'TAK-828 0.5 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG002', 'title': 'TAK-828 3 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG003', 'title': 'TAK-828 15 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG004', 'title': 'TAK-828 50 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG005', 'title': 'TAK-828 100 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG006', 'title': 'TAK-828 100 mg/ Fed in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG007', 'title': 'TAK-828 200 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG008', 'title': 'TAK-828 15 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG009', 'title': 'TAK-828 100 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG010', 'title': 'TAK-828 150 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.38', 'spread': '0.568', 'groupId': 'OG001'}, {'value': '4.94', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '6.53', 'spread': '1.14', 'groupId': 'OG003'}, {'value': '7.51', 'spread': '1.95', 'groupId': 'OG004'}, {'value': '7.53', 'spread': '1.32', 'groupId': 'OG005'}, {'value': '7.04', 'spread': '0.701', 'groupId': 'OG006'}, {'value': '7.97', 'spread': '1.42', 'groupId': 'OG007'}, {'value': '6.71', 'spread': '1.37', 'groupId': 'OG008'}, {'value': '6.71', 'spread': '0.950', 'groupId': 'OG009'}, {'value': '6.44', 'spread': '0.406', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F. T1/2z was not calculated for the TAK-828 0.1 mg arm because Lambda z, required for the calculation, was not calculated due to the lack of a well-defined terminal elimination phase.'}, {'type': 'SECONDARY', 'title': 'AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-828F (Free Base of TAK-828)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-828 0.1 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.1 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG001', 'title': 'TAK-828 0.5 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 0.5 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG002', 'title': 'TAK-828 3 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 3 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG003', 'title': 'TAK-828 15 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 1 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG004', 'title': 'TAK-828 50 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 50 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG005', 'title': 'TAK-828 100 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 4.'}, {'id': 'OG006', 'title': 'TAK-828 100 mg/ Fed in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohorts 1 and 2 who received TAK-828 100 mg oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5.'}, {'id': 'OG007', 'title': 'TAK-828 200 mg/ Fasted in Non-Japanese Participants', 'description': 'Non-Japanese participants in Cohort 2 who received TAK-828 200 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}, {'id': 'OG008', 'title': 'TAK-828 15 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 15 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1.'}, {'id': 'OG009', 'title': 'TAK-828 100 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 100 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 2.'}, {'id': 'OG010', 'title': 'TAK-828 150 mg/ Fasted in Japanese Participants', 'description': 'Japanese participants in Cohort 3 who received TAK-828 150 mg oral solution, fasted (after an 8 hour fast), on Day 1 of Period 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '214', 'spread': '30.4', 'groupId': 'OG001'}, {'value': '1150', 'spread': '211', 'groupId': 'OG002'}, {'value': '5930', 'spread': '1430', 'groupId': 'OG003'}, {'value': '23100', 'spread': '5400', 'groupId': 'OG004'}, {'value': '45400', 'spread': '10300', 'groupId': 'OG005'}, {'value': '38000', 'spread': '7370', 'groupId': 'OG006'}, {'value': '106000', 'spread': '20800', 'groupId': 'OG007'}, {'value': '8560', 'spread': '1610', 'groupId': 'OG008'}, {'value': '54600', 'spread': '13400', 'groupId': 'OG009'}, {'value': '83700', 'spread': '16400', 'groupId': 'OG010'}]}]}], 'analyses': [{'groupIds': ['OG005', 'OG006'], 'paramType': 'Point estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.896', 'ciLowerLimit': '0.833', 'ciUpperLimit': '0.964', 'estimateComment': 'Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted', 'groupDescription': 'Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means and ratios of geometric means on the original scale.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence interval of 0.80 to 1.25'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Set included participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F.Food effect statistical analysis is based on 10 participants who received TAK-828 100 mg fasted and fed.AUC∞ was not calculated for TAK-828 0.1 mg arm due to lack of well-defined terminal elimination phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1, Sequence I', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG001', 'title': 'Cohort 1, Sequence II', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG002', 'title': 'Cohort 1, Sequence III', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG003', 'title': 'Cohort 1, Sequence IV', 'description': 'Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG004', 'title': 'Cohort 2, Sequence I', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG005', 'title': 'Cohort 2, Sequence II', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG006', 'title': 'Cohort 2, Sequence III', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG007', 'title': 'Cohort 2, Sequence IV', 'description': 'Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. There was a 7-day washout period between each period. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG008', 'title': 'Cohort 3, Sequence I', 'description': 'Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG009', 'title': 'Cohort 3, Sequence II', 'description': 'Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'FG010', 'title': 'Cohort 3, Sequence III', 'description': 'Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed = completed study drug', 'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Other 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': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 2 investigative sites in the United States from 01 March 2016 to 17 June 2016.', 'preAssignmentDetails': 'Non-Japanese healthy participants were randomized to Cohort 1 or Cohort 2 with 4 different sequences to receive TAK-828 or placebo in a ratio of 9:3. Japanese healthy participants were randomized into Cohort 3 with 3 different sequences to receive TAK-828 or placebo in a ratio of 8:4.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '36', 'groupId': 'BG011'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1, Sequence I', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG001', 'title': 'Cohort 1, Sequence II', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG002', 'title': 'Cohort 1, Sequence III', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG003', 'title': 'Cohort 1, Sequence IV', 'description': 'Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG004', 'title': 'Cohort 2, Sequence I', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG005', 'title': 'Cohort 2, Sequence II', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG006', 'title': 'Cohort 2, Sequence III', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG007', 'title': 'Cohort 2, Sequence IV', 'description': 'Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. There was a 7-day washout period between each period. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG008', 'title': 'Cohort 3, Sequence I', 'description': 'Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG009', 'title': 'Cohort 3, Sequence II', 'description': 'Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG010', 'title': 'Cohort 3, Sequence III', 'description': 'Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.'}, {'id': 'BG011', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '10.26', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '11.68', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '4.16', 'groupId': 'BG002'}, {'value': '36.7', 'spread': '9.71', 'groupId': 'BG003'}, {'value': '28.0', 'spread': '6.24', 'groupId': 'BG004'}, {'value': '40.3', 'spread': '8.39', 'groupId': 'BG005'}, {'value': '32.3', 'spread': '10.69', 'groupId': 'BG006'}, {'value': '40.7', 'spread': '5.51', 'groupId': 'BG007'}, {'value': '37.5', 'spread': '10.02', 'groupId': 'BG008'}, {'value': '34.3', 'spread': '6.65', 'groupId': 'BG009'}, {'value': '43.8', 'spread': '5.44', 'groupId': 'BG010'}, {'value': '35.9', 'spread': '8.45', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '34', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '31', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '13', 'groupId': 'BG011'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '17', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '36', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '176.3', 'spread': '3.21', 'groupId': 'BG000'}, {'value': '176.3', 'spread': '2.89', 'groupId': 'BG001'}, {'value': '173.3', 'spread': '5.69', 'groupId': 'BG002'}, {'value': '176.7', 'spread': '1.53', 'groupId': 'BG003'}, {'value': '169.7', 'spread': '12.50', 'groupId': 'BG004'}, {'value': '166.1', 'spread': '9.54', 'groupId': 'BG005'}, {'value': '178.0', 'spread': '4.36', 'groupId': 'BG006'}, {'value': '170.3', 'spread': '7.23', 'groupId': 'BG007'}, {'value': '174.3', 'spread': '6.24', 'groupId': 'BG008'}, {'value': '168.5', 'spread': '5.00', 'groupId': 'BG009'}, {'value': '173.0', 'spread': '8.64', 'groupId': 'BG010'}, {'value': '172.9', 'spread': '6.82', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.87', 'spread': '8.686', 'groupId': 'BG000'}, {'value': '85.23', 'spread': '2.686', 'groupId': 'BG001'}, {'value': '78.60', 'spread': '9.569', 'groupId': 'BG002'}, {'value': '83.23', 'spread': '9.160', 'groupId': 'BG003'}, {'value': '75.53', 'spread': '8.173', 'groupId': 'BG004'}, {'value': '66.87', 'spread': '8.135', 'groupId': 'BG005'}, {'value': '81.63', 'spread': '11.946', 'groupId': 'BG006'}, {'value': '77.13', 'spread': '16.354', 'groupId': 'BG007'}, {'value': '66.73', 'spread': '1.563', 'groupId': 'BG008'}, {'value': '65.18', 'spread': '3.149', 'groupId': 'BG009'}, {'value': '69.88', 'spread': '10.806', 'groupId': 'BG010'}, {'value': '74.93', 'spread': '10.416', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.28', 'spread': '1.828', 'groupId': 'BG000'}, {'value': '27.41', 'spread': '0.755', 'groupId': 'BG001'}, {'value': '26.08', 'spread': '1.765', 'groupId': 'BG002'}, {'value': '26.65', 'spread': '2.727', 'groupId': 'BG003'}, {'value': '26.34', 'spread': '3.071', 'groupId': 'BG004'}, {'value': '24.25', 'spread': '1.772', 'groupId': 'BG005'}, {'value': '25.73', 'spread': '3.170', 'groupId': 'BG006'}, {'value': '26.37', 'spread': '3.709', 'groupId': 'BG007'}, {'value': '22.05', 'spread': '1.864', 'groupId': 'BG008'}, {'value': '22.96', 'spread': '0.527', 'groupId': 'BG009'}, {'value': '23.20', 'spread': '1.622', 'groupId': 'BG010'}, {'value': '25.01', 'spread': '2.584', 'groupId': 'BG011'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification', 'classes': [{'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '33', 'groupId': 'BG011'}]}]}, {'title': 'Current Smoker', 'categories': [{'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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Classification', 'classes': [{'title': 'Never Drunk', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '16', 'groupId': 'BG011'}]}]}, {'title': 'Current Drinker', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '11', 'groupId': 'BG011'}]}]}, {'title': 'Ex-drinker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', '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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Xanthine/Caffeine Consumption', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '25', 'groupId': 'BG011'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '11', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Female Reproductive Status', 'classes': [{'title': 'Postmenopausal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}, {'title': 'Surgically Sterile', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}, {'title': 'Female of Childbearing Potential', 'categories': [{'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'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}]}, {'title': 'N/A (Participant is Male)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '34', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-10', 'studyFirstSubmitDate': '2016-03-08', 'resultsFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2016-03-08', 'lastUpdatePostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-10', 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1 up to 30 days after last dose of study drug (up to 85 days)', '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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.'}, {'measure': 'Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)', 'timeFrame': 'Day 1 up to 30 days after last dose of study drug (up to 85 days)'}, {'measure': 'Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose', 'timeFrame': 'Day 1 up to 7 days after last dose of study drug (up to 52 days)', 'description': 'Hematology and Chemistry values that met the following criteria were considered to be markedly abnormal:\n\nErythrocytes, Hematocrit and Hemoglobin \\<0.8\\*Lower Limit of Normal (LLN) or \\>1.2\\*Upper Limit of Normal ULN.; Leukocytes \\<0.5\\*LLN or \\>1.5\\*ULN; Platelet \\<75 or \\>600 10\\^9/liter (L).\n\nAlanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase \\>3\\*ULN; Albumin \\<25 g/L; Bilirubin \\> 34.2 umol/L; Blood Urea Nitrogen \\>10.7 mmol/L; Chloride \\<75 or \\>126 mmol/L; Creatinine \\>177 umol/L; Direct Bilirubin \\>2\\*ULN; Glucose \\<2.8 or \\>19.4 mmol/L; Potassium \\<3.0 or \\>6.0 mmol/L; Protein \\<0.8\\*LLN or \\>1.2\\*ULN; Sodium \\<130 or \\>150 mmol/L.'}, {'measure': 'Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose', 'timeFrame': 'Day 1 up to 7 days after last dose of study drug (up to 52 days)', 'description': 'Vital signs measurements that met the following criteria were considered to be markedly abnormal:\n\nSystolic Blood Pressure (SBP) \\<85 mmHg or \\>180 mmHg supine laying face upward) or standing; Diastolic Blood Pressure (DBP) \\<50 mmHg or \\>110 mmHg supine or standing; Pulse Rate (PR) \\<50 beats/minute (bpm) or \\>120 bpm supine or standing; Temperature \\<35.6 degrees Celsius (C) or \\>37.7 degrees C.'}, {'measure': 'Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Measurements at Least Once Post-dose', 'timeFrame': 'Day 1 up to 7 days after last dose of study drug (up to 52 days)', 'description': "Heart Rate \\<50 beats per minute (bpm) \\>120 bpm; QTcB (Bazett's Correction Formula) ≤50 milliseconds (msec) or ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec; QTcF (Fridericia's Correction Formula) ≤50 msec or ≥500 msec OR ≥30 msec change from Baseline (CFB) and ≥450 msec."}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration for TAK-828F (Free Base of TAK-828)', 'timeFrame': 'Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose'}, {'measure': 'Tmax: Time of First Occurrence of Cmax for TAK-828F (Free Base of TAK-828)', 'timeFrame': 'Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose'}, {'measure': 't1/2z: Terminal Disposition Phase Half-Life for TAK-828F (Free Base of TAK-828)', 'timeFrame': 'Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose'}, {'measure': 'AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-828F (Free Base of TAK-828)', 'timeFrame': 'Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Dose Finding Study']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.', 'detailedDescription': 'The drug being tested in this study is called TAK-828. TAK-828 is being tested to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.\n\nThe study enrolled 36 healthy participants. An interleaving crossover design with placebo substitution was used for Cohorts 1 and 2, and a crossover design was used in Cohort 3. Each cohort consisted of 12 participants, and participants were randomized to treatment sequence to receive TAK-828 or placebo after undergoing a fasting stage of at least 8 hours through intervention periods 1-4 for Cohorts 1 and 2 and through intervention periods 1 - 3 for Cohort 3. The assigned treatment sequence will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). An additional interventional period 5 (fed state) is planned to be conducted in either cohort 1 or 2, based on the dose of TAK-828 that will be chosen to be studied under fed conditions. Cohorts 1 and 2 were conducted in non-Japanese participants and Cohort 3 in Japanese participants.\n\nThis multi-center trial was conducted in the United States. Participants remained confined to the study site from check-in (Day -1) through Day 4 of each intervention period and returned 7 to 10 days after last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: -\n\n1. Is a healthy male and female (non-child bearing potential) participants.\n2. Cohorts 1 and 2: non-Japanese participants aged 18 to 55 years, inclusive, with body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m\\^ 2), inclusive, and body weight greater than or equal (\\>=) 50 kilograms (kg).\n3. Cohort 3: Japanese participants (born to Japanese parents and grandparents) aged 20 to 55 years, inclusive, with BMI of 18.5 to 25 kg/m\\^ 2, inclusive, and body weight \\>= 45 kg.\n\nExclusion Criteria: -\n\n1\\. Has used prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to Check-in (Day -1). Herbal supplements and hormone replacement therapy (HRT) must be discontinued 28 days prior to Check-in (Day -1). As an exception, acetaminophen may be used at doses of less than equal to (\\<=) 1 gram per day (g/day). Limited use of nonprescription medications that are not believed to affect participant safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.'}, 'identificationModule': {'nctId': 'NCT02706834', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Non-Japanese and Japanese Subjects', 'orgStudyIdInfo': {'id': 'TAK-828-1001'}, 'secondaryIdInfos': [{'id': 'U1111-1177-8044', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Sequence I', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Sequence II', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Sequence III', 'description': 'Non-Japanese participants. TAK-828 0.1 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, Sequence IV', 'description': 'Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 0.5 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 15 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Sequence I', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Sequence II', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Sequence III', 'description': 'Non-Japanese participants. TAK-828 3 mg, oral solution, fasted (after an 8 hour fast) on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Sequence IV', 'description': 'Non-Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 50 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 200 mg, oral solution, fasted, on Day 1 of Period 3; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 4; followed by, TAK-828 100 mg, oral solution, fed (high-fat, high-calorie meal 30 minutes prior to administration of study drug), on Day 1 of Period 5. There was a 7-day washout period between each period. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3, Sequence I', 'description': 'Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3, Sequence II', 'description': 'Japanese participants. TAK-828 15 mg, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, placebo-matching TAK-828, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3, Sequence III', 'description': 'Japanese participants. Placebo-matching TAK-828, oral solution, fasted (after an 8 hour fast), on Day 1 of Period 1; followed by, TAK-828 100 mg, oral solution, fasted, on Day 1 of Period 2; followed by, TAK-828 150 mg, oral solution, fasted, on Day 1 of Period 3. Each period lasted 4 days with a 7-day washout period between periods.', 'interventionNames': ['Drug: TAK-828', 'Drug: Placebo']}], 'interventions': [{'name': 'TAK-828', 'type': 'DRUG', 'description': 'TAK-828 oral solution', 'armGroupLabels': ['Cohort 1, Sequence I', 'Cohort 1, Sequence II', 'Cohort 1, Sequence III', 'Cohort 1, Sequence IV', 'Cohort 2, Sequence I', 'Cohort 2, Sequence II', 'Cohort 2, Sequence III', 'Cohort 2, Sequence IV', 'Cohort 3, Sequence I', 'Cohort 3, Sequence II', 'Cohort 3, Sequence III']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'TAK-828 placebo-matching oral solution', 'armGroupLabels': ['Cohort 1, Sequence I', 'Cohort 1, Sequence II', 'Cohort 1, Sequence III', 'Cohort 1, Sequence IV', 'Cohort 2, Sequence I', 'Cohort 2, Sequence II', 'Cohort 2, Sequence III', 'Cohort 2, Sequence IV', 'Cohort 3, Sequence I', 'Cohort 3, Sequence II', 'Cohort 3, Sequence III']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}