Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2026-03-05 @ 11:21 AM
Study NCT ID:
NCT02850406
Status:
TERMINATED
Last Update Posted:
2025-08-15
First Post:
2016-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628792', 'term': 'voxelotor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part A: From start of treatment on Day 1 up to 2 weeks after last dose (up to Day 15); Part B, C and D: From start of treatment on Day 1 up to 4 weeks after last dose (up to Week 28 for Part B and up to Week 52 for Parts C and D).', 'description': 'An AE term may be reported as both serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population comprised of all participants who received any amount of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 22, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 46, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 23}, {'id': 'EG005', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG006', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 21, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Sickle cell anaemia with crisis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Acute chest syndrome', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Osteonecrosis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Priapism', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Nausea', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Abdominal pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Vomiting', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Diarrhoea', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Constipation', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Abdominal pain upper', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Abdominal distension', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dental caries', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Gastritis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Toothache', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pain in extremity', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Back pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Arthralgia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Flank pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Musculoskeletal pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Myalgia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Viral infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Upper respiratory tract infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Acute sinusitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Body tinea', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Cellulitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Conjunctivitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Gastroenteritis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pharyngitis streptococcal', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rhinitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Sinusitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Headache', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dizziness', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part 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'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Migraine', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Syncope', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Non-cardiac chest pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pyrexia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Fatigue', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Chest discomfort', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Chest pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Peripheral swelling', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Oropharyngeal pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Nasal congestion', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Cough', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Epistaxis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dyspnoea', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rhinorrhoea', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Upper-airway cough syndrome', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pruritus', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dermatitis contact', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rash', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rash generalised', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rash papular', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Urticaria', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Anaemia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Neutropenia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Reticulocytopenia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Thrombocytopenia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Thrombocytosis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Arthropod bite', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Fall', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Joint injury', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Laceration', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Transaminases increased', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Bacterial test positive', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Anxiety', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Insomnia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Mental status changes', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Stress', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Cholelithiasis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Ocular icterus', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Tachycardia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypoacusis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Tinnitus', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Retinopathy sickle cell', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Seasonal allergy', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Vitamin D deficiency', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Micturition urgency', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'gastrointestinal disorder', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Influenza', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Lower respiratory tract infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Nasopharyngitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Otitis media', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Urinary tract infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'COVID-19', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Febrile infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hepatitis A', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Impetigo', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Sepsis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Tinea faciei', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Tooth abscess', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Viral upper respiratory tract infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Gait disturbance', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Bone pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Muscular weakness', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Musculoskeletal chest pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pain in jaw', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypoxia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Obstructive sleep apnoea syndrome', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Paranasal sinus hypersecretion', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Sinus congestion', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Tonsillar erythema', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Tonsillar hypertrophy', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Depressed level of consciousness', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypersomnia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dermatitis allergic', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dry skin', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rash maculo-papular', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Alanine aminotransferase increased', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Aspartate aminotransferase increased', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Blood bilirubin increased', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Breath sounds abnormal', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Electrocardiogram QT prolonged', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Haemoglobin decreased', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Influenza A virus test positive', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Neutrophil count decreased', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Splenomegaly', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Cardiomegaly', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Diastolic dysfunction', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Left atrial dilatation', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Ventricular hypertrophy', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Sports injury', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Epiphyseal fracture', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Foot fracture', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Muscle strain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Eye pain', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Visual impairment', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Albuminuria', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dysuria', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Proteinuria', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Allergic oedema', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Decreased appetite', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dehydration', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Encopresis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Enuresis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Post-traumatic stress disorder', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypertransaminasaemia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypersplenism', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Pneumonia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dactylitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Respiratory tract infection viral', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Tonsillitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Gastroenteritis rotavirus', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Lip infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Oral herpes', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Respiratory syncytial virus infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rotavirus infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Viral rash', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Lip blister', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Joint swelling', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypercoagulation', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Rash pruritic', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Blood alkaline phosphatase increased', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Ultrasound head abnormal', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Foreign body ingestion', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Jaundice', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Benign lymph node neoplasm', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypertonic bladder', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Flatulence', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Allergic respiratory symptom', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}], 'seriousEvents': [{'term': 'Sickle cell anaemia with crisis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Influenza', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Tonsillitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Viral infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Hemolytic anaemia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Hypoxia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Priapism', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Acute chest syndrome', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Pneumonia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Pyrexia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Hypersplenism', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Platelet disorder', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Salmonellosis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Electrocardiogram T wave inversion', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Haemoglobin decreased', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Periorbital swelling', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Cholecystitis acute', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Hypersensitivity', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Dehydration', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Pleural effusion', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Rash', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Pallor', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Anaemia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Bacteraemia', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Bronchiolitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Bronchitis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Malaria', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Rotavirus infection', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Sepsis', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Constipation', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Vomiting', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Ultrasound head abnormal', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Pain in extremity', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Splenectomy', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA19.1'}, {'term': 'Pneumonia necrotising', 'notes': 'MedDRA v19.1 for Part A and Part B arms, MedDRA v25.1 for Part C arms and MedDRA v26.0 for Part D arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Maximum Concentration (Cmax) of Voxelotor in Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '24300', 'spread': '36.39', 'groupId': 'OG000'}, {'value': '47300', 'spread': '43.62', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma.'}, {'type': 'PRIMARY', 'title': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1570000', 'spread': '38.13', 'groupId': 'OG000'}, {'value': '2540000', 'spread': '50.25', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-last was calculated using the linear/log trapezoid rule.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma.'}, {'type': 'PRIMARY', 'title': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1520000', 'spread': '40.98', 'groupId': 'OG000'}, {'value': '2570000', 'spread': '50.59', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96,168 and 336 hours post-dose', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration for whole blood and lambdaz=elimination rate constant.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Part B: Change From Baseline to Week 24 in Hemoglobin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'Gram per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Part C: Change From Baseline to Week 48 in Cerebral Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '16.76', 'groupId': 'OG000'}, {'value': '-26.3', 'spread': '11.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Cerebral blood flow was measured using transcranial Doppler (TCD) sonography. Change from baseline in cerebral blood flow as measured by the time-averaged mean of the maximum (TAMM) TCD velocity is reported.', 'unitOfMeasure': 'Centimeter per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Part D: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Non-SCD related TEAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Non-SCD related SAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'SCD related TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'SCD related SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment up to 28 days after study treatment discontinuation (Up to 52 weeks)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. TEAE was defined as an AE that emerged on or after initiation of study drug (having been absent pre-treatment), or an AE that existed pre-treatment and worsened on treatment (relative to the pre-treatment state) through 28 days after study drug discontinuation. An SAE was any AE that resulted in any of the following outcomes: death, life threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, other important medical events. AEs were classified as SCD-related and non-SCD related.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population comprised of all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Part A: Maximum Concentration (Cmax) of Voxelotor in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1880', 'spread': '32.49', 'groupId': 'OG000'}, {'value': '3390', 'spread': '37.82', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Maximum Concentration (Cmax) of Voxelotor in Red Blood Cells (RBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '91500', 'spread': '33.17', 'groupId': 'OG000'}, {'value': '168000', 'spread': '35.56', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '104000', 'spread': '20.85', 'groupId': 'OG000'}, {'value': '148000', 'spread': '38.69', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-last was calculated using the linear/log trapezoid rule.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in RBC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6070000', 'spread': '28.69', 'groupId': 'OG000'}, {'value': '8950000', 'spread': '47.05', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-last was calculated using the linear/log trapezoid rule.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '101000', 'spread': '20.51', 'groupId': 'OG000'}, {'value': '150000', 'spread': '38.01', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration for plasma and lambdaz is the elimination rate constant.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in RBC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '5550000', 'spread': '24.31', 'groupId': 'OG000'}, {'value': '9070000', 'spread': '47.47', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant.', 'unitOfMeasure': 'Hours*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '7.67', 'upperLimit': '49.9'}, {'value': '8.73', 'groupId': 'OG001', 'lowerLimit': '7.78', 'upperLimit': '25.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma.'}, {'type': 'SECONDARY', 'title': 'Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '1.95', 'upperLimit': '9.00'}, {'value': '2.83', 'groupId': 'OG001', 'lowerLimit': '2.57', 'upperLimit': '8.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in RBC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000', 'lowerLimit': '7.67', 'upperLimit': '49.9'}, {'value': '8.75', 'groupId': 'OG001', 'lowerLimit': '8.72', 'upperLimit': '25.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '18.76', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '26.18', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '6.40', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '31.48', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in RBC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'spread': '12.89', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '30.95', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of all participants who received any amount of study drug and who provided PK data from at least one post-dose sample in plasma. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Percentage Hemoglobin (Hb) Occupancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'OG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}], 'timeFrame': '15 days', 'description': 'Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula:\n\n(\\[Concentration of voxelotor in whole blood- {1-hematocrit}\\]\\*\\[Concentration of voxelotor in plasma/hematocrit\\])/5000\\*100.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected as the model for Hb occupancy within RBCs was not developed for single dose administration (Part A). The model used to determine % Hb Occupancy was constructed via populational PK modelling and required data from multiple dose administration, thus cannot be applied to estimate the % Hb Occupancy for single doses.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Days With SCD Symptom Exacerbation During the First 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'timeFrame': 'From Day 1 up to 24 weeks', 'description': 'SCD symptoms were measured using the Patient Reported Outcome (PRO), Sickle Cell Disease Severity Measure (SCDSM) which was a self-administered 9-item questionnaire of SCD core symptoms including pain severity, frequency, and type, as well as fatigue and mental acuity, on a 4-point response scale that was completed daily using a handheld electronic device by the participants.', 'reportingStatus': 'POSTED', 'populationDescription': 'The variable represents a derivation from a new instrument developed by the sponsor specifically for this clinical program. Due to challenges in the validation of "Percentage of Days With SCD Symptom Exacerbation" from the instrument, specifically with the impact of missing data, the construct of this variable was not possible. A decision not to analyze this variable was documented in the statistical analysis plan.'}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline to Week 21 to 24 in the Sickle Cell Disease Severity Measure (SCDSM) Total Symptom Score (TSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '17.98', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '18.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 21 to 24', 'description': 'The SCDSM was a self-administered 9-item questionnaire of SCD core symptoms including pain severity, frequency, and type, as well as fatigue and mental acuity, on a 4-point response scale with a range of 0 (strongly disagree) to 4 (strongly agree) that was completed daily using a handheld electronic device by the participants. TSS was calculated as the sum of the 9-item questionnaire scores scaled to a 100-point scale with a range of 0 (no symptoms) to 100 (most severe symptoms). Baseline TSS was the average of the non-missing score during the Screening period. The average of change from baseline in SCDSM TSS score for the 4-week period (Week 21 to 24) is reported.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Percent Change From Baseline to Weeks 12 and 24 in Lactate Dehydrogenase (LDH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '32.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '22.47', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '14.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12 and 24', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part B: Percent Change From Baseline to Weeks 12 and 24 in Indirect Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-32.1', 'spread': '31.98', 'groupId': 'OG000'}, {'value': '-29.9', 'spread': '33.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-37.5', 'spread': '29.07', 'groupId': 'OG000'}, {'value': '-32.1', 'spread': '31.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12 and 24', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part B: Percent Change From Baseline to Weeks 12 and 24 in Percentage Reticulocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.7', 'spread': '36.46', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '42.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.1', 'spread': '34.06', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '43.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12 and 24', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part B: Cmax of Voxelotor in Whole Blood and Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'title': 'Cmax, plasma', 'categories': [{'measurements': [{'value': '5.64', 'spread': '41', 'groupId': 'OG000'}, {'value': '9.81', 'spread': '37', 'groupId': 'OG001'}]}]}, {'title': 'Cmax, whole blood', 'categories': [{'measurements': [{'value': '102', 'spread': '38', 'groupId': 'OG000'}, {'value': '159', 'spread': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 8, 24 hours post-dose), pre-dose on Weeks 2, 4, 8, 12, 16, 20 and 24', 'unitOfMeasure': 'Microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information.'}, {'type': 'SECONDARY', 'title': 'Part B: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor for Whole Blood and Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'title': 'AUC0-inf, plasma', 'categories': [{'measurements': [{'value': '113', 'spread': '46', 'groupId': 'OG000'}, {'value': '195', 'spread': '40', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-inf, whole blood', 'categories': [{'measurements': [{'value': '2090', 'spread': '43', 'groupId': 'OG000'}, {'value': '3290', 'spread': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 8, 24 hours post-dose), pre-dose on Weeks 2, 4, 8, 12, 16, 20 and 24', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant.', 'unitOfMeasure': 'Hours*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information.'}, {'type': 'SECONDARY', 'title': 'Part B: Terminal Elimination Half-life of Voxelotor for Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'title': 'T1/2, plasma', 'categories': [{'measurements': [{'value': '33', 'spread': '41', 'groupId': 'OG000'}, {'value': '33.9', 'spread': '44', 'groupId': 'OG001'}]}]}, {'title': 'T1/2, whole blood', 'categories': [{'measurements': [{'value': '31.1', 'spread': '39', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 8, 24 hours post-dose), pre-dose on Weeks 2, 4, 8, 12, 16, 20 and 24', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information.'}, {'type': 'SECONDARY', 'title': 'Part B: Accumulation Ratio (Rac) of Voxelotor for Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'title': 'Rac, plasma', 'categories': [{'measurements': [{'value': '2.57', 'spread': '29', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '33', 'groupId': 'OG001'}]}]}, {'title': 'Rac, whole blood', 'categories': [{'measurements': [{'value': '2.46', 'spread': '27', 'groupId': 'OG000'}, {'value': '2.47', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (0 to 24 hours post-dose) and Day 28 (0 to 24 hours post-dose)', 'description': 'Accumulation ratio was calculated as ratio of area under the concentration-time curve from time 0 to 24 hours (AUC0-24) at steady-state (Day 28) to AUC0-24 on Day 1.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage Hemoglobin Occupancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '34', 'groupId': 'OG000'}, {'value': '29.5', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28', 'description': 'Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula:\n\n(\\[Concentration of voxelotor in whole blood- {1-hematocrit}\\]\\*\\[Concentration of voxelotor in plasma/hematocrit\\])/5000\\*100.', 'unitOfMeasure': 'Percentage of bound hemoglobin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information.'}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline to Week 12 and 24 in Cerebral Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'OG001', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '16.48', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '9.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '14.03', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '14.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12 and 24', 'description': 'Cerebral blood flow was measured using TCD sonography. Change from baseline in cerebral blood flow as measured by TAMM TCD velocity is reported.', 'unitOfMeasure': 'Centimeter per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part C: Change From Baseline to Weeks 24 and 48 in Hemoglobin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part C: Percent Change From Baseline to Weeks 24 and 48 in LDH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '21.95', 'groupId': 'OG000'}, {'value': '-22.4', 'spread': '22.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '23.80', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '8.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part C: Percent Change From Baseline to Weeks 24 and 48 in Indirect Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-36.9', 'spread': '26.55', 'groupId': 'OG000'}, {'value': '-45.7', 'spread': '24.93', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.6', 'spread': '37.05', 'groupId': 'OG000'}, {'value': '-33.0', 'spread': '36.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part C: Percent Change From Baseline to Weeks 24 and 48 in Percentage Reticulocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.76', 'spread': '42.999', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '31.595', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '46.353', 'groupId': 'OG000'}, {'value': '2.94', 'spread': '38.295', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part C: Change From Baseline to Week 24 in Cerebral Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '15.69', 'groupId': 'OG000'}, {'value': '-11.8', 'spread': '18.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Cerebral blood flow was measured using TCD sonography. Change from baseline in cerebral blood flow as measured by TAMM TCD velocity is reported.', 'unitOfMeasure': 'Centimeter per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part C: Time to Initial Hemoglobin Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '4.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of study treatment (Day 1) up to Week 48', 'description': 'Time to initial Hb response was defined as the time from first dose of study treatment to the first occurrence of a change from baseline in Hb \\> 1 gram per deciliter (g/dL).', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part C: Cmax of Voxelotor for Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Cmax, plasma', 'categories': [{'measurements': [{'value': '7.83', 'spread': '61', 'groupId': 'OG000'}, {'value': '9.04', 'spread': '43', 'groupId': 'OG001'}]}]}, {'title': 'Cmax, whole blood', 'categories': [{'measurements': [{'value': '127', 'spread': '52', 'groupId': 'OG000'}, {'value': '137', 'spread': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (15 minutes to 2 hours post-dose), pre-dose on Weeks 4, 8, 12, 16, 20, 24, 36 and 48', 'unitOfMeasure': 'Microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part C: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor for Whole Blood and Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'AUC0-inf, plasma', 'categories': [{'measurements': [{'value': '160', 'spread': '72', 'groupId': 'OG000'}, {'value': '184', 'spread': '44', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-inf, whole blood', 'categories': [{'measurements': [{'value': '2660', 'spread': '64', 'groupId': 'OG000'}, {'value': '2880', 'spread': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (15 minutes to 2 hours post-dose), pre-dose on Weeks 4, 8, 12, 16, 20, 24, 36 and 48', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant.', 'unitOfMeasure': 'Hours*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part C: Terminal Elimination Half-life (T1/2) of Voxelotor for Whole Blood and Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'T1/2, plasma', 'categories': [{'measurements': [{'value': '41.6', 'spread': '50', 'groupId': 'OG000'}, {'value': '35.6', 'spread': '28', 'groupId': 'OG001'}]}]}, {'title': 'T1/2, whole blood', 'categories': [{'measurements': [{'value': '37.4', 'spread': '48', 'groupId': 'OG000'}, {'value': '32.7', 'spread': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (15 minutes to 2 hours post-dose), pre-dose on Weeks 4, 8, 12, 16, 20, 24, 36 and 48', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part C: Percentage Hemoglobin Occupancy of Voxelotor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'spread': '47', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28', 'description': 'Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula:\n\n(\\[Concentration of voxelotor in whole blood- {1-hematocrit}\\]\\*\\[Concentration of voxelotor in plasma/hematocrit\\])/5000\\*100.', 'unitOfMeasure': 'Percentage of bound hemoglobin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part C: Percentage of Participants With Normal Transcranial Doppler (TCD) Flow Velocity at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Baseline normal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000', 'lowerLimit': '15.69'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '18.82'}]}]}, {'title': 'Baseline conditional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Normal TCD flow velocity was considered as \\< 170 centimeter per second (cm/sec) by non-imagining TCD or \\< 155 cm/sec by imaging transcranial Doppler (TCDi). Percentage of participants with normal TCD flow velocity at Week 48 by Baseline TCD group (i.e. Baseline normal TCD \\[\\<170 cm/sec\\] and Baseline conditional TCD \\[\\>=170 cm/sec\\] is reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. All participants reported under, 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for each row. Here, 'Number Analyzed ' signifies number of participants evaluable for each row."}, {'type': 'SECONDARY', 'title': 'Part C: Annualized Incidence Rate of Vaso-occlusive Crisis (VOC) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.246', 'groupId': 'OG000', 'lowerLimit': '0.912', 'upperLimit': '1.662'}, {'value': '2.250', 'groupId': 'OG001', 'lowerLimit': '1.123', 'upperLimit': '4.025'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': 'VOC events included preferred terms of sickle cell anaemia with crisis, acute chest syndrome, pneumonia necrotising and pneumonia. Annualized incidence rate was calculated as total number of events divided by total person years. Total person years=sum of participants treatment period in years, which covered the time from first dose to last dose.', 'unitOfMeasure': 'VOC events per person year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy-Evaluable Population comprised of all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Part C: Annualized Incidence Rate of Stroke Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.100'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.754'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': 'Annualized incidence rate was calculated as total number of events divided by total person years. Total person years=sum of participants treatment period in years, which covered the time from first dose to last dose.', 'unitOfMeasure': 'Stroke events per person year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy-Evaluable Population comprised of all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Part D: Cmax of Voxelotor for Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Cmax, plasma', 'categories': [{'measurements': [{'value': '5.01', 'spread': '73', 'groupId': 'OG000'}, {'value': '9.45', 'spread': '34', 'groupId': 'OG001'}]}]}, {'title': 'Cmax, whole blood', 'categories': [{'measurements': [{'value': '87.2', 'spread': '74', 'groupId': 'OG000'}, {'value': '149', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (anytime between 15 minutes to 2 hours post-dose), pre-dose on Weeks 2, 8, 12, 16, 24, 36 and 48', 'unitOfMeasure': 'Microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part D: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor for Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'AUC0-inf, plasma', 'categories': [{'measurements': [{'value': '89.9', 'spread': '110', 'groupId': 'OG000'}, {'value': '186', 'spread': '38', 'groupId': 'OG001'}]}]}, {'title': 'AUC0-inf, whole blood', 'categories': [{'measurements': [{'value': '1600', 'spread': '120', 'groupId': 'OG000'}, {'value': '3040', 'spread': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (anytime between 15 minutes to 2 hours post-dose), pre-dose on Weeks 2, 8, 12, 16, 24, 36 and 48', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant.', 'unitOfMeasure': 'Hours*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part D: T1/2 of Voxelotor for Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'T1/2, plasma', 'categories': [{'measurements': [{'value': '24.1', 'spread': '70', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '40', 'groupId': 'OG001'}]}]}, {'title': 'T1/2, whole blood', 'categories': [{'measurements': [{'value': '21.7', 'spread': '82', 'groupId': 'OG000'}, {'value': '32.7', 'spread': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (anytime between 15 minutes to 2 hours post-dose), pre-dose on Weeks 2, 8, 12, 16, 24, 36 and 48', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part D: Percentage Hemoglobin Occupancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '60', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28', 'description': 'Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula:\n\n(\\[Concentration of voxelotor in whole blood- {1-hematocrit}\\]\\*\\[Concentration of voxelotor in plasma/hematocrit\\])/5000\\*100.', 'unitOfMeasure': 'Percentage of bound hemoglobin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK population comprised of participants who received at least one dose of voxelotor and had at least 1 measurable voxelotor concentration observation in plasma or whole blood with associated sampling time and dosing information. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part D: Change From Baseline to Weeks 24 and 48 in Hemoglobin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part D: Percent Change From Baseline to Weeks 24 and 48 in LDH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.6', 'spread': '56.46', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '31.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '43.98', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '45.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part D: Percent Change From Baseline to Weeks 24 and 48 in Indirect Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.4', 'spread': '28.11', 'groupId': 'OG000'}, {'value': '-24.5', 'spread': '24.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '42.05', 'groupId': 'OG000'}, {'value': '-24.5', 'spread': '21.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part D: Percent Change From Baseline to Weeks 24 and 48 in Reticulocytes Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '28.64', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '31.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.5', 'spread': '31.19', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '29.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Part D: Time to Initial Hemoglobin Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '7.60', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '8.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of study treatment (Day 1) up to Week 48', 'description': 'Time to initial Hb response, defined as the time from first dose of study treatment to the first occurrence of a change from baseline in Hb \\> 1 g/dL.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy-Evaluable Population comprised of all participants who received any amount of study drug. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part D: Annualized Incidence Rate of VOC Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.473', 'groupId': 'OG000', 'lowerLimit': '0.706', 'upperLimit': '2.708'}, {'value': '1.399', 'groupId': 'OG001', 'lowerLimit': '0.914', 'upperLimit': '2.050'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': "VOC events included preferred terms of 'Sickle cell anemia with crisis', 'Acute chest syndrome', 'Pneumonia necrotising,' and 'Pneumonia. Annualized incidence rate was calculated as total number of events divided by total person years. Total person years=sum of participants treatment period in years, which covered the time from first dose to last dose.", 'unitOfMeasure': 'VOC events per person year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy-Evaluable Population comprised of all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Part D: Annualized Incidence Rate of Stroke Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'OG001', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.543'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.198'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': 'Annualized incidence rate was calculated as total number of events divided by total person years. Total person years=sum of participants treatment period in years, which covered the time from first dose to last dose.', 'unitOfMeasure': 'Stroke events per person year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy-Evaluable Population comprised of all participants who received any amount of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'FG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}, {'id': 'FG002', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'FG003', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}, {'id': 'FG004', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'FG005', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'FG006', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'FG007', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}], 'periods': [{'title': 'Part A (Up to 15 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Part B (Up to 28 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'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'}]}, {'type': 'Non compliance', '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'}]}]}, {'title': 'Part C (Up to 52 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'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'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Part D (Up to 52 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study consisted of four parts-Part A, B, C and D. The study was terminated as the emerging clinical data indicated that the risk profile of voxelotor in people with sickle cell disease (SCD) exceeded the benefits observed in previously generated global research and required further assessment.', 'preAssignmentDetails': 'A total of 147 pediatric participants with SCD (13 in Part A, 40 in Part B, 62 in Part C and 32 in Part D) were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}, {'value': '147', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: Participants Aged 12 to 17 Years: Voxelotor 600 mg', 'description': 'Participants aged 12 to 17 years received a single oral dose of voxelotor 600 milligrams (mg) on Day 1.'}, {'id': 'BG001', 'title': 'Part A: Participants Aged 6 to 11 Years: Voxelotor 600 mg', 'description': 'Participants aged 6 to 11 years received a single oral dose of voxelotor 600 mg on Day 1.'}, {'id': 'BG002', 'title': 'Part B: Voxelotor 900 mg QD', 'description': 'Participants aged 12 to 17 years received once daily (QD) oral dose of voxelotor 900 mg for 24 weeks.'}, {'id': 'BG003', 'title': 'Part B: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 24 weeks.'}, {'id': 'BG004', 'title': 'Part C: Participants Aged 4 to 11 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 4 to 11 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'BG005', 'title': 'Part C: Participants Aged 12 to 17 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 12 to 17 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'BG006', 'title': 'Part D: Participants Aged 6 Months to <2 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 6 months to \\<2 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'BG007', 'title': 'Part D: Participants Aged 2 to <4 Years: Voxelotor 1500 mg QD', 'description': 'Participants aged 2 to \\<4 years received once daily oral dose of voxelotor 1500 mg for 48 weeks.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '0.79', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '1.72', 'groupId': 'BG001'}, {'value': '14.0', 'spread': '1.68', 'groupId': 'BG002'}, {'value': '13.9', 'spread': '1.58', 'groupId': 'BG003'}, {'value': '7.3', 'spread': '2.06', 'groupId': 'BG004'}, {'value': '13.1', 'spread': '1.04', 'groupId': 'BG005'}, {'value': '1.4', 'spread': '0.41', 'groupId': 'BG006'}, {'value': '3.0', 'spread': '0.51', 'groupId': 'BG007'}, {'value': '8.9', 'spread': '4.76', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '71', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}, {'value': '140', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Arab/Middle Eastern', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', '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': '1', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '104', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '28', 'groupId': 'BG008'}]}, {'title': 'Multi-racial', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}, {'title': 'Middle Eastern or North African', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population comprised of all participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-28', 'size': 11551837, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-16T13:38', 'hasProtocol': True}, {'date': '2023-10-03', 'size': 1030844, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-16T13:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'whyStopped': 'Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04724421', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2016-07-01', 'resultsFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2016-07-27', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-13', 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Maximum Concentration (Cmax) of Voxelotor in Whole Blood', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose'}, {'measure': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in Whole Blood', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-last was calculated using the linear/log trapezoid rule.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in Whole Blood', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96,168 and 336 hours post-dose', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration for whole blood and lambdaz=elimination rate constant.'}, {'measure': 'Part B: Change From Baseline to Week 24 in Hemoglobin Level', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Part C: Change From Baseline to Week 48 in Cerebral Blood Flow', 'timeFrame': 'Baseline, Week 48', 'description': 'Cerebral blood flow was measured using transcranial Doppler (TCD) sonography. Change from baseline in cerebral blood flow as measured by the time-averaged mean of the maximum (TAMM) TCD velocity is reported.'}, {'measure': 'Part D: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From start of study treatment up to 28 days after study treatment discontinuation (Up to 52 weeks)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. TEAE was defined as an AE that emerged on or after initiation of study drug (having been absent pre-treatment), or an AE that existed pre-treatment and worsened on treatment (relative to the pre-treatment state) through 28 days after study drug discontinuation. An SAE was any AE that resulted in any of the following outcomes: death, life threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, other important medical events. AEs were classified as SCD-related and non-SCD related.'}], 'secondaryOutcomes': [{'measure': 'Part A: Maximum Concentration (Cmax) of Voxelotor in Plasma', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose'}, {'measure': 'Part A: Maximum Concentration (Cmax) of Voxelotor in Red Blood Cells (RBC)', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose'}, {'measure': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in Plasma', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-last was calculated using the linear/log trapezoid rule.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Voxelotor in RBC', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-last was calculated using the linear/log trapezoid rule.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in Plasma', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration for plasma and lambdaz is the elimination rate constant.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor in RBC', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant.'}, {'measure': 'Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in Whole Blood', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose'}, {'measure': 'Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in Plasma', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose'}, {'measure': 'Part A: Time at Which Cmax Was Observed (Tmax) for Voxelotor in RBC', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose'}, {'measure': 'Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in Whole Blood', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.'}, {'measure': 'Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in Plasma', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.'}, {'measure': 'Part A: Terminal Elimination Half-Life (T1/2) for Voxelotor in RBC', 'timeFrame': 'pre-dose, 2, 8, 24, 48, 96, 168 and 336 hours post-dose', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.'}, {'measure': 'Part A: Percentage Hemoglobin (Hb) Occupancy', 'timeFrame': '15 days', 'description': 'Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula:\n\n(\\[Concentration of voxelotor in whole blood- {1-hematocrit}\\]\\*\\[Concentration of voxelotor in plasma/hematocrit\\])/5000\\*100.'}, {'measure': 'Part B: Percentage of Days With SCD Symptom Exacerbation During the First 24 Weeks of Treatment', 'timeFrame': 'From Day 1 up to 24 weeks', 'description': 'SCD symptoms were measured using the Patient Reported Outcome (PRO), Sickle Cell Disease Severity Measure (SCDSM) which was a self-administered 9-item questionnaire of SCD core symptoms including pain severity, frequency, and type, as well as fatigue and mental acuity, on a 4-point response scale that was completed daily using a handheld electronic device by the participants.'}, {'measure': 'Part B: Change From Baseline to Week 21 to 24 in the Sickle Cell Disease Severity Measure (SCDSM) Total Symptom Score (TSS)', 'timeFrame': 'Baseline, Weeks 21 to 24', 'description': 'The SCDSM was a self-administered 9-item questionnaire of SCD core symptoms including pain severity, frequency, and type, as well as fatigue and mental acuity, on a 4-point response scale with a range of 0 (strongly disagree) to 4 (strongly agree) that was completed daily using a handheld electronic device by the participants. TSS was calculated as the sum of the 9-item questionnaire scores scaled to a 100-point scale with a range of 0 (no symptoms) to 100 (most severe symptoms). Baseline TSS was the average of the non-missing score during the Screening period. The average of change from baseline in SCDSM TSS score for the 4-week period (Week 21 to 24) is reported.'}, {'measure': 'Part B: Percent Change From Baseline to Weeks 12 and 24 in Lactate Dehydrogenase (LDH)', 'timeFrame': 'Baseline, Weeks 12 and 24'}, {'measure': 'Part B: Percent Change From Baseline to Weeks 12 and 24 in Indirect Bilirubin', 'timeFrame': 'Baseline, Weeks 12 and 24'}, {'measure': 'Part B: Percent Change From Baseline to Weeks 12 and 24 in Percentage Reticulocytes', 'timeFrame': 'Baseline, Weeks 12 and 24'}, {'measure': 'Part B: Cmax of Voxelotor in Whole Blood and Plasma', 'timeFrame': 'Day 1 (pre-dose, 2, 8, 24 hours post-dose), pre-dose on Weeks 2, 4, 8, 12, 16, 20 and 24'}, {'measure': 'Part B: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor for Whole Blood and Plasma', 'timeFrame': 'Day 1 (pre-dose, 2, 8, 24 hours post-dose), pre-dose on Weeks 2, 4, 8, 12, 16, 20 and 24', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant.'}, {'measure': 'Part B: Terminal Elimination Half-life of Voxelotor for Plasma and Whole Blood', 'timeFrame': 'Day 1 (pre-dose, 2, 8, 24 hours post-dose), pre-dose on Weeks 2, 4, 8, 12, 16, 20 and 24', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.'}, {'measure': 'Part B: Accumulation Ratio (Rac) of Voxelotor for Plasma and Whole Blood', 'timeFrame': 'Day 1 (0 to 24 hours post-dose) and Day 28 (0 to 24 hours post-dose)', 'description': 'Accumulation ratio was calculated as ratio of area under the concentration-time curve from time 0 to 24 hours (AUC0-24) at steady-state (Day 28) to AUC0-24 on Day 1.'}, {'measure': 'Part B: Percentage Hemoglobin Occupancy', 'timeFrame': 'Day 28', 'description': 'Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula:\n\n(\\[Concentration of voxelotor in whole blood- {1-hematocrit}\\]\\*\\[Concentration of voxelotor in plasma/hematocrit\\])/5000\\*100.'}, {'measure': 'Part B: Change From Baseline to Week 12 and 24 in Cerebral Blood Flow', 'timeFrame': 'Baseline, Weeks 12 and 24', 'description': 'Cerebral blood flow was measured using TCD sonography. Change from baseline in cerebral blood flow as measured by TAMM TCD velocity is reported.'}, {'measure': 'Part C: Change From Baseline to Weeks 24 and 48 in Hemoglobin Level', 'timeFrame': 'Baseline, Weeks 24 and 48'}, {'measure': 'Part C: Percent Change From Baseline to Weeks 24 and 48 in LDH', 'timeFrame': 'Baseline, Weeks 24 and 48'}, {'measure': 'Part C: Percent Change From Baseline to Weeks 24 and 48 in Indirect Bilirubin', 'timeFrame': 'Baseline, Weeks 24 and 48'}, {'measure': 'Part C: Percent Change From Baseline to Weeks 24 and 48 in Percentage Reticulocytes', 'timeFrame': 'Baseline, Weeks 24 and 48'}, {'measure': 'Part C: Change From Baseline to Week 24 in Cerebral Blood Flow', 'timeFrame': 'Baseline, Week 24', 'description': 'Cerebral blood flow was measured using TCD sonography. Change from baseline in cerebral blood flow as measured by TAMM TCD velocity is reported.'}, {'measure': 'Part C: Time to Initial Hemoglobin Response', 'timeFrame': 'From first dose of study treatment (Day 1) up to Week 48', 'description': 'Time to initial Hb response was defined as the time from first dose of study treatment to the first occurrence of a change from baseline in Hb \\> 1 gram per deciliter (g/dL).'}, {'measure': 'Part C: Cmax of Voxelotor for Plasma and Whole Blood', 'timeFrame': 'Day 1 (15 minutes to 2 hours post-dose), pre-dose on Weeks 4, 8, 12, 16, 20, 24, 36 and 48'}, {'measure': 'Part C: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor for Whole Blood and Plasma', 'timeFrame': 'Day 1 (15 minutes to 2 hours post-dose), pre-dose on Weeks 4, 8, 12, 16, 20, 24, 36 and 48', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant.'}, {'measure': 'Part C: Terminal Elimination Half-life (T1/2) of Voxelotor for Whole Blood and Plasma', 'timeFrame': 'Day 1 (15 minutes to 2 hours post-dose), pre-dose on Weeks 4, 8, 12, 16, 20, 24, 36 and 48', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.'}, {'measure': 'Part C: Percentage Hemoglobin Occupancy of Voxelotor', 'timeFrame': 'Day 28', 'description': 'Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula:\n\n(\\[Concentration of voxelotor in whole blood- {1-hematocrit}\\]\\*\\[Concentration of voxelotor in plasma/hematocrit\\])/5000\\*100.'}, {'measure': 'Part C: Percentage of Participants With Normal Transcranial Doppler (TCD) Flow Velocity at Week 48', 'timeFrame': 'Week 48', 'description': 'Normal TCD flow velocity was considered as \\< 170 centimeter per second (cm/sec) by non-imagining TCD or \\< 155 cm/sec by imaging transcranial Doppler (TCDi). Percentage of participants with normal TCD flow velocity at Week 48 by Baseline TCD group (i.e. Baseline normal TCD \\[\\<170 cm/sec\\] and Baseline conditional TCD \\[\\>=170 cm/sec\\] is reported.'}, {'measure': 'Part C: Annualized Incidence Rate of Vaso-occlusive Crisis (VOC) Events', 'timeFrame': 'Up to Week 48', 'description': 'VOC events included preferred terms of sickle cell anaemia with crisis, acute chest syndrome, pneumonia necrotising and pneumonia. Annualized incidence rate was calculated as total number of events divided by total person years. Total person years=sum of participants treatment period in years, which covered the time from first dose to last dose.'}, {'measure': 'Part C: Annualized Incidence Rate of Stroke Events', 'timeFrame': 'Up to Week 48', 'description': 'Annualized incidence rate was calculated as total number of events divided by total person years. Total person years=sum of participants treatment period in years, which covered the time from first dose to last dose.'}, {'measure': 'Part D: Cmax of Voxelotor for Plasma and Whole Blood', 'timeFrame': 'Day 1 (anytime between 15 minutes to 2 hours post-dose), pre-dose on Weeks 2, 8, 12, 16, 24, 36 and 48'}, {'measure': 'Part D: Area Under the Concentration-Time Curve (AUC) From Time 0 Extrapolated to Infinity (AUC0-inf) of Voxelotor for Plasma and Whole Blood', 'timeFrame': 'Day 1 (anytime between 15 minutes to 2 hours post-dose), pre-dose on Weeks 2, 8, 12, 16, 24, 36 and 48', 'description': 'AUC0-inf was calculated as AUCt + Ct/lambdaz, where AUCt=area under the concentration-time curve at designated time, Ct is the last quantifiable concentration and lambdaz is the elimination rate constant.'}, {'measure': 'Part D: T1/2 of Voxelotor for Plasma and Whole Blood', 'timeFrame': 'Day 1 (anytime between 15 minutes to 2 hours post-dose), pre-dose on Weeks 2, 8, 12, 16, 24, 36 and 48', 'description': 'T1/2 was the time measured for the drug concentration to decrease by one half.'}, {'measure': 'Part D: Percentage Hemoglobin Occupancy', 'timeFrame': 'Day 28', 'description': 'Percentage hemoglobin occupancy (% Hb Occupancy) refers to the percentage of hemoglobin molecules within red blood cells that were bound to study drug. Concentration of voxelotor in whole blood and plasma was used to calculate %Hb occupancy. Percentage Hb occupancy within RBCs was estimated using the formula:\n\n(\\[Concentration of voxelotor in whole blood- {1-hematocrit}\\]\\*\\[Concentration of voxelotor in plasma/hematocrit\\])/5000\\*100.'}, {'measure': 'Part D: Change From Baseline to Weeks 24 and 48 in Hemoglobin Level', 'timeFrame': 'Baseline, Weeks 24 and 48'}, {'measure': 'Part D: Percent Change From Baseline to Weeks 24 and 48 in LDH', 'timeFrame': 'Baseline, Weeks 24 and 48'}, {'measure': 'Part D: Percent Change From Baseline to Weeks 24 and 48 in Indirect Bilirubin', 'timeFrame': 'Baseline, Weeks 24 and 48'}, {'measure': 'Part D: Percent Change From Baseline to Weeks 24 and 48 in Reticulocytes Count', 'timeFrame': 'Baseline, Weeks 24 and 48'}, {'measure': 'Part D: Time to Initial Hemoglobin Response', 'timeFrame': 'From first dose of study treatment (Day 1) up to Week 48', 'description': 'Time to initial Hb response, defined as the time from first dose of study treatment to the first occurrence of a change from baseline in Hb \\> 1 g/dL.'}, {'measure': 'Part D: Annualized Incidence Rate of VOC Events', 'timeFrame': 'Up to Week 48', 'description': "VOC events included preferred terms of 'Sickle cell anemia with crisis', 'Acute chest syndrome', 'Pneumonia necrotising,' and 'Pneumonia. Annualized incidence rate was calculated as total number of events divided by total person years. Total person years=sum of participants treatment period in years, which covered the time from first dose to last dose."}, {'measure': 'Part D: Annualized Incidence Rate of Stroke Events', 'timeFrame': 'Up to Week 48', 'description': 'Annualized incidence rate was calculated as total number of events divided by total person years. Total person years=sum of participants treatment period in years, which covered the time from first dose to last dose.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '35451176', 'type': 'DERIVED', 'citation': 'Estepp JH, Kalpatthi R, Woods G, Trompeter S, Liem RI, Sims K, Inati A, Inusa BPD, Campbell A, Piccone C, Abboud MR, Smith-Whitley K, Dixon S, Tonda M, Washington C, Griffin NM, Brown C. Safety and efficacy of voxelotor in pediatric patients with sickle cell disease aged 4 to 11 years. Pediatr Blood Cancer. 2022 Aug;69(8):e29716. doi: 10.1002/pbc.29716. Epub 2022 Apr 21.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=GBT440-007', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study consists of four parts, Parts A, B, C, and D.\n\n* Part A is a single dose pharmacokinetic (PK) study in pediatric participants with Sickle Cell Disease ages 6 to 17 years.\n* Part B is a multiple dose, safety, exploratory, efficacy, and PK study in adolescent participants with Sickle Cell Disease ages 12 to 17 years.\n* Part C is a multiple dose, safety, tolerability, and PK study, which includes the assessment of hematological effects and the effect on TCD flow velocity of voxelotor in pediatric participants with Sickle Cell Disease ages 4 to 17 years.\n* Part D is a multiple dose, safety, tolerability, and PK study, which examines the hematological effects of voxelotor in pediatric participants with Sickle Cell Disease ages 6 months to \\< 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants with homozygous hemoglobin SS (HbSS) or hemoglobin S beta0 thalassemia (HbS β0thal)\n* Age:\n\n * Part A - 6 to 17 years of age\n * Part B - 12 to 17 years of age\n * Part C - 4 to 17 years of age\n * Part D - 6 months to \\<4 years of age\n* Hydroxyurea (HU) therapy:\n\n * Parts A, B, and C: A participant taking hydroxyurea (HU) may be enrolled if the dose has been stable for at least 3 months with no anticipated need for dose adjustment during the study and no sign of hematological toxicity.\n * Part D: A participant taking HU may be enrolled if the dose has been stable for at least 1 month. Titration to the maximum tolerated dose (MTD) is allowed during the study.\n* Hemoglobin (HB):\n\n * Part A - No restriction\n * Parts B, C, \\& D - Hb ≤ 10.5 g/dL\n* For Part C only: Participants 12 to 17 years of age must have a TCD velocity of ≥ 140 cm/sec measured anytime during screening.\n\nExclusion Criteria:\n\n* Any one of the following requiring medical attention within 14 days of signing the Informed Consent Form (ICF):\n\n * Vaso-occlusive crisis (VOC)\n * Acute chest syndrome (ACS)\n * Splenic sequestration crisis\n * Dactylitis\n* Requires chronic transfusion therapy\n* History of stroke or meeting criteria for primary stroke prophylaxis (history of two TCD measurements ≥ 200 cm/sec by non-imaging TCD or ≥185 cm/sec by TCDi).\n* Transfusion within 30 days prior to signing the ICF\n\nExclusion Criteria for Part D Only:\n\n* Body weight \\<5 kg for 1 month prior to the screening visit and at the screening visit.'}, 'identificationModule': {'nctId': 'NCT02850406', 'acronym': 'HOPE-KIDS', 'briefTitle': 'Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2a, Open-label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Treatment Effect of GBT440 in Pediatric Participants With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'GBT440-007'}, 'secondaryIdInfos': [{'id': 'C5341020', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Voxelotor', 'description': 'Subjects to receive daily oral dosing of voxelotor according to which Part (A, B, C, or D), the subject is participating in:\n\n* Part A: Subjects to receive daily oral dosing of voxelotor for 1 day (single dose)\n* Part B: Subjects to receive daily oral dosing of voxelotor for up to 24 weeks (multiple dose)\n* Part C: Subjects to receive daily oral dosing of voxelotor for up to 48 weeks (1500mg or 1500mg equivalent dose)\n* Part D: Subjects to receive daily oral dosing of voxelotor for up to 48 weeks (1500mg equivalent dose)', 'interventionNames': ['Drug: Voxelotor']}], 'interventions': [{'name': 'Voxelotor', 'type': 'DRUG', 'description': '* Part A: Voxelotor will be administered as oral capsules or tablets\n* Part B: Voxelotor will be administered as oral capsules or tablets\n* Part C: Voxelotor will be administered as oral dispersible tablets or powder for oral suspension\n* Part D: Voxelotor will be administered as oral dispersible tablets or powder for oral suspension', 'armGroupLabels': ['Voxelotor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94513', 'city': 'Brentwood', 'state': 'California', 'country': 'United States', 'facility': "Brentwood Clinic UCSF Benioff Children's Hospital Oakland", 'geoPoint': {'lat': 37.93187, 'lon': -121.69579}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta Scottish Rite", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago Clinical Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': "Our Lady of the Lake Children's Hospital (IP Address)", 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers-Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Brody School of Medicine at East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut - Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Rafik Hariri University Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Tripoli', 'country': 'Lebanon', 'facility': 'Nini Hospital', 'geoPoint': {'lat': 34.43352, 'lon': 35.84415}}, {'zip': 'NW1 2PG', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'University College London Hospital, NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust, The Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thoma's NHS Foundation Trust, Evelina London Children's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': "Manchester University NHS Foundation Trust, Royal Manchester Children's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}