Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-12 @ 4:45 PM
Study NCT ID:
NCT02684058
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2016-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D005729', 'term': 'Ganglioneuroma'}, {'id': 'D018303', 'term': 'Ganglioglioma'}, {'id': 'D018306', 'term': 'Neurocytoma'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561627', 'term': 'dabrafenib'}, {'id': 'C560077', 'term': 'trametinib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'On-treatment AEs: from first dose to 30 days after last dose of treatment (or start of crossover treatment), up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment deaths: from 31 days post-treatment to end of study (or start of crossover treatment), up to 4.6 years (LGG) and 5.1 years (HGG).Crossover on-treatment: AEs from first dose to 30 days after last dose of crossover treatment, up to 4.2 years.', 'description': 'Deaths in the post treatment follow-up period are not considered Adverse Events. The total number at risk in the post treatment includes patients that entered the post treatment follow-up period (post-treatment efficacy and/or survival follow-up). Analysis performed in the safety set including participants who received at least one dose of study treatment. None of the patients who crossed-over were included in the crossover post-treatment efficacy/survival follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib (On-treatment)', 'description': 'AEs collected during on-treatment period with dabrafenib and trametinib in the HGG cohort (up to 30 days post- treatment)', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'deathsNumAffected': 6, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up)', 'description': 'Deaths collected in the post- treatment follow-up period for participants in the HGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 11, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'LGG Cohort: Dabrafenib and Trametinib (On-treatment)', 'description': 'AEs collected during on-treatment period with dabrafenib and trametinib in the LGG cohort (up to 30 days post- treatment)', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 73, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 34}, {'id': 'EG003', 'title': 'LGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up)', 'description': 'Deaths collected in the post- treatment follow-up period for participants in the LGG cohort treated with dabrafenib and trametinib (starting from day 31 post- treatment). No AEs were collected during this period', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'LGG Cohort: Carboplatin and Vincristine (On-treatment)', 'description': 'AEs collected during on-treatment period with carboplatin and vincristine in the LGG cohort (up to 30 days post- treatment or start date of crossover treatment, whichever was earlier)', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 33, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG005', 'title': 'LGG Cohort: Carboplatin and Vincristine (Post-treatment Follow-up)', 'description': 'Deaths collected in the post- treatment follow-up period (starting from day 31 post- treatment) for participants in the LGG cohort treated with carboplatin and vincristine. No AEs were collected during this period', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'LGG Cohort: Carboplatin and Vincristine (Crossover On-treatment)', 'description': 'AEs collected during crossover on-treatment period with dabrafenib and trametinib for participants in the LGG cohort randomized to carboplatin and vincristine who crossedover to dabrafenib and trametinib after disease progression (up to 30 days post- crossover treatment)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'LGG Cohort: Carboplatin and Vincristine (Crossover Post-treatment Follow-up)', 'description': 'Deaths collected in the crossover post- treatment follow-up period (starting from day 31 post- crossover treatment) for participants in the LGG cohort treated with carboplatin and vincristine who crossed over to dabrafenib and trametinib. No AEs were collected during this period', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Angular cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'SARS-CoV-2 test negative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebral salt-wasting syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hand dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Keratosis pilaris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Skin striae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Growth hormone deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyperpyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tinea manuum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Streptococcus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Immobilisation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Somatic symptom disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Snoring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dyshidrotic eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ventricular enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Detachment of retinal pigment epithelium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Brain abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Encephalomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Toxic shock syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Viral myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Shunt malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tooth avulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebral ventricle dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebrospinal fluid circulation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Papilloedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haematological infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vulvitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Optic perineuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '4.9999'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '58.6'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '25.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.19', 'ciLowerLimit': '2.3', 'ciUpperLimit': '22.4', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'one-sided p-value at 2.5% level of significance'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately (approx.) 3 years', 'description': 'Percentage of participants in the LGG cohort with a best overall confirmed Complete Response (CR) or Partial Response (PR) as assessed per RANO criteria by central independent assessment. The 95% confidence intervals (CIs) were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'PRIMARY', 'title': 'HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '71.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx. 3.2 years', 'description': 'Percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: ORR by Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'title': 'Up to approx. 3 years', 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '42.7', 'upperLimit': '66.5'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '28.8'}]}]}, {'title': 'Up to approx. 4.2 years', 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '46.8', 'upperLimit': '70.3'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '35.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Percentage of participants in the LGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator assessment. The 95% CIs were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'title': 'Up to approx. 3 years', 'categories': [{'measurements': [{'value': '20.3', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': 'NA'}]}]}, {'title': 'Up to approx 4.2 years', 'categories': [{'measurements': [{'value': '30.0', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': 'NA'}, {'value': '19.4', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered with a confirmed CR or PR as per central independent review assessment using RANO criteria. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'title': 'Up to approx. 3 years', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '25.5', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': 'NA'}]}]}, {'title': 'Up to approx 4.2 years', 'categories': [{'measurements': [{'value': '44.4', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '33.1', 'upperLimit': 'NA'}, {'value': '22.5', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered with a confirmed CR or PR as per investigator review assessment using RANO criteria. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'title': 'Up to approx. 3 years', 'categories': [{'measurements': [{'value': '20.1', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': 'NA'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '11.8'}]}]}, {'title': 'Up to approx 4.2 years', 'categories': [{'measurements': [{'value': '24.9', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '31.6'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '11.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.55', 'pValueComment': 'Log-rank test at an overall one-sided 2.5% level of significance', 'groupDescription': 'Up to approx. 3 years', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Time from the date of randomization to the date of first documented disease progression as per central independent review assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'title': 'Up to approx. 3 years', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': 'NA'}]}]}, {'title': 'Up to approx 4.2 years', 'categories': [{'measurements': [{'value': '46.0', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '38.6', 'upperLimit': 'NA'}, {'value': '30.8', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Time from the date of randomization to the date of first documented disease progression as per investigator assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 4.2 years', 'description': 'Time from randomization to first documented response of CR or PR as per central independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 4.2 years', 'description': 'Time from randomization to first documented response of CR or PR as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Clinical Benefit Rate (CBR) by Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000', 'lowerLimit': '76.2', 'upperLimit': '93.2'}, {'value': '43.2', 'groupId': 'OG001', 'lowerLimit': '27.1', 'upperLimit': '60.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx. 4.2 years', 'description': 'Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.\n\nSD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Clinical Benefit Rate (CBR) by Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.8', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '96.9'}, {'value': '56.8', 'groupId': 'OG001', 'lowerLimit': '39.5', 'upperLimit': '72.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx. 4.2 years', 'description': 'Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.\n\nSD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4.6 years', 'description': 'Time from first dose to death due to any cause in the LGG cohort. Confidence Intervals were estimated using the Brookmeyer Crowley method. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: 2-year OS Estimate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '96.9', 'groupId': 'OG001', 'lowerLimit': '79.8', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years from first dose', 'description': 'OS was defined as the time from the first dose to death due to any cause in the LGG cohort. The 2-year Kaplan-Meier OS estimate represented the estimated percentage of participants remaining free from OS events for up to 2 years. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: ORR by Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'title': 'Up to approx. 3.2 years', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '73.7'}]}]}, {'title': 'Up to approx. 4.8 years', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000', 'lowerLimit': '44.5', 'upperLimit': '75.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx. 3.2 years and up to approx. 4.8 years', 'description': 'ORR in the HGG cohort defined as the percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator assessment. The 95% CIs were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'title': 'Up to approx. 3.2 years', 'categories': [{'measurements': [{'value': '22.2', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': 'NA'}]}]}, {'title': 'Up to approx. 4.8 years', 'categories': [{'measurements': [{'value': '27.4', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 3.2 years and up to approx. 4.8 years', 'description': 'Time from first documented response (PR or CR) until disease progression or death as per central independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment with a confirmed CR or PR as per central independent assessment using RANO criteria'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'title': 'Up to approx. 3.2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.6', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': 'NA'}]}]}, {'title': 'Up to approx. 4.8 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.7', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 3.2 years and up to approx. 4.8 years', 'description': 'Time from first documented response (PR or CR) until disease progression or death as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment with a confirmed CR or PR as per investigator assessment using RANO criteria'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Kaplan-Meier Estimates of Progression Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '20.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Time from the date of first dose of study treatment to the date of first documented disease progression as per central independent review assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Kaplan-Meier Estimates of Progression Free Survival (PFS) as Per Investigatort Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Time from the date of first dose of study treatment to the date of first documented disease progression as per investigator assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Time from start of treatment to first documented response of CR or PR as per independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Time from start of treatment to first documented response of CR or PR as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Clinical Benefit Rate (CBR) as Per Central Independent Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000', 'lowerLimit': '49.4', 'upperLimit': '79.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.\n\nSD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Clinical Benefit Rate (CBR) as Per Investigator Assessment Using RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000', 'lowerLimit': '59.7', 'upperLimit': '87.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.\n\nSD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'HGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable (NA) due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '19.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5.1 years', 'description': 'Time from first dose to death due to any cause in the LGG cohort. Confidence Intervals were estimated using the Brookmeyer Crowley method. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'AUClast for Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '282', 'spread': '53.7', 'groupId': 'OG000'}, {'value': '328', 'spread': '33.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast).', 'unitOfMeasure': 'hour (hr) * nanogram (ng)/mililiter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib with an evaluable AUClast PK parameter'}, {'type': 'SECONDARY', 'title': 'Cmax for Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '41.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib with an evaluable Cmax PK parameter'}, {'type': 'SECONDARY', 'title': 'AUCtau for Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '307', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '339', 'spread': '22.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state', 'unitOfMeasure': 'hr * ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib with an evaluable AUCtau PK parameter'}, {'type': 'SECONDARY', 'title': 'Tmax for Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '58.1', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '54.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations.', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib with an evaluable Tmax PK parameter'}, {'type': 'SECONDARY', 'title': 'T1/2 for Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '62.6', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '37.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. T1/2 is the elimination half-life', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib with an evaluable T1/2 PK parameter'}, {'type': 'SECONDARY', 'title': 'Ctrough for Trametinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.73', 'spread': '72.7', 'groupId': 'OG000'}, {'value': '9.82', 'spread': '30.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Ctrough is the pre-dose plasma concentration', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib with an evaluable Ctrough PK parameter'}, {'type': 'SECONDARY', 'title': 'AUClast for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Dabrafenib', 'categories': [{'measurements': [{'value': '4330', 'spread': '44.7', 'groupId': 'OG000'}, {'value': '4870', 'spread': '60.3', 'groupId': 'OG001'}]}]}, {'title': 'Carboxy-dabrafenib', 'categories': [{'measurements': [{'value': '73400', 'spread': '31.5', 'groupId': 'OG000'}, {'value': '64200', 'spread': '46.9', 'groupId': 'OG001'}]}]}, {'title': 'Desmethyl-dabrafenib', 'categories': [{'measurements': [{'value': '3520', 'spread': '60.2', 'groupId': 'OG000'}, {'value': '3870', 'spread': '68.2', 'groupId': 'OG001'}]}]}, {'title': 'Hydroxy-dabrafenib', 'categories': [{'measurements': [{'value': '2810', 'spread': '36.5', 'groupId': 'OG000'}, {'value': '2980', 'spread': '50.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast).', 'unitOfMeasure': 'hr * ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib with an evaluable AUClast PK parameter'}, {'type': 'SECONDARY', 'title': 'Cmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Dabrafenib', 'categories': [{'measurements': [{'value': '1520', 'spread': '65.9', 'groupId': 'OG000'}, {'value': '1330', 'spread': '93.5', 'groupId': 'OG001'}]}]}, {'title': 'Carboxy-dabrafenib', 'categories': [{'measurements': [{'value': '9050', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '7210', 'spread': '51.6', 'groupId': 'OG001'}]}]}, {'title': 'Desmethyl-dabrafenib', 'categories': [{'measurements': [{'value': '388', 'spread': '67.2', 'groupId': 'OG000'}, {'value': '377', 'spread': '67.2', 'groupId': 'OG001'}]}]}, {'title': 'Hydroxy-dabrafenib', 'categories': [{'measurements': [{'value': '801', 'spread': '58.8', 'groupId': 'OG000'}, {'value': '687', 'spread': '82.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib with an evaluable Cmax PK parameter'}, {'type': 'SECONDARY', 'title': 'AUCtau for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4300', 'spread': '44.7', 'groupId': 'OG000'}, {'value': '4910', 'spread': '54.0', 'groupId': 'OG001'}]}]}, {'title': 'Carboxy-dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71200', 'spread': '34.0', 'groupId': 'OG000'}, {'value': '60700', 'spread': '45.7', 'groupId': 'OG001'}]}]}, {'title': 'Desmethyl-dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3360', 'spread': '57.7', 'groupId': 'OG000'}, {'value': '3660', 'spread': '66.9', 'groupId': 'OG001'}]}]}, {'title': 'Hydroxy-dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2840', 'spread': '35.7', 'groupId': 'OG000'}, {'value': '2960', 'spread': '47.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state', 'unitOfMeasure': 'hr * ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib with an evaluable AUCtau PK parameter'}, {'type': 'SECONDARY', 'title': 'Tmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Dabrafenib', 'categories': [{'measurements': [{'value': '1.47', 'spread': '54.2', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '52.9', 'groupId': 'OG001'}]}]}, {'title': 'Carboxy-dabrafenib', 'categories': [{'measurements': [{'value': '3.37', 'spread': '35.4', 'groupId': 'OG000'}, {'value': '3.66', 'spread': '51.4', 'groupId': 'OG001'}]}]}, {'title': 'Desmethyl-dabrafenib', 'categories': [{'measurements': [{'value': '2.21', 'spread': '76.7', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '82.0', 'groupId': 'OG001'}]}]}, {'title': 'Hydroxy-dabrafenib', 'categories': [{'measurements': [{'value': '1.97', 'spread': '45.9', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '57.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib with an evaluable Tmax PK parameter'}, {'type': 'SECONDARY', 'title': 'T1/2 for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.48', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '36.4', 'groupId': 'OG001'}]}]}, {'title': 'Carboxy-dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.12', 'spread': '32.3', 'groupId': 'OG000'}, {'value': '6.59', 'spread': '43.9', 'groupId': 'OG001'}]}]}, {'title': 'Desmethyl-dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.06', 'spread': '392.5', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}]}]}, {'title': 'Hydroxy-dabrafenib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.66', 'spread': '47.8', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '71.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. T1/2 is the elimination half-life', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib with an evaluable T1/2 PK parameter'}, {'type': 'SECONDARY', 'title': 'Ctrough for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Dabrafenib', 'categories': [{'measurements': [{'value': '38.0', 'spread': '162.0', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '125.1', 'groupId': 'OG001'}]}]}, {'title': 'Carboxy-dabrafenib', 'categories': [{'measurements': [{'value': '3980', 'spread': '46.1', 'groupId': 'OG000'}, {'value': '3190', 'spread': '54.4', 'groupId': 'OG001'}]}]}, {'title': 'Desmethyl-dabrafenib', 'categories': [{'measurements': [{'value': '275', 'spread': '116.5', 'groupId': 'OG000'}, {'value': '310', 'spread': '70.1', 'groupId': 'OG001'}]}]}, {'title': 'Hydroxy-dabrafenib', 'categories': [{'measurements': [{'value': '41.8', 'spread': '123.8', 'groupId': 'OG000'}, {'value': '44.3', 'spread': '99.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 3 Day 1 pre-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Ctrough is the pre-dose plasma concentration', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib with an evaluable Ctrough PK parameter'}, {'type': 'SECONDARY', 'title': 'HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Taste of the Medication Before Rinsing the Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Week 1', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on how it tasted before rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib as dispersible tablet for oral suspension and completed the palatability questionnaire for dabrafenib at week 1 or 5.'}, {'type': 'SECONDARY', 'title': 'HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Questionnaire Item: Taste of the Medication Before Rinsing the Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Week 1', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on how it tasted before rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib oral solution and completed the palatability questionnaire for trametinib at week 1 or 5.'}, {'type': 'SECONDARY', 'title': 'HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Assessment: After- Taste Once the Medication Was Swallowed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Week 1', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after the medication was swallowed, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib as dispersible tablet for oral suspension and completed the palatability questionnaire for dabrafenib at week 1 or 5.'}, {'type': 'SECONDARY', 'title': 'HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: After- Taste Once the Medication Was Swallowed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Week 1', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after the medication was swallowed, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib oral solution and completed the palatability questionnaire for trametinib at week 1 or 5.'}, {'type': 'SECONDARY', 'title': 'HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Immediate Reaction Once the Medication Was Placed Into the Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Week 1', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the immediate reaction once the medication was placed into their mouth, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib as dispersible tablet for oral suspension and completed the palatability questionnaire for dabrafenib at week 1 or 5.'}, {'type': 'SECONDARY', 'title': 'HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: Immediate Reaction Once the Medication Was Placed Into the Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Week 1', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Very Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Very Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the immediate reaction once the medication was placed into their mouth, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib oral solution and completed the palatability questionnaire for trametinib at week 1 or 5.'}, {'type': 'SECONDARY', 'title': 'HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Remaining After-taste Once Rinsing the Mouth With Water', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Week 1', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of dabrafenib as dispersible tablet for oral suspension and completed the palatability questionnaire for dabrafenib at week 1 or 5.'}, {'type': 'SECONDARY', 'title': 'HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: Remaining After-taste Once Rinsing the Mouth With Water', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}], 'classes': [{'title': 'Week 1', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Very Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'title': 'Very good, good, and neither good nor bad', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Very Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Unable to answer question', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of trametinib oral solution and completed the palatability questionnaire for trametinib at week 1 or 5.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Global Health Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.67', 'spread': '10.068', 'groupId': 'OG000'}, {'value': '42.89', 'spread': '10.502', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.14', 'spread': '9.439', 'groupId': 'OG000'}, {'value': '39.06', 'spread': '10.109', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.83', 'spread': '9.461', 'groupId': 'OG000'}, {'value': '38.36', 'spread': '7.759', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.68', 'spread': '9.159', 'groupId': 'OG000'}, {'value': '41.11', 'spread': '10.798', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.27', 'spread': '9.168', 'groupId': 'OG000'}, {'value': '36.57', 'spread': '6.241', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.46', 'spread': '8.887', 'groupId': 'OG000'}, {'value': '40.96', 'spread': '7.159', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.37', 'spread': '9.687', 'groupId': 'OG000'}, {'value': '38.84', 'spread': '4.960', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.83', 'spread': '9.421', 'groupId': 'OG000'}, {'value': '41.56', 'spread': '6.953', 'groupId': 'OG001'}]}]}, {'title': 'Week 56 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.54', 'spread': '8.876', 'groupId': 'OG000'}, {'value': '38.66', 'spread': '8.851', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.21', 'spread': '8.967', 'groupId': 'OG000'}]}]}, {'title': 'Week 88 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.91', 'spread': '8.847', 'groupId': 'OG000'}]}]}, {'title': 'Week 104 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.60', 'spread': '8.231', 'groupId': 'OG000'}]}]}, {'title': 'Week 120 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.41', 'spread': '7.317', 'groupId': 'OG000'}]}]}, {'title': 'Week 136 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.45', 'spread': '8.074', 'groupId': 'OG000'}]}]}, {'title': 'Week 152 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.88', 'spread': '10.534', 'groupId': 'OG000'}]}]}, {'title': 'Week 168 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.48', 'spread': '9.888', 'groupId': 'OG000'}]}]}, {'title': 'EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.98', 'spread': '10.274', 'groupId': 'OG000'}, {'value': '39.69', 'spread': '10.536', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.40', 'groupId': 'OG000'}, {'value': '45.53', 'spread': '6.288', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.70', 'groupId': 'OG000'}, {'value': '39.70', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.60', 'groupId': 'OG000'}, {'value': '34.60', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.20', 'groupId': 'OG000'}, {'value': '43.60', 'spread': '8.061', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.40', 'groupId': 'OG000'}, {'value': '37.90', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.45', 'spread': '7.425', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)', 'description': 'The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 7 items measuring the global health of the patient. 4 items used a 5-level Likert scale with 1=poor and 5=excellent; 1 item used a 5-level Likert scale with 1=never and 5=always; and 2 items used a 5-level Likert scale with 1=never and 5=almost always. The total raw global health score, ranging from 7 to 35, was computed by summing item values, with higher scores indicating better overall well-being. Raw scores were then transformed into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores reflected better global health status.\n\nParticipants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization (regardless of whether or not treatment was administered) and contributed to this analysis. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.\n\nNumber analyzed indicated number of participants with available data for this outcome measure at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.14', 'spread': '7.658', 'groupId': 'OG000'}, {'value': '52.64', 'spread': '7.054', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.11', 'spread': '7.275', 'groupId': 'OG000'}, {'value': '50.97', 'spread': '6.263', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.93', 'spread': '7.727', 'groupId': 'OG000'}, {'value': '51.00', 'spread': '6.037', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.72', 'spread': '7.300', 'groupId': 'OG000'}, {'value': '51.75', 'spread': '6.330', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.65', 'spread': '7.450', 'groupId': 'OG000'}, {'value': '51.81', 'spread': '7.937', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.77', 'spread': '6.647', 'groupId': 'OG000'}, {'value': '49.59', 'spread': '6.387', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.87', 'spread': '6.389', 'groupId': 'OG000'}, {'value': '52.52', 'spread': '7.402', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.89', 'spread': '6.581', 'groupId': 'OG000'}, {'value': '51.20', 'spread': '5.903', 'groupId': 'OG001'}]}]}, {'title': 'Week 56 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.14', 'spread': '6.496', 'groupId': 'OG000'}, {'value': '53.99', 'spread': '5.466', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.46', 'spread': '6.498', 'groupId': 'OG000'}]}]}, {'title': 'Week 88 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.82', 'spread': '6.083', 'groupId': 'OG000'}]}]}, {'title': 'Week 104 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.74', 'spread': '6.605', 'groupId': 'OG000'}]}]}, {'title': 'Week 120 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.56', 'spread': '7.583', 'groupId': 'OG000'}]}]}, {'title': 'Week 136 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.16', 'spread': '5.305', 'groupId': 'OG000'}]}]}, {'title': 'Week 152 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.42', 'spread': '6.765', 'groupId': 'OG000'}]}]}, {'title': 'Week 168 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.61', 'spread': '6.298', 'groupId': 'OG000'}]}]}, {'title': 'EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.46', 'spread': '6.830', 'groupId': 'OG000'}, {'value': '52.87', 'spread': '6.113', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.05', 'groupId': 'OG000'}, {'value': '50.60', 'spread': '4.900', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.51', 'groupId': 'OG000'}, {'value': '43.25', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.05', 'groupId': 'OG000'}, {'value': '43.25', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.51', 'groupId': 'OG000'}, {'value': '43.25', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.51', 'groupId': 'OG000'}, {'value': '43.25', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.88', 'spread': '10.790', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)', 'description': 'The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 1 item measuring the pain of the participants. Pain item used a 5-level Likert scale with 1= never and 5= almost always, higher scores indicate worsening pain. Raw scores were then converted into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicated more severe pain experiences.\n\nParticipants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the PROMIS Parent Proxy Global 7+2 Health questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization (regardless of whether or not treatment was administered) and contributed to this analysis. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.\n\nNumber analyzed indicated number of participants with available data for this outcome measure at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.30', 'spread': '6.731', 'groupId': 'OG000'}, {'value': '54.37', 'spread': '7.981', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.96', 'spread': '7.588', 'groupId': 'OG000'}, {'value': '56.88', 'spread': '6.430', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.68', 'spread': '6.967', 'groupId': 'OG000'}, {'value': '58.10', 'spread': '4.823', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.22', 'spread': '6.983', 'groupId': 'OG000'}, {'value': '57.81', 'spread': '6.193', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.04', 'spread': '8.005', 'groupId': 'OG000'}, {'value': '55.02', 'spread': '7.248', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.49', 'spread': '7.219', 'groupId': 'OG000'}, {'value': '57.66', 'spread': '5.899', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.27', 'spread': '7.450', 'groupId': 'OG000'}, {'value': '58.49', 'spread': '7.072', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.65', 'spread': '7.362', 'groupId': 'OG000'}, {'value': '53.48', 'spread': '8.004', 'groupId': 'OG001'}]}]}, {'title': 'Week 56 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.51', 'spread': '7.150', 'groupId': 'OG000'}, {'value': '57.63', 'spread': '7.254', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.93', 'spread': '6.910', 'groupId': 'OG000'}]}]}, {'title': 'Week 88 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.52', 'spread': '7.358', 'groupId': 'OG000'}]}]}, {'title': 'Week 104 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.11', 'spread': '6.899', 'groupId': 'OG000'}]}]}, {'title': 'Week 120 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.40', 'spread': '7.317', 'groupId': 'OG000'}]}]}, {'title': 'Week 136 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.97', 'spread': '8.667', 'groupId': 'OG000'}]}]}, {'title': 'Week 152 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.71', 'spread': '8.037', 'groupId': 'OG000'}]}]}, {'title': 'Week 168 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.21', 'spread': '8.188', 'groupId': 'OG000'}]}]}, {'title': 'EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.35', 'spread': '7.565', 'groupId': 'OG000'}, {'value': '56.88', 'spread': '5.246', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.94', 'groupId': 'OG000'}, {'value': '52.36', 'spread': '6.840', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.62', 'groupId': 'OG000'}, {'value': '62.62', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.94', 'groupId': 'OG000'}, {'value': '48.94', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.07', 'groupId': 'OG000'}, {'value': '48.94', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.62', 'groupId': 'OG000'}, {'value': '48.94', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.78', 'spread': '9.673', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment Follow-Up 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)', 'description': 'The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 1 item measuring the fatigue interference of the participants. Fatigue item used a 5-level Likert scale with 1= never and 5= almost always, higher scores indicate worsening fatigue. Raw scores were then converted into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicated a greater level of reported fatigue.\n\nParticipants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the PROMIS Parent Proxy Global 7+2 Health questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered and contributed to this analysis. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. Number analyzed indicated number of participants with available data for this outcome measure at the specified timepoints.'}, {'type': 'POST_HOC', 'title': 'All-collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}, {'id': 'OG002', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'title': 'On- treatment deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Post-treatment efficacy/survival follow-up deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Crossover on-treatment deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Crossover post-treatment efficacy/survival follow-up deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'All deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On-treatment: Up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment: Up to 4.6 years (LGG) and 5.1 years (HGG).Crossover arm: on-treatment: up to 4.2 years', 'description': 'On-treatment deaths were collected from 1st dose to 30 days after last dose of treatment (or start of crossover treatment), up to 4.2 years (LGG) and 4.1 years (HGG). Post- treatment (efficacy/survival) follow-up deaths were collected from 31 days post-treatment to end of study (or start of crossover treatment), up to 4.6 years (LGG) and 5.1 years (HGG). For participants in the LGG cohort who crossed over to dabrafenib and trametinib, on-treatment deaths were collected from 1st dose to 30 days after last dose of crossover treatment, up to 4.2 years. None of the patients who crossed-over were included in the crossover post-treatment efficacy/survival follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set including all participants who received at least one dose of study treatment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria (Longer Follow-up Time)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'OG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '42.7', 'upperLimit': '66.5'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '32.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx 4.2 years', 'description': 'Percentage of participants with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. This analysis was conducted at the end of the trial (after the primary endpoint analysis cut-off date) and includes a longer follow-up time', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria (Longer Follow-up Time)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '71.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approx 4.8 years', 'description': 'Percentage of participants with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. This analysis was conducted at the end of the trial (after the primary endpoint analysis cut-off date) and includes a longer follow-up time', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'FG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}, {'id': 'FG002', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'New therapy for study indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Post-treatment Efficacy Follow-up', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who discontinued study treatment for reasons other than disease progression, death, loss to follow up, or withdrawal of consent', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'New therapy for study indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Post-treatment Survival Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'comment': 'Alive at the end of the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Crossover Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Participants randomized to the carboplatin with vincristine treatment arm were allowed to cross-over to receive dabrafenib in combination with trametinib treatment after centrally confirmed and RANO-defined disease progression', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted in 58 centers across 20 countries', 'preAssignmentDetails': 'Pediatric patients for both cohorts were screened for eligibility during the 28 days immediately prior to starting study treatment on Day 1.\n\nIn the LGG cohort, 121 patients were screened of whom 110 patients were randomized in a 2:1 ratio to the dabrafenib and trametinib arm or the carboplatin with vincristine arm. 4 participants randomized to chemotherapy arm were never treated.\n\nIn the HGG cohort, 46 patients were screened of whom 41 patients entered the HGG cohort'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)'}, {'id': 'BG001', 'title': 'LGG Cohort: Carboplatin and Vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.'}, {'id': 'BG002', 'title': 'HGG Cohort: Dabrafenib and Trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Black Or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-12', 'size': 1598079, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-26T04:13', 'hasProtocol': True}, {'date': '2023-05-17', 'size': 4453846, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-26T04:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'dispFirstSubmitDate': '2022-07-25', 'completionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2016-02-04', 'dispFirstSubmitQcDate': '2022-08-10', 'resultsFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2016-02-11', 'dispFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-18', 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria (Longer Follow-up Time)', 'timeFrame': 'Up to approx 4.2 years', 'description': 'Percentage of participants with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. This analysis was conducted at the end of the trial (after the primary endpoint analysis cut-off date) and includes a longer follow-up time'}, {'measure': 'HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria (Longer Follow-up Time)', 'timeFrame': 'Up to approx 4.8 years', 'description': 'Percentage of participants with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. This analysis was conducted at the end of the trial (after the primary endpoint analysis cut-off date) and includes a longer follow-up time'}], 'primaryOutcomes': [{'measure': 'LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria', 'timeFrame': 'Up to approximately (approx.) 3 years', 'description': 'Percentage of participants in the LGG cohort with a best overall confirmed Complete Response (CR) or Partial Response (PR) as assessed per RANO criteria by central independent assessment. The 95% confidence intervals (CIs) were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3.2 years', 'description': 'Percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}], 'secondaryOutcomes': [{'measure': 'LGG Cohort: ORR by Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Percentage of participants in the LGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator assessment. The 95% CIs were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Time from the date of randomization to the date of first documented disease progression as per central independent review assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.'}, {'measure': 'LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3 years and up to approx 4.2 years', 'description': 'Time from the date of randomization to the date of first documented disease progression as per investigator assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.'}, {'measure': 'LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.2 years', 'description': 'Time from randomization to first documented response of CR or PR as per central independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.2 years', 'description': 'Time from randomization to first documented response of CR or PR as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'LGG Cohort: Clinical Benefit Rate (CBR) by Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.2 years', 'description': 'Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.\n\nSD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.'}, {'measure': 'LGG Cohort: Clinical Benefit Rate (CBR) by Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.2 years', 'description': 'Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.\n\nSD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.'}, {'measure': 'LGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS)', 'timeFrame': 'Up to 4.6 years', 'description': 'Time from first dose to death due to any cause in the LGG cohort. Confidence Intervals were estimated using the Brookmeyer Crowley method. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact.'}, {'measure': 'LGG Cohort: 2-year OS Estimate', 'timeFrame': '2 years from first dose', 'description': 'OS was defined as the time from the first dose to death due to any cause in the LGG cohort. The 2-year Kaplan-Meier OS estimate represented the estimated percentage of participants remaining free from OS events for up to 2 years. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact'}, {'measure': 'HGG Cohort: ORR by Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3.2 years and up to approx. 4.8 years', 'description': 'ORR in the HGG cohort defined as the percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator assessment. The 95% CIs were computed using two-sided exact binomial method.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3.2 years and up to approx. 4.8 years', 'description': 'Time from first documented response (PR or CR) until disease progression or death as per central independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 3.2 years and up to approx. 4.8 years', 'description': 'Time from first documented response (PR or CR) until disease progression or death as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'HGG Cohort: Kaplan-Meier Estimates of Progression Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Time from the date of first dose of study treatment to the date of first documented disease progression as per central independent review assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.'}, {'measure': 'HGG Cohort: Kaplan-Meier Estimates of Progression Free Survival (PFS) as Per Investigatort Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Time from the date of first dose of study treatment to the date of first documented disease progression as per investigator assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.'}, {'measure': 'HGG Cohort: Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Time from start of treatment to first documented response of CR or PR as per independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'HGG Cohort: Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Time from start of treatment to first documented response of CR or PR as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.'}, {'measure': 'HGG Cohort: Clinical Benefit Rate (CBR) as Per Central Independent Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.\n\nSD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.'}, {'measure': 'HGG Cohort: Clinical Benefit Rate (CBR) as Per Investigator Assessment Using RANO Criteria', 'timeFrame': 'Up to approx. 4.8 years', 'description': 'Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer.\n\nCR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses.\n\nPR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.\n\nSD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status.'}, {'measure': 'HGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS)', 'timeFrame': 'Up to 5.1 years', 'description': 'Time from first dose to death due to any cause in the LGG cohort. Confidence Intervals were estimated using the Brookmeyer Crowley method. If a patient was not known to have died at the time of analysis cut-off, OS was censored at the date of last contact.'}, {'measure': 'AUClast for Trametinib', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast).'}, {'measure': 'Cmax for Trametinib', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration'}, {'measure': 'AUCtau for Trametinib', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state'}, {'measure': 'Tmax for Trametinib', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations.'}, {'measure': 'T1/2 for Trametinib', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. T1/2 is the elimination half-life'}, {'measure': 'Ctrough for Trametinib', 'timeFrame': 'Week 3 Day 1 pre-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Ctrough is the pre-dose plasma concentration'}, {'measure': 'AUClast for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast).'}, {'measure': 'Cmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum plasma drug concentration after single dose administration'}, {'measure': 'AUCtau for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. AUCtau is the AUC calculated to the end of a dosing interval (tau) at steady-state'}, {'measure': 'Tmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum plasma concentration. Actual recorded sampling times were considered for the calculations.'}, {'measure': 'T1/2 for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'timeFrame': 'Week 3 Day 1 pre-dose and 0.5, 1, 2, 3, 4, 6, 8 hours post-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. T1/2 is the elimination half-life'}, {'measure': 'Ctrough for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib)', 'timeFrame': 'Week 3 Day 1 pre-dose', 'description': 'PK parameters were calculated by standard non-compartmental analysis. Ctrough is the pre-dose plasma concentration'}, {'measure': 'HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Taste of the Medication Before Rinsing the Mouth', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on how it tasted before rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.'}, {'measure': 'HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Questionnaire Item: Taste of the Medication Before Rinsing the Mouth', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on how it tasted before rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.'}, {'measure': 'HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Assessment: After- Taste Once the Medication Was Swallowed', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after the medication was swallowed, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.'}, {'measure': 'HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: After- Taste Once the Medication Was Swallowed', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after the medication was swallowed, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.'}, {'measure': 'HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Immediate Reaction Once the Medication Was Placed Into the Mouth', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the immediate reaction once the medication was placed into their mouth, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.'}, {'measure': 'HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: Immediate Reaction Once the Medication Was Placed Into the Mouth', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the immediate reaction once the medication was placed into their mouth, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.'}, {'measure': 'HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension Based on the Palatability Questionnaire Item: Remaining After-taste Once Rinsing the Mouth With Water', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the dabrafenib dispersible tablets for oral suspension completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.'}, {'measure': 'HGG and LGG Cohort: Palatability of Trametinib Oral Solution Based on the Palatability Assessment: Remaining After-taste Once Rinsing the Mouth With Water', 'timeFrame': 'Week 1 and Week 5', 'description': 'Participants who received the trametinib oral solution completed a questionnaire to evaluate the palatability of the pediatric formulation. After taking the medication, participants provided feedback on the after-taste of the medication after rinsing with water, rating their experience as very good, good, neither good nor bad, bad or very bad. The ratings of very good, good, and neither good nor bad were grouped together for reporting purposes.'}, {'measure': 'LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Global Health Score', 'timeFrame': 'Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)', 'description': 'The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 7 items measuring the global health of the patient. 4 items used a 5-level Likert scale with 1=poor and 5=excellent; 1 item used a 5-level Likert scale with 1=never and 5=always; and 2 items used a 5-level Likert scale with 1=never and 5=almost always. The total raw global health score, ranging from 7 to 35, was computed by summing item values, with higher scores indicating better overall well-being. Raw scores were then transformed into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores reflected better global health status.\n\nParticipants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.'}, {'measure': 'LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Pain Score', 'timeFrame': 'Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)', 'description': 'The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 1 item measuring the pain of the participants. Pain item used a 5-level Likert scale with 1= never and 5= almost always, higher scores indicate worsening pain. Raw scores were then converted into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicated more severe pain experiences.\n\nParticipants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the PROMIS Parent Proxy Global 7+2 Health questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.'}, {'measure': 'LGG Cohort: PROMIS Parent Proxy Global Health 7+2 Scores- Fatigue Score', 'timeFrame': 'Baseline, and Day 1 of Week 5, 8, 16, 24, 32, 49, 48 and 56, and thereafter every 16 weeks until end of treatment (EOT), EOT, and every 16 weeks in the post-treatment efficacy follow-up phase until disease progression (assessed up to 4.6 years)', 'description': 'The PROMIS Parent Proxy Global Health 7+2 was used to evaluate the quality of life of participants. The questionnaire included 1 item measuring the fatigue interference of the participants. Fatigue item used a 5-level Likert scale with 1= never and 5= almost always, higher scores indicate worsening fatigue. Raw scores were then converted into T-scores, standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicated a greater level of reported fatigue.\n\nParticipants who discontinued treatment for reasons other than disease progression entered the post-treatment efficacy follow-up phase, where the PROMIS Parent Proxy Global 7+2 Health questionnaire was performed every 16 weeks until disease progression, withdrawal of consent by patient or a parental/legal guardian, or lost to follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malignant glioma', 'BRAF mutant positive', 'High grade glioma', 'Low grade glioma', 'Dabrafenib', 'Trametinib', 'Pediatrics', 'Brain neoplasma'], 'conditions': ['Diffuse Astrocytoma', 'Anaplastic Astrocytoma', 'Astrocytoma', 'Oligodendroglioma, Childhood', 'Anaplastic Oligodendroglioma', 'Glioblastoma', 'Pilocytic Astrocytoma', 'Giant Cell Astrocytoma', 'Pleomorphic Xanthoastrocytoma', 'Anaplastic Pleomorphic Xanthoastrocytoma', 'Angiocentric Glioma', 'Chordoid Glioma of Third Ventricle', 'Gangliocytoma', 'Ganglioglioma', 'Anaplastic Ganglioglioma', 'Dysplastic Gangliocytoma of Cerebrellum', 'Desmoplastic Infantile Astrocytoma and Ganglioglioma', 'Papillary Glioneuronal Tumor', 'Rosette-forming Glioneurona Tumor', 'Central Neurocytoma', 'Extraventricular Neurocytoma', 'Cerebellar Iponeurocytoma']}, 'referencesModule': {'references': [{'pmid': '37733309', 'type': 'DERIVED', 'citation': 'Bouffet E, Hansford JR, Garre ML, Hara J, Plant-Fox A, Aerts I, Locatelli F, van der Lugt J, Papusha L, Sahm F, Tabori U, Cohen KJ, Packer RJ, Witt O, Sandalic L, Bento Pereira da Silva A, Russo M, Hargrave DR. Dabrafenib plus Trametinib in Pediatric Glioma with BRAF V600 Mutations. N Engl J Med. 2023 Sep 21;389(12):1108-1120. doi: 10.1056/NEJMoa2303815.'}, {'pmid': '37643378', 'type': 'DERIVED', 'citation': 'Hargrave DR, Terashima K, Hara J, Kordes UR, Upadhyaya SA, Sahm F, Bouffet E, Packer RJ, Witt O, Sandalic L, Kieloch A, Russo M, Cohen KJ; Investigators involved in the high-grade glioma cohort. Phase II Trial of Dabrafenib Plus Trametinib in Relapsed/Refractory BRAF V600-Mutant Pediatric High-Grade Glioma. J Clin Oncol. 2023 Nov 20;41(33):5174-5183. doi: 10.1200/JCO.23.00558. Epub 2023 Aug 29.'}, {'pmid': '37610803', 'type': 'DERIVED', 'citation': 'Barbato MI, Nashed J, Bradford D, Ren Y, Khasar S, Miller CP, Zolnik BS, Zhao H, Li Y, Bi Y, Shord SS, Amatya AK, Mishra-Kalyani PS, Scepura B, Al-Matari RA, Pazdur R, Kluetz PG, Donoghue M, Singh H, Drezner N. FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation-Positive Low-Grade Glioma. Clin Cancer Res. 2024 Jan 17;30(2):263-268. doi: 10.1158/1078-0432.CCR-23-1503.'}, {'pmid': '34331515', 'type': 'DERIVED', 'citation': 'Shahid S, Kushner BH, Modak S, Basu EM, Rubin EM, Gundem G, Papaemmanuil E, Roberts SS. Association of BRAF V600E mutations with vasoactive intestinal peptide syndrome in MYCN-amplified neuroblastoma. Pediatr Blood Cancer. 2021 Oct;68(10):e29265. doi: 10.1002/pbc.29265. Epub 2021 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high grade glioma (HGG)', 'detailedDescription': 'This study combines two pediatric glioma cohorts (LGG and HGG cohorts) into a multi-center, open-label, Phase II study:\n\n* The LGG cohort is a multi-center, randomized, open-label part of this Phase II study conducted in children and adolescent patients with BRAF V600 mutation-positive LGG whose tumor was unresectable and who required first systemic treatment. Participants in the LGG cohort were randomized in a 2:1 ratio to either dabrafenib plus trametinib or carboplatin with vincristine.\n* The HGG cohort is a multi-center, single-arm, open-label part of this Phase II study conducted in children and adolescent patients with BRAF V600 mutation-positive, refractory or relapsed HGG tumors after having received at least one previous standard therapy.\n\nThe duration of treatment for participants on dabrafenib plus trametinib in LGG and for all patients in the HGG cohort was continued until the loss of clinical benefit in the opinion of the Investigator, unacceptable toxicity, start of a new anti-neoplastic therapy, discontinuation at the discretion of the investigator or patient/legal guardian, lost to follow-up, death, study termination by the sponsor, or until disease progression. The duration of treatment for patients in the carboplatin with vincristine arm in LGG cohort was continued for the prescribed number of cycles, as tolerated or until unacceptable toxicity, start of a new anti-neoplastic therapy, discontinuation at the discretion of the investigator or patient/legal guardian, lost to follow-up, death, study is terminated by the sponsor or until disease progression. Participants randomized to the carboplatin with vincristine treatment arm were allowed to cross over to receive dabrafenib in combination with trametinib after centrally confirmed RANO-defined disease progression. Crossover was allowed during the treatment period or the post-treatment period.\n\nAfter discontinuation of study treatment, all participants (LGG and HGG cohorts) were followed for safety for at least 30 days after the last dose of study treatment. All participants who discontinued study treatment for reasons other than disease progression, death, loss to follow up, or withdrawal of consent moved into the post-treatment efficacy follow-up phase. Finally, all participants were followed for survival once they discontinued study treatment for at least 2 years after the last patient first study treatment (except if consent was withdrawn, death, or the patient was lost to follow-up or discontinued study)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of BRAF V600 mutant High Grade glioma that had relapsed, progressed or failed to respond to frontline therapy\n* Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following surgical excision, or non-surgical candidates with necessity to begin first systemic treatment because of a risk of neurological impairment with progression.\n* Confirmed measurable disease\n\nKey Exclusion Criteria:\n\n* Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK inhibitor\n* HGG patient: Cancer treatment within the past 3 weeks. LGG patient: Any systemic therapy or radiotherapy prior to enrollment\n* LGG patients: history of allergic reaction or contraindications to the use of carboplatin or vincristine\n* Stem cell transplant within the past 3 months\n* History of heart disease\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT02684058', 'briefTitle': 'Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)', 'orgStudyIdInfo': {'id': 'CDRB436G2201'}, 'secondaryIdInfos': [{'id': '2015-004015-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LGG cohort: dabrafenib and trametinib', 'description': 'Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)', 'interventionNames': ['Drug: Dabrafenib', 'Drug: trametinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LGG cohort: carboplatin and vincristine', 'description': 'Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Vincristine']}, {'type': 'EXPERIMENTAL', 'label': 'HGG cohort: dabrafenib and trametinib', 'description': 'Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)', 'interventionNames': ['Drug: Dabrafenib', 'Drug: trametinib']}], 'interventions': [{'name': 'Dabrafenib', 'type': 'DRUG', 'otherNames': ['DRB436'], 'description': 'Dabrafenib was available as 50 mg and 75 mg hard capsules and as 10 mg dispersible tablets for oral suspension. Dabrafenib was administered orally, twice daily, and was dosed based on age and weight Patients \\< 12 years old and ≥ 16 kg were to be administered either the dabrafenib capsules or dabrafenib dispersible tablets for oral suspension (dose: 5.25 mg/kg/day) Patients ≥ 12 years old and ≥ 19 kg were to be administered either the dabrafenib capsules or dabrafenib dispersible tablets for oral suspension (dose: 4.5 mg/kg/day) Patients \\< 12 years old and \\< 16 kg were to be administered dabrafenib dispersible tablets for oral suspension (dose: 5.25 mg/kg/day) Patients ≥12 years old and \\<19 kg were to be administered dabrafenib dispersible tablets for oral suspension (dose: 4.5 mg/kg/day)', 'armGroupLabels': ['HGG cohort: dabrafenib and trametinib', 'LGG cohort: dabrafenib and trametinib']}, {'name': 'trametinib', 'type': 'DRUG', 'otherNames': ['TMT212'], 'description': 'Trametinib was available as 0.5 mg and 2 mg film-coated tablets and as 5.0 mg powder in bottle for oral solution (0.05 mg/ml after reconstitution with 90 ml water).Trametinib was administered orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on age and weight.\n\nPatients \\<6 years old and \\<26 kg were to be administered the trametinib oral solution (dose: 0.032 mg/kg/day) Patients \\<6 years old and ≥26 kg were to be administered either the trametinib oral solution or trametinib tablets (dose: 0.032 mg/kg/day) Patients ≥6 years old and ≥10 kg \\< 33 kg were to be administered the trametinib oral solution (dose: 0.025 mg/kg/day) Patients ≥6 years old and ≥33 kg were to be administered either the trametinib oral solution or the trametinib tablets (dose: 0.025 mg/kg/day)', 'armGroupLabels': ['HGG cohort: dabrafenib and trametinib', 'LGG cohort: dabrafenib and trametinib']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin was supplied locally as commercially available and labelled accordingly to comply with legal requirements of each country. Carboplatin was administered as one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Each maintenance cycle was 6 weeks, and consisted of 4 weeks of chemotherapy with 2 weeks of rest.\n\nInduction: 175 mg/m\\^2 as weekly intravenous (IV) infusion on weeks 1 to 4, and on weeks 7 to 10, on the same day as vincristine dosing Maintenance: 175 mg/m\\^2 as weekly IV infusion over 60 minutes on weeks 1 to 4 of each cycle.', 'armGroupLabels': ['LGG cohort: carboplatin and vincristine']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'Vincristine was supplied locally as commercially available and labelled accordingly to comply with legal requirements of each country. Vincristine was administered as one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy.\n\nInduction: 1.5 mg/m\\^2 as weekly IV bolus infusion (0.05 mg/kg if child is \\<12 kg) (maximum dose of 2.0 mg) for 10 weeks.\n\nMaintenance: 1.5 mg/m\\^2 as weekly IV bolus infusion (0.05 mg/kg if child is \\<12 kg) (maximum dose of 2.0 mg) on weeks 1 to 3 of each cycle, on the same day as carboplatin dosing.', 'armGroupLabels': ['LGG cohort: carboplatin and vincristine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Childrens National Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Nicklaus Childrens Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ann and Robert H Lurie Childrens Hospital of Chicago .', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202-2810', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine .', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University IDS Pharmacy John Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine SC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Childrens Hospital Medical Center Cancer & Blood Disease Inst.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Children s Hospital Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'C1428AQK', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': '2130', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'BE-B-1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '14784 400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '04829-310', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '08270-070', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '613 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '150 06', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '2100 O', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75231', 'city': 'Paris', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '86179', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '49202', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '50139', 'city': 'Florence', 'state': 'FI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16147', 'city': 'Genova', 'state': 'GE', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00165', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'state': 'TO', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '812-8582', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '157-8535', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '534-0021', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '3584', 'city': 'Utrecht', 'state': 'CS', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '117198', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'WC1N 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}