Viewing Study NCT02055157

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 6:57 PM
Ignite Modification Date: 2026-04-17 @ 5:12 AM
Study NCT ID: NCT02055157
Status: COMPLETED
Last Update Posted: 2021-01-15
First Post: 2013-04-18
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000130', 'term': 'Achondroplasia'}, {'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632572', 'term': 'vosoritide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alice.huntsmanlabed@bmrn.com', 'phone': '+44 207 4203392', 'title': 'Alice Hunstman-Labed', 'organization': 'BioMarin Pharmaceutical Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Month 25 ± 7 Days', 'description': 'Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period.\n\nExtension Safety Analysis Population consists of all subjects who received at least one dose of study treatment in the extension period and were used for safety analysis in the extension period.', 'eventGroups': [{'id': 'EG000', 'title': 'Initial 6-Months Period 2.5 µg/kg.', 'description': 'BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Initial 6-Months Period 7.5 µg/kg.', 'description': 'BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Initial 6-Months Period 15 µg/kg.', 'description': 'BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Initial 6-Months Period 30 µg/kg.', 'description': 'BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for initial 6-month period.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Extension Period 2.5 µg/kg.', 'description': 'BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 135.4 days.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Extension Period 7.5 µg/kg.', 'description': 'BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 83.1 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Extension Period 15 µg/kg.', 'description': 'BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for mean duration of 464.7 days.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Extension Period 30 µg/kg.', 'description': 'BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for mean duration of 546.4 days.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Entire Study Period 2.5 µg/kg.', 'description': 'BMN 111 at 2.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 298.8 days.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Entire Study Period 7.5 µg/kg.', 'description': 'BMN 111 at 7.5 μg/kg subcutaneous injection, once daily in the morning for mean duration of 175.5 days.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Entire Study Period 15 µg/kg.', 'description': 'BMN 111 at 15 μg/kg subcutaneous injection, once daily in the morning for mean duration of 549.6 days.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'Entire Study Period 30 µg/kg.', 'description': 'BMN 111 at 30 μg/kg subcutaneous injection, once daily in the morning for mean duration of 650.9 days.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 15}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 8}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 17}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 14}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 8}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Medical device site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Scarlet fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Snoring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Malpositioned teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Parotid gland enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Procedural anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Skin striae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ear swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tympanic membrane hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vitamin D decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood immunoglobulin E increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Respiratory rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sleep study abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Emotional disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Attention deficit/hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Frustration tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypermetropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ear tube insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Wolff-Parkinson-White syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Thyroglossal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Thyroglossal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Summary of Adverse Events During Initial 6-Month Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Subjects with at Least 1 Reported TEAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Subjects Least Reported Study Drug-Related TEAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Subjects with at Least 1 Reported SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Subjects Least Reported Study Drug-Related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Subjects Who Died', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 6 ± 7 Days', 'description': 'A treatment-emergent Adverse Events (TEAE) is any Adverse Events that newly appeared, increased in frequency or worsened in severity following initiation of study drug administration.\n\nSerious adverse event (SAE).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population includes all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period.'}, {'type': 'PRIMARY', 'title': 'Overall Summary of Adverse Events During Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Subjects with at Least 1 Reported TEAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Subjects Least Reported Study Drug-Related TEAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Subjects with at Least 1 Reported SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Subjects Least Reported Study Drug-Related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Subjects Who Died', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 25 ± 7 Days', 'description': 'A treatment-emergent Adverse Events (TEAE) is any Adverse Events that newly appeared, increased in frequency or worsened in severity following initiation of study drug administration.\n\nTEAE - Treatment-emergent adverse event. SAE - Serious adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Annualized Growth Velocity (AGV) During Initial 6-Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.755', 'spread': '1.1094', 'groupId': 'OG000'}, {'value': '2.891', 'spread': '1.3920', 'groupId': 'OG001'}, {'value': '4.044', 'spread': '2.2751', 'groupId': 'OG002'}, {'value': '4.492', 'spread': '1.1889', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.371', 'spread': '1.5920', 'groupId': 'OG000'}, {'value': '1.276', 'spread': '1.4387', 'groupId': 'OG001'}, {'value': '2.014', 'spread': '1.9990', 'groupId': 'OG002'}, {'value': '2.085', 'spread': '2.1375', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6 month (Day 183)', 'description': 'Annualized Growth Velocity at Day 183 is assessed on standing height as ((Height at Day 183 Visit - Height at Baseline Visit)/(Date at Day 183 Visit - Baseline Visit Date)) x 365.25.', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population includes all subjects who received at least one dose of study treatment and who had post treatment data for any efficacy endpoint in the corresponding period were included in the Efficacy Analysis and Extension Efficacy Analysis population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.044', 'spread': '2.2751', 'groupId': 'OG000'}, {'value': '4.492', 'spread': '1.1889', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'categories': [{'measurements': [{'value': '1.744', 'spread': '1.7974', 'groupId': 'OG000'}, {'value': '1.538', 'spread': '1.3387', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'Annualized Growth Velocity at Day 183 visit is assessed on standing height as ((Height at Day 183 Visit - Height at Baseline Visit)/(Date at Day 183 Visit - Baseline Visit Date)) x 365.25.', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 1 and 2 Switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.629', 'spread': '1.1586', 'groupId': 'OG000'}, {'value': '3.510', 'spread': '0.8327', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at >=12 Months on 15μg/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.846', 'spread': '2.1466', 'groupId': 'OG000'}, {'value': '2.245', 'spread': '0.9176', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'Annualized Growth Velocity at 1st visit with \\>= 12 months on 15ug/kg is assessed on standing height as ((Height at 1st Visit with \\>= 12 Months on 15 μg/kg - Height at 1st Visit on 15 μg/kg)/(Date of the 1st Visit with \\>= 12 months on 15 μg/kg - Date of at 1st Visit on 15 μg/kg)) x 365.25.', 'unitOfMeasure': 'cm/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height Z-Scores Using Centers for Disease Control and Prevention (CDC) Reference Standard During Initial 6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.056', 'spread': '0.6331', 'groupId': 'OG000'}, {'value': '-5.145', 'spread': '0.8530', 'groupId': 'OG001'}, {'value': '-4.613', 'spread': '1.1355', 'groupId': 'OG002'}, {'value': '-5.193', 'spread': '0.7486', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.008', 'spread': '0.1788', 'groupId': 'OG000'}, {'value': '0.078', 'spread': '0.1440', 'groupId': 'OG001'}, {'value': '0.229', 'spread': '0.1505', 'groupId': 'OG002'}, {'value': '0.265', 'spread': '0.1869', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 (Day 183)', 'description': "Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 Standard Deviation Scores (SDs) indicate a child's height is no longer within normal height range for average stature children of the same sex and age.\n\nZ-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC).", 'unitOfMeasure': 'z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '-4.613', 'spread': '1.1355', 'groupId': 'OG000'}, {'value': '-5.193', 'spread': '0.7486', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'categories': [{'measurements': [{'value': '0.788', 'spread': '0.2842', 'groupId': 'OG000'}, {'value': '0.896', 'spread': '0.3010', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': "Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 SDs indicate a child's height is no longer within normal height range for average stature children of the same sex and age.\n\nZ-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC).", 'unitOfMeasure': 'z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 1 and 2 Switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.064', 'spread': '0.6932', 'groupId': 'OG000'}, {'value': '-4.912', 'spread': '0.7708', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to >=12 Months on 15ug/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.520', 'spread': '0.2950', 'groupId': 'OG000'}, {'value': '0.259', 'spread': '0.1887', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': "Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 SDs indicate a child's height is no longer within normal height range for average stature children of the same sex and age.\n\nZ-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC).", 'unitOfMeasure': 'z score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper to Lower Body Ratios During Initial 6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.094', 'spread': '0.0984', 'groupId': 'OG000'}, {'value': '2.027', 'spread': '0.1793', 'groupId': 'OG001'}, {'value': '1.911', 'spread': '0.2286', 'groupId': 'OG002'}, {'value': '1.962', 'spread': '0.1822', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.0626', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0510', 'groupId': 'OG001'}, {'value': '-0.024', 'spread': '0.0369', 'groupId': 'OG002'}, {'value': '-0.030', 'spread': '0.0811', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Upper to Lower Body ratio prior to treatment, at baseline, and through 6 months is assessed on Sitting Height / (Standing Height - Sitting Height)', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.911', 'spread': '0.2286', 'groupId': 'OG000'}, {'value': '1.962', 'spread': '0.1822', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'categories': [{'measurements': [{'value': '-0.067', 'spread': '0.0451', 'groupId': 'OG000'}, {'value': '-0.121', 'spread': '0.1058', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Upper to Lower Body ratio prior to treatment, at baseline, and through 24 months is assessed on Sitting Height / (Standing Height - Sitting Height)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Arm Length to Lower Arm (Forearm) Length Ratio During Initial 6-Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.130', 'spread': '0.1168', 'groupId': 'OG000'}, {'value': '1.143', 'spread': '0.0924', 'groupId': 'OG001'}, {'value': '1.130', 'spread': '0.1190', 'groupId': 'OG002'}, {'value': '1.106', 'spread': '0.0816', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.0623', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.0521', 'groupId': 'OG001'}, {'value': '-0.048', 'spread': '0.1002', 'groupId': 'OG002'}, {'value': '0.003', 'spread': '0.0869', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 6 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.130', 'spread': '0.1190', 'groupId': 'OG000'}, {'value': '1.106', 'spread': '0.0816', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.0673', 'groupId': 'OG000'}, {'value': '-0.027', 'spread': '0.0504', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 24 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 1 and 2 Switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.119', 'spread': '0.0812', 'groupId': 'OG000'}, {'value': '2.053', 'spread': '0.1746', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to >=12 Months on 15ug/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.078', 'spread': '0.0452', 'groupId': 'OG000'}, {'value': '-0.078', 'spread': '0.1271', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Upper to Lower Body ratio prior to treatment, at baseline, and through 24 months is assessed on Sitting Height / (Standing Height - Sitting Height)', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.131', 'spread': '0.1280', 'groupId': 'OG000'}, {'value': '1.114', 'spread': '0.0520', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to >=12 Months on 15ug/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.0056', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '0.1181', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 24 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Initial 6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.672', 'spread': '0.0600', 'groupId': 'OG000'}, {'value': '0.662', 'spread': '0.0585', 'groupId': 'OG001'}, {'value': '0.687', 'spread': '0.0268', 'groupId': 'OG002'}, {'value': '0.691', 'spread': '0.0847', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.0401', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.0462', 'groupId': 'OG001'}, {'value': '0.007', 'spread': '0.0411', 'groupId': 'OG002'}, {'value': '-0.006', 'spread': '0.0810', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 6 months is assessed on Upper Leg Length (Thigh) / Knee to Heel Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.687', 'spread': '0.0268', 'groupId': 'OG000'}, {'value': '0.691', 'spread': '0.0847', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.0503', 'groupId': 'OG000'}, {'value': '-0.033', 'spread': '0.1065', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh) / Knee to Heel Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.659', 'spread': '0.0541', 'groupId': 'OG000'}, {'value': '0.673', 'spread': '0.0579', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to >=12 Months on 15ug/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0228', 'groupId': 'OG000'}, {'value': '0.006', 'spread': '0.0618', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh) / Knee to Heel Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Initial 6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.089', 'spread': '0.1067', 'groupId': 'OG000'}, {'value': '1.074', 'spread': '0.1350', 'groupId': 'OG001'}, {'value': '1.107', 'spread': '0.0607', 'groupId': 'OG002'}, {'value': '1.061', 'spread': '0.1341', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0774', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.0863', 'groupId': 'OG001'}, {'value': '0.034', 'spread': '0.1048', 'groupId': 'OG002'}, {'value': '0.015', 'spread': '0.1571', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 6 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.107', 'spread': '0.0607', 'groupId': 'OG000'}, {'value': '1.061', 'spread': '0.1341', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.0888', 'groupId': 'OG000'}, {'value': '-0.012', 'spread': '0.1477', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.080', 'spread': '0.1139', 'groupId': 'OG000'}, {'value': '1.100', 'spread': '0.1447', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to >=12 Months on 15ug/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.0297', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.1602', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Arm Span to Height Ratio During Initial 6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.901', 'spread': '0.0189', 'groupId': 'OG000'}, {'value': '0.889', 'spread': '0.0906', 'groupId': 'OG001'}, {'value': '0.913', 'spread': '0.0123', 'groupId': 'OG002'}, {'value': '0.893', 'spread': '0.0284', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline to Day 183', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.0111', 'groupId': 'OG000'}, {'value': '-0.005', 'spread': '0.0079', 'groupId': 'OG001'}, {'value': '0.007', 'spread': '0.0063', 'groupId': 'OG002'}, {'value': '0.001', 'spread': '0.0143', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Arm Span to Height Ratio prior to treatment, at baseline, and through 6 months is assessed by Arm Span / Standing Height.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population\n\nArm span measurement was optional until July 2015. Therefore data was not collected for all subjects for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Arm Span to Height Ratio During Entire Study Period - Cohort 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'OG001', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.911', 'spread': '0.0119', 'groupId': 'OG000'}, {'value': '0.900', 'spread': '0.0315', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Month 24', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0123', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.0290', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Arm Span to Height Ratio prior to treatment, at baseline, and through 24 months is assessed by Arm Span / Standing Height.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Arm Span to Height Ratio During Entire Study Period - Cohort 1 and 2 Switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.881', 'spread': '0.0480', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to >=12 Months on 15ug/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.014', 'spread': '0.0179', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 24', 'description': 'The Arm Span to Height Ratio prior to treatment, at baseline, and through 24 months is assessed by Arm Span / Standing Height.\n\nValues are not available for participants in cohort 1 switchers for Change from Baseline to \\>=12 Months on 15ug/kg.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'FG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'FG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}], 'periods': [{'title': 'Initial 6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Subject discontinued due to NeedlePhobia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Consent withdrawn by subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '18-month Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject discontinued due to NeedlePhobia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at nine study centers in United States, Australia, United Kingdom and France.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'Initial 6 months: BMN 111 at 2.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 2.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, 7 subjects escalated to 7.5 μg/kg daily subcutaneous injection, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'Initial 6 months: BMN 111 at 7.5 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 7.5 μg/kg daily subcutaneous injection, dose determined to be suboptimal after the end of the initial 6 months, discontinued 1 subject escalating 6 subjects to BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'BG002', 'title': 'Cohort 3', 'description': 'Initial 6 months: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 15.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'BG003', 'title': 'Cohort 4', 'description': 'Initial 6 months: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 6 months.\n\n18-month extension: BMN 111 at 30.0 μg/kg daily subcutaneous injection, over a period of 18 months.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '1.58', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '2.19', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '1.63', 'groupId': 'BG002'}, {'value': '6.9', 'spread': '1.17', 'groupId': 'BG003'}, {'value': '7.6', 'spread': '1.68', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'yrs', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Population consists of all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-22', 'size': 16922870, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-18T17:26', 'hasProtocol': True}, {'date': '2018-06-11', 'size': 3686952, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-18T17:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'dispFirstSubmitDate': '2018-09-19', 'completionDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2013-04-18', 'dispFirstSubmitQcDate': '2018-09-19', 'resultsFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2014-02-03', 'dispFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-22', 'studyFirstPostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Summary of Adverse Events During Initial 6-Month Period', 'timeFrame': 'Up to Month 6 ± 7 Days', 'description': 'A treatment-emergent Adverse Events (TEAE) is any Adverse Events that newly appeared, increased in frequency or worsened in severity following initiation of study drug administration.\n\nSerious adverse event (SAE).'}, {'measure': 'Overall Summary of Adverse Events During Entire Study Period', 'timeFrame': 'Up to Month 25 ± 7 Days', 'description': 'A treatment-emergent Adverse Events (TEAE) is any Adverse Events that newly appeared, increased in frequency or worsened in severity following initiation of study drug administration.\n\nTEAE - Treatment-emergent adverse event. SAE - Serious adverse event.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Annualized Growth Velocity (AGV) During Initial 6-Month', 'timeFrame': 'At 6 month (Day 183)', 'description': 'Annualized Growth Velocity at Day 183 is assessed on standing height as ((Height at Day 183 Visit - Height at Baseline Visit)/(Date at Day 183 Visit - Baseline Visit Date)) x 365.25.'}, {'measure': 'Change From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 3 and 4', 'timeFrame': 'At month 24', 'description': 'Annualized Growth Velocity at Day 183 visit is assessed on standing height as ((Height at Day 183 Visit - Height at Baseline Visit)/(Date at Day 183 Visit - Baseline Visit Date)) x 365.25.'}, {'measure': 'Change From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 1 and 2 Switchers', 'timeFrame': 'At month 24', 'description': 'Annualized Growth Velocity at 1st visit with \\>= 12 months on 15ug/kg is assessed on standing height as ((Height at 1st Visit with \\>= 12 Months on 15 μg/kg - Height at 1st Visit on 15 μg/kg)/(Date of the 1st Visit with \\>= 12 months on 15 μg/kg - Date of at 1st Visit on 15 μg/kg)) x 365.25.'}, {'measure': 'Change From Baseline in Height Z-Scores Using Centers for Disease Control and Prevention (CDC) Reference Standard During Initial 6-Months', 'timeFrame': 'At month 6 (Day 183)', 'description': "Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 Standard Deviation Scores (SDs) indicate a child's height is no longer within normal height range for average stature children of the same sex and age.\n\nZ-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC)."}, {'measure': 'Change From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 3 and 4', 'timeFrame': 'At month 24', 'description': "Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 SDs indicate a child's height is no longer within normal height range for average stature children of the same sex and age.\n\nZ-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC)."}, {'measure': 'Change From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 1 and 2 Switchers', 'timeFrame': 'At month 24', 'description': "Height Z scores indicates how far a particular child is from the average height for children of the same sex and age. A positive height Z score indicates the child's height is above average whilst a negative Z score indicates the child's height is below average. Height Z scores below -2 SDs indicate a child's height is no longer within normal height range for average stature children of the same sex and age.\n\nZ-scores are derived using non-ACH age-sex-specific reference data (means and standard deviations) per Centers for Disease Control and Prevention (CDC)."}, {'measure': 'Change From Baseline in Upper to Lower Body Ratios During Initial 6-Months', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Upper to Lower Body ratio prior to treatment, at baseline, and through 6 months is assessed on Sitting Height / (Standing Height - Sitting Height)'}, {'measure': 'Change From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 3 and 4', 'timeFrame': 'At month 24', 'description': 'The Upper to Lower Body ratio prior to treatment, at baseline, and through 24 months is assessed on Sitting Height / (Standing Height - Sitting Height)'}, {'measure': 'Change From Baseline in Upper Arm Length to Lower Arm (Forearm) Length Ratio During Initial 6-Months', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 6 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.'}, {'measure': 'Change From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 3 and 4', 'timeFrame': 'At month 24', 'description': 'The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 24 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.'}, {'measure': 'Change From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 1 and 2 Switchers', 'timeFrame': 'At month 24', 'description': 'The Upper to Lower Body ratio prior to treatment, at baseline, and through 24 months is assessed on Sitting Height / (Standing Height - Sitting Height)'}, {'measure': 'Change From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers', 'timeFrame': 'At month 24', 'description': 'The Upper Arm Length to Lower Arm (Forearm) Length ratio prior to treatment, at baseline, and through 24 months is assessed on Upper Arm Length / Lower Arm (Forearm) Length.'}, {'measure': 'Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Initial 6-months', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 6 months is assessed on Upper Leg Length (Thigh) / Knee to Heel Length.'}, {'measure': 'Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 3 and 4', 'timeFrame': 'At month 24', 'description': 'The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh) / Knee to Heel Length.'}, {'measure': 'Change From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers', 'timeFrame': 'At month 24', 'description': 'The Upper Leg Length (Thigh) to Knee to Heel Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh) / Knee to Heel Length.'}, {'measure': 'Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Initial 6-months', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 6 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.'}, {'measure': 'Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 3 and 4', 'timeFrame': 'At month 24', 'description': 'The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.'}, {'measure': 'Change From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 1 and 2 Switchers', 'timeFrame': 'At month 24', 'description': 'The Upper Leg Length (Thigh) to Tibial Length Ratio prior to treatment, at baseline, and through 24 months is assessed by Upper Leg Length (Thigh)/ Tibial Leg Length.'}, {'measure': 'Change From Baseline in Arm Span to Height Ratio During Initial 6-months', 'timeFrame': 'At month 6 (Day 183)', 'description': 'The Arm Span to Height Ratio prior to treatment, at baseline, and through 6 months is assessed by Arm Span / Standing Height.'}, {'measure': 'Change From Baseline in Arm Span to Height Ratio During Entire Study Period - Cohort 3 and 4', 'timeFrame': 'At month 24', 'description': 'The Arm Span to Height Ratio prior to treatment, at baseline, and through 24 months is assessed by Arm Span / Standing Height.'}, {'measure': 'Change From Baseline in Arm Span to Height Ratio During Entire Study Period - Cohort 1 and 2 Switchers', 'timeFrame': 'At month 24', 'description': 'The Arm Span to Height Ratio prior to treatment, at baseline, and through 24 months is assessed by Arm Span / Standing Height.\n\nValues are not available for participants in cohort 1 switchers for Change from Baseline to \\>=12 Months on 15ug/kg.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Achondroplasia', 'Dwarfism', 'Bone Diseases, Developmental', 'Bone Diseases'], 'conditions': ['Achondroplasia']}, 'referencesModule': {'references': [{'pmid': '38649657', 'type': 'DERIVED', 'citation': 'Qi Y, Chan ML, Mould DR, Larimore K, Fisheleva E, Cherukuri A, Day J, Savarirayan R, Irving M, Bacino CA, Hoover-Fong J, Ozono K, Mohnike K, Wilcox WR, Bober MB, Henshaw J. Development of a Weight-Band Dosing Approach for Vosoritide in Children with Achondroplasia Using a Population Pharmacokinetic Model. Clin Pharmacokinet. 2024 May;63(5):707-719. doi: 10.1007/s40262-024-01371-6. Epub 2024 Apr 23.'}, {'pmid': '34431071', 'type': 'DERIVED', 'citation': 'Chan ML, Qi Y, Larimore K, Cherukuri A, Seid L, Jayaram K, Jeha G, Fisheleva E, Day J, Huntsman-Labed A, Savarirayan R, Irving M, Bacino CA, Hoover-Fong J, Ozono K, Mohnike K, Wilcox WR, Horton WA, Henshaw J. Pharmacokinetics and Exposure-Response of Vosoritide in Children with Achondroplasia. Clin Pharmacokinet. 2022 Feb;61(2):263-280. doi: 10.1007/s40262-021-01059-1. Epub 2021 Aug 25.'}, {'pmid': '31269546', 'type': 'DERIVED', 'citation': 'Savarirayan R, Irving M, Bacino CA, Bostwick B, Charrow J, Cormier-Daire V, Le Quan Sang KH, Dickson P, Harmatz P, Phillips J, Owen N, Cherukuri A, Jayaram K, Jeha GS, Larimore K, Chan ML, Huntsman Labed A, Day J, Hoover-Fong J. C-Type Natriuretic Peptide Analogue Therapy in Children with Achondroplasia. N Engl J Med. 2019 Jul 4;381(1):25-35. doi: 10.1056/NEJMoa1813446. Epub 2019 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, open-label, sequential cohort dose-escalation study of BMN 111 in children with achondroplasia. The primary objective is to assess the safety and tolerability of daily BMN 111 administered to children with achondroplasia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parent(s) or guardian(s) are willing and able to provide written, signed informed consent\n* 5 to 14 years old at end of study\n* ACH, documented by clinical grounds, confirmed by genetic testing\n* At least 6-month of pretreatment growth assessment in Study 111-901 before study entry, and one standing height at least 6 months prior to screening for 111-202\n* Negative pregnancy test at the Screening Visit for females ≥ 10 years old or who have begun menses\n* If sexually active, willing to use a highly effective method of contraception while participating in the study\n* Ambulatory, able to stand without assistance\n* Willing and able to perform all study procedures as physically possible\n* Parents/caregivers willing to administer daily injections to the subjects\n\nAdditional inclusion Criteria Optional, Open-label Extension Phase:\n\n* Appropriate written informed consent\n\nExclusion Criteria:\n\n* Hypochondroplasia or short stature condition other than ACH\n* Have any of the following:\n\n * Hypothyroidism or hyperthyroidism\n * Insulin-requiring diabetes mellitus\n * Autoimmune inflammatory disease\n * Inflammatory bowel disease\n * Autonomic neuropathy\n * Recent acute illness associated with volume dehydration not completely resolved prior to the first dose of study drug\n* Unstable condition requiring surgical intervention during the study\n* Growth plates have fused\n* Have a history of any of the following:\n\n * Renal insufficiency, defined as creatinine \\> 2 mg/dl\n * Anemia\n * Baseline systolic BP \\< 75 mm Hg or recurrent symptomatic hypotension or recurrent symptomatic hypotension, recurrent symptomatic orthostatic hypotension\n * Cardiac or vascular disease, including the following:\n\n * Cardiac dysfunction (abnormal echocardiogram \\[ECHO\\] including left ventricle \\[LV\\] mass) at Screening Visit\n * Hypertrophic cardiomyopathy\n * Pulmonary Hypertension\n * Congenital heart disease with ongoing cardiac dysfunction\n * Cerebrovascular disease\n * Aortic insufficiency\n * Clinically significant atrial or ventricular arrhythmias\n* Have an ECG showing any of the following:\n\n * Right or left atrial enlargement or ventricular hypertrophy\n * PR (period of time from the beginning of atrial depolarization until the beginning of ventricular depolarization) interval \\> 200 msec\n * QRS (The Q, R, and S heart waves that are measured on an electrocardiogram) interval \\> 110 msec\n * Corrected QTc-F (Measure of the corrected time between the start of the Q wave and end of the T wave in the heart's electrical cycle) \\> 450 msec\n * Second- or third-degree atrioventricular block\n* Documented Vitamin D deficiency\n* Require any investigational agent prior to completion of study period\n* Have received another investigational product or investigational medical device within 30 days before the Screening visit\n* Use of any other investigational product or investigational medical device for the treatment of ACH or short stature\n* Current chronic therapy with antihypertensive medications, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, diuretics, beta-blockers, calcium-channel blockers, cardiac glycosides, systemic anticholinergic agents, any medication that may impair or enhance compensatory tachycardia, diuretics, or other drugs known to alter renal or tubular function\n* Treatment with growth hormone, IGF-1 (Insulin-like growth factor), or anabolic steroids in the previous 6 months or long-term treatment (\\> 3 months) at any time\n* Long-term treatment (\\> 1 month) with oral corticosteroids\n* Concomitant medication that prolongs the QT/QTc-F interval within 14 days or 5 half-lives, whichever is longer, before the Screening visit\n* Pregnant or breastfeeding at the Screening Visit or planning to become pregnant (self or partner) at any time during the study\n* Limb-lengthening or bone-related surgery \\< 18 months prior to study enrollment\n* Had a fracture of the long bones or spine within 6 months prior to screening (except for fracture of digits or toes)\n* AST (Aspartate Transaminase) or ALT (Alanine Transaminase) at least 3x upper limit of normal (ULN) or total bilirubin at least 2x ULN\n* Evidence of severe sleep apnea requiring surgery or new initiation of CPAP (Continuous positive airway pressure).\n* History of malignancy and chemotherapy/radiation or currently under work-up for suspected malignancy\n* Known hypersensitivity to BMN 111 or its excipients\n* Have a condition or circumstance that, in the view of the Investigator, places the subject at high risk for poor treatment compliance or for not completing the study\n* Concurrent disease or condition that would interfere with study participation or safety\n* Have abnormal findings on baseline clinical hip exam or imaging assessments that are determined to be clinically significant as determined by the PI.\n* Have a history of hip surgery or severe hip dysplasia\n* Have a history of clinically significant hip injury in the 30 days prior to screening.\n* History of slipped capital femoral epiphysis or avascular necrosis of the femoral head.\n* Are unable to lie flat when in prone position\n\nAdditional Exclusion Criteria for Optional, Open-label Extension Phase:\n\n* Use of restricted therapies during the initial 6 months of the study\n* Permanently discontinued BMN 111 during the initial 6 months of the study"}, 'identificationModule': {'nctId': 'NCT02055157', 'acronym': 'ACH', 'briefTitle': 'A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioMarin Pharmaceutical'}, 'officialTitle': 'A Phase 2, Open-label, Sequential Cohort Dose-escalation Study of BMN 111 in Children With Achondroplasia', 'orgStudyIdInfo': {'id': '111-202'}, 'secondaryIdInfos': [{'id': '2013-004137-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Cohort 1: 2.5 ug/kg', 'interventionNames': ['Drug: BMN 111']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Cohort 2: 7.5 ug/kg,', 'interventionNames': ['Drug: BMN 111']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Cohort 3: 15 ug/Kg', 'interventionNames': ['Drug: BMN 111']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'Cohort 4: 30 ug/kg', 'interventionNames': ['Drug: BMN 111']}], 'interventions': [{'name': 'BMN 111', 'type': 'DRUG', 'otherNames': ['Modified recombinant human C-type natriuretic peptide', 'Vosoritide'], 'description': 'BMN 111 will be administered daily for 24 months in an open-label sequential dose adjustment fashion.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital & Research Center Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'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': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins McKusick - Institute of Genetic Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '37232-2578', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Murdoch Children's Research Institute", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Guys & St. Thomas NHS Foundation Trust Evelina Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BioMarin Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioMarin Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}