Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-07 @ 6:25 AM
Study NCT ID:
NCT03199469
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2017-06-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of AT132 in Young Children With X-Linked Myotubular Myopathy (XLMTM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020914', 'term': 'Myopathies, Structural, Congenital'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '8008887704', 'title': 'Clinical Transparency', 'organization': 'Astellas Pharma Global Development, Inc. (APGD)'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose to 5 years', 'description': 'All-cause mortality and AEs included SAF population that consisted of all randomized participants who received resamirigene bilparvovec.', 'eventGroups': [{'id': 'EG000', 'title': '1.3 x 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '3.5 x 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'deathsNumAffected': 3, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Coronary sinus dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pulmonary valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Right ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Tricuspid valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dolichocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Laryngeal cleft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Portal venous system anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Talipes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Precocious puberty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Astigmatism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Catheter site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Developmental delay', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Medical device site granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Electrocardiogram ST segment elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Electrocardiogram low voltage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Faecal fat increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Haptoglobin decreased', 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'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lymphocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lymphocyte morphology abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Myocardial necrosis marker increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Neutrophil toxic granulation present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pancreatic enzymes increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Prealbumin decreased', 'stats': [{'groupId': 'EG000', 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'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Serratia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cholesteatoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Adenoidal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Epiglottic oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Withdrawal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hours of Ventilation Support at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.92', 'spread': '9.31', 'groupId': 'OG000'}, {'value': '-5.84', 'spread': '5.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24', 'description': 'The hours of ventilation support were based on diary data from participants for whom diary data was collected at baseline and by assessment of time off ventilator questionnaire for all other participants. Weekly scores were the average of ventilation hours needed for at least 5 out of the 7 days leading up to and including the analysis visit day (e.g., Day 168 for Week 24). For cases where the diary or the ventilator assessment indicated the ventilator type = "None", then zero was imputed for the number of hours on ventilator.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Functionally Independent Sitting for At Least 30 Seconds by Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'title': 'Achieved', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '61.5', 'groupId': 'OG001'}]}]}, {'title': 'Not Achieved', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Independence to sit is defined as a participant who sits for at least 30 seconds without assistance from another person or object. Data was determined from the motor milestone electronic case report form (eCRF) or the Bayley Scales of Infant and Toddler Development (BSID) subtest performance criteria number 26, used to determine whether the participant achieves (Yes) or doesn\'t achieve (No) the milestone. If data was not available then they would be included as "missing".', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Time to Reduction in Required Ventilator Support to ≤ 16 Hours a Day From Dosing to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '16.1'}, {'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using Kaplan-Meier \\[KM\\] and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG001', 'lowerLimit': '17.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to week 24', 'description': 'The reduced ventilator time was obtained directly from the daily diary or assessment of the time off ventilator questionnaire. The first instance of time reduction reported as ≤ 16 hours per day was considered as an event. Kaplan- Meier estimate was used for analysis.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) Total Score at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.86', 'spread': '15.12', 'groupId': 'OG000'}, {'value': '13.25', 'spread': '13.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24', 'description': 'The CHOP INTEND is an assessment scale that was originally designed to quantify motor abilities in infants aged 1.4 to 37.9 months, with spinal muscular atrophy type I (SMA-I) and has been validated for X-linked myotubular myopathy (XLMTM). The scale contains 16 questions, each of which is scored on a scale of 0 to 4, with 0 being no response/ability to perform the movement and 4 highest abilities to perform the task, per CHOP INTEND item instructions. The score used for analysis is the total sum of all 16 questions, which will range from 0 to 64. Higher score indicates better neuromuscular function. If an item is missing or scored as "Could Not Test (CNT)" then 0 will be imputed for the item score.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximal Inspiratory Pressure (MIP) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.07', 'spread': '35.03', 'groupId': 'OG000'}, {'value': '26.72', 'spread': '28.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24', 'description': 'MIP is a quick and non-invasive test to measure strength of inspiratory muscles, primarily diaphragm, and allows for assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. MIP refers to how much air pressure force an individual creates by inhaling through the mouth as hard as possible.', 'unitOfMeasure': 'centimeter of water (cmH2O)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative Analysis of Myotubularin Expression in the Muscle Biopsy at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '923.69', 'spread': '816.09', 'groupId': 'OG000'}, {'value': '2848.40', 'spread': '2903.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24', 'description': 'Myotubularin is a protein, a highly conserved, dual-specific lipid phosphatase that is involved in the development, maturation, and maintenance of skeletal muscle cells. Myotubularin is encoded by an MTM1 gene. The concentration of the sample was normalized such that the equivalent amount of protein was tested per sample.', 'unitOfMeasure': 'picograms (pg)/15 microgram(µg) protein', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Total Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.12', 'spread': '18.81', 'groupId': 'OG000'}, {'value': '13.82', 'spread': '12.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24', 'description': 'ACEND was developed to measure impact on lives of parents/legally authorized representatives /caregivers caring for children with severe neuromuscular disorders. ACEND has 41 items which reflected 2 domains (physical impact \\[feeding/grooming/dressing {6 items}, sitting/play {5 items}, transfers {5 items} and mobility {7 items}\\] and general caregiver impact \\[time {4 items}, emotion {9 items}, and finance {5 items}\\]). Score for each item was based on 6- or 5-point ordinal scale, and scores for each domain and subdomain were scored on 0 - 100 scale. Higher scores reflected caregivers experiencing less intense care-giving impact. Raw scores for each subdomain was created by computing algebraic mean of items for those respondents who completed one item or more; setting missing for those items with no responses. Then, arithmetic mean of responded items was standardized to 0 to 100 score and transformed scores were from 0 to 100 for each subdomain. Higher score indicated a better outcome.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Assessment Total Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.39', 'spread': '15.51', 'groupId': 'OG000'}, {'value': '12.06', 'spread': '19.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24', 'description': 'PedsQL is a tool designed to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. PedsQL measures the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. This questionnaire has different modules that are administered depending on the age and condition of the child. Each item of the questionnaire is measured on a 5-point likert scale from - 0 (Never) to 4 (Almost always). The module is composed of 25 items comprising 3 dimensions: About My Neuromuscular Disease (17 items), Communication (3 items), About Our Family Resources (5 items). Items are reversed scored and linearly transformed to a total score of 0-100 scale. Higher scales/scores indicate lower problems.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Mean Percent of Age-appropriate Clinically Relevant Gross Motor Function Milestones Attained Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '12.50', 'spread': '15.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.00', 'spread': '28.28', 'groupId': 'OG000'}, {'value': '23.33', 'spread': '19.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '26.85', 'spread': '15.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '25.25', 'spread': '16.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '19.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, weeks 4, 12, 16 and 24', 'description': 'Motor Developmental Milestones included: head control (holds head erect for at least 15 seconds without support), rolls from back to sides (turns from back to both sides), sits without support (sits alone without support for at least 10 seconds), stands with assistance (supports own weight for at least 2 seconds), crawls (makes forward progress of at least 5 feet by crawling on hands and knees), pulls to stand (raises self to standing position using chair or other convenient object for support), walks with assistance (child walks by making coordinated, alternating stepping movements. May hold on with 1 or 2 hands for support), stands alone (stands alone for at least 3 seconds after you release hands), walks alone (takes at least 3 steps without support, even if gait is stiff-legged and wobbly). Mean percentage of gross motor function milestones attained was reported.', 'unitOfMeasure': 'Percentage of gross motor function', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Full Ventilator Independence at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'title': 'Achieved', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Not Achieved', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': '"Full ventilator independence" is defined as: the date of removal from ventilator field on the "Assessment of Ventilator Parameters" eCRF is not blank or "Is subject on a ventilator" = "No" on the same eCRF.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Participants with available data were reported.'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 5 years', 'description': 'Survival status was assessed at each visit until the participant withdraws consent or completes the study. If the participant missed a visit or withdraws for a reason other than withdrawal of consent or death, the site contacted the parent(s)/legally authorized representatives to ascertain if the participant was alive. For participants who withdrew from the study, the participant was contacted every 6 months for 5 years after administration and to assess for survival. Kaplan- Meier estimate was used for analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'OG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose to 5 years', 'description': 'An AE is any untoward medical occurrence in a participant administered a study drug not necessarily having a causal relationship with this treatment. An AE can therefore be any unfavorable \\& unintended sign, symptom, or disease temporally associated with the use of medicinal product (MP) whether or not considered related to MP. A TEAE is any AEs, regardless of relationship to study drug, that begins or worsens on or after baseline (dosing) visit date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF) consisted of all randomized participants who received resamirigene bilparvovec.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1.3 × 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'FG001', 'title': '3.5 × 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Delayed Treatment Control (DTC) Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'comment': '2 participants were randomized but did not receive study intervention.', 'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Immediate Treatment Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'comment': '1 participant was randomized but did not receive study intervention.', 'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Randomized, not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'Participants diagnosed with X-linked myotubular myopathy (XLMTM) resulting from a genetically confirmed mutation in the myotubular myopathy (MTM) 1 gene as assessed by a Sponsor-approved testing facility were enrolled in this study.', 'preAssignmentDetails': 'Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. The study is ongoing, and data for efficacy is reported for Part 1 (week 24) of the study only with mortality and safety data being reported up to data cut-off date 30 June 2023 (up to 5 years).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1.3 x 10^14 vg/kg (Low Dose)', 'description': 'Participants received 1.3 x 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'BG001', 'title': '3.5 x 10^14 vg/kg (High Dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.78', 'spread': '15.47', 'groupId': 'BG000'}, {'value': '37.66', 'spread': '24.55', 'groupId': 'BG001'}, {'value': '33.54', 'spread': '23.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ventilation Support', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'spread': '4.69', 'groupId': 'BG000'}, {'value': '23.71', 'spread': '0.52', 'groupId': 'BG001'}, {'value': '22.89', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The hours of ventilation support was based on diary data from participants for whom diary data was collected at baseline and by assessment of time off ventilator questionnaire for all other participants. Baseline is defined as the average of the diary data values in the 7 days leading up to and including the day of administration of the study drug (i.e. Analysis Day - 6 through Day 1).', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full Analysis Set (FAS) population (included all randomized and enrolled participants who received resamirigene bilparvovec and had at least 1 post-dose efficacy assessment) with available data was reported.'}], 'populationDescription': 'Included all participants who were randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-17', 'size': 18739772, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-11T23:35', 'hasProtocol': True}, {'date': '2024-04-15', 'size': 4677978, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-11T23:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'ASPIRO was being conducted in two parts. Part 1 was a dose escalation phase that was evaluating the preliminary safety and efficacy of resamirigene bilparvovec at doses of 1.3x10\\^14 vg/kg and 3.5x10\\^14 vg/kg. Part 2 of ASPIRO was a pivotal expansion cohort designed to confirm the safety and efficacy of resamirigene bilparvovec at a dose of 3.5x10\\^14 vg/kg. The pivotal expansion cohort enrolled eight subjects, consisting of four age-matched pairs (within +/- 6 months of age). One subject from each pair was randomized to receive a single dose of resamirigene bilparvovec at 3.5x10\\^14 vg/kg, and the other served as a delayed treatment control. Eligible delayed treatment control subjects administered resamirigene bilparvovec after that individual subject completed the Week 24 visit as a delayed treatment control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2017-06-21', 'resultsFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-07-24', 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hours of Ventilation Support at Week 24', 'timeFrame': 'Baseline, week 24', 'description': 'The hours of ventilation support were based on diary data from participants for whom diary data was collected at baseline and by assessment of time off ventilator questionnaire for all other participants. Weekly scores were the average of ventilation hours needed for at least 5 out of the 7 days leading up to and including the analysis visit day (e.g., Day 168 for Week 24). For cases where the diary or the ventilator assessment indicated the ventilator type = "None", then zero was imputed for the number of hours on ventilator.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Functionally Independent Sitting for At Least 30 Seconds by Week 24', 'timeFrame': 'Week 24', 'description': 'Independence to sit is defined as a participant who sits for at least 30 seconds without assistance from another person or object. Data was determined from the motor milestone electronic case report form (eCRF) or the Bayley Scales of Infant and Toddler Development (BSID) subtest performance criteria number 26, used to determine whether the participant achieves (Yes) or doesn\'t achieve (No) the milestone. If data was not available then they would be included as "missing".'}, {'measure': 'Time to Reduction in Required Ventilator Support to ≤ 16 Hours a Day From Dosing to Week 24', 'timeFrame': 'Baseline up to week 24', 'description': 'The reduced ventilator time was obtained directly from the daily diary or assessment of the time off ventilator questionnaire. The first instance of time reduction reported as ≤ 16 hours per day was considered as an event. Kaplan- Meier estimate was used for analysis.'}, {'measure': "Change From Baseline in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) Total Score at Week 24", 'timeFrame': 'Baseline, week 24', 'description': 'The CHOP INTEND is an assessment scale that was originally designed to quantify motor abilities in infants aged 1.4 to 37.9 months, with spinal muscular atrophy type I (SMA-I) and has been validated for X-linked myotubular myopathy (XLMTM). The scale contains 16 questions, each of which is scored on a scale of 0 to 4, with 0 being no response/ability to perform the movement and 4 highest abilities to perform the task, per CHOP INTEND item instructions. The score used for analysis is the total sum of all 16 questions, which will range from 0 to 64. Higher score indicates better neuromuscular function. If an item is missing or scored as "Could Not Test (CNT)" then 0 will be imputed for the item score.'}, {'measure': 'Change From Baseline in Maximal Inspiratory Pressure (MIP) at Week 24', 'timeFrame': 'Baseline, week 24', 'description': 'MIP is a quick and non-invasive test to measure strength of inspiratory muscles, primarily diaphragm, and allows for assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. MIP refers to how much air pressure force an individual creates by inhaling through the mouth as hard as possible.'}, {'measure': 'Change From Baseline in Quantitative Analysis of Myotubularin Expression in the Muscle Biopsy at Week 24', 'timeFrame': 'Baseline, week 24', 'description': 'Myotubularin is a protein, a highly conserved, dual-specific lipid phosphatase that is involved in the development, maturation, and maintenance of skeletal muscle cells. Myotubularin is encoded by an MTM1 gene. The concentration of the sample was normalized such that the equivalent amount of protein was tested per sample.'}, {'measure': 'Change From Baseline in Quality of Life Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) Total Score at Week 24', 'timeFrame': 'Baseline, week 24', 'description': 'ACEND was developed to measure impact on lives of parents/legally authorized representatives /caregivers caring for children with severe neuromuscular disorders. ACEND has 41 items which reflected 2 domains (physical impact \\[feeding/grooming/dressing {6 items}, sitting/play {5 items}, transfers {5 items} and mobility {7 items}\\] and general caregiver impact \\[time {4 items}, emotion {9 items}, and finance {5 items}\\]). Score for each item was based on 6- or 5-point ordinal scale, and scores for each domain and subdomain were scored on 0 - 100 scale. Higher scores reflected caregivers experiencing less intense care-giving impact. Raw scores for each subdomain was created by computing algebraic mean of items for those respondents who completed one item or more; setting missing for those items with no responses. Then, arithmetic mean of responded items was standardized to 0 to 100 score and transformed scores were from 0 to 100 for each subdomain. Higher score indicated a better outcome.'}, {'measure': 'Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Assessment Total Score at Week 24', 'timeFrame': 'Baseline, week 24', 'description': 'PedsQL is a tool designed to measure health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. PedsQL measures the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. This questionnaire has different modules that are administered depending on the age and condition of the child. Each item of the questionnaire is measured on a 5-point likert scale from - 0 (Never) to 4 (Almost always). The module is composed of 25 items comprising 3 dimensions: About My Neuromuscular Disease (17 items), Communication (3 items), About Our Family Resources (5 items). Items are reversed scored and linearly transformed to a total score of 0-100 scale. Higher scales/scores indicate lower problems.'}, {'measure': 'Mean Percent of Age-appropriate Clinically Relevant Gross Motor Function Milestones Attained Through Week 24', 'timeFrame': 'Baseline, weeks 4, 12, 16 and 24', 'description': 'Motor Developmental Milestones included: head control (holds head erect for at least 15 seconds without support), rolls from back to sides (turns from back to both sides), sits without support (sits alone without support for at least 10 seconds), stands with assistance (supports own weight for at least 2 seconds), crawls (makes forward progress of at least 5 feet by crawling on hands and knees), pulls to stand (raises self to standing position using chair or other convenient object for support), walks with assistance (child walks by making coordinated, alternating stepping movements. May hold on with 1 or 2 hands for support), stands alone (stands alone for at least 3 seconds after you release hands), walks alone (takes at least 3 steps without support, even if gait is stiff-legged and wobbly). Mean percentage of gross motor function milestones attained was reported.'}, {'measure': 'Percentage of Participants Achieving Full Ventilator Independence at Week 24', 'timeFrame': 'Week 24', 'description': '"Full ventilator independence" is defined as: the date of removal from ventilator field on the "Assessment of Ventilator Parameters" eCRF is not blank or "Is subject on a ventilator" = "No" on the same eCRF.'}, {'measure': 'Duration of Overall Survival', 'timeFrame': 'Baseline up to 5 years', 'description': 'Survival status was assessed at each visit until the participant withdraws consent or completes the study. If the participant missed a visit or withdraws for a reason other than withdrawal of consent or death, the site contacted the parent(s)/legally authorized representatives to ascertain if the participant was alive. For participants who withdrew from the study, the participant was contacted every 6 months for 5 years after administration and to assess for survival. Kaplan- Meier estimate was used for analysis.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose to 5 years', 'description': 'An AE is any untoward medical occurrence in a participant administered a study drug not necessarily having a causal relationship with this treatment. An AE can therefore be any unfavorable \\& unintended sign, symptom, or disease temporally associated with the use of medicinal product (MP) whether or not considered related to MP. A TEAE is any AEs, regardless of relationship to study drug, that begins or worsens on or after baseline (dosing) visit date.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AAV8-Delivered Gene Therapy', 'XLMTM', 'Adeno Associated Virus'], 'conditions': ['X-Linked Myotubular Myopathy']}, 'referencesModule': {'references': [{'pmid': '37977713', 'type': 'DERIVED', 'citation': 'Shieh PB, Kuntz NL, Dowling JJ, Muller-Felber W, Bonnemann CG, Seferian AM, Servais L, Smith BK, Muntoni F, Blaschek A, Foley AR, Saade DN, Neuhaus S, Alfano LN, Beggs AH, Buj-Bello A, Childers MK, Duong T, Graham RJ, Jain M, Coats J, MacBean V, James ES, Lee J, Mavilio F, Miller W, Varfaj F, Murtagh M, Han C, Noursalehi M, Lawlor MW, Prasad S, Rico S. Safety and efficacy of gene replacement therapy for X-linked myotubular myopathy (ASPIRO): a multinational, open-label, dose-escalation trial. Lancet Neurol. 2023 Dec;22(12):1125-1139. doi: 10.1016/S1474-4422(23)00313-7.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/S1474-4422(23)00313-7', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "X-linked myotubular myopathy (XLMTM) is a rare and serious condition present at birth where the muscles do not work properly. There are currently no therapies for this serious condition.\n\nThe protein myotubularin is needed for muscle development and movement. A gene called MTM1 tells the body to make myotubularin. XLMTM is caused by changes, or mutations, in the MTM1 gene. Changes in the MTM1 gene causes low levels of myotubularin to be made, so the muscles do not work properly. XLMTM may also affect the liver, and in some cases, this can be dangerous and threaten the patient´s life.\n\nGene therapy is a way of getting a healthy copy of a gene into the body. This allows the body's cells to make a normal protein that may reduce disease symptoms. AT132 is a gene therapy that gets a healthy MTM1 gene into the body to help improve muscle development and function in young children with the disease. AT132 does not treat liver disease, and because of the way the treatment works, it may make liver problems worse.\n\nAT132 was the gene therapy treatment given to children who participated in this study and is not available to the public. In this study, AT132 was given to children for the first time. Due to the occurrence of severe complications and fatalities associated with administration of AT132, the study has been stopped and no further participants will be enrolled.\n\nThe main aim of the study is to check how long young children need machines to support breathing (ventilation support) after AT132.\n\nDue to the occurrence of severe complications and fatalities associated with administration of AT132, the study has been stopped and no further participants will be enrolled. This study included children with XLMTM under 5 years old who had breathing problems caused by XLMTM. They couldn't take part if they were born prematurely, recently had surgery, had liver disease or other condition or disease the study doctor thought was medically important. The study did enroll participants with medically significant liver disease.\n\nThis is an open-label study. This means that young children and their caregivers, and clinic staff know that young children received AT132. This study was designed with 2 parts and is now in a long-term follow-up phase to collect information on the safety and improvements in muscle function in the children who received AT132.\n\nIn Part 1, small groups of young children were given different doses of AT132, with one group receiving a lower dose and one group receiving a higher dose of AT132. The purpose of giving the two doses was to determine which dose was best for treating the muscle disease. After receiving AT132, a medical panel of experts reviewed each child for safety and for how their muscles responded. AT132 did not demonstrate appropriate safety at either dose. Administration of AT132 was stopped. Children who received AT132 are being monitored for 10 years for safety and to understand how their muscles function over time.", 'detailedDescription': 'This study evaluated safety and efficacy of gene transfer in X-Linked Myotubular Myopathy. Participants received a single dose of resamirigene bilparvovec delivered intravenously.\n\nASPIRO was being conducted in two parts. Part 1 was a dose escalation phase that was evaluating the preliminary safety and efficacy of Resamirigene bilparvovec at doses of 1.3x10\\^14 vg/kg and 3.5x10\\^14 vg/kg. Part 2 of ASPIRO was a pivotal expansion cohort designed to confirm the safety and efficacy of resamirigene bilparvovec at a dose of 3.5x10\\^14 vg/kg. The pivotal expansion cohort enrolled eight participants, consisting of four age-matched pairs (within +/- 6 months of age). One participant from each pair was randomized to receive a single dose of resamirigene bilparvovec at 3.5x10\\^14 vg/kg, and the other served as a delayed treatment control. Eligible delayed treatment control participants administered resamirigene bilparvovec after that individual participant completed the Week 24 visit as a delayed treatment control.\n\nThe primary efficacy endpoint measures assessed at Week 24. Participants were followed for a total of 10 years after administration of resamirigene bilparvovec. Only Part 1 of the study was reported.\n\nThis study utilized an independent Data Monitoring Committee (DMC) that monitored participant safety and provided recommendations to Astellas regarding dose escalation, dose expansion, and safety matters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has a diagnosis of XLMTM resulting from a genetically confirmed mutation in the MTM1 gene as assessed by a Sponsor-approved testing facility.\n* Subject is male.\n* Subject is aged less than 5 years old at dosing\n* Subject requires mechanical ventilatory support:\n\nPart 1: Subject requires some mechanical ventilatory support (e.g., ranging from 24 hours per day full time mechanical ventilation, to noninvasive support such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) during sleeping hours).\n\nPart 2: Subject requires invasive mechanical ventilatory support ranging from 20 - 24 hours per day at screening (confirmed by daytime polysomnographic study).\n\n* Subject requiring invasive mechanical ventilator support is fitted with or willing to be fitted with a cuffed tracheostomy tube for some respiratory assessments.\n* Subject has ventilator maximum positive end-expiratory pressure (PEEP) \\<8 cm H2O at screening.\n* UNIQUE to France: Subject's weight is ≥ 4.8 kg.\n\nExclusion Criteria:\n\n* Subject is participating in an interventional study designed to treat XLMTM.\n* Subject born \\<35 weeks gestation who is still not term as per corrected age.\n* Subject tests positive for AAV8 neutralizing antibody with titers above protocol specified threshold.\n* Subject had recent surgery (\\<3 months before Day 1) or has planned surgery that may confound data collection during the first 48 weeks of the study.\n* Subject has a clinically important condition other than XLMTM in the opinion of the investigator.\n* Subject has a clinically significant underlying liver disease.\n* Subject is currently experiencing a clinically important respiratory infection or other active infection.\n* Subject has received pyridostigmine or any medication to treat XLMTM within 3 months before Day 1.\n* Other than as required per protocol, subject has received immune-modulating agents within 3 months before Day 1 (use of inhaled corticosteroids to manage chronic respiratory conditions is allowed); use of other concomitant medications to manage chronic conditions must have been stable for at least 4 weeks before dosing.\n* Subject has a contraindication to prednisolone.\n* Subject has a contraindication to study drug or ingredients.\n* Subject has previous scoliosis repair surgery/procedure, or planned/expected scoliosis repair surgery/procedure in the 12 months following Day 1 (Part 2 including any subjects enrolled under protocol v8 and beyond).\n* Subject has contractures, scoliosis, or other medical condition that would limit the potential to achieve unassisted sitting, in the opinion of the investigator (Part 2 including any subjects enrolled under protocol V8 and beyond).\n* Subject is able to sit without assistance for at least 30 seconds at screening, in the opinion of the investigator (Part 2 including any subjects enrolled under protocol V8 and beyond).\n* Subject has a clinically important condition, including CTCAE v4.03 Grade ≥ 2 anemia (\\< 10 g/dL hemoglobin).\n* Subject has a contraindication to ursodiol (ursodeoxycholic acid).\n* UNIQUE to France: Subject has a prior diagnosis or history of cardiac arrhythmias, myocarditis, or any other cardiac disease.\n* UNIQUE to France: Subject has a contraindication to general anesthesia and to muscle biopsy procedures."}, 'identificationModule': {'nctId': 'NCT03199469', 'acronym': 'ASPIRO', 'briefTitle': 'A Study of AT132 in Young Children With X-Linked Myotubular Myopathy (XLMTM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'ASPIRO: A Phase 1/2/3, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Efficacy of AT132, an AAV8-Delivered Gene Therapy in X-Linked Myotubular Myopathy (XLMTM) Patients', 'orgStudyIdInfo': {'id': 'ATX-MTM-002'}, 'secondaryIdInfos': [{'id': '2024-512637-32', 'type': 'OTHER', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.3 × 10^14 vg/kg (Low dose)', 'description': 'Participants received 1.3 x 10\\^14 viral genomes per kilogram (vg/kg) of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.', 'interventionNames': ['Genetic: Resamirigene bilparvovec']}, {'type': 'EXPERIMENTAL', 'label': '3.5 × 10^14 vg/kg (High dose)', 'description': 'Participants received 3.5 × 10\\^14 vg/kg of body weight resamirigene bilparvovec as a single dose intravenously on Day 1. A sentinel dose was given to first participant and if there were no safety concerns, subsequent participants received either resamirigene bilparvovec at the same dose or control with delayed treatment after at least 4 weeks of post-dose data from the sentinel participant.', 'interventionNames': ['Genetic: Resamirigene bilparvovec']}], 'interventions': [{'name': 'Resamirigene bilparvovec', 'type': 'GENETIC', 'otherNames': ['AT132'], 'description': 'Resamirigene bilparvovec is an AAV8 vector containing a functional copy of the human MTM1 (hMTM1) gene.', 'armGroupLabels': ['1.3 × 10^14 vg/kg (Low dose)', '3.5 × 10^14 vg/kg (High dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '208892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institute of Neurological Disorders and Stroke/NIH Porter', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': 'M5G0A4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Armad Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '80337', 'city': 'München', 'country': 'Germany', 'facility': 'Kinderklinik und Kinderpoliklinik im Dr. Von Haunerschen Kinderspital Klinikum der Universitat Munchen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Gene Therapies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}