Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-13 @ 8:05 AM
Study NCT ID:
NCT03920293
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629409', 'term': 'ravulizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@alexion.com', 'phone': '+1 855-752-2356', 'title': 'Alexion Pharmaceuticals Inc.', 'organization': 'Alexion Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 (after dosing) up to 2 years', 'description': 'Treatment-emergent adverse events were reported for 26-week randomized-controlled period and open-label extension period separately.', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized-Controlled Period: Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 77, 'seriousNumAtRisk': 86, 'deathsNumAffected': 2, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Randomized-Controlled Period: Placebo', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 75, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Open-Label Extension Period: Placebo to Ravulizumab', 'description': 'After the randomized-controlled part of the study, participants in the placebo group were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 79, 'seriousNumAtRisk': 83, 'deathsNumAffected': 3, 'seriousNumAffected': 32}, {'id': 'EG003', 'title': 'Open-Label Extension Period: Ravulizumab to Ravulizumab', 'description': 'After the randomized-controlled part of the study, participants in the ravulizumab group were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 77, 'seriousNumAtRisk': 78, 'deathsNumAffected': 3, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 32, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'MedDRA 24.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pancreatic cystadenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vein rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '-0.7', 'pValueComment': 'Statistical significance was tested at α=0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. The QMG scoring system was considered to be an objective evaluation of therapy for MG and was based on quantitative testing of sentinel muscle groups. A decrease in score indicated improvement. Estimates were based on MMRM that included treatment group, stratification factor region, and QMG total score at baseline, study visit, and study visit by treatment group interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '43.5'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '21.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. A decrease in score indicated improvement. Percentage of participants with a ≥5-point reduction in the QMG total score are reported. Estimates were based on a generalized linear mixed model (GLMM) that included treatment group, stratification factor region and QMG total score at baseline, study visit and study visit by treatment group interaction.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': "The revised Myasthenia Gravis Qualify of Life 15-item scale (MG-QOL15r) is a health-related QoL evaluative instrument specific to participants with MG. The MG-QOL15r was designed to provide information about participants' perception of impairment and disability, determine the degree to which disease manifestations are tolerated, and to be administered and interpreted easily. Each item was graded on a scale of 0 to 2, with 2 being the most severe. The range of MG-QOL15r score is 0 to 30. Higher scores indicated greater extent of and dissatisfaction with MG-related dysfunction. Estimates are based on MMRM that included treatment group, stratification factor region and MG-QOL15r score at baseline, study visit and study visit by treatment group interaction.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The Neuro-QOL Fatigue is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each items was rated on a scale of 1 to 5, with 5 being the most severe. The range of total score is 19 to 95. Higher scores indicated greater fatigue and greater impact of MG on activities. Estimates were based on MMRM that included treatment group, stratification factor region and Neuro-QoL Fatigue score at baseline, study visit, and study visit by treatment group interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '44.3', 'upperLimit': '68.3'}, {'value': '34.1', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '46.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Percentage of participants with a ≥3-point reduction in the MG-ADL total score are reported. Estimates were based on a GLMM that included treatment group, stratification factor region and MG-ADL total score at baseline, study visit and study visit by treatment group interaction.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ravulizumab to Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'FG001', 'title': 'Placebo to Ravulizumab', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}], 'periods': [{'title': 'Randomized-Controlled Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open- Label Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Participants who transitioned to alternative treatment by the Investigator when the study closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'Participants were randomized 1:1 to either the ravulizumab or placebo group during the Randomized-Controlled Period. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ravulizumab', 'description': 'Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. After the randomized-controlled part of the study, participants were transitioned to the ongoing open-label extension period to receive treatment with ravulizumab IV for up to 2 years.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '13.82', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '16.05', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '15.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set: All randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-25', 'size': 4053449, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-03T13:01', 'hasProtocol': True}, {'date': '2021-06-10', 'size': 1107478, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-03T13:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2022-03-11', 'completionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2019-04-16', 'dispFirstSubmitQcDate': '2022-03-11', 'resultsFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2019-04-16', 'dispFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-03', 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. The QMG scoring system was considered to be an objective evaluation of therapy for MG and was based on quantitative testing of sentinel muscle groups. A decrease in score indicated improvement. Estimates were based on MMRM that included treatment group, stratification factor region, and QMG total score at baseline, study visit, and study visit by treatment group interaction.'}, {'measure': 'Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26', 'timeFrame': 'Week 26', 'description': 'The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. A decrease in score indicated improvement. Percentage of participants with a ≥5-point reduction in the QMG total score are reported. Estimates were based on a generalized linear mixed model (GLMM) that included treatment group, stratification factor region and QMG total score at baseline, study visit and study visit by treatment group interaction.'}, {'measure': 'Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "The revised Myasthenia Gravis Qualify of Life 15-item scale (MG-QOL15r) is a health-related QoL evaluative instrument specific to participants with MG. The MG-QOL15r was designed to provide information about participants' perception of impairment and disability, determine the degree to which disease manifestations are tolerated, and to be administered and interpreted easily. Each item was graded on a scale of 0 to 2, with 2 being the most severe. The range of MG-QOL15r score is 0 to 30. Higher scores indicated greater extent of and dissatisfaction with MG-related dysfunction. Estimates are based on MMRM that included treatment group, stratification factor region and MG-QOL15r score at baseline, study visit and study visit by treatment group interaction."}, {'measure': 'Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'The Neuro-QOL Fatigue is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each items was rated on a scale of 1 to 5, with 5 being the most severe. The range of total score is 19 to 95. Higher scores indicated greater fatigue and greater impact of MG on activities. Estimates were based on MMRM that included treatment group, stratification factor region and Neuro-QoL Fatigue score at baseline, study visit, and study visit by treatment group interaction.'}, {'measure': 'Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26', 'timeFrame': 'Week 26', 'description': 'The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Percentage of participants with a ≥3-point reduction in the MG-ADL total score are reported. Estimates were based on a GLMM that included treatment group, stratification factor region and MG-ADL total score at baseline, study visit and study visit by treatment group interaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Myasthenia Gravis']}, 'referencesModule': {'references': [{'pmid': '38319212', 'type': 'DERIVED', 'citation': 'Vu T, Meisel A, Mantegazza R, Annane D, Katsuno M, Aguzzi R, Enayetallah A, Beasley KN, Rampal N, Howard JF. Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis. NEJM Evid. 2022 May;1(5):EVIDoa2100066. doi: 10.1056/EVIDoa2100066. Epub 2022 Apr 26.'}, {'pmid': '37103755', 'type': 'DERIVED', 'citation': 'Meisel A, Annane D, Vu T, Mantegazza R, Katsuno M, Aguzzi R, Frick G, Gault L, Howard JF Jr; CHAMPION MG Study Group. Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. J Neurol. 2023 Aug;270(8):3862-3875. doi: 10.1007/s00415-023-11699-x. Epub 2023 Apr 27.'}, {'pmid': '36890354', 'type': 'DERIVED', 'citation': 'Vu T, Ortiz S, Katsuno M, Annane D, Mantegazza R, Beasley KN, Aguzzi R, Howard JF Jr. Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis. J Neurol. 2023 Jun;270(6):3129-3137. doi: 10.1007/s00415-023-11617-1. Epub 2023 Mar 9.'}, {'pmid': '36852670', 'type': 'DERIVED', 'citation': 'Vanoli F, Mantegazza R. Ravulizumab for the treatment of myasthenia gravis. Expert Opin Biol Ther. 2023 Mar;23(3):235-241. doi: 10.1080/14712598.2023.2185131. Epub 2023 Mar 8.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ALXN1210-MG-306&attachmentIdentifier=f164e5fa-8534-413e-a765-e3c6b87e017c&fileName=ALXN1210-MG-306_CSR_Synopsis_redacted.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.\n2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.\n3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).\n4. Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening.\n2. History of thymectomy within the 12 months prior to screening.\n3. History of N meningitidis infection.\n4. Use of the following within the time period specified below:\n\n * IV immunoglobulin within 4 weeks of randomization\n * Use of plasma exchange within 4 weeks of randomization\n * Use of rituximab within 6 months of screening\n5. Participants who have received previous treatment with complement inhibitors (for example, eculizumab).'}, 'identificationModule': {'nctId': 'NCT03920293', 'briefTitle': 'Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'ALXN1210-MG-306'}, 'secondaryIdInfos': [{'id': '2018-003243-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ravulizumab', 'description': 'Participants will receive ravulizumab for the duration of the study.', 'interventionNames': ['Biological: Ravulizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ravulizumab', 'type': 'BIOLOGICAL', 'otherNames': ['ALXN1210', 'Ultomiris'], 'description': 'Concentrated sterile, preservative-free aqueous solution (10 milligrams \\[mg\\]/milliliter \\[mL\\]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.', 'armGroupLabels': ['Ravulizumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92617', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.04835, 'lon': 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'geoPoint': {'lat': 42.08419, 'lon': -88.01313}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02116', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research 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