Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02841267
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2016-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of PF-06252616 in Ambulatory Participants With LGMD2I
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564612', 'term': 'Muscular Dystrophy, Limb-Girdle, Type 2I'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wagnerk@kennedykrieger.org', 'phone': '443-923-9525', 'title': 'Dr. Kathryn R. Wagner', 'organization': 'Hugo W. Moser Research Institute at Kennedy Krieger Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 124 weeks', 'description': 'Subject reported adverse events, as well as clinically relevant changes in laboratory screening, physical examination, suicide screening, cardiac screening are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Lead-in', 'description': 'All subjects were observed in a 16-week untreated lead-in-phase prior to allocation to dosing cohorts.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 9, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort 1 - Low Dose', 'description': 'Subjects received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks for 32 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 1 - High Dose', 'description': 'Following the Low Dose period, subjects in Cohort 1 received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 1 Extension', 'description': 'Subjects enrolled in Cohort 1 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 28 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 2', 'description': 'Subjects received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 2 Extension', 'description': 'Subjects enrolled in Cohort 2 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 40 weeks.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Cohort 3', 'description': 'Subjects received 40 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 3 Extension', 'description': 'Subjects enrolled in Cohort 3 were given the option to receive PF 06252616 at 40 mg/kg every 4 weeks for an additional 24 weeks.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain associated with muscle biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Numbness following biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lower extremity edema following biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin avulsion following biopsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intravenous catheter infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ecchymosis at IV site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fall - not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Musculoskeletal pain post fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fracture - pelvic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Knee injury post fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Shoulder injury post fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Facial injury post fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ankle injury post fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Shoulder pain - not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Knee pain - not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neck pain - not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hip pain - not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Worsening cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 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'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ketones detected in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Red blood cells in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Elevated serum iron levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Low serum iron levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Elevated amylase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Elevated serum ferritin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Low serum ferritin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hemoccult positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'New diagnosis - carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'New diagnosis - hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'New diagnosis - umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'New diagnosis - bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'New diagnosis - personality disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Dose Limiting or Intolerability Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': '4 subjects received 32 weeks of treatment with 5mg/kg PF 06252616 IV every 4 weeks followed by an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2, Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3, High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 64 weeks', 'description': 'Adverse events include subject-reported symptoms as well as clinically-significant changes in laboratory testing, vital signs, and suicide screening (based on the Columbia Suicide Severity Rating Scale).', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration at Steady State (Cmax, ss) of GDF-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.02', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '8.96', 'spread': '3.02', 'groupId': 'OG001'}, {'value': '9.67', 'spread': '6.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3', 'description': 'The concentration of myostatin (GDF-8) was measured in serum 2 hours after dose administration at two visits (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3)where drug concentration had reached steady state. The highest concentration from these two time points was averaged for each cohort.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 40mg/kg dosing period.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration at Steady State (Ctrough,ss) of GDF-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.80', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '9.68', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '9.78', 'spread': '7.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3', 'description': 'The concentration of myostatin (GDF-8) was measured in serum prior to dose administration at two time points (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3) where drug concentration had reached steady state. The lowest concentration from these two time points was averaged for each cohort.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 40mg/kg dosing period.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of PF-06252616', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '215306.5', 'spread': '29490.4', 'groupId': 'OG000'}, {'value': '779015.7', 'spread': '115450.0', 'groupId': 'OG001'}, {'value': '1625203', 'spread': '271159.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 113 and Day 169', 'description': 'The peak concentration of study drug (PF-06252616) was measured in serum following dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The higher concentration from these two time points was averaged for each cohort.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were analyzed. For Cohort 1, measurements are provided for 5mg/kg dosing period.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration (Ctrough) of PF-06252616', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '67016.8', 'spread': '25887.3', 'groupId': 'OG000'}, {'value': '224024.1', 'spread': '58734.5', 'groupId': 'OG001'}, {'value': '408814.1', 'spread': '96607.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 113 and Day 169', 'description': 'The peak concentration of study drug (PF-06252616) was measured in serum prior to dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The lower concentration from these two time points was averaged for each cohort.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 5mg/kg dosing period.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: Incidence of Anti-drug Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 96 weeks', 'description': 'Blood samples were tested for the presence of anti-drug antibodies prior to the initiation of study drug, at dose escalation (Cohort 1 only), and at 3 separate time points after the last dose was given.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in 10 Meter Walk/Run Time in Seconds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.60', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Subjects are asked to run or walk as quickly as possible for 10 meters from a standing position. The total time to traverse 10 meters is recorded in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subject were included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline of Forced Vital Capacity in Liters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 32 weeks', 'description': 'The total forced vital capacity was measured using a bedside spirometer. The best of 3 trials was recorded.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects were included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in 2MWD in Meters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.25', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '7.77', 'groupId': 'OG001'}, {'value': '2.13', 'spread': '5.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Average change in distance (in meters) walked in 2 minutes.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were analyzed. For Cohort 1, measurements are provided for the 5mg/kg dosing period.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in TUG in Seconds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '1.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 32 weeks', 'description': 'The timed-up-and-go test (TUG) is the total time it takes the subject to rise from a seated position, walk to a marker 3 meters away, return to the chair, and sit.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects are included in the analysis. For Cohort 1, data is provided for the 5mg/kg dosing period.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Muscle Strength as Measured by Modified MRC Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'OG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.75', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '7.57', 'spread': '8.62', 'groupId': 'OG001'}, {'value': '2.43', 'spread': '4.54', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Twenty-two muscle groups were measured on a modified MRC scale ranging from 1 through 12. The total scores from all 22 muscle groups were added to generate a summary score ranging from 12 to 264 with higher scores signifying greater strength. The change in summary score was calculated over the first 32 weeks of treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were analyzed after 32 weeks of treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose, Cohort 1', 'description': '4 subjects will be enrolled in cohort 1 and will receive an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, if no stopping rules have been met, subjects will be receive an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.\n\nPF 06252616'}, {'id': 'FG001', 'title': 'Middle Dose, Cohort 2', 'description': '8 subjects will be enrolled in cohort 2 and receive 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.\n\nPF 06252616'}, {'id': 'FG002', 'title': 'High Dose, Cohort 3', 'description': '8 subjects will be enrolled in cohort 3 and receive 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.\n\nPF 06252616'}], 'periods': [{'title': 'Lead-in (Untreated)', 'milestones': [{'type': 'STARTED', 'comment': 'Participants were observed for 16 weeks prior to treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Cohort 1 was invited to continue receiving 40mg/kg of study drug every 4 weeks for 28 weeks.', 'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Cohort 1 was invited to continue receiving 40mg/kg of study drug every 4 weeks for 28 weeks.', 'groupId': 'FG000', 'numSubjects': '4'}, {'comment': 'Cohort 2 was invited to continue receiving 40mg/kg of study drug every 4 weeks for 40 weeks.', 'groupId': 'FG001', 'numSubjects': '6'}, {'comment': 'Cohort 3 was invited to continue receiving 40mg/kg of study drug every 4 weeks for 24 weeks.', 'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One participant in Cohort 2 was consented, but elected to withdraw from the study prior to assignment to a treatment arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 - Low Dose', 'description': '4 subjects were enrolled in cohort 1 and received an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment, subjects received an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.'}, {'id': 'BG001', 'title': 'Cohort 2 - Middle Dose', 'description': '7 subjects were enrolled in cohort 2 and received 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'BG002', 'title': 'Cohort 3 - High Dose', 'description': '8 subjects were enrolled in cohort 3 and received 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '8', 'groupId': 'BG000'}, {'value': '41', 'spread': '18', 'groupId': 'BG001'}, {'value': '34', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '39', 'spread': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Target enrollment was reached for Cohort 1 and Cohort 3. For Cohort 2, 8 subjects were screened, but 1 voluntarily withdrew prior to enrollment and was not replaced.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-01', 'size': 563861, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-22T17:55', 'hasProtocol': False}, {'date': '2018-02-14', 'size': 3144148, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-22T17:59', 'hasProtocol': True}, {'date': '2019-02-07', 'size': 644670, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-22T18:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-23', 'studyFirstSubmitDate': '2016-07-12', 'resultsFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-23', 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose Limiting or Intolerability Treatment Related Adverse Events', 'timeFrame': 'Baseline through 64 weeks', 'description': 'Adverse events include subject-reported symptoms as well as clinically-significant changes in laboratory testing, vital signs, and suicide screening (based on the Columbia Suicide Severity Rating Scale).'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration at Steady State (Cmax, ss) of GDF-8', 'timeFrame': 'Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3', 'description': 'The concentration of myostatin (GDF-8) was measured in serum 2 hours after dose administration at two visits (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3)where drug concentration had reached steady state. The highest concentration from these two time points was averaged for each cohort.'}, {'measure': 'Minimum Observed Serum Trough Concentration at Steady State (Ctrough,ss) of GDF-8', 'timeFrame': 'Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3', 'description': 'The concentration of myostatin (GDF-8) was measured in serum prior to dose administration at two time points (Day 337 and Day 393 for Cohort 1; Day 113 and 169 for Cohorts 2 and 3) where drug concentration had reached steady state. The lowest concentration from these two time points was averaged for each cohort.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of PF-06252616', 'timeFrame': 'Day 113 and Day 169', 'description': 'The peak concentration of study drug (PF-06252616) was measured in serum following dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The higher concentration from these two time points was averaged for each cohort.'}, {'measure': 'Minimum Observed Serum Trough Concentration (Ctrough) of PF-06252616', 'timeFrame': 'Day 113 and Day 169', 'description': 'The peak concentration of study drug (PF-06252616) was measured in serum prior to dose administration at two time points (Day 113 and Day 169) where drug concentration had reached steady state. The lower concentration from these two time points was averaged for each cohort.'}, {'measure': 'Immunogenicity: Incidence of Anti-drug Antibody', 'timeFrame': 'Baseline through 96 weeks', 'description': 'Blood samples were tested for the presence of anti-drug antibodies prior to the initiation of study drug, at dose escalation (Cohort 1 only), and at 3 separate time points after the last dose was given.'}, {'measure': 'Mean Change From Baseline in 10 Meter Walk/Run Time in Seconds', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Subjects are asked to run or walk as quickly as possible for 10 meters from a standing position. The total time to traverse 10 meters is recorded in seconds.'}, {'measure': 'Mean Change From Baseline of Forced Vital Capacity in Liters', 'timeFrame': 'Baseline through 32 weeks', 'description': 'The total forced vital capacity was measured using a bedside spirometer. The best of 3 trials was recorded.'}, {'measure': 'Mean Change From Baseline in 2MWD in Meters', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Average change in distance (in meters) walked in 2 minutes.'}, {'measure': 'Mean Change From Baseline in TUG in Seconds', 'timeFrame': 'Baseline through 32 weeks', 'description': 'The timed-up-and-go test (TUG) is the total time it takes the subject to rise from a seated position, walk to a marker 3 meters away, return to the chair, and sit.'}, {'measure': 'Mean Change From Baseline in Muscle Strength as Measured by Modified MRC Scale', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Twenty-two muscle groups were measured on a modified MRC scale ranging from 1 through 12. The total scores from all 22 muscle groups were added to generate a summary score ranging from 12 to 264 with higher scores signifying greater strength. The change in summary score was calculated over the first 32 weeks of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['LGMD2I']}, 'referencesModule': {'references': [{'pmid': '32429923', 'type': 'DERIVED', 'citation': 'Leung DG, Bocchieri AE, Ahlawat S, Jacobs MA, Parekh VS, Braverman V, Summerton K, Mansour J, Bibat G, Morris C, Marraffino S, Wagner KR. Longitudinal functional and imaging outcome measures in FKRP limb-girdle muscular dystrophy. BMC Neurol. 2020 May 19;20(1):196. doi: 10.1186/s12883-020-01774-5.'}]}, 'descriptionModule': {'briefSummary': 'The investigational product PF 06252616, a humanized anti myostatin monoclonal antibody that neutralizes myostatin (GDF8) is in development for the treatment of Limb Girdle Muscular Dystrophy 2I (LGMD2I) to preserve and/or improve muscle function.\n\nThis study will provide the clinical assessment of the safety, tolerability, Pharmacokinetics and Pharmacodynamics of PF 06252616 following repeat IV doses in ambulatory adults with LGMD2I.', 'detailedDescription': 'This study is a Phase 1b/2, open-label multiple ascending dose escalation study to evaluate the safety, tolerability, efficacy, PK and PD of PF 06252616 in ambulatory adults with LGMD2I. The study design is intended to determine the optimal safe and pharmacologically active dose of PF 06252616 in LGMD2I while providing an opportunity for all subjects to receive active drug for a rare and disabling disorder. The study will be conducted in three periods: Lead-In, Treatment and Follow-up periods. The Lead-In and Follow-up periods will each be 16 weeks to allow an assessment of the change of various outcome measures of this period of time and comparison of change in function before, during and after treatment. The Treatment period will be 32 weeks. Three cohorts of participants will be enrolled and receive escalating doses of PF 06252616. The first cohort will have the option to crossover to the highest dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female patients age ≥ 18\n2. Diagnosis of LGMD2I as defined by clinical presentation consistent with LGMD2I and FKRP gene testing showing biallelic alterations known or likely to be pathogenic. Diagnosis must be confirmed in subject's medical history and by genetic testing obtained during routine clinical care for diagnostic purposes as reported from an appropriate regulated laboratory using a clinically validated genetic test (genetic testing is not provided by the sponsor).\n3. Ability to walk/run 10m\n4. Ability to rise from chair\n5. Adequate hepatic and renal function on screening laboratory assessments\n6. Iron content estimate on the screening liver MRI within the normal range as determined by R2\\* value (R2\\* ≤ 139 Hz at 3.0T).\n7. Participant must provide written informed consent for participating in study.\n8. Participant must possess the ability, per the Principal Investigator (PI), to understand and comply with protocol instruction for the entire duration of the study.\n\nExclusion Criteria:\n\n1. Known cognitive impairment or behavioral issues that would impede the ability to provide informed consent or to follow study instructions.\n2. History of major surgical procedure within 6 weeks of signing the informed consent or planned surgery during the study.\n3. Any injury which may impact functional testing. Previous injuries must be fully healed prior to consent. Prior lower limb fractures must be fully healed and at least 3 months from injury dates.\n4. Previous treatment with another investigational product within 30 days or 5 half-lives, (whichever is longer) prior to consenting.\n5. Corticosteroid treatment within 3 months prior to consenting.\n6. Compromised cardiac function (left ventricular ejection fraction \\<50%).\n7. Unwilling or unable (e.g. metal implants, requires sedation) to undergo examination with closed MRI without sedation.\n8. History of allergic or anaphylactic reaction to a therapeutic or diagnostic protein.\n9. Female subjects who are pregnant or nursing.\n10. Subjects who, are biologically capable of having children who are unwilling or unable to use highly effective methods of contraception (as outlined in this protocol) during sexual activity for the duration of the study and through completion of final study visit.\n11. Predisposition to iron accumulation. (Serum iron \\>1.2 X ULN, serum ferritin \\>1.2 ULNN).\n12. Underlying disposition for bleeding disorder on screening laboratory assessment (PT/INR\\>1.25 X ULN, aPTT \\> 1.25 ULN, fecal occult blood is positive)\n13. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease.\n14. Unwillingness or inability to comply with the requirements of this protocol (in the opinion of the PI) including, but not limited to, the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to return for study visits or adhere to the visit schedule."}, 'identificationModule': {'nctId': 'NCT02841267', 'briefTitle': 'A Trial of PF-06252616 in Ambulatory Participants With LGMD2I', 'organization': {'class': 'OTHER', 'fullName': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}, 'officialTitle': 'A Phase 1b/2, Open-Label, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Ambulatory Participants With LGMD2I', 'orgStudyIdInfo': {'id': 'WI203720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose, Cohort 1', 'description': '4 subjects will be enrolled in cohort 1 and will receive an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, if no stopping rules have been met, subjects will be receive an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks.', 'interventionNames': ['Drug: PF 06252616']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Middle dose, Cohort 2', 'description': '8 subjects will be enrolled in cohort 2 and receive 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks.', 'interventionNames': ['Drug: PF 06252616']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose, Cohort 3', 'description': '8 subjects will be enrolled in cohort 3 and receive 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks.', 'interventionNames': ['Drug: PF 06252616']}], 'interventions': [{'name': 'PF 06252616', 'type': 'DRUG', 'armGroupLabels': ['High dose, Cohort 3', 'Low Dose, Cohort 1', 'Middle dose, Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Kathryn R Wagner, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kathryn Wagner', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Genetic Muscle Disorders', 'investigatorFullName': 'Kathryn Wagner', 'investigatorAffiliation': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}}}}