Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-30 @ 2:18 AM
Study NCT ID:
NCT03963232
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2019-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628360', 'term': 'galcanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800- 545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Follow-up (Up To 10 months)', 'description': 'All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.\n\nPer protocol, AE analysis was planned per treatment regimen received in each study phase', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months during this phase.', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 29, 'seriousNumAtRisk': 259, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.', 'otherNumAtRisk': 261, 'deathsNumAtRisk': 261, 'otherNumAffected': 32, 'seriousNumAtRisk': 261, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo/Galcanezumab 120mg - Open-Label Treatment Phase', 'description': 'After completion of Placebo double-blind phase, participants had an option to enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.', 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 12, 'seriousNumAtRisk': 241, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment Phase', 'description': 'After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.', 'otherNumAtRisk': 243, 'deathsNumAtRisk': 243, 'otherNumAffected': 7, 'seriousNumAtRisk': 243, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Placebo - Follow-up', 'description': 'Participants entered follow-up phase from Placebo double-blind treatment phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Galcanezumab 120mg - Follow-up', 'description': 'Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo/Galcanezumab 120mg - Follow-up', 'description': 'Participants entered follow-up phase from Placebo/Galcanezumab 120 mg open-label treatment phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 0, 'seriousNumAtRisk': 236, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Galcanezumab 120mg/Galcanezumab 120mg - Follow-up', 'description': 'Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab 120mg open-label treatment phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 0, 'seriousNumAtRisk': 236, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 37, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 47, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Thymic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Infected dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Mucosal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Traumatic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thoracic outlet syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abortion threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Borderline personality disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 243, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-3.81', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.82', 'ciLowerLimit': '-2.32', 'ciUpperLimit': '-1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society \\[IHS\\] International Classification of Headache Disorders 3rd edition \\[ICHD-3\\], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'title': '30% responder', 'categories': [{'measurements': [{'value': '50.3', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '73.0', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': '50% responder', 'categories': [{'measurements': [{'value': '32.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '54.9', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': '75% responder', 'categories': [{'measurements': [{'value': '12.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': '100% responder', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.674', 'ciLowerLimit': '2.010', 'ciUpperLimit': '3.557', 'groupDescription': '30% responder', 'statisticalMethod': 'GLIMMIX', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.481', 'ciLowerLimit': '1.869', 'ciUpperLimit': '3.293', 'groupDescription': '50% responder', 'statisticalMethod': 'GLIMMIX', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.824', 'ciLowerLimit': '2.007', 'ciUpperLimit': '3.972', 'groupDescription': '75% responder', 'statisticalMethod': 'GLIMMIX', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.309', 'ciLowerLimit': '1.989', 'ciUpperLimit': '5.504', 'groupDescription': '100% responder', 'statisticalMethod': 'GLIMMIX', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 Months', 'description': 'Participant having:\n\n* 30% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 30% response rate to treatment or "30% responder."\n* 50% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 50% response rate to treatment or "50% responder."\n* 75% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 75% response rate to treatment or "75% responder."\n* 100% reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 100% response rate to treatment or "100% responder." Overall mean is derived from the average of months 1 to 3 using generalized linear mixed model (GLIMMIX) with the fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariate of baseline value.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ v2.1) During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.94', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '21.01', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.07', 'ciLowerLimit': '5.20', 'ciUpperLimit': '8.95', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'MSQ v2.1 is a self-administered instrument that was developed to address physical, emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains: Role Function-Restrictive (items 1-7), Role Function- Preventive (items 8-11) and Emotional Function (items 12-14). All item responses ranges from 1 (none of the time) to 6 (all of the time). Total raw scores for each domain is the sum of the raw scores of each item in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \\& a positive change in scores reflecting functional improvement. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-2.49', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.78', 'ciLowerLimit': '-2.25', 'ciUpperLimit': '-1.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.09', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-3.91', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.82', 'ciLowerLimit': '-2.35', 'ciUpperLimit': '-1.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly headache days is the number of calendar days in a 30-day period on which a headache occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.04', 'ciLowerLimit': '1.92', 'ciUpperLimit': '4.81', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1 to Month 3', 'description': 'Percentage of participants who maintained 50% response rate to treatment in all 3 months of the double-blind treatment phase.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.57', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-2.46', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.89', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '-0.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly migraine attacks is the number of sets of consecutive days with migraine or probable migraine separated by at least one migraine-free day in a 30-day period day. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'migraine attacks per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.83', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-31.72', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.88', 'ciLowerLimit': '-23.21', 'ciUpperLimit': '-14.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.20', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly migraine headache hours is the total number of headache hours in a 30-day period on days when a migraine or probable migraine occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'hours per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.94', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-32.18', 'spread': '2.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.24', 'ciLowerLimit': '-23.73', 'ciUpperLimit': '-14.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly headache hours is the total number of headache hours in a 30-day period on which a headache occurred. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'hours per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 Months', 'description': 'Severity of Migraine Headache was measured on a headache severity scale ranging from 1 to 3 with 1=mild, 2=moderate, and 3=severe. The mean severity of migraine headache for each month will be calculated as: sum of severity of migraine headache days divided by number of migraine headache days. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.610', 'spread': '0.0961', 'groupId': 'OG000'}, {'value': '-0.834', 'spread': '0.0930', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0284', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.224', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1021', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'PGI-S is a 7-point scale that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options range from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean change was calculated using analysis of variance (ANCOVA) model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline value, non-missing post baseline value at month 3.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.181', 'spread': '3.0597', 'groupId': 'OG000'}, {'value': '-22.610', 'spread': '2.9582', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.429', 'ciLowerLimit': '-18.81', 'ciUpperLimit': '-6.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.2484', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': "The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on migraineurs' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean change was calculated using ANCOVA model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline value, non-missing post baseline value at month 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once per month SC for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 3', 'description': 'A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \\>= 20.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline ADA value.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '14696', 'spread': '5675', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'PK: Serum concentration of galcanezumab', 'unitOfMeasure': 'Nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of galcanezumab and had evaluable serum concentrations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '* Double-blind treatment phase: Participants received placebo once per month SC for 3 months during this phase.\n* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}, {'id': 'FG001', 'title': 'Galcanezumab 120mg', 'description': '* Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.\n* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}], 'periods': [{'title': 'Double-Blind Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '261'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '261'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'groupId': 'FG001', 'numSubjects': '245'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Open-Label Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants from double-blind treatment phase had the option to enter the open-label treatment phase or proceed directly to the follow-up phase.', 'groupId': 'FG000', 'numSubjects': '241'}, {'comment': 'Participants from double-blind treatment phase had the option to enter the open-label treatment phase or proceed directly to the follow-up phase.', 'groupId': 'FG001', 'numSubjects': '243'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '232'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants from double-blind or open-label treatment phases entered the follow-up phase.', 'groupId': 'FG000', 'numSubjects': '243'}, {'comment': 'Participants from double-blind or open-label treatment phases entered the follow-up phase.', 'groupId': 'FG001', 'numSubjects': '247'}]}, {'type': 'Entered From Double-blind Treatment Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Entered From Open-Label Treatment Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '236'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '238'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was designed to be conducted in three phases: a 3-month double-blind treatment phase, an optional 3-month open-label treatment phase and a 4-month follow-up phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '* Double-blind treatment phase: Participants received placebo once per month SC for 3 months during this phase.\n* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}, {'id': 'BG001', 'title': 'Galcanezumab 120 mg', 'description': '* Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.\n* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.80', 'spread': '9.83', 'groupId': 'BG000'}, {'value': '37.20', 'spread': '9.33', 'groupId': 'BG001'}, {'value': '37.00', 'spread': '9.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, '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'}]}, {'title': 'Asian', 'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Monthly Migraine Headache Days (MHD)', 'classes': [{'categories': [{'measurements': [{'value': '8.34', 'spread': '2.70', 'groupId': 'BG000'}, {'value': '8.16', 'spread': '2.83', 'groupId': 'BG001'}, {'value': '8.25', 'spread': '2.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days per month', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-10', 'size': 793754, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-04T10:50', 'hasProtocol': True}, {'date': '2021-08-24', 'size': 5604062, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-04T10:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2019-05-16', 'resultsFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-27', 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, 3 Months', 'description': 'MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society \\[IHS\\] International Classification of Headache Disorders 3rd edition \\[ICHD-3\\], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}], 'secondaryOutcomes': [{'measure': 'Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.', 'timeFrame': '3 Months', 'description': 'Participant having:\n\n* 30% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 30% response rate to treatment or "30% responder."\n* 50% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 50% response rate to treatment or "50% responder."\n* 75% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 75% response rate to treatment or "75% responder."\n* 100% reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 100% response rate to treatment or "100% responder." Overall mean is derived from the average of months 1 to 3 using generalized linear mixed model (GLIMMIX) with the fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariate of baseline value.'}, {'measure': 'Overall Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ v2.1) During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, 3 Months', 'description': 'MSQ v2.1 is a self-administered instrument that was developed to address physical, emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains: Role Function-Restrictive (items 1-7), Role Function- Preventive (items 8-11) and Emotional Function (items 12-14). All item responses ranges from 1 (none of the time) to 6 (all of the time). Total raw scores for each domain is the sum of the raw scores of each item in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \\& a positive change in scores reflecting functional improvement. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}, {'measure': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}, {'measure': 'Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly headache days is the number of calendar days in a 30-day period on which a headache occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}, {'measure': 'Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.', 'timeFrame': 'Month 1 to Month 3', 'description': 'Percentage of participants who maintained 50% response rate to treatment in all 3 months of the double-blind treatment phase.'}, {'measure': 'Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly migraine attacks is the number of sets of consecutive days with migraine or probable migraine separated by at least one migraine-free day in a 30-day period day. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}, {'measure': 'Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly migraine headache hours is the total number of headache hours in a 30-day period on days when a migraine or probable migraine occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}, {'measure': 'Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, 3 Months', 'description': 'Number of monthly headache hours is the total number of headache hours in a 30-day period on which a headache occurred. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}, {'measure': 'Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, 3 Months', 'description': 'Severity of Migraine Headache was measured on a headache severity scale ranging from 1 to 3 with 1=mild, 2=moderate, and 3=severe. The mean severity of migraine headache for each month will be calculated as: sum of severity of migraine headache days divided by number of migraine headache days. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}, {'measure': 'Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, Month 3', 'description': 'PGI-S is a 7-point scale that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options range from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean change was calculated using analysis of variance (ANCOVA) model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.'}, {'measure': 'Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline, Month 3', 'description': "The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on migraineurs' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean change was calculated using ANCOVA model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction."}, {'measure': 'Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase.', 'timeFrame': 'Baseline to Month 3', 'description': 'A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \\>= 20.'}, {'measure': 'Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase.', 'timeFrame': 'Month 3', 'description': 'PK: Serum concentration of galcanezumab'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prevention', 'prophylactic'], 'conditions': ['Episodic Migraine']}, 'referencesModule': {'references': [{'pmid': '37542222', 'type': 'DERIVED', 'citation': 'Zhou J, Zhong L, Chowdhury D, Skorobogatykh K, Luo G, Yang X, Zhang M, Sun L, Liu H, Qian C, Yu S. Galcanezumab in patients with episodic migraine: results from the open-label period of the phase 3 PERSIST study. J Headache Pain. 2023 Aug 4;24(1):103. doi: 10.1186/s10194-023-01613-1.'}, {'pmid': '35896988', 'type': 'DERIVED', 'citation': 'Hu B, Li G, Li X, Wu S, Yu T, Li X, Zhao H, Jia Z, Zhuang J, Yu S. Galcanezumab in episodic migraine: the phase 3, randomized, double-blind, placebo-controlled PERSIST study. J Headache Pain. 2022 Jul 28;23(1):90. doi: 10.1186/s10194-022-01458-0.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/31dBGbS2DbVt4INep01n59', 'label': 'A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine'}]}, 'descriptionModule': {'briefSummary': 'The reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. The study will last about 53 weeks and may include up to 12 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2) (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and migraine onset prior to age 50\n* Prior to screening, participants must have a history of 4-14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months\n\nExclusion Criteria:\n\n* Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study\n* Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody\n* Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (for example, adalimumab, infliximab, trastuzumab, bevacizumab, etc.)\n* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab\n* Women who are pregnant or nursing\n* History of chronic migraine, daily persistent headache, cluster headache, medication overuse headache, migraine with brainstem aura, or hemiplegic migraine'}, 'identificationModule': {'nctId': 'NCT03963232', 'acronym': 'PERSIST', 'briefTitle': 'A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study', 'orgStudyIdInfo': {'id': '17054'}, 'secondaryIdInfos': [{'id': 'I5Q-MC-CGAX', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '* Double-blind treatment phase: Participants received placebo once per month subcutaneously (SC) for 3 months.\n* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 milligram (mg) loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Galcanezumab 120 mg', 'description': '* Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.\n* Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.', 'interventionNames': ['Drug: Galcanezumab']}], 'interventions': [{'name': 'Galcanezumab', 'type': 'DRUG', 'otherNames': ['LY2951742'], 'description': 'Administered SC', 'armGroupLabels': ['Galcanezumab 120 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital-Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affiliated Hospital Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': 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'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '20040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'HuaShan Hospital Affiliated To Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '650032', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'First Affiliated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310013', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '014040', 'city': 'Baotou', 'state': 'Zizhiqu', 'country': 'China', 'facility': 'Bao Tou Central Hospital', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'zip': '382428', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Apollo Hospitals International Ltd.', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '122001', 'city': 'Gurgaon', 'state': 'Haryana', 'country': 'India', 'facility': 'Artemis Hospital', 'geoPoint': {'lat': 28.4601, 'lon': 77.02635}}, {'zip': '575003', 'city': 'Mangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Mangala Hospitals & Mangala Kidney Foundation', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '452008', 'city': 'Indore', 'state': 'Madh Prad', 'country': 'India', 'facility': 'CHL - Apollo Hospital', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'zip': '440012', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Getwell Hospital & Research Institute', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '422001', 'city': 'Nashik', 'state': 'Maharashtra', 'country': 'India', 'facility': 'HCG Manavata Cancer Centre', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '411004', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Deenanath Mangeshkar Hospital & Research Centre', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110029', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110060', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Sir Ganga Ram Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110002', 'city': 'New Delhi', 'country': 'India', 'facility': 'Gobind Ballabh Pant Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'First Moscow State Medical University n.a. Sechenov', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121467', 'city': 'Moscow', 'country': 'Russia', 'facility': 'University Headache Clinic', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603137', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'OOO "Medis"', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Academician I.P. Pavlov First St-Petersburg State Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'http://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}