Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-01-01 @ 1:14 PM
Study NCT ID:
NCT02614261
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2015-11-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Galcanezumab in the Prevention of Chronic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 16 months for main study plus additional 3 years if enrolled in Israel continued-access addendum.', 'description': 'All participants from safety population. Per protocol, AE analysis was planned per treatment regimen received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Double-Blind Treatment Phase', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.', 'otherNumAtRisk': 558, 'deathsNumAtRisk': 558, 'otherNumAffected': 170, 'seriousNumAtRisk': 558, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Galcanezumab 120mg - Double-Blind Treatment Phase', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 273, 'otherNumAffected': 98, 'seriousNumAtRisk': 273, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Galcanezumab 240mg - Double-Blind Treatment Phase', 'description': 'Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.', 'otherNumAtRisk': 282, 'deathsNumAtRisk': 282, 'otherNumAffected': 105, 'seriousNumAtRisk': 282, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Placebo/Galcanezumab - Open-Label Extension Phase', 'description': 'After completion of Placebo double-blind phase, participants had an option to enter open-label extension phase where they received 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.', 'otherNumAtRisk': 501, 'deathsNumAtRisk': 501, 'otherNumAffected': 223, 'seriousNumAtRisk': 501, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG004', 'title': 'Galcanezumab 120mg/Galcanezumab - Open-Label Extension Phase', 'description': 'After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 117, 'seriousNumAtRisk': 259, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Galcanezumab 240mg/Galcanezumab - Open-Label Extension Phase', 'description': 'After completion of Galcanezumab 240mg double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.', 'otherNumAtRisk': 262, 'deathsNumAtRisk': 262, 'otherNumAffected': 120, 'seriousNumAtRisk': 262, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG006', 'title': 'Placebo - Follow-up Phase', 'description': 'Participants entered follow-up phase from placebo double-blind treatment phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Galcanezumab 120mg - Follow-up Phase', 'description': 'Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Galcanezumab 240mg - Follow-up Phase', 'description': 'Participants entered follow-up phase from from Galcanezumab 240mg double-blind treatment phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Placebo/Galcanezumab - Follow-up Phase', 'description': 'Participants entered follow-up phase from Placebo/Galcanezumabopen-label extension phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 438, 'deathsNumAtRisk': 438, 'otherNumAffected': 57, 'seriousNumAtRisk': 438, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG010', 'title': 'Galcanezumab 120mg/Galcanezumab - Follow-up Phase', 'description': 'Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 19, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Galcanezumab 240mg/Galcanezumab - Follow-up Phase', 'description': 'Participants entered follow-up phase from Galcanezumab 240mg/Galcanezumab open-label extension phase and were observed for 4 months. No treatments administered.', 'otherNumAtRisk': 228, 'deathsNumAtRisk': 228, 'otherNumAffected': 27, 'seriousNumAtRisk': 228, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG012', 'title': 'Israel Addendum', 'description': "Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.", 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 26, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 31, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 33, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 51, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 56, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 33, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 55, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pancreas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Congenital diaphragmatic hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alcoholic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Complicated appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Malignant nipple neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tongue neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 433, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 433, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 186, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.74', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-4.83', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '-4.62', 'spread': '0.43', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.09', 'ciLowerLimit': '-2.92', 'ciUpperLimit': '-1.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.88', 'ciLowerLimit': '-2.71', 'ciUpperLimit': '-1.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.', 'unitOfMeasure': 'Migraine Headache Days per Month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '498', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg of galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'title': '≥50%', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': '≥75%', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': '≥100%', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.623', 'ciLowerLimit': '1.167', 'ciUpperLimit': '2.256', 'groupDescription': 'Reduction from Baseline ≥50%,', 'statisticalMethod': 'CPRMM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical pseudo likelihood-based repeated measures model (CPRMM)'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.788', 'ciLowerLimit': '1.291', 'ciUpperLimit': '2.474', 'groupDescription': 'Reduction from Baseline ≥50%', 'statisticalMethod': 'CPRMM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical pseudo likelihood-based repeated measures model (CPRMM)'}, {'pValue': '.102', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.498', 'ciLowerLimit': '0.923', 'ciUpperLimit': '2.430', 'groupDescription': 'Reduction from Baseline ≥75%', 'statisticalMethod': 'CPRMM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical pseudo likelihood-based repeated measures model (CPRMM)'}, {'pValue': '.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.819', 'ciLowerLimit': '1.146', 'ciUpperLimit': '2.888', 'groupDescription': 'Reduction from Baseline ≥75%', 'statisticalMethod': 'CPRMM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical pseudo likelihood-based repeated measures model (CPRMM)'}, {'pValue': '0.729', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.761', 'ciLowerLimit': '0.163', 'ciUpperLimit': '3.563', 'groupDescription': 'Reduction from Baseline ≥100%', 'statisticalMethod': 'CPRMM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical pseudo likelihood-based repeated measures model (CPRMM)'}, {'pValue': '.276', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.897', 'ciLowerLimit': '0.600', 'ciUpperLimit': '5.998', 'groupDescription': 'Reduction from Baseline ≥100%', 'statisticalMethod': 'CPRMM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Categorical pseudo likelihood-based repeated measures model (CPRMM)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.76', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '21.81', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '23.05', 'spread': '1.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.06', 'ciLowerLimit': '2.12', 'ciUpperLimit': '7.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.50', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.29', 'ciLowerLimit': '3.03', 'ciUpperLimit': '9.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.66', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \\& friends, leisure time, productivity, concentration, energy, tiredness \\& feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),\\& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.\n\nLSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.23', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-4.74', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '-4.25', 'spread': '0.40', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.51', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '-1.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.01', 'ciLowerLimit': '-2.77', 'ciUpperLimit': '-1.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.', '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 and at least one post baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '0.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '-0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'PGI-S scale is a participant-rated instrument 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 were from 1 ("normal, not at all ill") to 7 ("extremely ill"). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.'}, {'type': 'SECONDARY', 'title': 'Overall Mean Change From Baseline in Headache Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240 mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.44', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '-36.15', 'spread': '4.74', 'groupId': 'OG001'}, {'value': '-31.53', 'spread': '4.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.71', 'ciLowerLimit': '-31.74', 'ciUpperLimit': '-13.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.60', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.09', 'ciLowerLimit': '-27.09', 'ciUpperLimit': '-9.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.58', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.', 'unitOfMeasure': 'Headache 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 post baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '504', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.53', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '-20.27', 'spread': '4.07', 'groupId': 'OG001'}, {'value': '-17.02', 'spread': '4.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.74', 'ciLowerLimit': '-16.39', 'ciUpperLimit': '-1.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.90', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.157', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.49', 'ciLowerLimit': '-13.10', 'ciUpperLimit': '2.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.88', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '535', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.263', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.290', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 1 through Month 3', 'description': 'A Treatment Emergent Anti-Drug Antibodies (TE ADA) evaluable participant is considered to be TE ADA+ 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+ if there is at least one post baseline result of ADA Present with titer \\>= 20.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had at least one non-missing test result for ADA for each of the baseline period and the post baseline period.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'timeFrame': 'Baseline through Month 3', 'description': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo once a month by subcutaneous injection for 3 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG002', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.529', 'spread': '0.612', 'groupId': 'OG000'}, {'value': '4.02', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '4.85', 'spread': '1.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).', 'unitOfMeasure': 'Nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had measurable plasma concentrations.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Galcanezumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Galcanezumab 120mg', 'description': 'Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.'}, {'id': 'OG001', 'title': 'Galcanezumab 240mg', 'description': 'Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16900', 'spread': '7140', 'groupId': 'OG000'}, {'value': '29000', 'spread': '11300', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Serum concentrations 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 measurable serum concentrations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '* Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension 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 loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}, {'id': 'FG002', 'title': 'Galcanezumab 240mg', 'description': '* Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}, {'id': 'FG003', 'title': 'Israel Addendum', 'description': "Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first."}], 'periods': [{'title': 'Double-Blind Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '559'}, {'groupId': 'FG001', 'numSubjects': '279'}, {'groupId': 'FG002', 'numSubjects': '279'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '558'}, {'groupId': 'FG001', 'numSubjects': '278'}, {'groupId': 'FG002', 'numSubjects': '277'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '558'}, {'comment': '5 participants discontinued after receiving loading dose of 240mg. They were included under 240mg arm for safety analysis.', 'groupId': 'FG001', 'numSubjects': '273'}, {'groupId': 'FG002', 'numSubjects': '282'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '509'}, {'groupId': 'FG001', 'numSubjects': '262'}, {'groupId': 'FG002', 'numSubjects': '266'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants from double-blind treatment phase had the option to enter the open-label extension phase or proceed directly to the follow-up phase.', 'groupId': 'FG000', 'numSubjects': '501'}, {'comment': 'Participants from double-blind treatment phase had the option to enter the open-label extension phase or proceed directly to the follow-up phase.', 'groupId': 'FG001', 'numSubjects': '259'}, {'comment': 'Participants from double-blind treatment phase had the option to enter the open-label extension phase or proceed directly to the follow-up phase.', 'groupId': 'FG002', 'numSubjects': '262'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '501'}, {'groupId': 'FG001', 'numSubjects': '259'}, {'groupId': 'FG002', 'numSubjects': '262'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '204'}, {'groupId': 'FG002', 'numSubjects': '208'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants from double-blind treatment or open-label extension phases entered the follow-up phase.', 'groupId': 'FG000', 'numSubjects': '453'}, {'comment': 'Participants from double-blind treatment or open-label extension phases entered the follow-up phase.', 'groupId': 'FG001', 'numSubjects': '228'}, {'comment': 'Participants from double-blind treatment or open-label extension phases entered the follow-up phase.', 'groupId': 'FG002', 'numSubjects': '231'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Entered From Double-blind Treatment Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'comment': '1 among these participants discontinued from double-blind treatment phase after receiving 240mg loading dose and entered Follow-up phase.', 'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Safety Population (Entered From Double-blind Treatment Phase)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'comment': '1 participant who discontinued from double-blind treatment phase after receiving 240mg loading dose and entered Follow-up phase was included under 240mg arm for safety analysis.', 'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Entered From Open-label Extension Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '438'}, {'groupId': 'FG001', 'numSubjects': '223'}, {'groupId': 'FG002', 'numSubjects': '228'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Safety Population (Entered From Open-label Extension Phase)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '438'}, {'groupId': 'FG001', 'numSubjects': '223'}, {'groupId': 'FG002', 'numSubjects': '228'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '421'}, {'groupId': 'FG001', 'numSubjects': '217'}, {'groupId': 'FG002', 'numSubjects': '217'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Israel Addendum', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Main study arm.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Main study arm.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Main study arm.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Eligible participants from main study enrolled in Israel addendum.', 'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '1. Main study: This randomised part of study was conducted in 3 phases\n\n * a 3-month double-blind treatment phase\n * an optional 9-month open-label extension phase\n * a 4-month follow-up phase\n2. Israel addendum: Participants in Israel who completed all phases in main study, benefited from galcanezumab and had no other suitable alternative treatment options available were provided continued-access to galcanezumab where safety was monitored.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '* Double-blind treatment phase: Participants received placebo once a month by subcutaneous injection for 3 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}, {'id': 'BG001', 'title': 'Galcanezumab 120mg', 'description': '* Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}, {'id': 'BG002', 'title': 'Galcanezumab 240mg', 'description': '* Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '41.61', 'spread': '12.07', 'groupId': 'BG000'}, {'value': '39.66', 'spread': '11.86', 'groupId': 'BG001'}, {'value': '41.06', 'spread': '12.36', 'groupId': 'BG002'}, {'value': '40.98', 'spread': '12.11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '484', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '950', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}, {'value': '792', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '433', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}, {'value': '882', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '629', 'groupId': 'BG003'}]}]}, {'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '1117', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Migraine Headache Days (MHD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '558', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}, {'value': '1113', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19.55', 'spread': '4.59', 'groupId': 'BG000'}, {'value': '19.36', 'spread': '4.27', 'groupId': 'BG001'}, {'value': '19.17', 'spread': '4.60', 'groupId': 'BG002'}, {'value': '19.41', 'spread': '4.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.', 'unitOfMeasure': 'Days per Month', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized participants who received at least one dose of study drug.'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-22', 'size': 3512395, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-02T17:21', 'hasProtocol': True}, {'date': '2017-04-25', 'size': 816465, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-02T17:22', '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': 1117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'dispFirstSubmitDate': '2018-03-15', 'completionDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2015-11-23', 'dispFirstSubmitQcDate': '2018-03-15', 'resultsFirstSubmitDate': '2018-10-19', 'studyFirstSubmitQcDate': '2015-11-23', 'dispFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-12', 'studyFirstPostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'MHD: A calendar day on which a migraine headache or probable migraine headache occurred.'}, {'measure': 'Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain', 'timeFrame': 'Baseline, Month 3', 'description': 'MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \\& friends, leisure time, productivity, concentration, energy, tiredness \\& feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),\\& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items 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.'}, {'measure': 'Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.\n\nOverall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.'}, {'measure': 'Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score', 'timeFrame': 'Baseline, Month 3', 'description': 'PGI-S scale is a participant-rated instrument 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 were from 1 ("normal, not at all ill") to 7 ("extremely ill"). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.'}, {'measure': 'Overall Mean Change From Baseline in Headache Hours', 'timeFrame': 'Baseline, Month 1 through Month 3', 'description': 'Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.'}, {'measure': 'Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score', 'timeFrame': 'Baseline, Month 3', 'description': 'The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.'}, {'measure': 'Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab', 'timeFrame': 'Month 1 through Month 3', 'description': 'A Treatment Emergent Anti-Drug Antibodies (TE ADA) evaluable participant is considered to be TE ADA+ 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+ if there is at least one post baseline result of ADA Present with titer \\>= 20.'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab', 'timeFrame': 'Baseline through Month 3', 'description': 'Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.'}, {'measure': 'Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)', 'timeFrame': 'Month 3', 'description': 'Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).'}, {'measure': 'Serum Concentrations of Galcanezumab', 'timeFrame': 'Month 3', 'description': 'Serum concentrations of Galcanezumab'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prevention', 'prophylaxis', 'headache'], 'conditions': ['Chronic Migraine']}, 'referencesModule': {'references': [{'pmid': '39901101', 'type': 'DERIVED', 'citation': 'Diener HC, Day KA, Lipsius S, Aurora SK, Hindiyeh NA, Detke HC. Shift from chronic to episodic migraine frequency in a long-term phase 3 study of galcanezumab. J Headache Pain. 2025 Feb 3;26(1):26. doi: 10.1186/s10194-025-01956-x.'}, {'pmid': '35392739', 'type': 'DERIVED', 'citation': 'Pozo-Rosich P, Detke HC, Wang S, Dolezil D, Li LQ, Aurora SK, Reuter U. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 May;38(5):731-742. doi: 10.1080/03007995.2022.2059975. Epub 2022 Apr 15.'}, {'pmid': '35076090', 'type': 'DERIVED', 'citation': 'Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25.'}, {'pmid': '34264500', 'type': 'DERIVED', 'citation': 'Citrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.'}, {'pmid': '33950375', 'type': 'DERIVED', 'citation': 'Pozo-Rosich P, Samaan KH, Schwedt TJ, Nicholson RA, Rettiganti M, Pearlman EM. Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis. Adv Ther. 2021 Jun;38(6):3154-3165. doi: 10.1007/s12325-021-01708-8. Epub 2021 May 5.'}, {'pmid': '33549036', 'type': 'DERIVED', 'citation': 'Ament M, Day K, Stauffer VL, Skljarevski V, Rettiganti M, Pearlman E, Aurora SK. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. J Headache Pain. 2021 Feb 6;22(1):6. doi: 10.1186/s10194-021-01215-9.'}, {'pmid': '33544305', 'type': 'DERIVED', 'citation': 'Kuruppu DK, North JM, Kovacik AJ, Dong Y, Pearlman EM, Hutchinson SL. Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials. Adv Ther. 2021 Mar;38(3):1614-1626. doi: 10.1007/s12325-021-01632-x. Epub 2021 Feb 5.'}, {'pmid': '33143451', 'type': 'DERIVED', 'citation': 'Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3.'}, {'pmid': '33069214', 'type': 'DERIVED', 'citation': 'Ailani J, Andrews JS, Rettiganti M, Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 2020 Oct 17;21(1):123. doi: 10.1186/s10194-020-01190-7.'}, {'pmid': '32930994', 'type': 'DERIVED', 'citation': 'Ford J, Tassorelli C, Leroux E, Wang S, Ayer D, Nichols R, Detke H. Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN). Qual Life Res. 2021 Jan;30(1):105-115. doi: 10.1007/s11136-020-02623-1. Epub 2020 Sep 15.'}, {'pmid': '32576229', 'type': 'DERIVED', 'citation': 'Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.'}, {'pmid': '31952501', 'type': 'DERIVED', 'citation': 'Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7.'}, {'pmid': '31482569', 'type': 'DERIVED', 'citation': 'Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.'}, {'pmid': '31104507', 'type': 'DERIVED', 'citation': 'Ruff DD, Ford JH, Tockhorn-Heidenreich A, Sexson M, Govindan S, Pearlman EM, Wang SJ, Khan A, Aurora SK. Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure. Cephalalgia. 2019 Jul;39(8):931-944. doi: 10.1177/0333102419847957. Epub 2019 May 19.'}, {'pmid': '30594122', 'type': 'DERIVED', 'citation': 'Forderreuther S, Zhang Q, Stauffer VL, Aurora SK, Lainez MJA. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018 Dec 29;19(1):121. doi: 10.1186/s10194-018-0951-2.'}, {'pmid': '30462830', 'type': 'DERIVED', 'citation': 'Nichols R, Doty E, Sacco S, Ruff D, Pearlman E, Aurora SK. Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. Headache. 2019 Feb;59(2):192-204. doi: 10.1111/head.13443. Epub 2018 Nov 21.'}, {'pmid': '30446596', 'type': 'DERIVED', 'citation': 'Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e2221. doi: 10.1212/WNL.0000000000006640. Epub 2018 Nov 16.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/FnCyu97viesEckigw4wmc', 'label': 'A Study of LY2951742 in the Prevention of Chronic Migraine (REGAIN)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMain Study:\n\n* Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.\n\nIsrael addendum:\n\n* Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.\n* Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.\n\nExclusion Criteria:\n\n* Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.\n* Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.\n* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.\n* History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.'}, 'identificationModule': {'nctId': 'NCT02614261', 'acronym': 'REGAIN', 'briefTitle': 'Evaluation of Galcanezumab in the Prevention of Chronic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study', 'orgStudyIdInfo': {'id': '15769'}, 'secondaryIdInfos': [{'id': 'I5Q-MC-CGAI', 'type': 'OTHER', 'domain': 'Eli Lillly and Company'}, {'id': '2015-001883-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '* Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.', 'interventionNames': ['Drug: Galcanezumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Galcanezumab 120 mg', 'description': '* Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by SC injection for 2 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.', 'interventionNames': ['Drug: Galcanezumab']}, {'type': 'EXPERIMENTAL', 'label': 'Galcanezumab 240 mg', 'description': '* Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.\n* Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months.\n* Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.', 'interventionNames': ['Drug: Galcanezumab']}, {'type': 'EXPERIMENTAL', 'label': 'Israel Addendum', 'description': "Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.", 'interventionNames': ['Drug: Galcanezumab']}], 'interventions': [{'name': 'Galcanezumab', 'type': 'DRUG', 'otherNames': ['LY2951742'], 'description': 'Administered SC', 'armGroupLabels': ['Galcanezumab 120 mg', 'Galcanezumab 240 mg', 'Israel Addendum', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': '21st Century Neurology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute, Encino', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Fullerton Neurology and Headache Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute, Los Alamitos', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute, Newport Beach', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Valley Research', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Anderson Clinical Research', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Optimus Medical Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Neurosciences Research, LLC', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Associated Neurologists of Southern Connecticut', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Research LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions Inc', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': '|Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Psychiatric Inst of Florida-Clinical Neuroscience Solutions', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Premiere Research Institute at Palm Beach Neurology', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Northwest Clinical Trials', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'Christie Clinic, LLC', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '60015', 'city': 'Riverwoods', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robbins Headache Clinic', 'geoPoint': {'lat': 42.16753, 'lon': -87.89701}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Institute for Clinical Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66208', 'city': 'Prairie Village', 'state': 'Kansas', 'country': 'United States', 'facility': 'Phoenix Medical Research, Inc', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'PharmaSite Research Inc', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Clinical Trials Inc', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Head, Pain and Neurological Institute', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Research Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63042', 'city': 'Hazelwood', 'state': 'Missouri', 'country': 'United States', 'facility': 'Healthcare Research Network - Hazelwood', 'geoPoint': {'lat': 38.77144, 'lon': -90.37095}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'ClinVest', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Albuquerque Clinical Trials', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Dent Neurological Institute', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '11803', 'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'facility': 'Island Neuro Associates,PC', 'geoPoint': {'lat': 40.77649, 'lon': -73.46735}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Univ of Cincinnati College of Medicine', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Healthcare Research Consultant', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '15236', 'city': 'Pleasant Hills', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Preferred Primary Care Physicians', 'geoPoint': {'lat': 40.33563, 'lon': -79.96061}}, {'zip': '19090', 'city': 'Willow Grove', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Neurological Associates', 'geoPoint': {'lat': 40.144, 'lon': -75.11573}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Trials of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center, Inc.', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29307', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'BG Neurology', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'ClinSearch', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Neurology and Sleep Lab', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Headache Medicine Specialist of North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Foothill Family Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Health Research of Hampton Roads Inc', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23456', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Neurology Specialists', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98007-4209', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Premier Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53562', 'city': 'Middleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Dean Foundation for Health Research and Education', 'geoPoint': {'lat': 43.09722, 'lon': -89.50429}}, {'zip': 'C1056ABJ', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1012AAR', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'C1013AAB', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'C1046AAQ', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'C1128AAF', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'C1204AAD', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'C1428AQK', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'C1430EGF', 'city': 'Ciudad Autonoma de Buenos Aire', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': 'X5000EDC', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5021FPQ', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'L6T 0G1', 'city': 'Brampton', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'V1Y 1Z9', 'city': 'Kelowna', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'K2G 6E2', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '656 91', 'city': 'Brno', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '27201', 'city': 'Kladno', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}, {'zip': '100 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '120 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '160 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '1790 12', 'city': 'Prague', 'country': 'Czechia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '33647', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '44787', 'city': 'Bochum', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '34121', 'city': 'Kassel', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '61462', 'city': 'Königstein', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.9157, 'lon': 14.07186}}, {'zip': '83209', 'city': 'Prien am Chiemsee', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.85602, 'lon': 12.34623}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'zip': '4420122', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '5266202', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '40139', 'city': 'Bologna', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '40124', 'city': 'Modena', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '00163', 'city': 'Roma', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '20217', 'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'zip': '80020', 'city': 'Culiacán', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'zip': '03310', 'city': 'México', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '1078 VV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '8025 AB', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '00674', 'city': 'Manatí', 'country': 'Puerto Rico', 'facility': 'Office of Dr. Ruddy Guerra', 'geoPoint': {'lat': 18.42745, 'lon': -66.49212}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'GCM Medical Group PSC', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Instituto de Neurologia Dra. Ivonne Fraga', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00926', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Neuro GI Wellness Center', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47005', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '80756', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '70142', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '71004', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '220', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], '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': 'https://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'}}}}