Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-01 @ 5:19 PM
Study NCT ID:
NCT02439320
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C554777', 'term': 'lasmiditan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinicaltrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 11 weeks', 'description': 'All randomized participants who had received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': '100 mg Lasmiditan', 'description': 'Any participant who received 100 milligrams (mg) lasmiditan administered PO.', 'otherNumAtRisk': 630, 'deathsNumAtRisk': 630, 'otherNumAffected': 258, 'seriousNumAtRisk': 630, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '200 mg Lasmiditan', 'description': 'Any participant who received 200 milligrams (mg) lasmiditan administered PO.', 'otherNumAtRisk': 609, 'deathsNumAtRisk': 609, 'otherNumAffected': 280, 'seriousNumAtRisk': 609, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Any participant who received placebo administered PO.', 'otherNumAtRisk': 617, 'deathsNumAtRisk': 617, 'otherNumAffected': 113, 'seriousNumAtRisk': 617, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mydriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bowel movement irregularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 2, 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'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Feeling drunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Feeling of relaxation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Breast cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'sourceVocabulary': 'MedDRA 18.0'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 617, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 630, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 609, 'numEvents': 1, 'numAffected': 1}, 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milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}, {'value': '32.2', 'groupId': 'OG001'}, {'value': '15.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '1.6', 'ciUpperLimit': '3.0', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '2.0', 'ciUpperLimit': '3.6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants defined as mild, moderate, or severe headache pain becoming none.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '488', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}, {'value': '29.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.3', 'ciUpperLimit': '2.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '1.3', 'ciUpperLimit': '2.1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable MBS data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Have Headache Relief After First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '59.5', 'groupId': 'OG001'}, {'value': '42.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '1.8', 'ciUpperLimit': '3.1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '1.9', 'ciUpperLimit': '3.3', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable headache relief data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Headache Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.029', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.1', 'ciUpperLimit': '2.8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '1.3', 'ciUpperLimit': '3.4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 hours post dose up to 48 hours', 'description': 'Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '20.7', 'groupId': 'OG001'}, {'value': '46.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.2', 'ciUpperLimit': '0.4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post dose', 'description': 'Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}, {'value': '255', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}, {'value': '11.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.120', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.1', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.035', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.4', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Anytime between 2-24 hours post dose', 'description': 'Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Anytime 24-48 hours post dose', 'description': 'Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Nausea Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000'}, {'value': '64.1', 'groupId': 'OG001'}, {'value': '62.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.386', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.4', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.470', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.4', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants without nausea.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Phonophobia Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000'}, {'value': '58.7', 'groupId': 'OG001'}, {'value': '52.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.037', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '1.0', 'ciUpperLimit': '1.6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants without phonophobia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Photophobia Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}, {'value': '51.5', 'groupId': 'OG001'}, {'value': '38.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.5', 'ciUpperLimit': '2.4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.4', 'ciUpperLimit': '02.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants without photophobia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.'}, {'type': 'SECONDARY', 'title': 'Participants With Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}, {'value': '617', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 11 weeks', 'description': 'Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '406', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}, {'value': '617', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Lasmiditan/100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. An optional 100 mg Lasmiditan dose was administered between 2 and 24 hours for rescue or recurrence of migraine.'}, {'id': 'OG001', 'title': '100 mg Lasmiditan/Placebo', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.'}, {'id': 'OG002', 'title': '200 mg Lasmiditan/200 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. An optional 100 mg lasmiditan dose was administered between 2 and 24 hours for rescue or recurrence of migraine.'}, {'id': 'OG003', 'title': '200 mg Lasmiditan/Placebo', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.'}, {'id': 'OG004', 'title': 'Placebo/Placebo', 'description': 'Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.'}], 'classes': [{'title': '6 Months prior to enrolling', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}, {'value': '3.0', 'groupId': 'OG002'}, {'value': '2.5', 'groupId': 'OG003'}, {'value': '2.8', 'groupId': 'OG004'}]}]}, {'title': 'During time of study', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}, {'value': '0.5', 'groupId': 'OG003'}, {'value': '0.6', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack', 'description': 'Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study', 'calculatePct': False, 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who used at least 1 dose of study drug, regardless of whether or not they underwent any study assessments.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'FG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '744'}, {'groupId': 'FG001', 'numSubjects': '745'}, {'groupId': 'FG002', 'numSubjects': '742'}]}, {'type': 'Confirmed Eligibility', 'achievements': [{'groupId': 'FG000', 'numSubjects': '710'}, {'groupId': 'FG001', 'numSubjects': '695'}, {'groupId': 'FG002', 'numSubjects': '705'}]}, {'type': '1st Dose (by 4 Hours Migraine Onset)', 'comment': 'Safety population based on the first dose. Participants received at least 1 dose of study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '630'}, {'groupId': 'FG001', 'numSubjects': '609'}, {'groupId': 'FG002', 'numSubjects': '617'}]}, {'type': '2nd Dose (After 2 Hour Assessment)', 'comment': 'Participants received second dose of study drug after 4 hours.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '238'}, {'groupId': 'FG002', 'numSubjects': '401'}]}, {'type': 'COMPLETED', 'comment': 'Included participants who received study drug and participants who did not receive study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '648'}, {'groupId': 'FG001', 'numSubjects': '631'}, {'groupId': 'FG002', 'numSubjects': '643'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '99'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Noncompliance with Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Sponsor Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Randomization Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '34'}]}]}], 'preAssignmentDetails': 'Participants were randomized in a double-blind, placebo-controlled parallel group study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'BG000'}, {'value': '609', 'groupId': 'BG001'}, {'value': '617', 'groupId': 'BG002'}, {'value': '1856', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '100 mg Lasmiditan', 'description': '100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose'}, {'id': 'BG001', 'title': '200 mg Lasmiditan', 'description': '200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '11.67', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '12.04', 'groupId': 'BG001'}, {'value': '42.4', 'spread': '12.30', 'groupId': 'BG002'}, {'value': '42.0', 'spread': '12.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '512', 'groupId': 'BG000'}, {'value': '515', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}, {'value': '1552', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '304', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '544', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}, {'value': '1600', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '471', 'groupId': 'BG000'}, {'value': '450', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}, {'value': '1400', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Unknown or Not reported row is listed as Other in the Clinical Study Report.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '630', 'groupId': 'BG000'}, {'value': '609', 'groupId': 'BG001'}, {'value': '617', 'groupId': 'BG002'}, {'value': '1856', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Migraine History', 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'spread': '12.98', 'groupId': 'BG000'}, {'value': '18.9', 'spread': '13.12', 'groupId': 'BG001'}, {'value': '19.3', 'spread': '12.65', 'groupId': 'BG002'}, {'value': '19.3', 'spread': '12.92', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2018-04-03', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-02', 'studyFirstSubmitDate': '2015-03-18', 'dispFirstSubmitQcDate': '2018-04-03', 'resultsFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2015-05-06', 'dispFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-08', 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Resource Utilization', 'timeFrame': '6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack', 'description': 'Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Who Are Headache Pain Free', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants defined as mild, moderate, or severe headache pain becoming none.'}, {'measure': 'Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Have Headache Relief After First Dose', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.'}, {'measure': 'Percentage of Participants With Headache Recurrence', 'timeFrame': 'From 2 hours post dose up to 48 hours', 'description': 'Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.'}, {'measure': 'Percentage of Participants Who Used Rescue Medication', 'timeFrame': '2 hours post dose', 'description': 'Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).'}, {'measure': 'Percentage of Participants Who Used Rescue Medication', 'timeFrame': 'Anytime between 2-24 hours post dose', 'description': 'Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).'}, {'measure': 'Percentage of Participants Who Used Rescue Medication', 'timeFrame': 'Anytime 24-48 hours post dose', 'description': 'Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).'}, {'measure': 'Percentage of Participants Nausea Free', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants without nausea.'}, {'measure': 'Percentage of Participants Phonophobia Free', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants without phonophobia.'}, {'measure': 'Percentage of Participants Photophobia Free', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants without photophobia.'}, {'measure': 'Participants With Serious Adverse Events (SAE)', 'timeFrame': 'Baseline up to 11 weeks', 'description': 'Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Migraine']}, 'referencesModule': {'references': [{'pmid': '36125279', 'type': 'DERIVED', 'citation': "Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072."}, {'pmid': '35779194', 'type': 'DERIVED', 'citation': 'Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.'}, {'pmid': '35471625', 'type': 'DERIVED', 'citation': 'Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.'}, {'pmid': '35350937', 'type': 'DERIVED', 'citation': 'Charleston L 4th, Savage-Edwards B, Bragg SM, Baygani SK, Dennehy EB. Migraine history and response to lasmiditan across racial and ethnic groups. Curr Med Res Opin. 2022 May;38(5):721-730. doi: 10.1080/03007995.2022.2057152. Epub 2022 Apr 3.'}, {'pmid': '34644189', 'type': 'DERIVED', 'citation': 'Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.'}, {'pmid': '34454420', 'type': 'DERIVED', 'citation': 'Lipton RB, Baygani SK, Tepper SJ, Krege JH, Vasudeva R, Pearlman EM, Hauck PM, Loo LS. A close association of freedom from pain, migraine-related functional disability, and other outcomes: results of a post hoc analysis of randomized lasmiditan studies SAMURAI and SPARTAN. J Headache Pain. 2021 Aug 28;22(1):101. doi: 10.1186/s10194-021-01303-w.'}, {'pmid': '34366152', 'type': 'DERIVED', 'citation': 'Martin VT, Ahmed Z, Hochstetler HM, Baygani SK, Dong Y, Hauck PM, Khanna R. Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies. Clin Ther. 2021 Jun;43(6):1066-1078. doi: 10.1016/j.clinthera.2021.04.004. Epub 2021 Aug 6.'}, {'pmid': '33784930', 'type': 'DERIVED', 'citation': 'Peres MFP, Vasudeva R, Baygani SK, Dennehy EB, Vincent M, Friedman DI. Lasmiditan efficacy in migraine attacks with mild vs. moderate or severe pain. Curr Med Res Opin. 2021 Jun;37(6):1031-1038. doi: 10.1080/03007995.2021.1903846. Epub 2021 Apr 7.'}, {'pmid': '33730977', 'type': 'DERIVED', 'citation': 'Clemow DB, Hochstetler HM, Dong Y, Hauck P, Peres MFP, Ailani J. Effect of a change in lasmiditan dose on efficacy and safety in patients with migraine. Postgrad Med. 2021 May;133(4):449-459. doi: 10.1080/00325481.2020.1860619. Epub 2021 Mar 17.'}, {'pmid': '32783644', 'type': 'DERIVED', 'citation': 'Clemow DB, Baygani SK, Hauck PM, Hultman CB. Lasmiditan in patients with common migraine comorbidities: a post hoc efficacy and safety analysis of two phase 3 randomized clinical trials. Curr Med Res Opin. 2020 Nov;36(11):1791-1806. doi: 10.1080/03007995.2020.1808780. Epub 2020 Oct 6.'}, {'pmid': '32447545', 'type': 'DERIVED', 'citation': 'Smith T, Krege JH, Rathmann SS, Dowsett SA, Hake A, Nery ESM, Matthews BR, Doty EG. Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies. Neurol Ther. 2020 Dec;9(2):459-471. doi: 10.1007/s40120-020-00185-5. Epub 2020 May 23.'}, {'pmid': '31744319', 'type': 'DERIVED', 'citation': 'Knievel K, Buchanan AS, Lombard L, Baygani S, Raskin J, Krege JH, Loo LS, Komori M, Tobin J. Lasmiditan for the acute treatment of migraine: Subgroup analyses by prior response to triptans. Cephalalgia. 2020 Jan;40(1):19-27. doi: 10.1177/0333102419889350. Epub 2019 Nov 19.'}, {'pmid': '31529622', 'type': 'DERIVED', 'citation': 'Ashina M, Vasudeva R, Jin L, Lombard L, Gray E, Doty EG, Yunes-Medina L, Kinchen KS, Tassorelli C. Onset of Efficacy Following Oral Treatment With Lasmiditan for the Acute Treatment of Migraine: Integrated Results From 2 Randomized Double-Blind Placebo-Controlled Phase 3 Clinical Studies. Headache. 2019 Nov;59(10):1788-1801. doi: 10.1111/head.13636. Epub 2019 Sep 17.'}, {'pmid': '31464581', 'type': 'DERIVED', 'citation': 'Shapiro RE, Hochstetler HM, Dennehy EB, Khanna R, Doty EG, Berg PH, Starling AJ. Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials. J Headache Pain. 2019 Aug 29;20(1):90. doi: 10.1186/s10194-019-1044-6.'}, {'pmid': '31409292', 'type': 'DERIVED', 'citation': 'Loo LS, Plato BM, Turner IM, Case MG, Raskin J, Dowsett SA, Krege JH. Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN). BMC Neurol. 2019 Aug 13;19(1):191. doi: 10.1186/s12883-019-1420-5.'}, {'pmid': '31340760', 'type': 'DERIVED', 'citation': 'Loo LS, Ailani J, Schim J, Baygani S, Hundemer HP, Port M, Krege JH. Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials. J Headache Pain. 2019 Jul 24;20(1):84. doi: 10.1186/s10194-019-1032-x.'}, {'pmid': '31266353', 'type': 'DERIVED', 'citation': 'Doty EG, Krege JH, Jin L, Raskin J, Halker Singh RB, Kalidas K. Sustained responses to lasmiditan: Results from post-hoc analyses of two Phase 3 randomized clinical trials for acute treatment of migraine. Cephalalgia. 2019 Oct;39(12):1569-1576. doi: 10.1177/0333102419859313. Epub 2019 Jul 3.'}, {'pmid': '31166697', 'type': 'DERIVED', 'citation': 'Krege JH, Rizzoli PB, Liffick E, Doty EG, Dowsett SA, Wang J, Buchanan AS. Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN. Cephalalgia. 2019 Jul;39(8):957-966. doi: 10.1177/0333102419855080. Epub 2019 Jun 5.'}, {'pmid': '31152441', 'type': 'DERIVED', 'citation': 'Tepper SJ, Krege JH, Lombard L, Asafu-Adjei JK, Dowsett SA, Raskin J, Buchanan AS, Friedman DI. Characterization of Dizziness After Lasmiditan Usage: Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials. Headache. 2019 Jul;59(7):1052-1062. doi: 10.1111/head.13544. Epub 2019 Jun 1.'}, {'pmid': '30446595', 'type': 'DERIVED', 'citation': 'Kuca B, Silberstein SD, Wietecha L, Berg PH, Dozier G, Lipton RB; COL MIG-301 Study Group. Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study. Neurology. 2018 Dec 11;91(24):e2222-e2232. doi: 10.1212/WNL.0000000000006641. Epub 2018 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).', 'detailedDescription': "Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able and willing to give written informed consent.\n* Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).\n* History of disabling migraine for at least 1 year.\n* MIDAS score ≥11.\n* Migraine onset before the age of 50 years.\n* History of 3 - 8 migraine attacks per month (\\< 15 headache days per month).\n* Male or female, aged 18 years or above.\n* Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).\n* Able and willing to complete an electronic diary.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women.\n* Women of child-bearing potential not using or not willing to use highly effective contraception.\n* Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.\n* History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.\n* History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.\n* History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).\n* History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.\n* History of orthostatic hypotension with syncope.\n* Significant renal or hepatic impairment.\n* Participant is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit.\n* Known Hepatitis B or C or HIV infection.\n* History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is greater than 15 headache days per month.\n* Use of more than 3 doses per month of either opiates or barbiturates.\n* Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1."}, 'identificationModule': {'nctId': 'NCT02439320', 'acronym': 'SAMURAI', 'briefTitle': 'Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study', 'orgStudyIdInfo': {'id': '16888'}, 'secondaryIdInfos': [{'id': 'H8H-CD-LAHJ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'COL MIG-301', 'type': 'OTHER', 'domain': 'CoLucid Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lasmiditan 100 mg', 'description': 'Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.', 'interventionNames': ['Drug: Lasmiditan 100 mg', 'Drug: Placebo (matches lasmiditan doses)']}, {'type': 'EXPERIMENTAL', 'label': 'Lasmiditan 200 mg', 'description': 'Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.', 'interventionNames': ['Drug: Lasmiditan 200 mg', 'Drug: Placebo (matches lasmiditan doses)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.', 'interventionNames': ['Drug: Placebo (matches lasmiditan doses)']}], 'interventions': [{'name': 'Lasmiditan 100 mg', 'type': 'DRUG', 'otherNames': ['LY573144'], 'armGroupLabels': ['Lasmiditan 100 mg']}, {'name': 'Lasmiditan 200 mg', 'type': 'DRUG', 'otherNames': ['LY573144'], 'armGroupLabels': ['Lasmiditan 200 mg']}, {'name': 'Placebo (matches lasmiditan doses)', 'type': 'DRUG', 'armGroupLabels': ['Lasmiditan 100 mg', 'Lasmiditan 200 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southview Medical Group, P.C.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Simon-Williamson Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35261', 'city': 'Birmingham', 'state': 'Alabama', 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