Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00883051
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2009-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Sponsor:
Organization:
Raw JSON
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'adverseEventsModule': {'timeFrame': 'up to 8 weeks', 'description': 'All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.', 'eventGroups': [{'id': 'EG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 53, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 59, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 60, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 59, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 19, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 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'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 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'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Derealisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Illusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Peripheral coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Headache Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}, {'value': '49.3', 'groupId': 'OG002'}, {'value': '35.3', 'groupId': 'OG003'}, {'value': '74.1', 'groupId': 'OG004'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000'}, {'value': '64.2', 'groupId': 'OG001'}, {'value': '50.7', 'groupId': 'OG002'}, {'value': '64.7', 'groupId': 'OG003'}, {'value': '25.9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'Cochran-Armitage test for trend', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours postdose', 'description': 'Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a post-baseline evaluation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}, {'value': '27.9', 'groupId': 'OG003'}, {'value': '7.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '=0.0006', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Cochran-Armitage test for trend]', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.'}], '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 1 dose of study drug, a 2 hour postdose evaluation and evaluable headache relief data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Headache Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000'}, {'value': '57.7', 'groupId': 'OG001'}, {'value': '62.9', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '57.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 24 hours postdose', 'description': 'Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received a dose of study drug, were pain free at 2 hours postdose and had postdose headache severity or symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Headache Severity (4 Point Rating Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'title': 'None (0)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}, {'value': '27.9', 'groupId': 'OG003'}, {'value': '7.4', 'groupId': 'OG004'}]}]}, {'title': 'Mild(1)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}, {'value': '31.9', 'groupId': 'OG002'}, {'value': '36.8', 'groupId': 'OG003'}, {'value': '18.5', 'groupId': 'OG004'}]}]}, {'title': 'Moderate(2)', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '26.1', 'groupId': 'OG002'}, {'value': '20.6', 'groupId': 'OG003'}, {'value': '27.2', 'groupId': 'OG004'}]}]}, {'title': 'Severe(3)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '21.7', 'groupId': 'OG002'}, {'value': '13.2', 'groupId': 'OG003'}, {'value': '46.9', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours postdose', 'description': 'Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.', '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 Have Symptoms of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '31.65', 'groupId': 'OG000'}, {'value': '25.00', 'groupId': 'OG001'}, {'value': '35.29', 'groupId': 'OG002'}, {'value': '26.87', 'groupId': 'OG003'}, {'value': '40.74', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours postdose', 'description': 'Percentage of participants who have symptoms of nausea two hours post treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received a dose of study drug and had postdose symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Have Symptoms Phonophobia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '41.77', 'groupId': 'OG000'}, {'value': '23.75', 'groupId': 'OG001'}, {'value': '39.71', 'groupId': 'OG002'}, {'value': '31.34', 'groupId': 'OG003'}, {'value': '48.15', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours postdose', 'description': 'Percentage of participants who have symptoms of phonophobia two hours post treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received a dose of study drug and had postdose symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Have Photophobia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '46.84', 'groupId': 'OG000'}, {'value': '31.25', 'groupId': 'OG001'}, {'value': '41.18', 'groupId': 'OG002'}, {'value': '37.31', 'groupId': 'OG003'}, {'value': '65.43', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours postdose', 'description': 'Percentage of participants who have symptoms of photophobia two hours post treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received a dose of study drug and had postdose symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.06', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}, {'value': '7.35', 'groupId': 'OG002'}, {'value': '4.80', 'groupId': 'OG003'}, {'value': '11.11', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours postdose', 'description': 'Percentage of participants with vomiting 2 hours post treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received a dose of study drug and had postdose symptom assessments.'}, {'type': 'SECONDARY', 'title': 'Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'title': 'Not at all (0)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Mild interference (1)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}]}, {'title': 'Marked interference (2)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Completely needs bed rest (3)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours postdose', 'description': 'The participant is asked "How much is the migraine interfering with normal activities?" on a 4 point scale 0-Not at all, 1-Mild interference, 2-Marked interference ,3-Completely needs bed rest, with a lower score having lower interference and higher score worse interference.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had evaluable data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}, {'value': '61.2', 'groupId': 'OG002'}, {'value': '41.8', 'groupId': 'OG003'}, {'value': '68.8', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 2 through 24 hours', 'description': 'Rescue medication was permitted after completion of the 2 hour assessment if 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': 'Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'title': 'Very much better', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Much better', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'A little better', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}]}, {'title': 'A little worse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 hours postdose', 'description': 'PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse, a lower number indicates much better and a higher number indicates worse.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a PGI-I measurement post dose.'}, {'type': 'SECONDARY', 'title': 'Actual Time to Headache Relief and Time to Pain Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'title': 'Pain relief', 'categories': [{'measurements': [{'value': '650.87', 'spread': '77.53', 'groupId': 'OG000'}, {'value': '291.05', 'spread': '32.24', 'groupId': 'OG001'}, {'value': '407.16', 'spread': '52.48', 'groupId': 'OG002'}, {'value': '218.93', 'spread': '23.87', 'groupId': 'OG003'}, {'value': '760.15', 'spread': '71.19', 'groupId': 'OG004'}]}]}, {'title': 'Pain free', 'categories': [{'measurements': [{'value': '871.27', 'spread': '72.74', 'groupId': 'OG000'}, {'value': '767.33', 'spread': '74.36', 'groupId': 'OG001'}, {'value': '690.89', 'spread': '59.67', 'groupId': 'OG002'}, {'value': '437.12', 'spread': '36.05', 'groupId': 'OG003'}, {'value': '1046.47', 'spread': '77.90', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours postdose', 'description': 'The participant answered "Did your migraine pain go away completely (pain free) within 24 hours of dosing" and record the time.\n\nActual time to meaningful pain relief and actual time to pain free will be censored at 24 hours if meaningful pain relief or pain free is documented to be greater than 24 hours after dosing and "Did you experience meaningful relief (headache relief) from your migraine within 24 hours after dosing?".', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-27.0', 'upperLimit': '28.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '24.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '-18.0', 'upperLimit': '28.0'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '-21.0', 'upperLimit': '28.0'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '-66.0', 'upperLimit': '18.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Day 14', 'description': 'Change from baseline in assessment of vital signs (heart rate).', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had evaluable ECG parameters.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-30.0', 'upperLimit': '29.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-25.0', 'upperLimit': '42.0'}, {'value': '-1.5', 'groupId': 'OG002', 'lowerLimit': '-23.0', 'upperLimit': '35.0'}, {'value': '-0.5', 'groupId': 'OG003', 'lowerLimit': '-35.0', 'upperLimit': '36.0'}, {'value': '-0.0', 'groupId': 'OG004', 'lowerLimit': '-30.0', 'upperLimit': '35.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Day 14', 'description': 'Change from baseline in vital signs (systolic blood pressure).', 'unitOfMeasure': 'millimeters of mercury', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-14.0', 'upperLimit': '21.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-20.0', 'upperLimit': '25.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-22.0', 'upperLimit': '15.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-20.0', 'upperLimit': '20.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-20.0', 'upperLimit': '21.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Day 14', 'description': 'Change from baseline in vital signs (diastolic blood pressure).', 'unitOfMeasure': 'millimeters of mercury', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change From Baseline in Physical Examination Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '86', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'title': 'Skin', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Head, ears, nose, throat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Musculoskeletal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3.5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Day 14', 'description': 'Participants were evaluated for skin, head, ear, nose and throat, cardiovascular and musculoskeletal changes from a normal screening to an abnormal screening. Changes in the physical examination noted as non-serious AEs or SAEs, regardless of causality, are located in the Reported Adverse Events section.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at last 1 dose of study drug and had a physical examination.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematology Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.4', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.4', 'groupId': 'OG004'}]}]}, {'title': 'Red blood cells', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG004'}]}]}, {'title': 'White blood cells', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '1.7', 'groupId': 'OG003'}, {'value': '-0.2', 'spread': '1.6', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '14.7', 'groupId': 'OG002'}, {'value': '-3.2', 'spread': '14.7', 'groupId': 'OG003'}, {'value': '-3.9', 'spread': '9.9', 'groupId': 'OG004'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '25.9', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '48.4', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '34.7', 'groupId': 'OG003'}, {'value': '1.7', 'spread': '34.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Day 14', 'description': 'Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.', 'unitOfMeasure': 'million cells per liter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had evaluable blood parameters.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)'}, {'id': 'OG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)'}, {'id': 'OG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)'}, {'id': 'OG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally (PO)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 8 weeks', 'description': "A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.", 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug excluding one participant who was lost to follow-up and did not report adverse events.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered PO within 4 hours of a migraine attack'}, {'id': 'FG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered PO within 4 hours of a migraine attack'}, {'id': 'FG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered PO within 4 hours of a migraine attack'}, {'id': 'FG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered PO within 4 hours of a migraine attack'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of a migraine attack'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '99'}, {'groupId': 'FG004', 'numSubjects': '103'}]}, {'type': 'No Study Medication Used', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'comment': 'One participant was lost to follow up and did not provide adverse event data.', 'groupId': 'FG004', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Did not use study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}, {'value': '391', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered PO within 4 hours of a migraine attack'}, {'id': 'BG001', 'title': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered PO within 4 hours of a migraine attack'}, {'id': 'BG002', 'title': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered PO within 4 hours of a migraine attack'}, {'id': 'BG003', 'title': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered PO within 4 hours of a migraine attack'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Placebo administered PO within 4 hours of a migraine attack'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '65'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '65'}, {'value': '41', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '57'}, {'value': '40', 'groupId': 'BG003', 'lowerLimit': '20', 'upperLimit': '60'}, {'value': '41', 'groupId': 'BG004', 'lowerLimit': '19', 'upperLimit': '66'}, {'value': '41.0', 'groupId': 'BG005', 'lowerLimit': '18.0', 'upperLimit': '66.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}, {'value': '342', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}, {'value': '390', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}, {'value': '387', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '124', 'groupId': 'BG005'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '173', 'groupId': 'BG005'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 512}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2009-04-16', 'resultsFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2009-04-16', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-20', 'studyFirstPostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Headache Response', 'timeFrame': '2 hours postdose', 'description': 'Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after administration of study drug.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose', 'timeFrame': '2 hours post dose', 'description': 'The percentage of participants defined as mild, moderate, or severe headache pain becoming none.'}, {'measure': 'Percentage of Participants With Headache Recurrence', 'timeFrame': 'up to 24 hours postdose', 'description': 'Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.'}, {'measure': 'Percentage of Participants With Headache Severity (4 Point Rating Scale)', 'timeFrame': '2 hours postdose', 'description': 'Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.'}, {'measure': 'Percentage of Participants Who Have Symptoms of Nausea', 'timeFrame': '2 hours postdose', 'description': 'Percentage of participants who have symptoms of nausea two hours post treatment.'}, {'measure': 'Percentage of Participants Who Have Symptoms Phonophobia', 'timeFrame': '2 hours postdose', 'description': 'Percentage of participants who have symptoms of phonophobia two hours post treatment.'}, {'measure': 'Percentage of Participants Who Have Photophobia', 'timeFrame': '2 hours postdose', 'description': 'Percentage of participants who have symptoms of photophobia two hours post treatment.'}, {'measure': 'Percentage of Participants With Vomiting', 'timeFrame': '2 hours postdose', 'description': 'Percentage of participants with vomiting 2 hours post treatment.'}, {'measure': 'Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)', 'timeFrame': '2 hours postdose', 'description': 'The participant is asked "How much is the migraine interfering with normal activities?" on a 4 point scale 0-Not at all, 1-Mild interference, 2-Marked interference ,3-Completely needs bed rest, with a lower score having lower interference and higher score worse interference.'}, {'measure': 'Percentage of Participants Who Used Rescue Medication', 'timeFrame': 'Postdose 2 through 24 hours', 'description': 'Rescue medication was permitted after completion of the 2 hour assessment if migraine did not respond (participant was not pain free).'}, {'measure': 'Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)', 'timeFrame': '2 hours postdose', 'description': 'PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse, a lower number indicates much better and a higher number indicates worse.'}, {'measure': 'Actual Time to Headache Relief and Time to Pain Free', 'timeFrame': 'up to 24 hours postdose', 'description': 'The participant answered "Did your migraine pain go away completely (pain free) within 24 hours of dosing" and record the time.\n\nActual time to meaningful pain relief and actual time to pain free will be censored at 24 hours if meaningful pain relief or pain free is documented to be greater than 24 hours after dosing and "Did you experience meaningful relief (headache relief) from your migraine within 24 hours after dosing?".'}, {'measure': 'Change From Baseline in Heart Rate', 'timeFrame': 'Baseline through Day 14', 'description': 'Change from baseline in assessment of vital signs (heart rate).'}, {'measure': 'Change From Baseline in Systolic Blood Pressure', 'timeFrame': 'Baseline through Day 14', 'description': 'Change from baseline in vital signs (systolic blood pressure).'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure', 'timeFrame': 'Baseline through Day 14', 'description': 'Change from baseline in vital signs (diastolic blood pressure).'}, {'measure': 'Percentage of Participants With Change From Baseline in Physical Examination Parameters', 'timeFrame': 'Baseline through Day 14', 'description': 'Participants were evaluated for skin, head, ear, nose and throat, cardiovascular and musculoskeletal changes from a normal screening to an abnormal screening. Changes in the physical examination noted as non-serious AEs or SAEs, regardless of causality, are located in the Reported Adverse Events section.'}, {'measure': 'Change From Baseline in Hematology Tests', 'timeFrame': 'Baseline through Day 14', 'description': 'Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.'}, {'measure': 'Number of Serious Adverse Events', 'timeFrame': 'up to 8 weeks', 'description': "A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COL-144', 'acute treatment', 'migraine'], 'conditions': ['Migraine Disorders']}, 'referencesModule': {'references': [{'pmid': '37965170', 'type': 'DERIVED', 'citation': 'Blumenfeld A, Tepper SJ, Khanna R, Doty E, Vincent M, Miller SI. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023 Oct 27;14:1291102. doi: 10.3389/fneur.2023.1291102. eCollection 2023.'}, {'pmid': '22459549', 'type': 'DERIVED', 'citation': 'Farkkila M, Diener HC, Geraud G, Lainez M, Schoenen J, Harner N, Pilgrim A, Reuter U; COL MIG-202 study group. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012 May;11(5):405-13. doi: 10.1016/S1474-4422(12)70047-9. Epub 2012 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.', 'detailedDescription': 'Migraine is a common chronic neurological disorder characterized by recurrent disabling episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce its severity. Analgesics are commonly used or, if these are ineffective, triptans. Since triptans are contraindicated in patients with coronary artery disease, uncontrolled hypertension, and cerebrovascular disease alternative medications are required for patients where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically relevant concentrations and might meet this need. COL-144 was effective when given intravenously in a placebo-controlled dose-ranging study. This study investigates which dose of oral COL-144 is effective in the in acute treatment of migraine headache.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)\n* History of migraine of at least 1 year\n* Migraine onset before the age of 50 years\n* History of 1 - 8 migraine attacks per month\n* Male or female patients aged 18 to 65 years\n* Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)\n* Able and willing to give written informed consent\n* Able and willing to complete a migraine diary card to record details of the attack treated with study medication\n\nExclusion Criteria:\n\n* History of life threatening or intolerable adverse reaction to any triptan\n* Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation\n* Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis\n* Using 5-HT reuptake inhibitors\n* Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)\n* Pregnant or breast-feeding women\n* Women of child-bearing potential not using highly effective contraception\n* History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures\n* History of hypertension (controlled or uncontrolled)\n* History of orthostatic hypotension\n* Current use of hemodynamically active cardiovascular drugs\n* History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol\n* Significant renal or hepatic impairment\n* Previous participation in this clinical trial\n* Participation in any clinical trial of an experimental drug or device in the previous 30 days\n* Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study\n* Known Hepatitis B or C or HIV infection\n* Patients who are employees of the sponsor\n* Relatives of, or staff directly reporting to, the investigator\n* Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product\n* Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)'}, 'identificationModule': {'nctId': 'NCT00883051', 'briefTitle': 'Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine', 'orgStudyIdInfo': {'id': '16892'}, 'secondaryIdInfos': [{'id': 'H8H-CD-LAHO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2008-005010-43', 'type': 'EUDRACT_NUMBER'}, {'id': 'COL MIG-202', 'type': 'OTHER', 'domain': 'Colucid'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 mg Lasmiditan', 'description': '50 mg lasmiditan administered orally (PO)', 'interventionNames': ['Drug: Lasmiditan']}, {'type': 'EXPERIMENTAL', 'label': '100 mg Lasmiditan', 'description': '100 mg lasmiditan administered orally (PO)', 'interventionNames': ['Drug: Lasmiditan']}, {'type': 'EXPERIMENTAL', 'label': '200 mg Lasmiditan', 'description': '200 mg lasmiditan administered orally (PO)', 'interventionNames': ['Drug: Lasmiditan']}, {'type': 'EXPERIMENTAL', 'label': '400 mg Lasmiditan', 'description': '400 mg lasmiditan administered orally (PO)', 'interventionNames': ['Drug: Lasmiditan']}, {'type': 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'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'}, 'collaborators': [{'name': 'CoLucid Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}