Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT04804033
Status:
TERMINATED
Last Update Posted:
2025-03-27
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D012001', 'term': 'Hyperacusis'}, {'id': 'D020795', 'term': 'Photophobia'}, {'id': 'D009325', 'term': 'Nausea'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'DBT Phase: 12 weeks of treatment; OLE Phase: 52 weeks of treatment; Follow-up phase: 8 weeks after the discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase', 'eventGroups': [{'id': 'EG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 14, 'seriousNumAtRisk': 173, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 8, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Zavegepant Pooled (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.', 'otherNumAtRisk': 348, 'deathsNumAtRisk': 348, 'otherNumAffected': 22, 'seriousNumAtRisk': 348, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 13, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 11, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.', 'otherNumAtRisk': 174, 'deathsNumAtRisk': 174, 'otherNumAffected': 24, 'seriousNumAtRisk': 174, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Zavegepant 100 mg (OLE)', 'description': 'Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 12, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Zavegepant 200 mg (OLE)', 'description': 'Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 12, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Zavegepant 100 mg DBT/Zavegepant 100 mg OLE: Follow-up', 'description': 'Participants who received Zavegepant 100 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 0, 'seriousNumAtRisk': 154, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Zavegepant 200 mg DBT/ Zavegepant 200 mg OLE: Follow-up', 'description': 'Participants who received Zavegepant 200 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Placebo Matched to Zavegepant 100 mg (DBT)/ Zavegepant 100 mg OLE: Follow-up', 'description': 'Participants who received Placebo matched to Zavegepant 100 mg in DBT phase or Placebo matched to Zavegepant 100 mg in DBT phase and Zavegepant 100 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'Placebo Matched to Zavegepant 200 mg (DBT)/ Zavegepant 200 mg OLE: Follow-up', 'description': 'Participants who received Placebo matched to Zavegepant 200 mg in DBT phase or Placebo matched to Zavegepant 200 mg in DBT phase and Zavegepant 200 mg in OLE phase, were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT or OLE phase.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Placebo Pooled (DBT)/No Zavegepant OLE: Follow-up', 'description': 'Participants who received Placebo matched to Zavegepant 100 mg or 200 mg in DBT phase and no Zavegepant in OLE phase were followed up for safety for 8 weeks post discontinuation or completion of treatment in DBT phase.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 12}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 12}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 154, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA27.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'groupId': 'OG000', 'lowerLimit': '-8.10', 'upperLimit': '-5.92'}, {'value': '-6.3', 'groupId': 'OG001', 'lowerLimit': '-7.45', 'upperLimit': '-5.10'}, {'value': '-5.6', 'groupId': 'OG002', 'lowerLimit': '-6.80', 'upperLimit': '-4.37'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in least square mean (LSM)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.4', 'ciLowerLimit': '-2.72', 'ciUpperLimit': '-0.12', 'estimateComment': 'Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.7', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '0.69', 'estimateComment': 'Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12)', 'description': 'A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \\>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \\>= 1 of following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\\*(total number of migraine days through Month 3\\[Weeks 1 to 12\\] in on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\\[Weeks 1 to 12\\] in the on-DBT efficacy analysis period).', 'unitOfMeasure': 'Migraine Days per Month', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Migraine analysis set included participants in the DBT efficacy analysis set with \\>= 14 days of e-diary efficacy data in both the observation phase and \\>= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took \\>=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ statistical analysis plan (SAP).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >= 50 % Reduction in Number of Moderate to Severe Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '47.7', 'upperLimit': '65.1'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '37.8', 'upperLimit': '55.4'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '31.4', 'upperLimit': '48.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '16.6', 'ciLowerLimit': '4.4', 'ciUpperLimit': '28.8', 'estimateComment': 'Stratified by randomization stratum using Mantel-Haenszel risk estimation.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '6.6', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '18.9', 'estimateComment': 'Stratified by randomization stratum using Mantel-Haenszel risk estimation.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Entire DBT Phase: 12 weeks (Week 1 through 12)', 'description': 'A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\\>=) 30 minutes, and met at least one of following criteria (A and/or B): A. \\>=2 of following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \\>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\\*(total number of migraine days through Month 3\\[Weeks 1 to 12\\] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\\[Weeks 1 to 12\\] in on-DBT efficacy analysis period).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Migraine analysis set included participants in the DBT efficacy analysis set with \\>= 14 days of e-diary efficacy data in both the observation phase and \\>= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took \\>=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Observation Phase in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Placebo Pooled', 'description': 'Participants received 100 mg and 200 mg daily dose of 4 oral soft gel capsules for up to 52-weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'groupId': 'OG000', 'lowerLimit': '-9.11', 'upperLimit': '-6.59'}, {'value': '-7.2', 'groupId': 'OG001', 'lowerLimit': '-8.56', 'upperLimit': '-5.83'}, {'value': '-6.8', 'groupId': 'OG002', 'lowerLimit': '-8.22', 'upperLimit': '-5.38'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1', 'ciLowerLimit': '-2.68', 'ciUpperLimit': '0.58', 'estimateComment': 'Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.4', 'ciLowerLimit': '-2.10', 'ciUpperLimit': '1.31', 'estimateComment': 'Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Observation Phase: 28 days prior to randomization and baseline; DBT Phase: last 4 weeks (Week 9 through 12)', 'description': 'A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for greater than or equal to (\\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A.\\>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \\>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28\\* (total number of migraine days in the month\\[Week 9 to 12\\])/(total number of eDiary efficacy data days in the month\\[Week 9 to 12\\]).', 'unitOfMeasure': 'Migraine Days per Month', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Migraine analysis set analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Observation Phase in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.7', 'groupId': 'OG000', 'lowerLimit': '-6.89', 'upperLimit': '-4.51'}, {'value': '-5.1', 'groupId': 'OG001', 'lowerLimit': '-6.26', 'upperLimit': '-3.87'}, {'value': '-3.9', 'groupId': 'OG002', 'lowerLimit': '-5.10', 'upperLimit': '-2.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.8', 'ciLowerLimit': '-3.16', 'ciUpperLimit': '-0.42', 'estimateComment': 'Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.2', 'ciLowerLimit': '-2.53', 'ciUpperLimit': '0.22', 'estimateComment': 'Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Observation Phase: 28 days prior to randomization and baseline; DBT Phase: first 4 weeks (Week 1 through 4)', 'description': 'A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for greater than or equal to (\\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \\>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \\>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in the on-DBT efficacy analysis period as follows: 28\\* (total number of migraine days in the month\\[Week 1 to 4\\])/ (total number of eDiary efficacy data days in the month\\[Week 1 to 4\\]).', 'unitOfMeasure': 'Migraine Days per Month', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Migraine analysis set analyzed. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Acute Migraine -Specific Medication Days Per Month Over Entire DBT Phase (Weeks 1 to 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '3.43'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': '4.17'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '1.94', 'upperLimit': '4.46'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.8', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '0.05', 'estimateComment': 'Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.2', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.74', 'estimateComment': 'Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Entire DBT Phase: 12 weeks (Week 1 through 12)', 'description': 'Acute migraine (AM)-specific medication day was defined as any calendar day on which the participant took an acute migraine-specific medication during aura or to treat a headache. Acute migraine-specific medications were triptans and ergotamine. The number of acute migraine-specific medication days per month were prorated to 28 days and derived as follows: 28 \\* (total number of acute migraine-specific medication days through Month 3 \\[Week 1 to 12\\] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3 \\[Week 1 to 12\\] in the on-DBT efficacy analysis period).', 'unitOfMeasure': 'AM-specific Medication Days per Month', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Migraine analysis set included participants in the DBT efficacy analysis set with \\>= 14 days of e-diary efficacy data in both the observation phase and \\>= 1 month (4-week interval) in the DBT phase. DBT efficacy analysis set: participants who were enrolled and randomized only once and took \\>=1 dose of DB study drug (zavegepant or placebo). Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Migraine-specific Quality of Life Questionnaire (MSQ) v 2.1 Restrictive Role Function Domain Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '19.10', 'upperLimit': '29.83'}, {'value': '20.6', 'groupId': 'OG001', 'lowerLimit': '14.63', 'upperLimit': '26.61'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '14.92', 'upperLimit': '26.12'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '3.9', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '9.39', 'estimateComment': 'Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.1', 'ciLowerLimit': '-5.66', 'ciUpperLimit': '5.86', 'estimateComment': 'Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'DBT Phase: Baseline (before dose on Day 1), Week 12', 'description': "MSQ v 2.1 is 14-item questionnaire that assessed impact of treatment on participant-reported quality of life across 3 domains: role function-restrictive, preventive, and emotional function. Restrictive role function domain consists of 7 items that describe how migraine limits one's daily social, work-related activities. Participants respond to items using a 6-point scale ranging from 1 (none of the time) to 6 (all of the time), which are assigned scores of 1 to 6, respectively. Response from each item of restrictive role function domain were added providing a possible raw score range of 7 (no impairment) to 42 (maximum impairment). Raw score range of restrictive role function domain was then transformed to a 0 (no impairment) to 100 (maximum impairment), higher scores = higher impairment.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT efficacy analysis set included participants in the full analysis set who were randomized only once and took \\>= 1 dose of DB study drug (zavegepant or placebo). Here, " Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.8', 'groupId': 'OG000', 'lowerLimit': '-35.81', 'upperLimit': '-17.79'}, {'value': '-27.1', 'groupId': 'OG001', 'lowerLimit': '-36.62', 'upperLimit': '-17.61'}, {'value': '-17.9', 'groupId': 'OG002', 'lowerLimit': '-31.36', 'upperLimit': '-4.34'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-9', 'ciLowerLimit': '-18.10', 'ciUpperLimit': '0.19', 'estimateComment': 'Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-9.3', 'ciLowerLimit': '-18.95', 'ciUpperLimit': '0.41', 'estimateComment': 'Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'DBT Phase: Baseline (before dose on Day 1), Week 12', 'description': 'MIDAS is a retrospective, participant-reported, 5-item questionnaire that measured headache related disability as lost days due to headache from paid work or school, household work and non-work activities over past 3-months. The total score is calculated as the sum of item scores to all 5 questions on a scale of 0 (no disability) to 90 (maximum disability) resulting into overall possible MIDAS total score (range from 0 (no disability) to 450 (maximum disability). Higher scores = more severe disability.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT efficacy analysis set included participants in the full analysis set who were randomized only once and took \\>= 1 dose of DB study drug (zavegepant or placebo). Here, " Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Results were summarized by treatment group and the 2 matching placebo groups were pooled as pre-specified in protocol/ SAP.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate or Severe Adverse Events (AEs): DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Zavegepant Pooled (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG003', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG004', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG005', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT safety analysis set included the participants who were enrolled and took \\>= 1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs): DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Zavegepant Pooled (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG003', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG004', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG005', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT safety analysis set included the participants who were enrolled and took \\>= 1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Zavegepant Pooled (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG003', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG004', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG005', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT safety analysis set included the participants in the who were enrolled and who took \\>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Zavegepant Pooled (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG003', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG004', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG005', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Creatine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}, {'value': '170', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}, {'value': '142', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'LDL Cholesterol, fasting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'LDL Cholesterol, not fasting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Potassium, high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}, {'value': '142', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '71', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'DBT: During 12 weeks of treatment', 'description': 'Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT safety analysis set included the participants in the who were enrolled and who took \\>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date. Participants reported under "Overall Number of Participants Analyzed" contributed data but may not be evaluable for every row and "Number Analyzed" signifies participants evaluable for the specified rows.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate or Severe AEs: OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (OLE)', 'description': 'Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (OLE)', 'description': 'Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OLE: During 52 weeks of treatment', 'description': 'AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL safety analysis set included the participants who took \\>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SAEs: OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (OLE)', 'description': 'Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (OLE)', 'description': 'Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OLE: During 52 weeks of treatment', 'description': 'AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL safety analysis set included the participants who took \\>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (OLE)', 'description': 'Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (OLE)', 'description': 'Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OLE: During 52 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL safety analysis set included the participants who took \\>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (OLE)', 'description': 'Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (OLE)', 'description': 'Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.'}], 'classes': [{'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Glucose fasting, low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol, fasting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol, not fasting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, high', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, fasting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides, not fasting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OLE: During 52 weeks of treatment', 'description': 'Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL safety analysis set included the participants who took \\>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date. Here, "Number Analyzed" signifies participants evaluable for the specified rows. "Overall Number of Participants Analyzed" contributed data to table but may not have evaluable data for every row.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Zavegepant Pooled (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG003', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG004', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG005', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '4.9'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'DBT: Over 12 weeks of treatment', 'description': 'Elevations of AST or alanine aminotransferase (ALT) \\> 3 \\*upper limit of normal (ULN) concurrent with total bilirubin (TBL) \\> 2 \\*ULN (elevations on the same laboratory collection date) were included.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT safety analysis set included the participants in the who were enrolled and who took \\>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (OLE)', 'description': 'Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (OLE)', 'description': 'Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'OLE: Over 52 weeks of treatment', 'description': 'Elevations of AST or ALT \\> 3 \\* ULN concurrent with TBL \\> 2 \\*ULN were defined as elevations on the same collection date.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OL safety analysis set included the participants who took \\>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hepatic-related AEs by Intensity: DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Zavegepant Pooled (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG003', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG004', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG005', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT safety analysis set included the participants in the who were enrolled and who took \\>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: DBT Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '348', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'OG002', 'title': 'Zavegepant Pooled (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG003', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG004', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'OG005', 'title': 'Placebo Pooled (DBT)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg or 200 mg daily for 12 weeks in DBT phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DBT safety analysis set included the participants in the who were enrolled and who took \\>=1 dose of DB study drug (zavegepant or placebo), i.e., non-missing study drug start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hepatic-related AEs by Intensity: OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (OLE)', 'description': 'Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (OLE)', 'description': 'Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OLE: Over 52 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL safety analysis set included the participants who took \\>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: OLE Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant 100 mg (OLE)', 'description': 'Participants who received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.'}, {'id': 'OG001', 'title': 'Zavegepant 200 mg (OLE)', 'description': 'Participants who received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OLE: Over 52 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL safety analysis set included the participants who took \\>= 1 dose of OL zavegepant, i.e., nonmissing OL zavegepant start date.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zavegepant 100 mg (OLE/DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase. Eligible participants continued to receive Zavegepant in similar manner for another 52 weeks in OLE phase.'}, {'id': 'FG001', 'title': 'Zavegepant 200 mg (OLE/DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase. Eligible participants continued to receive Zavegepant in similar manner for another 52 weeks in OLE phase.'}, {'id': 'FG002', 'title': 'Placebo (DBT)/ Zavegepant 100 mg (OLE)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase. Eligible participants received Zavegepant 100 mg orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 52 weeks in OLE phase.'}, {'id': 'FG003', 'title': 'Placebo (DBT)/ Zavegepant 200 mg (OLE)', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase. Eligible participants received Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 52 weeks in OLE phase.'}], 'periods': [{'title': 'Period 1: DBT Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2: OLE Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Eligible participants who completed DBT phase and entered the OLE phase.', 'groupId': 'FG000', 'numSubjects': '105'}, {'comment': 'Eligible participants who completed DBT phase and entered the OLE phase.', 'groupId': 'FG001', 'numSubjects': '94'}, {'comment': 'Eligible participants who completed DBT phase and entered the OLE phase.', 'groupId': 'FG002', 'numSubjects': '50'}, {'comment': 'Eligible participants who completed DBT phase and entered the OLE phase.', 'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Failure to meet continuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period 3: Follow-up Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Eligible participants who entered follow-up phase either directly from DBT phase or after OLE phase.', 'groupId': 'FG000', 'numSubjects': '154'}, {'comment': 'Eligible participants who entered follow-up phase either directly from DBT phase or after OLE phase.', 'groupId': 'FG001', 'numSubjects': '162'}, {'comment': 'Eligible participants who entered follow-up phase either directly from DBT phase or after OLE phase.', 'groupId': 'FG002', 'numSubjects': '47'}, {'comment': 'Eligible participants who entered follow-up phase either directly from DBT phase or after OLE phase.', 'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'The study enrolled 1753 participants, out of which 1219 were not randomized. Only 534 participants were randomized in a 12-week double-blind treatment (DBT) phase. A total of 298 eligible participants then entered in a 52-week open-label extension (OLE) phase. Participants had a follow-up of 8 weeks after discontinuation or completion of treatment in DBT (if not entered OLE) or OLE phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '522', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Zavegepant 100 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 100 milligrams (mg) orally as soft gelatin capsules (25 mg \\*4 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'BG001', 'title': 'Zavegepant 200 mg (DBT)', 'description': 'Participants were randomized to receive Zavegepant 200 mg orally as soft gelatin capsules (25 mg \\*8 capsules) daily for 12 weeks in DBT phase.'}, {'id': 'BG002', 'title': 'Placebo (DBT) Matched to Zavegepant 100 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 100 mg daily for 12 weeks in DBT phase.'}, {'id': 'BG003', 'title': 'Placebo (DBT) Matched to Zavegepant 200 mg', 'description': 'Participants were randomized to receive placebo matched to Zavegepant 200 mg daily for 12 weeks in DBT phase.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'spread': '12.85', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '13.30', 'groupId': 'BG001'}, {'value': '41.7', 'spread': '13.15', 'groupId': 'BG002'}, {'value': '41.5', 'spread': '13.14', 'groupId': 'BG003'}, {'value': '42.2', 'spread': '13.09', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '413', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '374', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '391', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'DBT safety analysis set included participants in the safety analysis set who took greater than or equal to (\\>=) 1 dose of DB study drug (zavegepant or placebo), i.e., nonmissing DB study drug start date.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-16', 'size': 2624351, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-06T14:45', 'hasProtocol': True}, {'date': '2024-05-30', 'size': 2215368, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-06T14:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1753}}, 'statusModule': {'whyStopped': 'Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2021-03-05', 'resultsFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-25', 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Observation Phase (OP) in the Number of Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)', 'timeFrame': 'Observation Phase: 28 days prior to randomization and baseline; Entire DBT Phase: 12 weeks (Week 1 through 12)', 'description': 'A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \\>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \\>= 1 of following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\\*(total number of migraine days through Month 3\\[Weeks 1 to 12\\] in on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\\[Weeks 1 to 12\\] in the on-DBT efficacy analysis period).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With >= 50 % Reduction in Number of Moderate to Severe Migraine Days Per Month Over Entire DBT Phase (Weeks 1 to 12)', 'timeFrame': 'Entire DBT Phase: 12 weeks (Week 1 through 12)', 'description': 'A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as migraine with or without aura, lasting for greater than or equal to (\\>=) 30 minutes, and met at least one of following criteria (A and/or B): A. \\>=2 of following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \\>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived as follows: 28\\*(total number of migraine days through Month 3\\[Weeks 1 to 12\\] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3\\[Weeks 1 to 12\\] in on-DBT efficacy analysis period).'}, {'measure': 'Mean Change From Observation Phase in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of DBT Phase', 'timeFrame': 'Observation Phase: 28 days prior to randomization and baseline; DBT Phase: last 4 weeks (Week 9 through 12)', 'description': 'A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for greater than or equal to (\\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A.\\>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \\>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in on-DBT efficacy analysis period as follows: 28\\* (total number of migraine days in the month\\[Week 9 to 12\\])/(total number of eDiary efficacy data days in the month\\[Week 9 to 12\\]).'}, {'measure': 'Mean Change From Observation Phase in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of DBT Phase', 'timeFrame': 'Observation Phase: 28 days prior to randomization and baseline; DBT Phase: first 4 weeks (Week 1 through 4)', 'description': 'A migraine day was defined as any calendar day in which participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for greater than or equal to (\\>=) 30 minutes, and met at least one of the following criteria (A and/or B): A. \\>=2 of the following pain features: a. Unilateral location, b. Pulsating quality (throbbing), c. Moderate or severe pain intensity, d. Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) B. \\>= 1 of the following associated symptoms: a. Nausea and/or vomiting b. Photophobia and phonophobia. The number of migraine days per month were prorated to 28 days and derived for month (i.e., 4-week interval) in the on-DBT efficacy analysis period as follows: 28\\* (total number of migraine days in the month\\[Week 1 to 4\\])/ (total number of eDiary efficacy data days in the month\\[Week 1 to 4\\]).'}, {'measure': 'Mean Number of Acute Migraine -Specific Medication Days Per Month Over Entire DBT Phase (Weeks 1 to 12)', 'timeFrame': 'Entire DBT Phase: 12 weeks (Week 1 through 12)', 'description': 'Acute migraine (AM)-specific medication day was defined as any calendar day on which the participant took an acute migraine-specific medication during aura or to treat a headache. Acute migraine-specific medications were triptans and ergotamine. The number of acute migraine-specific medication days per month were prorated to 28 days and derived as follows: 28 \\* (total number of acute migraine-specific medication days through Month 3 \\[Week 1 to 12\\] in the on-DBT efficacy analysis period)/ (total number of eDiary efficacy data days through Month 3 \\[Week 1 to 12\\] in the on-DBT efficacy analysis period).'}, {'measure': 'Mean Change From Baseline in the Migraine-specific Quality of Life Questionnaire (MSQ) v 2.1 Restrictive Role Function Domain Score at Week 12', 'timeFrame': 'DBT Phase: Baseline (before dose on Day 1), Week 12', 'description': "MSQ v 2.1 is 14-item questionnaire that assessed impact of treatment on participant-reported quality of life across 3 domains: role function-restrictive, preventive, and emotional function. Restrictive role function domain consists of 7 items that describe how migraine limits one's daily social, work-related activities. Participants respond to items using a 6-point scale ranging from 1 (none of the time) to 6 (all of the time), which are assigned scores of 1 to 6, respectively. Response from each item of restrictive role function domain were added providing a possible raw score range of 7 (no impairment) to 42 (maximum impairment). Raw score range of restrictive role function domain was then transformed to a 0 (no impairment) to 100 (maximum impairment), higher scores = higher impairment."}, {'measure': 'Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12', 'timeFrame': 'DBT Phase: Baseline (before dose on Day 1), Week 12', 'description': 'MIDAS is a retrospective, participant-reported, 5-item questionnaire that measured headache related disability as lost days due to headache from paid work or school, household work and non-work activities over past 3-months. The total score is calculated as the sum of item scores to all 5 questions on a scale of 0 (no disability) to 90 (maximum disability) resulting into overall possible MIDAS total score (range from 0 (no disability) to 450 (maximum disability). Higher scores = more severe disability.'}, {'measure': 'Number of Participants With Moderate or Severe Adverse Events (AEs): DBT Phase', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs): DBT Phase', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.'}, {'measure': 'Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: DBT Phase', 'timeFrame': 'DBT: During 12 weeks of treatment', 'description': 'Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling.'}, {'measure': 'Number of Participants With Moderate or Severe AEs: OLE Phase', 'timeFrame': 'OLE: During 52 weeks of treatment', 'description': 'AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. AEs included both SAEs and all non-SAEs. Severity: Moderate=Alleviated with additional specific therapeutic intervention, interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe= Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.'}, {'measure': 'Number of Participants With SAEs: OLE Phase', 'timeFrame': 'OLE: During 52 weeks of treatment', 'description': 'AEs: new untoward medical occurrence or worsening of a pre-existing medical condition in participant or clinical investigation participant administered investigational product that does not necessarily have a causal relationship with treatment. SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.'}, {'measure': 'Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase', 'timeFrame': 'OLE: During 52 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities: OLE Phase', 'timeFrame': 'OLE: During 52 weeks of treatment', 'description': 'Laboratory tests included eosinophils, hemoglobin, leukocytes, lymphocytes, neutrophils, platelets; albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, bilirubin, calcium, cholesterol, potassium, sodium, triglycerides, uric acid, urinalysis, urine protein, creatine kinase (CK), creatinine, glomerular filtration rate (GFR), glucose, glucose fasting, lactate dehydrogenase, low density lipoprotein (LDL) Cholesterol, LDL Cholesterol. Number of participants with grade 3 to 4 laboratory test abnormalities were evaluated in this outcome measure. Only rows which included at least 1 participant in any reporting group with grade 3 to 4 abnormality were reported in this outcome measure. As per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) Grade 3= severe and Grade 4= life-threatening or disabling.'}, {'measure': 'Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: DBT Phase', 'timeFrame': 'DBT: Over 12 weeks of treatment', 'description': 'Elevations of AST or alanine aminotransferase (ALT) \\> 3 \\*upper limit of normal (ULN) concurrent with total bilirubin (TBL) \\> 2 \\*ULN (elevations on the same laboratory collection date) were included.'}, {'measure': 'Percentage of Participants With AST or ALT Elevations >3 * ULN With Total Bilirubin > 2 * ULN: OLE Phase', 'timeFrame': 'OLE: Over 52 weeks of treatment', 'description': 'Elevations of AST or ALT \\> 3 \\* ULN concurrent with TBL \\> 2 \\*ULN were defined as elevations on the same collection date.'}, {'measure': 'Number of Participants With Hepatic-related AEs by Intensity: DBT Phase', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.'}, {'measure': 'Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: DBT Phase', 'timeFrame': 'DBT Phase: During 12 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Number of Participants With Hepatic-related AEs by Intensity: OLE Phase', 'timeFrame': 'OLE: Over 52 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. AEs by intensity: Mild: Transient and may require only minimal treatment or therapeutic intervention. Event did not interfere with activities of daily living. Moderate: Alleviated with additional specific therapeutic intervention. Event interfered with activities of daily living, causing discomfort, but possessed no significant or permanent risk of harm. Severe: Interrupted activities of daily living significantly affected clinical status or required intensive therapeutic intervention.'}, {'measure': 'Number of Participants With Hepatic-related AEs Leading to Study Drug Discontinuation: OLE Phase', 'timeFrame': 'OLE: Over 52 weeks of treatment', 'description': 'An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine Prevention', 'Phonophobia', 'Photophobia', 'Nausea'], 'conditions': ['Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=BHV3500-302', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of\n\nHeadache Disorders, 3rd Edition, including the following:\n\n1. Age of onset of migraines prior to 50 years of age\n2. Migraine attacks, on average, lasting 4 - 72 hours if untreated\n3. Per subject report, at least 15 headache days per month, at lest 8 migraine days per month, and at least 1 headache-free day per month within the last 3 months prior to the Screening Visit\n4. Eight or more migraine days during the Observation Period\n5. 15 or more headache days during the Observation Period\n6. One or more non-headache days during the Observation Period\n7. Ability to distinguish migraine attacks from tension/cluster headaches\n8. Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.\n\nExclusion Criteria:\n\n1. Subject with a history of HIV disease\n2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening\n3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).\n4. Subjects with major depressive episode or anxiety disorder which require more than 1 daily medication for each disorder or subjects with a major depressive episode within the last 12 months. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening Visit.\n5. Subjects with active chronic pain syndromes, other pain syndromes (including trigeminal neuralgia), psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion interfere with study assessments of safety or efficacy.\n6. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease or condition (e.g. chronic pancreatitis, ulcerative colitis, etc.) that causes malabsorption.\n7. Body mass index \\> 33 kg/m2\n8. History of gallstones or cholecystectomy.\n9. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial"}, 'identificationModule': {'nctId': 'NCT04804033', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2/3 Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention', 'orgStudyIdInfo': {'id': 'BHV3500-302'}, 'secondaryIdInfos': [{'id': 'C5301006', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BHV-3500 200mg', 'description': 'Zavegepant 200mg oral soft gel capsule.', 'interventionNames': ['Drug: BHV-3500 (zavegepant)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 200mg', 'description': 'Matching placebo 200mg oral soft gel capsule.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BHV-3500 100mg', 'description': 'Zavegepant 100mg oral soft gel capsule.', 'interventionNames': ['Drug: BHV-3500 (zavegepant)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 100mg', 'description': 'Matching placebo 100mg oral soft gel capsule.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BHV-3500 (zavegepant)', 'type': 'DRUG', 'description': 'BHV-3500 (zavegepant) softgel capsule.', 'armGroupLabels': ['BHV-3500 100mg', 'BHV-3500 200mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo softgel capsule.', 'armGroupLabels': ['Placebo 100mg', 'Placebo 200mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 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