Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-01-03 @ 6:49 PM
Study NCT ID:
NCT02638103
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Germany', 'Hungary', 'Italy', 'Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604315', 'term': 'fremanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'USMedInfo@tevapharm.com', 'phone': '1-888-483-8279', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline (Day 0) up to follow-up visit (Day 533)', 'description': 'Safety population included all participants who received at least 1 dose of fremanezumab.', 'eventGroups': [{'id': 'EG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).', 'otherNumAtRisk': 418, 'deathsNumAtRisk': 418, 'otherNumAffected': 300, 'seriousNumAtRisk': 418, 'deathsNumAffected': 0, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).', 'otherNumAtRisk': 526, 'deathsNumAtRisk': 526, 'otherNumAffected': 367, 'seriousNumAtRisk': 526, 'deathsNumAffected': 0, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).', 'otherNumAtRisk': 419, 'deathsNumAtRisk': 419, 'otherNumAffected': 284, 'seriousNumAtRisk': 419, 'deathsNumAffected': 1, 'seriousNumAffected': 36}, {'id': 'EG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).', 'otherNumAtRisk': 525, 'deathsNumAtRisk': 525, 'otherNumAffected': 329, 'seriousNumAtRisk': 525, 'deathsNumAffected': 0, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 430, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 446, 'numAffected': 144}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 284, 'numAffected': 99}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 386, 'numAffected': 124}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 43, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 66, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 38, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 62, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 717, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 753, 'numAffected': 174}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 543, 'numAffected': 144}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 666, 'numAffected': 134}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 980, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 982, 'numAffected': 156}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 981, 'numAffected': 135}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 811, 'numAffected': 140}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 101, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 107, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 64, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 64, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 28, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 61, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 107, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 58, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 108, 'numAffected': 68}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 40, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 38, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 65, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 76, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 97, 'numAffected': 73}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 78, 'numAffected': 63}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 38, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 43, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 37, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrovascular arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Congenital cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Congenital cystic disease of liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hereditary haemochromatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': "Barrett's oesophagus", 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ileal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatitis alcoholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Petrositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ammonia increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vertebral osteophyte', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Breast cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Endometrial cancer', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'High grade B-cell lymphoma Burkitt-like lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Phyllodes tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Prostate cancer', 'notes': 'This is a gender-specific AE. Only male participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Superficial spreading melanoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cluster headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Perineurial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Primary progressive multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Status migrainosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abortion spontaneous', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Foetal death', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Premature baby', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Premature separation of placenta', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Adjustment disorder with mixed disturbance of emotion and conduct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Endometriosis', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemorrhagic ovarian cyst', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian cyst', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian cyst ruptured', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian mass', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 454, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Uterine haemorrhage', 'notes': 'This is a gender-specific AE. Only female participants were at risk.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 369, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 457, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lung consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Salpingo-oophorectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 418, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 525, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}, {'value': '419', 'groupId': 'OG002'}, {'value': '525', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}, {'value': '426', 'groupId': 'OG003'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '270', 'groupId': 'OG003'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'AEs leading to discontinuation from study', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0) up to follow-up visit (Day 533)', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of fremanezumab.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}, {'value': '173', 'groupId': 'OG005'}, {'value': '138', 'groupId': 'OG006'}, {'value': '173', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover CM Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover CM Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG004', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants', 'description': 'Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG005', 'title': 'TEV-48125 225 mg Monthly: Active Rollover EM Participants', 'description': 'Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG006', 'title': 'TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants', 'description': 'Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG007', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover EM Participants', 'description': 'Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'spread': '6.98', 'groupId': 'OG000'}, {'value': '-8.2', 'spread': '6.14', 'groupId': 'OG001'}, {'value': '-7.6', 'spread': '6.87', 'groupId': 'OG002'}, {'value': '-7.0', 'spread': '6.54', 'groupId': 'OG003'}, {'value': '-4.5', 'spread': '4.20', 'groupId': 'OG004'}, {'value': '-5.5', 'spread': '4.01', 'groupId': 'OG005'}, {'value': '-5.5', 'spread': '3.65', 'groupId': 'OG006'}, {'value': '-5.0', 'spread': '3.78', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: A calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day(0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)\\*28. Change was calculated as post-baseline value - baseline value.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set (FAS):all participants who received at least 1 dose of fremanezumab, had at least 10 days of efficacy assessments by e-diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants.'Overall number of participants analyzed'=participants evaluable for this outcome."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Monthly Average Number of Headache Days of Any Severity During the 4-Week Period at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}, {'value': '173', 'groupId': 'OG005'}, {'value': '138', 'groupId': 'OG006'}, {'value': '173', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover CM Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover CM Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG004', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants', 'description': 'Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG005', 'title': 'TEV-48125 225 mg Monthly: Active Rollover EM Participants', 'description': 'Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG006', 'title': 'TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants', 'description': 'Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG007', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover EM Participants', 'description': 'Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.7', 'spread': '6.79', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '6.01', 'groupId': 'OG001'}, {'value': '-7.2', 'spread': '6.48', 'groupId': 'OG002'}, {'value': '-7.1', 'spread': '6.88', 'groupId': 'OG003'}, {'value': '-4.4', 'spread': '4.25', 'groupId': 'OG004'}, {'value': '-5.0', 'spread': '3.90', 'groupId': 'OG005'}, {'value': '-5.0', 'spread': '3.63', 'groupId': 'OG006'}, {'value': '-4.8', 'spread': '3.74', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) \\* 28. The change was calculated as post-baseline value - baseline value.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '412', 'groupId': 'OG002'}, {'value': '513', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0) up to end of treatment (EOT) visit (Day 336)', 'description': 'Potentially clinically significant abnormal serum chemistry findings included: Blood Urea Nitrogen (BUN): greater than or equal to (\\>=) 10.71 millimoles/liter (mmol/L), creatinine: \\>=177 micromoles/liter (µmol/L), bilirubin: \\>=34.2 µmol/L, Alanine Aminotransferase (ALT) (units/liter \\[U/L\\]): \\>=3\\*upper limit of normal (ULN) Aspartate Aminotransferase (AST) (U/L): \\>=3\\*ULN, and Gamma Glutamyl Transferase (GGT) (U/L): \\>=3\\*ULN. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline serum chemistry values."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Abnormal Hematology Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '412', 'groupId': 'OG002'}, {'value': '513', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0) up to EOT visit (Day 336)', 'description': 'Potentially clinically significant abnormal hematology findings included: hemoglobin: less than (\\<) 115 grams/liter (g/L) (in males) or less than or equal to (\\<=) 95 g/L (in females), hematocrit: \\<0.37 L/L (in male) or \\<0.32 L/L (in female), leukocytes: \\>=20\\*10\\^9/L or \\<=3\\*10\\^9/L, eosinophils/leukocytes: \\>=10%, and platelets: \\>=700\\*10\\^9/L or \\<=75\\*10\\^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline hematology parameter values."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '517', 'groupId': 'OG001'}, {'value': '412', 'groupId': 'OG002'}, {'value': '513', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0) up to EOT visit (Day 336)', 'description': 'Potentially clinically significant abnormal urinalysis findings included: blood: \\>=2 unit increase from baseline, urine glucose (milligrams/decilitre \\[mg/dL\\]): \\>=2 unit increase from baseline, ketones (mg/dL): \\>=2 unit increase from baseline, urine protein (mg/dL): \\>=2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline urinalysis values."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}, {'value': '414', 'groupId': 'OG002'}, {'value': '519', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0) up to EOT visit (Day 336)', 'description': 'Potentially clinically significant abnormal vital signs findings included: pulse rate: \\<=50 beats/minute (bpm) and decrease of \\>=15 bpm, or \\>=120 bpm and increase of \\>=15 bpm; systolic blood pressure: \\<=90 millimeters of mercury (mmHg) and decrease of \\>=20 mmHg, or \\>=180 mmHg and increase of \\>=20 mmHg; diastolic blood pressure: \\<=50 mmHg and decrease of \\>=15 mmHg or \\>=105 mmHg and increase of \\>=15 mmHg; respiratory rate: \\<10 breaths/minute; and body temperature \\>=38.3 degrees centigrade and change of \\>=1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline vital signs values."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}, {'value': '489', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'title': 'Normal - Normal', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}, {'value': '296', 'groupId': 'OG003'}]}]}, {'title': 'Normal - Abnormal NCS', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}]}, {'title': 'Normal - Abnormal CS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS - Normal', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS - Abnormal NCS', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS - Abnormal CS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS - Normal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS - Abnormal NCS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS - Abnormal CS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0), endpoint (Day 336)', 'description': "ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed' = participants with both baseline and endpoint electrocardiogram findings."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}, {'value': '410', 'groupId': 'OG002'}, {'value': '513', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'title': 'PT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}, {'value': '410', 'groupId': 'OG002'}, {'value': '513', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Low-Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Low-Normal', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Low-High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal-Low', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Normal-Normal', 'measurements': [{'value': '370', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}, {'value': '451', 'groupId': 'OG003'}]}, {'title': 'Normal-High', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}, {'title': 'High-Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'High-Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}, {'title': 'High-High', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Prothrombin INR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}, {'value': '410', 'groupId': 'OG002'}, {'value': '513', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Low-Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Low-Normal', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': 'Low-High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal-Low', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Normal-Normal', 'measurements': [{'value': '366', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}, {'value': '372', 'groupId': 'OG002'}, {'value': '472', 'groupId': 'OG003'}]}, {'title': 'Normal-High', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'High-Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'High-Normal', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}, {'title': 'High-High', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'aPTT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}, {'value': '410', 'groupId': 'OG002'}, {'value': '513', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Low-Low', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Low-Normal', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Low-High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal-Low', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Normal-Normal', 'measurements': [{'value': '341', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}, {'title': 'Normal-High', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'High-Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'High-Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}, {'title': 'High-High', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0), endpoint (Day 336)', 'description': 'Coagulation parameters included: prothrombin time (PT) (seconds), prothrombin international normalized ratio (INR), activated partial thromboplastin time (aPTT) (seconds). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed' = participants with both baseline and endpoint coagulation laboratory test results. 'Number analyzed' = participants evaluable for specified categories."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}, {'value': '125', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}, {'value': '139', 'groupId': 'OG006'}, {'value': '174', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover CM Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover CM Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG004', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants', 'description': 'Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG005', 'title': 'TEV-48125 225 mg Monthly: Active Rollover EM Participants', 'description': 'Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG006', 'title': 'TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants', 'description': 'Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG007', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover EM Participants', 'description': 'Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '75', 'groupId': 'OG005'}, {'value': '68', 'groupId': 'OG006'}, {'value': '64', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period) \\* 28.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}, {'value': '174', 'groupId': 'OG005'}, {'value': '138', 'groupId': 'OG006'}, {'value': '174', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover CM Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover CM Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG004', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants', 'description': 'Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG005', 'title': 'TEV-48125 225 mg Monthly: Active Rollover EM Participants', 'description': 'Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG006', 'title': 'TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants', 'description': 'Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}, {'id': 'OG007', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover EM Participants', 'description': 'Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '72', 'groupId': 'OG005'}, {'value': '67', 'groupId': 'OG006'}, {'value': '68', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of at least moderate severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) \\* 28.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}, {'value': '419', 'groupId': 'OG002'}, {'value': '525', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'title': 'Injection site induration', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}]}, {'title': 'Injection site haemorrhage', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pruritus', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Injection site bruising', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Injection site rash', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Injection site urticaria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Injection site warmth', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Injection site dermatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Injection site haematoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Injection site inflammation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site discolouration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Injection site hypersensitivity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site hypoaesthesia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site irritation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Injection site oedema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site papule', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site paraesthesia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site vesicles', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pallor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from MedDRA version 18.1 were offered without a threshold applied. Injection site reactions included injection site induration, pain, erythema, haemorrhage, pruritus, swelling, bruising, rash, urticaria, warmth, dermatitis, haematoma, inflammation, discolouration, discomfort, hypersensitivity, hypoaesthesia, irritation, oedema, papule, paraesthesia, vesicles and pallor. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of fremanezumab.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}, {'value': '419', 'groupId': 'OG002'}, {'value': '525', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'OG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'classes': [{'title': 'Suicidal ideation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Suicidal attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of fremanezumab.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab (TEV-48125) 675 milligrams (mg) subcutaneously (SC) as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters \\[mL\\] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'FG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'FG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'FG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '419'}, {'groupId': 'FG001', 'numSubjects': '526'}, {'groupId': 'FG002', 'numSubjects': '420'}, {'groupId': 'FG003', 'numSubjects': '525'}]}, {'type': 'Safety Analysis Set', 'comment': 'Received at least 1 dose of study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '526'}, {'groupId': 'FG002', 'numSubjects': '419'}, {'groupId': 'FG003', 'numSubjects': '525'}]}, {'type': 'Full Analysis Set (FAS)', 'comment': 'Participants in safety analysis set who had at least 10 days of post-baseline efficacy assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '416'}, {'groupId': 'FG001', 'numSubjects': '520'}, {'groupId': 'FG002', 'numSubjects': '419'}, {'groupId': 'FG003', 'numSubjects': '523'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '313'}, {'groupId': 'FG001', 'numSubjects': '408'}, {'groupId': 'FG002', 'numSubjects': '335'}, {'groupId': 'FG003', 'numSubjects': '383'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '85'}, {'groupId': 'FG003', 'numSubjects': '142'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Non-compliance to Study Procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants with chronic or episodic migraine (CM or EM) who completed the pivotal efficacy studies of fremanezumab (TV48125-CNS-30049 \\[NCT02621931\\] and TV48125-CNS-30050 \\[NCT02629861\\]) and agreed to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), were enrolled in this study.', 'preAssignmentDetails': 'A total of 1890 participants were enrolled, including 917 participants with CM rolled over from Study TV48125-CNS-30049, 661 participants with EM rolled over from Study TV48125-CNS-30050, and 312 newly enrolled participants (193 with CM and 119 with EM).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'BG000'}, {'value': '526', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}, {'value': '525', 'groupId': 'BG003'}, {'value': '1890', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'BG001', 'title': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'BG002', 'title': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'BG003', 'title': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '12.09', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '11.97', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '11.67', 'groupId': 'BG002'}, {'value': '43.2', 'spread': '11.73', 'groupId': 'BG003'}, {'value': '43.5', 'spread': '11.87', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '365', 'groupId': 'BG000'}, {'value': '454', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}, {'value': '457', 'groupId': 'BG003'}, {'value': '1645', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '245', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '387', 'groupId': 'BG000'}, {'value': '481', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}, {'value': '1738', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}, {'value': '412', 'groupId': 'BG003'}, {'value': '1530', 'groupId': 'BG004'}]}, {'title': 'Black', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '191', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Migraine Days', 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '5.99', 'groupId': 'BG000'}, {'value': '13.1', 'spread': '5.49', 'groupId': 'BG001'}, {'value': '13.6', 'spread': '5.86', 'groupId': 'BG002'}, {'value': '13.2', 'spread': '5.26', 'groupId': 'BG003'}, {'value': '13.4', 'spread': '5.63', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine; a calendar day demonstrating a headache of any duration that was treated with migraine-specific medications.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Headache Days of Any Severity', 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '6.68', 'groupId': 'BG000'}, {'value': '12.7', 'spread': '6.20', 'groupId': 'BG001'}, {'value': '13.2', 'spread': '6.32', 'groupId': 'BG002'}, {'value': '12.9', 'spread': '6.02', 'groupId': 'BG003'}, {'value': '13.1', 'spread': '6.29', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat (ITT) analysis set included all participants who were randomized in this study for long-term safety evaluation, regardless if they receive study treatment or not.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-30', 'size': 8727232, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-05T07:50', 'hasProtocol': True}, {'date': '2017-06-13', 'size': 846239, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-05T07:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1890}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03539393', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2018-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-06', 'studyFirstSubmitDate': '2015-12-18', 'resultsFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2015-12-18', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-12', 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: A calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day(0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)\\*28. Change was calculated as post-baseline value - baseline value.'}, {'measure': 'Change From Baseline in Monthly Average Number of Headache Days of Any Severity During the 4-Week Period at Month 12', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) \\* 28. The change was calculated as post-baseline value - baseline value.'}, {'measure': 'Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period) \\* 28.'}, {'measure': 'Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of at least moderate severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) \\* 28.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline (Day 0) up to follow-up visit (Day 533)', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results', 'timeFrame': 'Baseline (Day 0) up to end of treatment (EOT) visit (Day 336)', 'description': 'Potentially clinically significant abnormal serum chemistry findings included: Blood Urea Nitrogen (BUN): greater than or equal to (\\>=) 10.71 millimoles/liter (mmol/L), creatinine: \\>=177 micromoles/liter (µmol/L), bilirubin: \\>=34.2 µmol/L, Alanine Aminotransferase (ALT) (units/liter \\[U/L\\]): \\>=3\\*upper limit of normal (ULN) Aspartate Aminotransferase (AST) (U/L): \\>=3\\*ULN, and Gamma Glutamyl Transferase (GGT) (U/L): \\>=3\\*ULN. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Abnormal Hematology Results', 'timeFrame': 'Baseline (Day 0) up to EOT visit (Day 336)', 'description': 'Potentially clinically significant abnormal hematology findings included: hemoglobin: less than (\\<) 115 grams/liter (g/L) (in males) or less than or equal to (\\<=) 95 g/L (in females), hematocrit: \\<0.37 L/L (in male) or \\<0.32 L/L (in female), leukocytes: \\>=20\\*10\\^9/L or \\<=3\\*10\\^9/L, eosinophils/leukocytes: \\>=10%, and platelets: \\>=700\\*10\\^9/L or \\<=75\\*10\\^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results', 'timeFrame': 'Baseline (Day 0) up to EOT visit (Day 336)', 'description': 'Potentially clinically significant abnormal urinalysis findings included: blood: \\>=2 unit increase from baseline, urine glucose (milligrams/decilitre \\[mg/dL\\]): \\>=2 unit increase from baseline, ketones (mg/dL): \\>=2 unit increase from baseline, urine protein (mg/dL): \\>=2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values', 'timeFrame': 'Baseline (Day 0) up to EOT visit (Day 336)', 'description': 'Potentially clinically significant abnormal vital signs findings included: pulse rate: \\<=50 beats/minute (bpm) and decrease of \\>=15 bpm, or \\>=120 bpm and increase of \\>=15 bpm; systolic blood pressure: \\<=90 millimeters of mercury (mmHg) and decrease of \\>=20 mmHg, or \\>=180 mmHg and increase of \\>=20 mmHg; diastolic blood pressure: \\<=50 mmHg and decrease of \\>=15 mmHg or \\>=105 mmHg and increase of \\>=15 mmHg; respiratory rate: \\<10 breaths/minute; and body temperature \\>=38.3 degrees centigrade and change of \\>=1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters', 'timeFrame': 'Baseline (Day 0), endpoint (Day 336)', 'description': "ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section."}, {'measure': 'Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results', 'timeFrame': 'Baseline (Day 0), endpoint (Day 336)', 'description': 'Coagulation parameters included: prothrombin time (PT) (seconds), prothrombin international normalized ratio (INR), activated partial thromboplastin time (aPTT) (seconds). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Injection Site Reactions', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from MedDRA version 18.1 were offered without a threshold applied. Injection site reactions included injection site induration, pain, erythema, haemorrhage, pruritus, swelling, bruising, rash, urticaria, warmth, dermatitis, haematoma, inflammation, discolouration, discomfort, hypersensitivity, hypoaesthesia, irritation, oedema, papule, paraesthesia, vesicles and pallor. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)', 'timeFrame': 'Baseline (Day -28 to Day -1), Month 12', 'description': 'eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '32913018', 'type': 'DERIVED', 'citation': 'Goadsby PJ, Silberstein SD, Yeung PP, Cohen JM, Ning X, Yang R, Dodick DW. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology. 2020 Nov 3;95(18):e2487-e2499. doi: 10.1212/WNL.0000000000010600. Epub 2020 Sep 10.'}, {'pmid': '32887548', 'type': 'DERIVED', 'citation': 'Buse DC, Gandhi SK, Cohen JM, Ramirez-Campos V, Cloud B, Yang R, Cowan RP. Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain. 2020 Sep 4;21(1):109. doi: 10.1186/s10194-020-01177-4.'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 \\[NCT02621931\\] and TV48125-CNS-30050 \\[NCT02629861\\]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants Rolling Over from the Pivotal Efficacy Studies:\n\n* Participant must have signed and dated the informed consent document.\n* Participant must have completed the pivotal efficacy study without major protocol violations.\n\n * Additional criteria apply, please contact the investigator for more information.\n\nParticipants Not Rolling Over from the Pivotal Efficacy Studies:\n\n* Males or females aged 18 to 70 years, inclusive, with migraine onset at less than or equal to (≤) 50 years of age.\n* Participant signed and dated the informed consent document.\n* Participant has a history of migraine or clinical judgment suggests a migraine diagnosis.\n* Participant fulfills the criteria for EM or CM with prospectively collected baseline information during the 28-day run-in period.\n* Body mass index (BMI) of 17.5 to 37.5 kilograms/square meter (kg/m\\^2) and a total body weight between 45 and 120 kg, inclusive.\n* All participants must be of non-childbearing potential.\n\n 1. Participants must simultaneously use 2 forms of highly effective contraception methods.\n 2. Participants will remain abstinent throughout the study.\n* Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test prior at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).\n* The participant must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation.\n\n * Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\nParticipants Rolling Over from the Pivotal Efficacy Studies:\n\n* Pregnant or nursing females\n* Compliance with daily diary entry lower than 75 percent (%) at the last month of the double-blind treatment period of the pivotal efficacy study.\n\n * Additional criteria apply, please contact the investigator for more information.\n\nParticipants Not Rolling Over from the Pivotal Efficacy Studies:\n\n* Clinically significant findings at the discretion of the investigator.\n* Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years.\n* History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \\[for example; cerebral ischemia\\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events) such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism -Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection.\n* Past or current history of cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma.\n* Pregnant or nursing females.\n* History of hypersensitivity reactions to injected proteins, including monoclonal antibodies.\n* Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer.\n* History of alcohol or drug abuse during the past 2 years, or alcohol or drug dependence during the past 5 years.\n* The participant cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:\n\n 1. mentally or legally incapacitated or unable to give consent for any reason.\n 2. in custody due to an administrative or a legal decision, under guardianship, or institutionalized.\n 3. unable to be contacted in case of emergency.\n 4. has any other condition, which, in the opinion of the investigator, makes the participant inappropriate for inclusion in the study.\n* Participant is a study center or sponsor employee who is directly involved in the study or the relative of such an employee.\n\n * Additional criteria apply, please contact the investigator for more information.'}, 'identificationModule': {'nctId': 'NCT02638103', 'acronym': 'HALO', 'briefTitle': 'Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine', 'orgStudyIdInfo': {'id': 'TV48125-CNS-30051'}, 'secondaryIdInfos': [{'id': '2015-004550-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'description': 'Participants with CM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive fremanezumab 675 milligrams (mg) SC as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters \\[mL\\] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).', 'interventionNames': ['Drug: Fremanezumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TEV-48125 225 mg Monthly: Active Rollover Participants', 'description': 'Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, will receive fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, will receive 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).', 'interventionNames': ['Drug: Fremanezumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).', 'interventionNames': ['Drug: Fremanezumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'description': 'Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, will receive fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).', 'interventionNames': ['Drug: Fremanezumab', 'Drug: Placebo']}], 'interventions': [{'name': 'Fremanezumab', 'type': 'DRUG', 'otherNames': ['TEV-48125'], 'description': 'Fremanezumab will be administered as per the dose and schedule specified in the respective arms.', 'armGroupLabels': ['TEV-48125 225 mg Monthly: Active Rollover Participants', 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.', 'armGroupLabels': ['TEV-48125 225 mg Monthly: Active Rollover Participants', 'TEV-48125 225 mg Monthly: New/Placebo Rollover Participants', 'TEV-48125 675 mg Quarterly: Active Rollover Participants', 'TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 13628', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 13577', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 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'country': 'United States', 'facility': 'Teva Investigational Site 13566', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Teva Investigational Site 13603', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '21208', 'city': 'Pikesville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 13582', 'geoPoint': {'lat': 39.37427, 'lon': -76.72247}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13590', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02301', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13589', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13543', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Teva Investigational Site 13539', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Teva Investigational Site 13542', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 13534', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 13536', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 13619', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68025', 'city': 'Fremont', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Teva Investigational Site 13618', 'geoPoint': {'lat': 41.43333, 'lon': -96.49808}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Teva Investigational Site 13605', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Teva Investigational Site 13578', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '08836', 'city': 'Martinsville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 13575', 'geoPoint': {'lat': 40.60121, 'lon': -74.55905}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 13622', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Teva Investigational Site 13588', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 13576', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '11803', 'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 13565', 'geoPoint': {'lat': 40.77649, 'lon': -73.46735}}, {'zip': '27405', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 13544', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 13574', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 13545', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44311', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 13609', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44311', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 13625', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44311', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 13634', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 13533', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 13624', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 13569', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 13626', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Teva Investigational Site 13561', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Teva Investigational Site 13601', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19046', 'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 13591', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 13554', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 13608', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '29650', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 13615', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 13556', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Teva Investigational Site 13560', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Teva Investigational Site 13551', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Teva Investigational Site 13532', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Teva Investigational Site 13552', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13541', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75214', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13623', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13611', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 13572', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Teva Investigational Site 13614', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Teva Investigational Site 13581', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '23454', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Teva Investigational Site 13630', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 13564', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 13586', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Teva Investigational Site 13600', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': 'L8N 1Y2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Teva Investigational Site 11124', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L3Y5G8', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Teva Investigational Site 11122', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'T3M 1M4', 'city': 'Calgary', 'country': 'Canada', 'facility': 'Teva Investigational Site 11120', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'H2W 1V1', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Teva Investigational Site 11121', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'country': 'Canada', 'facility': 'Teva Investigational Site 11123', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': '602 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54144', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '14800', 'city': 'Kunratice', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54141', 'geoPoint': {'lat': 50.01364, 'lon': 14.48341}}, {'zip': '53002', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54145', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '100 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54143', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '130 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54146', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 59', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Teva Investigational Site 54142', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '00180', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Teva Investigational Site 40018', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00930', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Teva Investigational Site 40017', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'Teva Investigational Site 40016', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Teva Investigational Site 80096', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'zip': '9112001', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Teva Investigational Site 80099', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '221001', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Teva Investigational Site 80098', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '4244916', 'city': 'Netanya', 'country': 'Israel', 'facility': 'Teva Investigational Site 80097', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'zip': '5265601', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Teva Investigational Site 80100', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Teva Investigational Site 80095', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '182-0006', 'city': 'Chofu-shi', 'country': 'Japan', 'facility': 'Teva Investigational Site 84072'}, {'zip': 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