Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-31 @ 8:26 AM
Study NCT ID:
NCT03303092
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2017-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'CL_OPCJ_RDA_Team@otsuka.jp', 'phone': '+81-3-6361-7366', 'title': 'Director of Clinical Trials', 'organization': 'Otsuka Pharmaceutical Co., LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Double-blind treatment period (12 weeks)', 'description': 'Safety set (SS):Subjects who received the IMP at least once.', 'eventGroups': [{'id': 'EG000', 'title': 'TEV-48125 (225/225/225 mg) Group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 69, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TEV-48125 (675 mg/Placebo/Placebo) Group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 74, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 77, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Purpura non-thrombocytopenic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site macule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Bacterial vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Helicobacter 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'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Cervical polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}, {'term': 'Tumour excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the Monthly (28 Days) Average Number of Migraine Days During the 12-week Period After the First Dose of Investigational Medicinal Product (IMP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 (225/225/225 mg) Group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).'}, {'id': 'OG001', 'title': 'TEV-48125 (675 mg/Placebo/Placebo) Group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.00', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-4.02', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-1.02', 'spread': '0.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period.\n\nSubjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).\n\nOverall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity.\n\nIf headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Reaching at Least 50% Reduction in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 (225/225/225 mg) Group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).'}, {'id': 'OG001', 'title': 'TEV-48125 (675 mg/Placebo/Placebo) Group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).'}], 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000'}, {'value': '45.3', 'groupId': 'OG001'}, {'value': '11.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period.\n\nSubjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).\n\nOverall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity.\n\nIf headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects meeting responder criteria.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Monthly Average Number of Days With Use of Any Acute Headache Medications During the 12-week Period After the First Dose of IMP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 (225/225/225 mg) Group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).'}, {'id': 'OG001', 'title': 'TEV-48125 (675 mg/Placebo/Placebo) Group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.30', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-3.29', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '0.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP in Patients Not Receiving Concomitant Preventive Migraine Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 (225/225/225 mg) Group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).'}, {'id': 'OG001', 'title': 'TEV-48125 (675 mg/Placebo/Placebo) Group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.42', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-4.21', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '-1.40', 'spread': '0.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period.\n\nSubjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).\n\nOverall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity.\n\nIf headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.', 'unitOfMeasure': 'days/month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Disability Score, as Measured by Migraine Disability Assessment (MIDAS) Questionnaire at 4 Weeks After the Final (Third) Dose of IMP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TEV-48125 (225/225/225 mg) Group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).'}, {'id': 'OG001', 'title': 'TEV-48125 (675 mg/Placebo/Placebo) Group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).'}, {'id': 'OG002', 'title': 'Placebo Group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.64', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-12.55', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '-7.41', 'spread': '1.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Using the MIDAS questionnaire, subjects assessed the degree of headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the last 3 months. The MIDAS questionnaire was a 5-item instrument. The total of the scores of the first 5 questions was used for grading the level of disability, with scores of 0 to 5, 6 to 10, 11 to 20, and ≥ 21 interpreted as disability grades I (little or no disability), II (mild disability), III (moderate disability), and IV (severe disability), respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set (FAS): Subjects who received the IMP at least once and had baseline and Week 12 data on monthly average number of migraine days. "Overall Number of Participants Analyzed" = the number of subjects with both baseline and assessment at each visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TEV-48125 (225/225/225 mg) Group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).'}, {'id': 'FG001', 'title': 'TEV-48125 (675 mg/Placebo/Placebo) Group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).'}, {'id': 'FG002', 'title': 'Placebo Group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'TEV-48125 (225/225/225 mg) Group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).'}, {'id': 'BG001', 'title': 'TEV-48125 (675 mg/Placebo/Placebo) Group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).'}, {'id': 'BG002', 'title': 'Placebo Group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '348', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '41.9', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '44.2', 'spread': '10.7', 'groupId': 'BG002'}, {'value': '43.5', 'spread': '10.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-08', 'size': 923886, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-15T21:32', 'hasProtocol': True}, {'date': '2019-12-12', 'size': 507717, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-16T00:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 357}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2017-10-02', 'resultsFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-16', 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in the Monthly (28 Days) Average Number of Migraine Days During the 12-week Period After the First Dose of Investigational Medicinal Product (IMP)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period.\n\nSubjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).\n\nOverall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity.\n\nIf headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects Reaching at Least 50% Reduction in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP', 'timeFrame': '12 weeks', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period.\n\nSubjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).\n\nOverall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity.\n\nIf headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.'}, {'measure': 'Mean Change From Baseline in the Monthly Average Number of Days With Use of Any Acute Headache Medications During the 12-week Period After the First Dose of IMP', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).'}, {'measure': 'Mean Change From Baseline in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP in Patients Not Receiving Concomitant Preventive Migraine Medications', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, the subjects were asked to enter headache data in the electronic headache diary for the previous 24-hour period.\n\nSubjects who reported headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications).\n\nOverall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity.\n\nIf headache was reported, then headache severity was subjectively rated by the subject as follows: Mild headache, Moderate headache, Severe headache. Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.'}, {'measure': 'Mean Change From Baseline in Disability Score, as Measured by Migraine Disability Assessment (MIDAS) Questionnaire at 4 Weeks After the Final (Third) Dose of IMP', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Using the MIDAS questionnaire, subjects assessed the degree of headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the last 3 months. The MIDAS questionnaire was a 5-item instrument. The total of the scores of the first 5 questions was used for grading the level of disability, with scores of 0 to 5, 6 to 10, 11 to 20, and ≥ 21 interpreted as disability grades I (little or no disability), II (mild disability), III (moderate disability), and IV (severe disability), respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '35139816', 'type': 'DERIVED', 'citation': 'Takeshima T, Nakai M, Shibasaki Y, Ishida M, Kim BK, Ning X, Koga N. Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients. J Headache Pain. 2022 Feb 9;23(1):24. doi: 10.1186/s10194-022-01393-0.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 (monthly TEV-48125 225 mg and TEV-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in Episodic Migraine patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition \\[beta version\\] criteria) or clinical judgment suggests a migraine diagnosis\n* Patient fulfills the criteria for Episodic migraine in baseline information collected during the 28 day screening period\n* Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.\n* Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.\n\nExclusion Criteria:\n\nPatients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses\n\n\\- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator'}, 'identificationModule': {'nctId': 'NCT03303092', 'briefTitle': 'Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine', 'orgStudyIdInfo': {'id': '406-102-00002'}, 'secondaryIdInfos': [{'id': 'JapicCTI-173725', 'type': 'OTHER', 'domain': 'Japic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEV-48125 (225/225/225 mg) group', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months (225/225/225 mg).', 'interventionNames': ['Drug: TEV-48125']}, {'type': 'EXPERIMENTAL', 'label': 'TEV-48125 (675 mg/placebo/placebo) group', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/placebo/placebo).', 'interventionNames': ['Drug: TEV-48125 or placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TEV-48125', 'type': 'DRUG', 'description': 'TEV-48125 will be subcutaneously administered once monthly for 3 months.', 'armGroupLabels': ['TEV-48125 (225/225/225 mg) group']}, {'name': 'TEV-48125 or placebo', 'type': 'DRUG', 'description': 'TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.', 'armGroupLabels': ['TEV-48125 (675 mg/placebo/placebo) group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be subcutaneously administered once monthly for 3 months.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Iruma', 'country': 'Japan', 'facility': 'Saitama Medical University Hospital', 'geoPoint': {'lat': 35.818, 'lon': 139.368}}], 'overallOfficials': [{'name': 'Takehisa Matsumaru', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}