Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT03737851
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2018-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723102', 'term': 'elezanumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 76 weeks', 'description': 'Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.\n\nplacebo: solution for infusion', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 52, 'seriousNumAtRisk': 70, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.\n\nelezanumab: solution for infusion', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 48, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.\n\nelezanumab: solution for infusion', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 54, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 23, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MULTIPLE SCLEROSIS RELAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MUSCLE SPASTICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DIVERTICULUM INTESTINAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HAEMATOCHEZIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'UMBILICAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'FRACTURE DISPLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SKULL FRACTURED BASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MYOCARDIAL STRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'MYELOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SEIZURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'TRIGEMINAL NEURALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "UHTHOFF'S PHENOMENON", 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ABORTION SPONTANEOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Overall Response Score (ORS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.\n\nplacebo: solution for infusion'}, {'id': 'OG001', 'title': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.\n\nelezanumab: solution for infusion'}, {'id': 'OG002', 'title': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.\n\nelezanumab: solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.175', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.179', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.177', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'description': 'The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).\n\nClinically significant worsening = -1, no change = 0, clinically significant improvement = +1.\n\nThe ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.'}, {'type': 'SECONDARY', 'title': 'Disability Improvement Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.\n\nplacebo: solution for infusion'}, {'id': 'OG001', 'title': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.\n\nelezanumab: solution for infusion'}, {'id': 'OG002', 'title': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.\n\nelezanumab: solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.202', 'ciLowerLimit': '0.559', 'ciUpperLimit': '2.584', 'groupDescription': 'Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'a statistical test was not performed'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.615', 'ciLowerLimit': '0.266', 'ciUpperLimit': '1.421', 'groupDescription': 'Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'a statistical test was not performed'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of EDSS, Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Response Score (ORS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.\n\nplacebo: solution for infusion'}, {'id': 'OG001', 'title': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.\n\nelezanumab: solution for infusion'}, {'id': 'OG002', 'title': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.\n\nelezanumab: solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.153', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.159', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.150', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).\n\nClinically significant worsening = -1, no change = 0, clinically significant improvement = +1.\n\nThe ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Response Score (ORS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.\n\nplacebo: solution for infusion'}, {'id': 'OG001', 'title': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.\n\nelezanumab: solution for infusion'}, {'id': 'OG002', 'title': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.\n\nelezanumab: solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.167', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.175', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.168', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).\n\nClinically significant worsening = -1, no change = 0, clinically significant improvement = +1.\n\nThe ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Response Score (ORS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.\n\nplacebo: solution for infusion'}, {'id': 'OG001', 'title': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.\n\nelezanumab: solution for infusion'}, {'id': 'OG002', 'title': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.\n\nelezanumab: solution for infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.180', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.184', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.183', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 36', 'description': 'The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).\n\nClinically significant worsening = -1, no change = 0, clinically significant improvement = +1.\n\nThe ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.\n\nplacebo: solution for infusion'}, {'id': 'FG001', 'title': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.\n\nelezanumab: solution for infusion'}, {'id': 'FG002', 'title': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.\n\nelezanumab: solution for infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'A total of 208 subjects from 44 sites in the United States \\& Canada were enrolled into the study and were randomized: 208 subjects received at least 1 dose of study drug. Of the 208 subjects who received study drug, 182 completed treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.\n\nplacebo: solution for infusion'}, {'id': 'BG001', 'title': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.\n\nelezanumab: solution for infusion'}, {'id': 'BG002', 'title': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.\n\nelezanumab: solution for infusion'}, {'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': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}]}, {'title': 'Non-White', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Multiple Sclerosis (MS)', 'classes': [{'categories': [{'title': 'relapsing remitting MS (RRMS)', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}, {'title': 'relapsing secondary-progressive MS (rSPMS)', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-22', 'size': 4890910, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-14T10:25', 'hasProtocol': True}, {'date': '2021-01-06', 'size': 481086, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-14T10:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'dispFirstSubmitDate': '2021-12-01', 'completionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2018-11-06', 'resultsFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2018-11-08', 'dispFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-04', 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Overall Response Score (ORS) at Week 52', 'timeFrame': 'Week 52', 'description': 'The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).\n\nClinically significant worsening = -1, no change = 0, clinically significant improvement = +1.\n\nThe ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.'}], 'secondaryOutcomes': [{'measure': 'Disability Improvement Response Rate', 'timeFrame': 'Week 52', 'description': 'Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of EDSS, Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).'}, {'measure': 'Overall Response Score (ORS)', 'timeFrame': 'Week 12', 'description': 'The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).\n\nClinically significant worsening = -1, no change = 0, clinically significant improvement = +1.\n\nThe ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.'}, {'measure': 'Overall Response Score (ORS)', 'timeFrame': 'Week 24', 'description': 'The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).\n\nClinically significant worsening = -1, no change = 0, clinically significant improvement = +1.\n\nThe ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.'}, {'measure': 'Overall Response Score (ORS)', 'timeFrame': 'Week 36', 'description': 'The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).\n\nClinically significant worsening = -1, no change = 0, clinically significant improvement = +1.\n\nThe ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsing multiple sclerosis', 'Multiple sclerosis', 'Elezanumab', 'ABT-555'], 'conditions': ['Multiple Sclerosis (MS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months.\n* Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS).\n* Participant has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.\n\nExclusion Criteria:\n\n\\- Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.'}, 'identificationModule': {'nctId': 'NCT03737851', 'briefTitle': 'A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'M18-918'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants randomized to receive double-blind placebo by intravenous infusion.', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Elezanumab Dose 1', 'description': 'Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.', 'interventionNames': ['Drug: elezanumab']}, {'type': 'EXPERIMENTAL', 'label': 'Elezanumab Dose 2', 'description': 'Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.', 'interventionNames': ['Drug: elezanumab']}], 'interventions': [{'name': 'elezanumab', 'type': 'DRUG', 'otherNames': ['ABT-555'], 'description': 'solution for infusion', 'armGroupLabels': ['Elezanumab Dose 1', 'Elezanumab Dose 2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'solution for infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham - 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Inst. /ID# 204249', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92011-4213', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'The Research Center of Southern California /ID# 204269', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '93230-5787', 'city': 'Hanford', 'state': 'California', 'country': 'United States', 'facility': 'Vladimir Royter MD /ID# 204392', 'geoPoint': {'lat': 36.32745, 'lon': -119.64568}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Health /ID# 205728', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '94304-1416', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford MS Center /ID# 204283', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817-2307', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Health-Neurological Surgery /ID# 204188', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143-0003', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF School of Medicine - Neurology /ID# 204251', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045-2527', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado School of Medicine /ID# 204250', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Neurosciences Research, LLC /ID# 204289', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '60637-1443', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medical Center /ID# 205319', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Univ School Medicine /ID# 204891', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Rowe Neurology Institute /ID# 204391', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '70810', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The NeuroMedical Center /ID# 204253', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70121-2429', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center /ID# 204189', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Duplicate_Parexel International /ID# 204273', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21093-6016', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'facility': 'International Neurorehabilitation Institute /ID# 213332', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pediatric Endocrine Associates /ID# 204279', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute for Neurological Disorders (MIND) /ID# 204194', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '48867-2116', 'city': 'Owosso', 'state': 'Michigan', 'country': 'United States', 'facility': 'Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328', 'geoPoint': {'lat': 42.9978, 'lon': -84.17664}}, {'zip': '55318-4551', 'city': 'Chaska', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383', 'geoPoint': {'lat': 44.78941, 'lon': -93.60218}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University-School of Medicine /ID# 204388', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63131-2322', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89106-0100', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Cleveland Clinic Lou Ruvo Cent /ID# 204745', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Med Res. Foundation /ID# 204389', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97225-6646', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Neurological Specialties - West /ID# 204248', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University /ID# 204281', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37064', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Advanced Neurosciences Institute /ID# 204557', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '37067-5914', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'KCA Neurology - Franklin /ID# 204208', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tri-State Mountain Neurology /ID# 204252', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '75243-1188', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Neurology Consultants of Dallas - 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MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Duplicate_London Health Sciences Centre - University Hospital /ID# 204848', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute /ID# 204842', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Unity Health Toronto - St. Michael's Hospital /ID# 206214", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J4V 2J2', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Recherche Sepmus Inc. /ID# 212851', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Neurological Institut /ID# 204843', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing, please refer to the link below.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}