Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-30 @ 1:48 AM
Study NCT ID:
NCT04338061
Status:
TERMINATED
Last Update Posted:
2025-03-21
First Post:
2020-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Evobrutinib in Participants With RMS (evolutionRMS 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C527525', 'term': 'teriflunomide'}, {'id': 'C000632111', 'term': 'evobrutinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@emdgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Communication Center', 'organization': 'Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The Final Analysis represents the analysis of the cumulative data collected up to the Primary Analysis trigger and beyond through DBE up to the final database lock. Therefore, the endpoints were evaluated considering a time period from the start of DBTP to the end of the DBE Period.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 170 weeks', 'description': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.', 'otherNumAtRisk': 583, 'deathsNumAtRisk': 583, 'otherNumAffected': 455, 'seriousNumAtRisk': 583, 'deathsNumAffected': 0, 'seriousNumAffected': 37}, {'id': 'EG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.', 'otherNumAtRisk': 581, 'deathsNumAtRisk': 581, 'otherNumAffected': 409, 'seriousNumAtRisk': 581, 'deathsNumAffected': 0, 'seriousNumAffected': 51}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 35, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 54, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 112, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 33, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 59, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 39, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 39, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 66, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 46, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 139, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 119, 'numAffected': 105}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 103, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 89, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 52, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 36, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 81, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 83, 'numAffected': 55}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 46, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 49, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 227, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 168, 'numAffected': 99}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 123, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 84, 'numAffected': 61}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 70, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 37, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 39, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 55, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 73, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 40, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 156, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 42, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 122, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 39, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 79, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 63, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 40, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 46, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 169, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 198, 'numAffected': 96}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 87, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 38, 'numAffected': 35}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ileus spastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Renal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Salpingo-oophoritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bladder injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Musculoskeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Symphysiolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemangioma of liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Synovial sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Autonomic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lumbosacral radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mood disorder due to a general medical condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neuropsychiatric symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abnormal uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cervical polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemorrhagic ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Paranasal sinus inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Miscarriage of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Subgaleal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Double Blind Treatment Period (DBTP) and Double Blind Extension (DBE) Period: Annualized Relapse Rate (ARR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '583', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.13'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.13'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \\[\\>\\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \\[\\>=\\] 30 days).', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Period: Percentage of Participants Without 12-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '583', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Week 96', 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '85.7', 'upperLimit': '91.4'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '88.9', 'upperLimit': '93.9'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '87.1'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '77.8', 'upperLimit': '90.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96 and Week 156 (combined DBTP and DBE periods)', 'description': 'Disability progression was defined as increase in EDSS of greater than or equal to \\[\\>=\\] 1 point from baseline EDSS score, if EDSS score at baseline is 5.0 or less and an increase of \\>=0.5 point, if the baseline score is 5.5. Disability progression is considered sustained for 12 weeks when the initial increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants without 12-week CDP.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment. The result reported for this outcome measure are the results from data of combined DBTP and DBE periods.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Period: Percentage of Participants Without 24-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '583', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Week 96', 'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '93.8'}, {'value': '93.6', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '95.5'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '86.5', 'upperLimit': '92.2'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '87.8', 'upperLimit': '93.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96 and Week 156 (combined DBTP and DBE periods)', 'description': 'Disability progression was defined as increase in EDSS of greater than or equal to \\[\\>=\\] 1 point from baseline EDSS score, if EDSS score at baseline is 5.0 or less and an increase of \\>=0.5 point, if the baseline score is 5.5. Disability progression is considered sustained for 24 weeks when the initial increase in the EDSS is confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants without 24-week CDP.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment. The result reported for this outcome measure are the results from data of combined DBTP and DBE periods.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Period: Percentage of Participants With 24-Week Confirmed Disability Improvement (CDI) as Measured by Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '583', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Week 96', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '15.0'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '10.7'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '16.4'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '11.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96 and Week 156 (combined DBTP and DBE periods)', 'description': 'Disability improvement was defined as a reduction of 1 point from Baseline EDSS score when the Baseline score is \\>= 2 and less than or equal to \\[\\<=\\] 6 and a reduction of 0.5 point from Baseline EDSS score when the Baseline score is \\>= 6.5 and \\<= 9.5. Disability improvement is considered sustained when the initial reduction in the EDSS score is confirmed at a regularly scheduled visit at least 24 weeks after the initial reduction. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants with 12-week CDI.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment. The result reported for this outcome measure are the results from data of combined DBTP and DBE periods.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 48, Week 96, Week 120, Week 144 and Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '-0.22', 'upperLimit': '0.72'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '-0.16', 'upperLimit': '0.78'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '-0.31', 'groupId': 'OG000', 'lowerLimit': '-0.88', 'upperLimit': '0.26'}, {'value': '-0.45', 'groupId': 'OG001', 'lowerLimit': '-1.03', 'upperLimit': '0.13'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '-0.56', 'groupId': 'OG000', 'lowerLimit': '-1.23', 'upperLimit': '0.11'}, {'value': '-0.19', 'groupId': 'OG001', 'lowerLimit': '-0.86', 'upperLimit': '0.48'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '-0.38', 'groupId': 'OG000', 'lowerLimit': '-1.12', 'upperLimit': '0.35'}, {'value': '-0.57', 'groupId': 'OG001', 'lowerLimit': '-1.31', 'upperLimit': '0.17'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Week 156 is not evaluable in the modelling due to the lack of participants in some of the covariate categories at that visit.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Week 156 is not evaluable in the modelling due to the lack of participants in some of the covariate categories at that visit.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48, Week 96, Week 120, Week 144 and Week 156 (Combined DBTP and DBE periods)', 'description': "Physical function was assessed with PROMISnq Short Form v2.0 - Physical Function - Multiple Sclerosis 15a (PROMISnq PF(MS) 15a). PROMISnq PF(MS) 15a assesses a participant's abilities and limitations with respect to everyday physical activities. Results are reported as a T-score. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 10 to 65. Higher T-scores represent higher physical function. Change from baseline in PROMIS PF score was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the result of the 2 periods (DBTP and DBE).", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. The result reported for this outcome measure are the results from data of combined DBTP and DBE periods.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score at Week 48, Week 96, Week 120, Week 144 and Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '-2.20', 'groupId': 'OG000', 'lowerLimit': '-2.81', 'upperLimit': '-1.60'}, {'value': '-2.59', 'groupId': 'OG001', 'lowerLimit': '-3.19', 'upperLimit': '-1.98'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '-2.17', 'groupId': 'OG000', 'lowerLimit': '-2.85', 'upperLimit': '-1.49'}, {'value': '-2.12', 'groupId': 'OG001', 'lowerLimit': '-2.81', 'upperLimit': '-1.44'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '-2.24', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '-1.48'}, {'value': '-2.59', 'groupId': 'OG001', 'lowerLimit': '-3.35', 'upperLimit': '-1.83'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '-2.41', 'groupId': 'OG000', 'lowerLimit': '-3.35', 'upperLimit': '-1.48'}, {'value': '-2.16', 'groupId': 'OG001', 'lowerLimit': '-3.10', 'upperLimit': '-1.22'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '-2.21', 'groupId': 'OG000', 'lowerLimit': '-3.62', 'upperLimit': '-0.81'}, {'value': '-2.34', 'groupId': 'OG001', 'lowerLimit': '-3.83', 'upperLimit': '-0.86'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48, Week 96, Week 120, Week 144 and Week 156 ((combined DBTP and DBE periods)', 'description': 'PROMIS Fatigue score was assessed with PROMIS Short Form v1.0 - Fatigue - Multiple Sclerosis 8a (PROMIS Fatigue (MS) 8a). PROMIS Fatigue (MS) 8a assesses level of fatigue and its interference on daily activities. Results are reported as a T-score. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33 to 85. Higher T-scores represent higher fatigue. Change from baseline in PROMIS fatigue score was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the result of the 2 periods (DBTP and DBE).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. The result reported for this outcome measure are the results from data of combined DBTP and DBE periods.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Period: Total Number of T1 Gadolinium-positive (Gd+) Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '544', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.34'}, {'value': '0.51', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '0.60'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Analysis of Gadolinium-positive T1 lesions was done using magnetic resonance imaging (MRI) scans.', 'unitOfMeasure': 'lesions per scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Period: New or Enlarging T2 Lesions Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '544', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.88', 'groupId': 'OG000', 'lowerLimit': '6.01', 'upperLimit': '7.87'}, {'value': '6.17', 'groupId': 'OG001', 'lowerLimit': '5.38', 'upperLimit': '7.07'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Analysis of new or enlarging T2 lesions rate was done using magnetic resonance imaging (MRI) scans. Negative binomial model for lesion count (summed over scans) includes treatment and covariates based on randomization strata and baseline volume of T2 lesion (continuous), with offset equal to the log of the time in years between the last available MRI scan and the baseline scan.', 'unitOfMeasure': 'lesions per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP Period: Neurofilament Light Chain (NfL) Concentration at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '544', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.09', 'groupId': 'OG000', 'lowerLimit': '12.69', 'upperLimit': '13.50'}, {'value': '12.51', 'groupId': 'OG001', 'lowerLimit': '12.13', 'upperLimit': '12.90'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 12', 'description': 'NfL is a biomarker of neuro-axonal damage whose concentration was assessed in blood at Week 12.', 'unitOfMeasure': 'nanogram per liter (ng/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '581', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '524', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}]}, {'title': 'Participants with AESIs', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Adverse event (AE): Any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: those AEs with an onset date on or after the date of first study intervention administration, or AEs present prior to any study intervention administration but exacerbating after. TEAEs included both Serious TEAEs and non-serious TEAEs. AESIs included liver AEs (possible drug-induced, non-infectious, non-alcoholic, and immune-mediated), infections (serious and opportunistic infections), lipase and amylase elevation, and seizure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '581', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Participants with Grade 1', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade 2', 'categories': [{'measurements': [{'value': '389', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade 3', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Severity of adverse events (AE) were assessed by the investigator per the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with Grades 1, 2, 3, 4 and 5 were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '2.4', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '11.50', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '1.4', 'spread': '8.73', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '8.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: diastolic blood pressure and systolic blood pressure from baseline up to 170 weeks were reported.', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '10.19', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '10.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: pulse rate from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: respiratory rate from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '5.447', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '5.310', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Changes in vital signs: weight from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.340', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.350', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: Temperature from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'degree Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Electrocardiograms (ECGs): Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '10.36', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '10.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Heart rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: heart rate from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "DBTP and DBE Periods: Change From Baseline in Electrocardiograms (ECGs): QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': "QT Interval - Fridericia's Correction Formula", 'categories': [{'measurements': [{'value': '-2.14', 'spread': '16.459', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '14.935', 'groupId': 'OG001'}]}]}, {'title': 'PR Interval', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '16.82', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '14.51', 'groupId': 'OG001'}]}]}, {'title': 'QRS Duration', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '6.77', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '8.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': "QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration from baseline up to 170 weeks were reported.", 'unitOfMeasure': 'milliseconds (msec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Erythrocytes Mean Corpuscular HGB Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '11.07', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '12.42', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '11.40', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '11.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Changes in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin from baseline up to 170 weeks were reported.', 'unitOfMeasure': 'gram per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants who were evaluable for the specified categories.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.4', 'spread': '48.38', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '52.24', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.954', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.883', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.471', 'spread': '1.7550', 'groupId': 'OG000'}, {'value': '0.156', 'spread': '1.7796', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0198', 'spread': '0.14809', 'groupId': 'OG000'}, {'value': '0.0238', 'spread': '0.14945', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0081', 'spread': '0.03882', 'groupId': 'OG000'}, {'value': '-0.0042', 'spread': '0.03902', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0797', 'spread': '0.19710', 'groupId': 'OG000'}, {'value': '0.0772', 'spread': '0.20715', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0241', 'spread': '0.57564', 'groupId': 'OG000'}, {'value': '0.0311', 'spread': '0.57810', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.001', 'spread': '23.3886', 'groupId': 'OG000'}, {'value': '-0.841', 'spread': '20.2200', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes. Changes in hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes from baseline up to 170 weeks were reported.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants who were evaluable for the specified categories.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameters: Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0107', 'spread': '0.03199', 'groupId': 'OG000'}, {'value': '-0.0085', 'spread': '0.03311', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Hematocrit. Changes in hematology parameter: Hematocrit from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'percentage of cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'spread': '1.603', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '1.941', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Changes in hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'picogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.48', 'spread': '4.150', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '5.217', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Changes in hematology parameter: Erythrocytes Mean Corpuscular Volume from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'femtoliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Bilirubin and Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '4.649', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '4.212', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '12.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Bilirubin and Creatinine. Changes in biochemistry parameters: Bilirubin and Creatinine from baseline up to 170 weeks were reported.', 'unitOfMeasure': 'micromoles per liter (mcmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants who were evaluable for the specified categories.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.64', 'spread': '15.365', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '13.219', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.40', 'spread': '33.878', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '32.018', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.32', 'spread': '15.875', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '15.659', 'groupId': 'OG001'}]}]}, {'title': 'Amylase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '14.42', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '15.91', 'groupId': 'OG001'}]}]}, {'title': 'Lipase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '18.35', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '17.26', 'groupId': 'OG001'}]}]}, {'title': 'Gamma Glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.71', 'spread': '26.084', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '20.207', 'groupId': 'OG001'}]}]}, {'title': 'Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.08', 'spread': '27.049', 'groupId': 'OG000'}, {'value': '-5.41', 'spread': '27.637', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase. Changes in biochemistry parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase from baseline up to 170 weeks were reported.', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants who were evaluable for the specified categories.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9286', 'spread': '2.56796', 'groupId': 'OG000'}, {'value': '0.7750', 'spread': '3.21185', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0405', 'spread': '0.48750', 'groupId': 'OG000'}, {'value': '0.0376', 'spread': '0.44331', 'groupId': 'OG001'}]}]}, {'title': 'Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.1197', 'groupId': 'OG000'}, {'value': '-0.008', 'spread': '0.1121', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.0656', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.0667', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.949', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.812', 'groupId': 'OG001'}]}]}, {'title': 'Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.30', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '3.53', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.126', 'spread': '1.2759', 'groupId': 'OG000'}, {'value': '0.122', 'spread': '1.1651', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.047', 'spread': '0.1944', 'groupId': 'OG000'}, {'value': '-0.024', 'spread': '0.1799', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '2.592', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '2.980', 'groupId': 'OG001'}]}]}, {'title': 'Corrected Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0290', 'spread': '0.10405', 'groupId': 'OG000'}, {'value': '0.0292', 'spread': '0.09775', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium. Changes in biochemistry parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium from baseline up to 170 weeks were reported.', 'unitOfMeasure': 'millimole per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants who were evaluable for the specified categories.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Total Protein and Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'Total protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '4.905', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '4.998', 'groupId': 'OG001'}]}]}, {'title': 'Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '3.497', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '3.287', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Total Protein and Albumin. Changes in biochemistry parameters: Total Protein and Albumin from baseline up to 170 weeks were reported.', 'unitOfMeasure': 'gram per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and "number analyzed"= participants who were evaluable for the specified categories.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Glomerular Filtration Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '13.41', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '13.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameter: Glomerular Filtration Rate. Changes in biochemistry parameter: Glomerular Filtration Rate from baseline up to 170 weeks were reported. The Glomerular Filtration Rate was measured as milliliter per minute per 1.73 square meter (mL/min/1.73m\\^2).', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.936', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.973', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Changes in urinalyses parameter: pH from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0015', 'spread': '0.04460', 'groupId': 'OG000'}, {'value': '-0.0017', 'spread': '0.03748', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: Specific Gravity of Urine. Changes in urinalyses parameter: Specific Gravity of Urine from baseline up to 170 weeks was reported.', 'unitOfMeasure': 'Kilogram per cubic meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Absolute Concentrations of Immunoglobulin (Ig) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'IgA', 'categories': [{'measurements': [{'value': '1.899', 'spread': '0.7787', 'groupId': 'OG000'}, {'value': '2.581', 'spread': '1.1201', 'groupId': 'OG001'}]}]}, {'title': 'IgG', 'categories': [{'measurements': [{'value': '10.082', 'spread': '2.1551', 'groupId': 'OG000'}, {'value': '10.990', 'spread': '2.4844', 'groupId': 'OG001'}]}]}, {'title': 'IgM', 'categories': [{'measurements': [{'value': '1.251', 'spread': '0.6445', 'groupId': 'OG000'}, {'value': '1.196', 'spread': '0.6151', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 170', 'description': 'Absolute Concentrations serum levels of IgG, IgA, IgM were assessed.', 'unitOfMeasure': 'gram per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'DBTP and DBE Periods: Change From Baseline in Immunoglobulin (Ig) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'OG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'classes': [{'title': 'IgA', 'categories': [{'measurements': [{'value': '-0.203', 'spread': '0.5704', 'groupId': 'OG000'}, {'value': '0.500', 'spread': '0.7197', 'groupId': 'OG001'}]}]}, {'title': 'IgG', 'categories': [{'measurements': [{'value': '-0.645', 'spread': '1.6188', 'groupId': 'OG000'}, {'value': '0.146', 'spread': '1.8712', 'groupId': 'OG001'}]}]}, {'title': 'IgM', 'categories': [{'measurements': [{'value': '-0.167', 'spread': '0.5094', 'groupId': 'OG000'}, {'value': '-0.175', 'spread': '0.3888', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Change from baseline serum levels of IgG, IgA, IgM were assessed.', 'unitOfMeasure': 'gram per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (SAF) analysis set included all participants who received at least one dose of study treatment. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'FG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}], 'periods': [{'title': 'Double-blind Treatment Period: 156 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '583'}, {'groupId': 'FG001', 'numSubjects': '583'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '409'}, {'groupId': 'FG001', 'numSubjects': '410'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '173'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Protocol Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomized, but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Double-blind Extension Period: 96 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}, {'groupId': 'FG001', 'numSubjects': '389'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '381'}, {'groupId': 'FG001', 'numSubjects': '377'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'BG000'}, {'value': '583', 'groupId': 'BG001'}, {'value': '1166', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Teriflunomide', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'BG001', 'title': 'Evobrutinib', 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '36', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '37', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '370', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '783', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity-Hispanic or Latino', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': 'Ethnicity-Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '553', 'groupId': 'BG000'}, {'value': '531', 'groupId': 'BG001'}, {'value': '1084', 'groupId': 'BG002'}]}]}, {'title': 'Ethnicity-Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Race-American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Race-Asian', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Race-Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Race-Multiple', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Race-Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Race-Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Race-Unknown or Not Reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Race-White', 'categories': [{'measurements': [{'value': '551', 'groupId': 'BG000'}, {'value': '556', 'groupId': 'BG001'}, {'value': '1107', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all participants who were randomized to study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-27', 'size': 3910469, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-01T08:27', 'hasProtocol': True}, {'date': '2023-11-20', 'size': 18351185, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-01T08:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1166}}, 'statusModule': {'whyStopped': 'Primary analysis of the RMS phase 3 study (MS200527\\_0082) resulted in the early termination of the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2020-04-06', 'resultsFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-19', 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Double Blind Treatment Period (DBTP) and Double Blind Extension (DBE) Period: Annualized Relapse Rate (ARR)', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \\[\\>\\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \\[\\>=\\] 30 days).'}], 'secondaryOutcomes': [{'measure': 'DBTP and DBE Period: Percentage of Participants Without 12-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Week 96 and Week 156 (combined DBTP and DBE periods)', 'description': 'Disability progression was defined as increase in EDSS of greater than or equal to \\[\\>=\\] 1 point from baseline EDSS score, if EDSS score at baseline is 5.0 or less and an increase of \\>=0.5 point, if the baseline score is 5.5. Disability progression is considered sustained for 12 weeks when the initial increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants without 12-week CDP.'}, {'measure': 'DBTP and DBE Period: Percentage of Participants Without 24-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Week 96 and Week 156 (combined DBTP and DBE periods)', 'description': 'Disability progression was defined as increase in EDSS of greater than or equal to \\[\\>=\\] 1 point from baseline EDSS score, if EDSS score at baseline is 5.0 or less and an increase of \\>=0.5 point, if the baseline score is 5.5. Disability progression is considered sustained for 24 weeks when the initial increase in the EDSS is confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants without 24-week CDP.'}, {'measure': 'DBTP and DBE Period: Percentage of Participants With 24-Week Confirmed Disability Improvement (CDI) as Measured by Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Week 96 and Week 156 (combined DBTP and DBE periods)', 'description': 'Disability improvement was defined as a reduction of 1 point from Baseline EDSS score when the Baseline score is \\>= 2 and less than or equal to \\[\\<=\\] 6 and a reduction of 0.5 point from Baseline EDSS score when the Baseline score is \\>= 6.5 and \\<= 9.5. Disability improvement is considered sustained when the initial reduction in the EDSS score is confirmed at a regularly scheduled visit at least 24 weeks after the initial reduction. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). Kaplan-Meier method was used to estimate the percentage of participants with 12-week CDI.'}, {'measure': 'DBTP and DBE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 48, Week 96, Week 120, Week 144 and Week 156', 'timeFrame': 'Baseline, Week 48, Week 96, Week 120, Week 144 and Week 156 (Combined DBTP and DBE periods)', 'description': "Physical function was assessed with PROMISnq Short Form v2.0 - Physical Function - Multiple Sclerosis 15a (PROMISnq PF(MS) 15a). PROMISnq PF(MS) 15a assesses a participant's abilities and limitations with respect to everyday physical activities. Results are reported as a T-score. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 10 to 65. Higher T-scores represent higher physical function. Change from baseline in PROMIS PF score was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the result of the 2 periods (DBTP and DBE)."}, {'measure': 'DBTP and DBE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score at Week 48, Week 96, Week 120, Week 144 and Week 156', 'timeFrame': 'Baseline, Week 48, Week 96, Week 120, Week 144 and Week 156 ((combined DBTP and DBE periods)', 'description': 'PROMIS Fatigue score was assessed with PROMIS Short Form v1.0 - Fatigue - Multiple Sclerosis 8a (PROMIS Fatigue (MS) 8a). PROMIS Fatigue (MS) 8a assesses level of fatigue and its interference on daily activities. Results are reported as a T-score. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33 to 85. Higher T-scores represent higher fatigue. Change from baseline in PROMIS fatigue score was analyzed using Mixed Effect Model for Repeated Measures (MMRM) to evaluate the result of the 2 periods (DBTP and DBE).'}, {'measure': 'DBTP and DBE Period: Total Number of T1 Gadolinium-positive (Gd+) Lesions', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Analysis of Gadolinium-positive T1 lesions was done using magnetic resonance imaging (MRI) scans.'}, {'measure': 'DBTP and DBE Period: New or Enlarging T2 Lesions Rate', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Analysis of new or enlarging T2 lesions rate was done using magnetic resonance imaging (MRI) scans. Negative binomial model for lesion count (summed over scans) includes treatment and covariates based on randomization strata and baseline volume of T2 lesion (continuous), with offset equal to the log of the time in years between the last available MRI scan and the baseline scan.'}, {'measure': 'DBTP Period: Neurofilament Light Chain (NfL) Concentration at Week 12', 'timeFrame': 'Week 12', 'description': 'NfL is a biomarker of neuro-axonal damage whose concentration was assessed in blood at Week 12.'}, {'measure': 'DBTP and DBE Periods: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Adverse event (AE): Any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: those AEs with an onset date on or after the date of first study intervention administration, or AEs present prior to any study intervention administration but exacerbating after. TEAEs included both Serious TEAEs and non-serious TEAEs. AESIs included liver AEs (possible drug-induced, non-infectious, non-alcoholic, and immune-mediated), infections (serious and opportunistic infections), lipase and amylase elevation, and seizure.'}, {'measure': 'DBTP and DBE Periods: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Severity of adverse events (AE) were assessed by the investigator per the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with Grades 1, 2, 3, 4 and 5 were reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: diastolic blood pressure and systolic blood pressure from baseline up to 170 weeks were reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Pulse Rate', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: pulse rate from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Respiratory Rate', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: respiratory rate from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Weight', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Changes in vital signs: weight from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Vital Signs: Temperature', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: Temperature from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Electrocardiograms (ECGs): Heart Rate', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Heart rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: heart rate from baseline up to 170 weeks was reported.'}, {'measure': "DBTP and DBE Periods: Change From Baseline in Electrocardiograms (ECGs): QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration", 'timeFrame': 'Baseline up to 170 weeks', 'description': "QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Changes in vital signs: QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration from baseline up to 170 weeks were reported."}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Changes in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin from baseline up to 170 weeks were reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes. Changes in hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes from baseline up to 170 weeks were reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameters: Hematocrit', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Hematocrit. Changes in hematology parameter: Hematocrit from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Changes in hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Changes in hematology parameter: Erythrocytes Mean Corpuscular Volume from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Bilirubin and Creatinine', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Bilirubin and Creatinine. Changes in biochemistry parameters: Bilirubin and Creatinine from baseline up to 170 weeks were reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase. Changes in biochemistry parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase from baseline up to 170 weeks were reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium. Changes in biochemistry parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium from baseline up to 170 weeks were reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Total Protein and Albumin', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameters: Total Protein and Albumin. Changes in biochemistry parameters: Total Protein and Albumin from baseline up to 170 weeks were reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Glomerular Filtration Rate', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the biochemistry parameter: Glomerular Filtration Rate. Changes in biochemistry parameter: Glomerular Filtration Rate from baseline up to 170 weeks were reported. The Glomerular Filtration Rate was measured as milliliter per minute per 1.73 square meter (mL/min/1.73m\\^2).'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Changes in urinalyses parameter: pH from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: Specific Gravity of Urine. Changes in urinalyses parameter: Specific Gravity of Urine from baseline up to 170 weeks was reported.'}, {'measure': 'DBTP and DBE Periods: Absolute Concentrations of Immunoglobulin (Ig) Levels', 'timeFrame': 'At Week 170', 'description': 'Absolute Concentrations serum levels of IgG, IgA, IgM were assessed.'}, {'measure': 'DBTP and DBE Periods: Change From Baseline in Immunoglobulin (Ig) Levels', 'timeFrame': 'Baseline up to 170 weeks', 'description': 'Change from baseline serum levels of IgG, IgA, IgM were assessed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Evobrutinib', 'Teriflunomide', 'Aubagio®', 'Relapsing Multiple Sclerosis'], 'conditions': ['Relapsing Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '39307151', 'type': 'RESULT', 'citation': 'Montalban X, Vermersch P, Arnold DL, Bar-Or A, Cree BAC, Cross AH, Kubala Havrdova E, Kappos L, Stuve O, Wiendl H, Wolinsky JS, Dahlke F, Le Bolay C, Shen Loo L, Gopalakrishnan S, Hyvert Y, Javor A, Guehring H, Tenenbaum N, Tomic D; evolutionRMS investigators. Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials. Lancet Neurol. 2024 Nov;23(11):1119-1132. doi: 10.1016/S1474-4422(24)00328-4. Epub 2024 Sep 19.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200527_0082', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://medical.emdserono.com/en_US/home.html', 'label': 'US Medical Information website, Medical Resources'}]}, 'descriptionModule': {'briefSummary': 'The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis \\[RRMS\\] or secondary progressive multiple sclerosis \\[SPMS\\] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018)\n* Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization\n* Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score less than or equal to \\[\\<=\\] 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years\n* Participants are neurologically stable for \\>= 30 days prior to both screening and baseline (Day 1)\n* Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure\n* Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure\n* Participants have given written informed consent prior to any study-related procedure\n* Other protocol defined inclusion criteria could apply.\n\nExclusion Criteria:\n\n* Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b) Participants with secondary progressive MS without evidence of relapse\n* Disease duration more than (\\>) 10 years in participants with an EDSS =\\< 2.0 at screening and Baseline (Day 1)\n* Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease\n* Other protocol defined exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT04338061', 'briefTitle': 'Study of Evobrutinib in Participants With RMS (evolutionRMS 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2)', 'orgStudyIdInfo': {'id': 'MS200527_0082'}, 'secondaryIdInfos': [{'id': '2019-004980-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Teriflunomide', 'interventionNames': ['Drug: Teriflunomide']}, {'type': 'EXPERIMENTAL', 'label': 'Evobrutinib', 'interventionNames': ['Drug: Evobrutinib']}], 'interventions': [{'name': 'Teriflunomide', 'type': 'DRUG', 'description': 'Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period.', 'armGroupLabels': ['Teriflunomide']}, {'name': 'Evobrutinib', 'type': 'DRUG', 'otherNames': ['M2951'], 'description': 'Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period.', 'armGroupLabels': ['Evobrutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site 752', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site 741', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site 704', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93230', 'city': 'Hanford', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 751', 'geoPoint': {'lat': 36.32745, 'lon': -119.64568}}, {'zip': '90048', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 737', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site 759', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site 725', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32714', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 746', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 718', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34105', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 702', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 740', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 726', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '34243', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 719', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 743', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33634', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 707', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 732', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '34607', 'city': 'Weeki Wachee', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 705', 'geoPoint': {'lat': 28.51555, 'lon': -82.57288}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 753', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Research Site 742', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site 715', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site 714', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '47904', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site 744', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site 717', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40356', 'city': 'Nicholasville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site 735', 'geoPoint': {'lat': 37.88063, 'lon': -84.573}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Research Site 706', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site 738', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site 723', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site 724', 'geoPoint': {'lat': 42.97839, 'lon': 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{'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site 335', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Research Site 328', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site 324', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site 338', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site 339', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site 342', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site 346', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saransk', 'country': 'Russia', 'facility': 'Research Site 326', 'geoPoint': {'lat': 54.18485, 'lon': 45.17166}}, {'city': 'Sestroretsk', 'country': 'Russia', 'facility': 'Research Site 321', 'geoPoint': {'lat': 60.09801, 'lon': 29.96378}}, {'city': 'Tyumen', 'country': 'Russia', 'facility': 'Research Site 337', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Research Site 493', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Research Site 571', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Research site 572', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Research Site 351', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Research Site 352', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Research Site 353', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Research Site 354', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Research Site 356', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Dubnica nad Váhom', 'country': 'Slovakia', 'facility': 'Research Site 359', 'geoPoint': {'lat': 48.95981, 'lon': 18.16634}}, {'city': 'Trenčín', 'country': 'Slovakia', 'facility': 'Research Site 358', 'geoPoint': {'lat': 48.89452, 'lon': 18.04436}}, {'city': 'Trnava', 'country': 'Slovakia', 'facility': 'Research Site 357', 'geoPoint': {'lat': 48.37773, 'lon': 17.58603}}, {'city': 'Celje', 'country': 'Slovenia', 'facility': 'Research Site 373', 'geoPoint': {'lat': 46.23092, 'lon': 15.26044}}, {'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Research Site 372', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'city': 'Maribor', 'country': 'Slovenia', 'facility': 'Research Site 371', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Research Site 501', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Research Site 502', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Research Site 503', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Research Site 504', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Alcorcón', 'country': 'Spain', 'facility': 'Research Site 384', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'city': 'Barakaldo', 'country': 'Spain', 'facility': 'Research Site 391', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site 390', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Research Site 382', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'El Palmar', 'country': 'Spain', 'facility': 'Research Site 389', 'geoPoint': {'lat': 39.31305, 'lon': -0.3174}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site 388', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Research Site 392', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Research Site 383', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Research Site 387', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Research Site 385', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Research Site 386', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'Research Site 381', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site 512', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Research site 514', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site 511', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site 513', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Research Site 404', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Research Site 402', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Research Site 403', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'city': 'Bangkoknoi', 'country': 'Thailand', 'facility': 'Research Site 583'}, {'city': 'Muang', 'country': 'Thailand', 'facility': 'Research Site 582'}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site 538', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site 544', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site 531', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site 534', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site 536', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site 541', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Research Site 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'country': 'Ukraine', 'facility': 'Research Site 417', 'geoPoint': {'lat': 51.50541, 'lon': 31.28656}}, {'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'Research Site 414', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'Research Site 416', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'Research Site 420', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Research Site 413', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Research Site 624', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Research Site 632', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Research Site 633', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kherson', 'country': 'Ukraine', 'facility': 'Research Site 419', 'geoPoint': {'lat': 46.63695, 'lon': 32.61458}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Research Site 411', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Research Site 418', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Lutsk', 'country': 'Ukraine', 'facility': 'Research Site 629', 'geoPoint': {'lat': 50.75784, 'lon': 25.35024}}, {'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Research Site 627', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Research Site 622', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'city': 'Rivne', 'country': 'Ukraine', 'facility': 'Research Site 625', 'geoPoint': {'lat': 50.62036, 'lon': 26.23695}}, {'city': 'Ternopil', 'country': 'Ukraine', 'facility': 'Research Site 628', 'geoPoint': {'lat': 49.55404, 'lon': 25.59067}}, {'city': 'Uzhhorod', 'country': 'Ukraine', 'facility': 'Research Site 630', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}, {'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Research Site 623', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Research Site 412', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Research Site 621', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Research Site 631', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'city': 'Zhytomyr', 'country': 'Ukraine', 'facility': 'Research Site 626', 'geoPoint': {'lat': 50.26235, 'lon': 28.67913}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'ipdSharingStatementModule': {'url': 'http://bit.ly/IPD21', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union', 'ipdSharing': 'YES', 'description': 'We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21', 'accessCriteria': "Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'EMD Serono Research & Development Institute, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}