Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT00459667
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2007-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068576', 'term': 'Interferon beta-1b'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': "The sponsor is interested in the publication of the results of every study it performs. As some of the information concerning the study drug and the sponsor's development activities may be strictly confidential, any publication manuscript (including conference contributions, etc.) must first be reviewed by the sponsor before its submission or presentation. Publication of subgroup data and single center data shall not be performed until the complete study has been published.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the termination of the study before start of Phase B according to protocol defined stopping rules, functional assessments of multiple sclerosis (FAMS) and EuroQoL (EQ-5D) were not performed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)', 'otherNumAtRisk': 586, 'otherNumAffected': 455, 'seriousNumAtRisk': 586, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)', 'otherNumAtRisk': 645, 'otherNumAffected': 467, 'seriousNumAtRisk': 645, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)', 'otherNumAtRisk': 180, 'otherNumAffected': 136, 'seriousNumAtRisk': 180, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Astenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscle spasticity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscle spams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremitiy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Menopausal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Multiple Sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bladder catheter replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Elective surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rehabilitation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dandy-Walker syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Papillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arteriogram coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Platelet aggregation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intra-uterine death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure actue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 645, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flu-like-syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)'}, {'id': 'OG001', 'title': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)'}, {'id': 'OG002', 'title': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '15.8', 'groupId': 'OG001'}, {'value': '31.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Number of patients w/ Flu-Like-Syndrome', 'ciPctValue': '95', 'paramValue': '17.4', 'ciLowerLimit': '14.4', 'ciUpperLimit': '20.7', 'groupDescription': 'The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Number of patients w/ Flu-Like-Syndrome', 'ciPctValue': '95', 'paramValue': '15.8', 'ciLowerLimit': '13.1', 'ciUpperLimit': '18.9', 'groupDescription': 'The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Number of patients w/ Flu-Like-Syndrome', 'ciPctValue': '95', 'paramValue': '31.1', 'ciLowerLimit': '24.4', 'ciUpperLimit': '38.4', 'groupDescription': 'The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '309 days', 'description': 'The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Flu-Like-Syndrome with 95% confidence intervals were provided.'}, {'type': 'PRIMARY', 'title': 'Injection-site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)'}, {'id': 'OG001', 'title': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)'}, {'id': 'OG002', 'title': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}, {'value': '26.2', 'groupId': 'OG001'}, {'value': '31.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'number of patients w/ IS reactions.', 'ciPctValue': '95', 'paramValue': '31.7', 'ciLowerLimit': '28.0', 'ciUpperLimit': '35.7', 'groupDescription': 'The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'number of patients w/ IS reactions.', 'ciPctValue': '95', 'paramValue': '26.2', 'ciLowerLimit': '22.8', 'ciUpperLimit': '29.8', 'groupDescription': 'The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'number of patients w/ IS reactions.', 'ciPctValue': '95', 'paramValue': '31.7', 'ciLowerLimit': '24.9', 'ciUpperLimit': '39.0', 'groupDescription': 'The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '309 days', 'description': 'The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Injection-site reactions with 95% confidence intervals were provided.'}, {'type': 'PRIMARY', 'title': 'Liver Enzyme Elevations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)'}, {'id': 'OG001', 'title': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)'}, {'id': 'OG002', 'title': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)'}], 'classes': [{'title': 'GGT increased', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'AST increased', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'ALT increased', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '4.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '309 days', 'description': 'The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of liver enzyme elevations were provided.'}, {'type': 'PRIMARY', 'title': 'Hematological Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)'}, {'id': 'OG001', 'title': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)'}, {'id': 'OG002', 'title': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)'}], 'classes': [{'title': 'White blood cells decreased', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin decreased', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '309 days', 'description': 'The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of hematological abnormalities were provided.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)'}, {'id': 'OG001', 'title': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)'}, {'id': 'OG002', 'title': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)'}], 'classes': [{'title': 'NAbs titer, cut-off value 20 NU/ml', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '16.6', 'groupId': 'OG002'}]}]}, {'title': 'NAbs titer, cut-off value 100 NU/ml', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}, {'value': '12.4', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}]}]}, {'title': 'NAbs titer, cut-off value 400 NU/ml', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '309 days', 'description': 'Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For the NAb analyses data were provided for 572 patients at Baseline, 238 at Week 26 and 1261 at EOS. The patients missing to the total number of 1411 patients had no data at the respective visits (table shows number of patients with positive titer in the extension treatment cohorts; the analyses provide frequencies of positive titers).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)'}, {'id': 'FG001', 'title': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)'}, {'id': 'FG002', 'title': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '592'}, {'groupId': 'FG001', 'numSubjects': '647'}, {'groupId': 'FG002', 'numSubjects': '181'}]}, {'type': 'Study Medication Dispensed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '586'}, {'groupId': 'FG001', 'numSubjects': '645'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'Started Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '586'}, {'groupId': 'FG001', 'numSubjects': '644'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '554'}, {'groupId': 'FG001', 'numSubjects': '600'}, {'groupId': 'FG002', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other disease modifying treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other reason (incl. 2 missing subjects)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'No treatment administered', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Eligible patients for this study included only those who completed the preceding BEYOND study. Patients were enrolled at the conclusion of the preceding study from 03 May 2007 until 14 March 2008. Patients who interrupted study medication in accordance with the investigator were eligible, provided it did not result in premature End of Study.', 'preAssignmentDetails': 'All enrolled patients who had been randomized during the predecessor study to IFNB 1b (Interferon 1b) continued on previously double-blinded medication in the BEYOND-FU study; all patients who had been previously randomized to Copaxone and all patients with premature end of study medication received open-label IFNB 1b 250 µg (IFNB 1b 250 µg\\*).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 'BG000'}, {'value': '645', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '1411', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)'}, {'id': 'BG001', 'title': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)'}, {'id': 'BG002', 'title': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Mean±Standard Deviation', 'categories': [{'measurements': [{'value': '36.2', 'spread': '9.36', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '9.17', 'groupId': 'BG001'}, {'value': '34.9', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '35.9', 'spread': '9.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': '>18 and <55 years', 'categories': [{'measurements': [{'value': '580', 'groupId': 'BG000'}, {'value': '640', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '1398', 'groupId': 'BG003'}]}]}, {'title': '>=55 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '414', 'groupId': 'BG000'}, {'value': '445', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '972', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '439', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-03', 'studyFirstSubmitDate': '2007-04-11', 'resultsFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2007-04-11', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-03', 'studyFirstPostDateStruct': {'date': '2007-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flu-like-syndrome', 'timeFrame': '309 days', 'description': 'The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.'}, {'measure': 'Injection-site Reactions', 'timeFrame': '309 days', 'description': 'The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.'}, {'measure': 'Liver Enzyme Elevations', 'timeFrame': '309 days', 'description': 'The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.'}, {'measure': 'Hematological Abnormalities', 'timeFrame': '309 days', 'description': 'The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values', 'timeFrame': '309 days', 'description': 'Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapsing multiple sclerosis', 'interferon beta 1b', 'Betaferon', 'Betaseron'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'references': [{'pmid': '21952094', 'type': 'DERIVED', 'citation': "Goodin DS, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Kappos L, Bogumil T, Knappertz V, Sandbrink R, Beckmann K, White R, Petkau J, Pohl C; BEYOND Study Group. Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler. 2012 Feb;18(2):181-95. doi: 10.1177/1352458511418629. Epub 2011 Sep 27."}]}, 'descriptionModule': {'briefSummary': 'The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.', 'detailedDescription': 'Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.\n\nPhase B (single arm): All patients will receive open-label IFNB 1b 500µg)\n\nRandomization: No randomization in this trial, patient\'s allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.\n\nThe trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.\n\nSecondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Completion of the BEYOND study 306440 as scheduled\n* Relapsing multiple sclerosis\n* Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.\n* Females of child-bearing potential:\n\n * Agreement to practice adequate contraception methods and\n * Negative pregnancy test and\n * No lactation\n* Written informed consent\n\nExclusion Criteria:\n\n* Serious or acute heart diseases\n* History of severe depression or suicide attempt\n* Epilepsy not adequately controlled by treatment\n* Known allergy to IFNs, to human albumin or to mannitol\n* Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study"}, 'identificationModule': {'nctId': 'NCT00459667', 'acronym': 'Beyond', 'briefTitle': 'BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg', 'orgStudyIdInfo': {'id': '91656'}, 'secondaryIdInfos': [{'id': '2006-005270-47', 'type': 'EUDRACT_NUMBER'}, {'id': '309363', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IFNB-1b 500 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 500 mcg administered s.c. every other day (double blind)', 'interventionNames': ['Drug: Interferon beta-1b (Betaseron, BAY86-5046)']}, {'type': 'EXPERIMENTAL', 'label': 'IFNB-1b 250 mcg', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day (double blind)', 'interventionNames': ['Drug: Interferon beta-1b (Betaseron, BAY86-5046)']}, {'type': 'EXPERIMENTAL', 'label': 'IFNB-1b 250 mcg*', 'description': 'Interferon beta 1b (\\[IFNB 1b\\] Betaseron) 250 mcg administered s.c. every other day\n\n\\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)', 'interventionNames': ['Drug: Interferon beta-1b (Betaseron, BAY86-5046)']}], 'interventions': [{'name': 'Interferon beta-1b (Betaseron, BAY86-5046)', 'type': 'DRUG', 'description': 'Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).', 'armGroupLabels': ['IFNB-1b 250 mcg']}, {'name': 'Interferon beta-1b (Betaseron, BAY86-5046)', 'type': 'DRUG', 'description': 'Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).', 'armGroupLabels': ['IFNB-1b 500 mcg']}, {'name': 'Interferon beta-1b (Betaseron, BAY86-5046)', 'type': 'DRUG', 'description': 'Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.\n\nPhase B: All patients will receive 500µg s.c.every other day (open-label).', 'armGroupLabels': ['IFNB-1b 250 mcg*']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-7340', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'geoPoint': 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