Viewing Study NCT00056160

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 2:17 AM

Ignite Modification Date: 2025-12-27 @ 11:39 PM

Study NCT ID: NCT00056160

Status: COMPLETED

Last Update Posted: 2017-10-19

First Post: 2003-03-06

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rknight@celgene.com', 'phone': '908-673-9749', 'title': 'Robert Knight, M.D.', 'organization': 'Celgene Corporation'}, 'certainAgreement': {'otherDetails': 'The investigator shall have the right to publish and/or present the clinical data generated from the study provided that such Investigator shall furnish sponsor with a copy of the proposed publication or presentation at least 60 days in advance of submission, delete any confidential information, and delay submission for up to 90 days to permit the preparation and filing of appropriate intellectual property applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Analyses for efficacy had data cutoff dates of 07 Jun 2005 and a data cutoff date of 23 Jul 2008 for overall survival. Only safety data were collected for 6 subjects ongoing beyond the 23 Jul 2008 data cutoff date.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 254 weeks (median=48 weeks; mean=77 weeks)', 'description': 'Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.', 'eventGroups': [{'id': 'EG000', 'title': 'CC-5013/Dex', 'description': 'CC-5013 (lenalidomide) plus oral high-dose dexamethasone', 'otherNumAtRisk': 177, 'otherNumAffected': 177, 'seriousNumAtRisk': 177, 'seriousNumAffected': 111}, {'id': 'EG001', 'title': 'Placebo/Dex', 'description': 'Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone', 'otherNumAtRisk': 175, 'otherNumAffected': 175, 'seriousNumAtRisk': 175, 'seriousNumAffected': 90}], 'otherEvents': [{'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'AGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 139, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 44, 'numAffected': 37}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'APPETITE DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 63, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 51, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 59, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 66, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 71, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 40, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'BALANCE IMPAIRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 31, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 25, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CATARACT UNILATERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 34, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 24, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CHEST WALL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 99, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 43, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 91, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 53, 'numAffected': 48}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'CUSHINGOID', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 31, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 174, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 85, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 102, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 54, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 41, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 37, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 64, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 47, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ECCHYMOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'FACE OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 191, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 164, 'numAffected': 105}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'FLUID RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'FLUSHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 79, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 66, 'numAffected': 54}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HERPES SIMPLEX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HICCUPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 26, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HOARSENESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 62, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 91, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HYPOMAGNESAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 34, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HYPOPHOSPHATAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 5, 'numAffected': 5}], 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0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PNEUMONIA FUNGAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 39, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PNEUMONIA PRIMARY ATYPICAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PNEUMONIA STAPHYLOCOCCAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PNEUMONIA STREPTOCOCCAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RADIUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RENAL TUBULAR NECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RETINAL DETACHMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RETINAL VEIN OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'RIB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SINUS TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SINUSITIS FUNGAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SKIN DESQUAMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SKIN DISCOLOURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SPINAL COMPRESSION FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SPINAL CORD COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'STAPHYLOCOCCAL SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'STREPTOCOCCAL BACTERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'STREPTOCOCCAL SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SUBACUTE ENDOCARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SUBDURAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SUPERIOR VENA CAVAL OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'SYSTEMIC INFLAMMATORY RESPONSE SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'TOOTH ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'UROSEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'VASCULAR GRAFT OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}, {'term': 'WRIST FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (5.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Tumor Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-5013/Dex', 'description': 'CC-5013 (lenalidomide) plus oral high-dose dexamethasone'}, {'id': 'OG001', 'title': 'Placebo/Dex', 'description': 'Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000', 'lowerLimit': '41.1', 'upperLimit': '80.0'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '21.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '60 weeks (median Time To Progression of CC-5013/Dex treatment group)', 'description': 'Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-5013/Dex', 'description': 'CC-5013 (lenalidomide) plus oral high-dose dexamethasone'}, {'id': 'OG001', 'title': 'Placebo/Dex', 'description': 'Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '170.1', 'groupId': 'OG000', 'lowerLimit': '142.1', 'upperLimit': '204.9'}, {'value': '136.4', 'groupId': 'OG001', 'lowerLimit': '104.1', 'upperLimit': '176.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '170 weeks (median overall survival of CC-5013/Dex treatment group)', 'description': 'Overall survival was calculated as the time from randomization to death from any cause.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.'}, {'type': 'SECONDARY', 'title': 'Myeloma Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-5013/Dex', 'description': 'CC-5013 (lenalidomide) plus oral high-dose dexamethasone'}, {'id': 'OG001', 'title': 'Placebo/Dex', 'description': 'Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Unblinding (07 Jun 2005)', 'description': 'The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.'}, {'type': 'SECONDARY', 'title': 'Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-5013/Dex', 'description': 'CC-5013 (lenalidomide) plus oral high-dose dexamethasone'}, {'id': 'OG001', 'title': 'Placebo/Dex', 'description': 'Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'spread': '30.02', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '16.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)', 'description': 'The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CC-5013/Dex', 'description': 'CC-5013 (lenalidomide) plus oral high-dose dexamethasone'}, {'id': 'FG001', 'title': 'Placebo/Dex', 'description': 'Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone'}], 'periods': [{'title': 'Up to Unblinding (07 Jun 2005)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '163'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Progression of disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}, {'title': 'Extended Follow-up Cutoff (23 Jul 2008)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Progression of disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Final Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Transferred into expanded access study.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Transferred into RevAssist Program', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects in the Placebo/Dex treatment group did not continue participation beyond the period "Up To Unblinding (07 Jun 2005"). Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)".', 'preAssignmentDetails': 'Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)". Data for the period "Extended Follow-up Cutoff (23 Jul 2008)" subsumes data for the period "Up To Unblinding (07 Jun 2005)".'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CC-5013/Dex', 'description': 'CC-5013 (lenalidomide) plus oral high-dose dexamethasone'}, {'id': 'BG001', 'title': 'Placebo/Dex', 'description': 'Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '9.84', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '9.81', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '9.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, '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': 353}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2008-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2003-03-06', 'resultsFirstSubmitDate': '2009-12-24', 'studyFirstSubmitQcDate': '2003-03-06', 'lastUpdatePostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-02-02', 'studyFirstPostDateStruct': {'date': '2003-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Tumor Progression (TTP)', 'timeFrame': '60 weeks (median Time To Progression of CC-5013/Dex treatment group)', 'description': 'Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '170 weeks (median overall survival of CC-5013/Dex treatment group)', 'description': 'Overall survival was calculated as the time from randomization to death from any cause.'}, {'measure': 'Myeloma Response', 'timeFrame': 'Up to Unblinding (07 Jun 2005)', 'description': 'The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.'}, {'measure': 'Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)', 'timeFrame': '30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)', 'description': 'The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Refractory and Relapsed', 'Revlimid', 'CC5013'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '18032763', 'type': 'RESULT', 'citation': 'Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.'}, {'pmid': '21273172', 'type': 'DERIVED', 'citation': 'San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120.'}, {'pmid': '19901114', 'type': 'DERIVED', 'citation': 'Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.'}, {'pmid': '18799726', 'type': 'DERIVED', 'citation': 'Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.'}], 'seeAlsoLinks': [{'url': 'http://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/clinical-study-report-csr-synopses/purposes-of-posting-clinical-study-report-csr-synopses', 'label': 'Link to CSR synopsis'}]}, 'descriptionModule': {'briefSummary': 'Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.', 'detailedDescription': 'This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.\n* No more than 3 previous anti-myeloma regimens\n* No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.\n* Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).\n\nExclusion Criteria:\n\n* Prior development of disease progression during high-dose dexamethasone containing therapy.\n* Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed\n* Laboratory abnormalities: Platelet count less than 75,000/mm cubed\n* Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL\n* Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase \\[AST\\]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase \\[ALT\\])greater than 3.0 x upper limit of normal\n* Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL\n* Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.\n* Known hypersensitivity to thalidomide or dexamethasone.\n* Development of a desquamating rash while taking thalidomide.'}, 'identificationModule': {'nctId': 'NCT00056160', 'briefTitle': 'CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CC-5013-MM-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CC-5013/Dex', 'description': 'CC-5013 (lenalidomide) plus oral high-dose dexamethasone', 'interventionNames': ['Drug: CC-5013', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/Dex', 'description': 'Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'CC-5013', 'type': 'DRUG', 'otherNames': ['lenalidomide', 'Revlimid'], 'description': 'Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.', 'armGroupLabels': ['CC-5013/Dex']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Decadron'], 'description': 'Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.', 'armGroupLabels': ['CC-5013/Dex', 'Placebo/Dex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Consultants, Inc.', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305-5112', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center, Division of Hematology', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic- Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Oncology 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