Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-31 @ 2:36 AM
Study NCT ID:
NCT00812968
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2008-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077269', 'term': 'Lenalidomide'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialdisclosure@celgene.com', 'phone': '1-888-260-1599', 'title': 'Associate Director, Clinical Trials Disclosure', 'organization': 'Celgene Corporation'}, 'certainAgreement': {'otherDetails': "Disclosure agreements vary; the Investigators shall not disclose any material/information disclosed by the Sponsor (Celgene KK) with the clinical trial or information obtained by conducting the clinical trial to third parties without Sponsor's prior written approval.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug through 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Basophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Haemorrhoidal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Lip Dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Acute Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Lymphadenitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Vulvitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Acute Febrile Neutrophilic Dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Fibrin Degradation Products Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Phosphorus Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Uric Acid Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Fibrin D Dimer Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Lactate Dehydrogenase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Potassium Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Urea Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blood Urea Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'International Normalised Ratio Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Mean Cell Volume Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Protein Total Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Myalgia Intercostal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Spinal Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Tooth Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Face Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Non-cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Iron Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Vitamin B12 Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Conjunctival Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Vitreous Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Upper Respiratory Tract Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Cervicobrachial Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Tension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Ear Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Hepatic Function Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}], 'seriousEvents': [{'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Liver Function Test Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Any adverse event (AE)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'AE related to study drug', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 or 4 AE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 or 4 AE related to study drug', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Serious AE (SAE)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'SAE related to study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related AE leading to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to a dose reduction or interruption', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Related AE leading to dose reduction/interruption', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).', 'description': 'An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):\n\n* Death;\n* Life-threatening event;\n* Any inpatient hospitalization or prolongation of existing hospitalization;\n* Persistent or significant disability or incapacity;\n* Congenital anomaly or birth defect;\n* Any other important medical event.\n\nThe investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.\n\nThe severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all patients who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide: Day 1', 'description': 'Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.'}, {'id': 'OG001', 'title': 'Lenalidomide: Day 4', 'description': 'Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '149', 'spread': '31.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all patients who adhered to the study treatment during the course of PK assessment (Days 1 to 5 of Cycle 1) and from whom blood and urine samples were collected.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration (Tmax) of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide: Day 1', 'description': 'Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.'}, {'id': 'OG001', 'title': 'Lenalidomide: Day 4', 'description': 'Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.52', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.95'}, {'value': '2.93', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide: Day 1', 'description': 'Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.'}, {'id': 'OG001', 'title': 'Lenalidomide: Day 4', 'description': 'Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '718.4', 'spread': '41.2', 'groupId': 'OG000'}, {'value': '803.5', 'spread': '46.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide: Day 1', 'description': 'Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.'}, {'id': 'OG001', 'title': 'Lenalidomide: Day 4', 'description': 'Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '866.5', 'spread': '44.1', 'groupId': 'OG000'}, {'value': '877.9', 'spread': '43.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.', 'description': 'Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population with available data'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'categories': [{'measurements': [{'value': '878.0', 'spread': '45.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.', 'description': 'Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population with available data'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (T1/2) of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide: Day 1', 'description': 'Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.'}, {'id': 'OG001', 'title': 'Lenalidomide: Day 4', 'description': 'Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.26', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '29.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population with available data'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (VzF) of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide: Day 1', 'description': 'Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.'}, {'id': 'OG001', 'title': 'Lenalidomide: Day 4', 'description': 'Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '30.9', 'groupId': 'OG000'}, {'value': '58.6', 'spread': '25.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).', 'unitOfMeasure': 'liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population with available data'}, {'type': 'SECONDARY', 'title': 'Apparent Total Plasma Clearance (CL/F) of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide: Day 1', 'description': 'Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.'}, {'id': 'OG001', 'title': 'Lenalidomide: Day 4', 'description': 'Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '189.8', 'spread': '45.1', 'groupId': 'OG000'}, {'value': '189.9', 'spread': '43.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).', 'unitOfMeasure': 'mL/minute', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population with available data'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Elimination Rate Constant of Lenalidomide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide: Day 1', 'description': 'Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.'}, {'id': 'OG001', 'title': 'Lenalidomide: Day 4', 'description': 'Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.213', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '0.194', 'spread': '39.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4).', 'unitOfMeasure': '1/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population with available data'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Erythroid Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Erythroid responders (major or minor)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Major erythroid responders', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Response was assessed every 28 days through Week 156.', 'description': 'Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.\n\nA major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin \\< 10 g/dL at Baseline a major response is defined as a \\> 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.\n\nMinor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: all patients who had a diagnosis of low- or intermediate-1-risk MDS associated with anemia based on confirmation by the central reviewers and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Erythroid Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Time to erythroid response (major or minor)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '11.1'}]}]}, {'title': 'Time to major erythroid response', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '31.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study drug through Week 156', 'description': 'Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}, {'type': 'SECONDARY', 'title': 'Duration of Erythroid Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Duration of erythroid response (major or minor)', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '152.0'}]}]}, {'title': 'Duration of major erythroid response', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '144.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study drug through Week 156', 'description': 'Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population with a erythroid response'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Baseline concentration', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '9.1'}]}]}, {'title': 'Maximum concentration during study', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '15.8'}]}]}, {'title': 'Change from Baseline to maximum value', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and from Day1 until the maximum observed value (up to 155 weeks)', 'description': 'Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population with a erythroid response'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Neutrophil Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Major response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Minor response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Response was assessed every 28 days through Week 156', 'description': 'Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count \\< 1,500/mm\\^3 is defined as a ≥ 100% increase or a ≥ 500/mm\\^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.\n\nA minor response for participants with a Baseline neutrophil count \\< 1,500/mm\\^3 is defined as a ≥ 100% increase, but an absolute increase \\< 500/mm\\^3, sustained for consecutive 56 days during the treatment period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population with Baseline neutrophil count \\< 1,500/mm\\^3.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Platelet Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'timeFrame': 'Response was assessed every 28 days through Week 156', 'description': 'Platelet response was determined using the IWG (2000) criteria. Major response in patients with Baseline platelet count \\< 100,000/mm\\^3 is defined as a ≥ 30,000/mm\\^3 increase sustained for consecutive 56 days during the treatment period. In platelet-transfusion-dependent patients at Baseline a major response is defined as stabilization of platelet counts and platelet transfusion independence sustained for consecutive 56 days during the treatment period.\n\nMinor response in patients with Baseline platelet count \\< 100,000/mm\\^3 is defined as a ≥ 50% increase in platelet count with an absolute increase \\> 10,000/mm\\^3 and \\< 30,000/mm\\^3 sustained for consecutive 56 days during the treatment period.', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population with a Baseline platelet count of \\< 100,000/mm\\^3 or who were platelet-transfusion dependent at Baseline. There were no patients with platelet count of \\< 100,000/mm3 or who were platelet-transfusion dependent at Baseline, and thus platelet response was not evaluated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Cytogenetic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Major response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Minor response', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Response was assessed every 12 weeks through Week 156', 'description': 'Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.\n\nA major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Bone Marrow Erythroblasts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Change from Baseline at the end of Cycle 3', 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '51.0'}]}]}, {'title': 'Change from Baseline at the end of Cycle 6', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '56.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).', 'description': 'Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.', 'unitOfMeasure': 'Percentage of Bone Marrow Erythroblasts', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population with available bone marrow specimens.'}, {'type': 'SECONDARY', 'title': 'Percentage of Bone Marrow Myeloblasts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Baseline (N=11)', 'categories': [{'measurements': [{'value': '3.77', 'groupId': 'OG000', 'lowerLimit': '1.20', 'upperLimit': '8.40'}]}]}, {'title': 'End of Cycle 3 (N=10)', 'categories': [{'measurements': [{'value': '1.47', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '4.55'}]}]}, {'title': 'End of Cycle 6 (N=10)', 'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).', 'description': 'Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.', 'unitOfMeasure': 'Percentage of myeloblasts', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population with available bone marrow specimens at each time point (indicated by "N").'}, {'type': 'SECONDARY', 'title': 'Percentage of Bone Marrow Promyelocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'classes': [{'title': 'Baseline (N=11)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '13'}]}]}, {'title': 'End of Cycle 3 (N=10)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}]}]}, {'title': 'End of Cycle 6 (N=10)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).', 'description': 'Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.', 'unitOfMeasure': 'Percentage of promyelocytes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population with available bone marrow specimens at each time point (indicated by "N").'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle. Treatment continued until disease progression or relapse following an erythroid improvement was documented, any of the criteria for treatment discontinuation was violated, or lenalidomide became commercially available for the treatment of MDS associated with a del (5q) cytogenetic abnormality, for up to 156 weeks (3 years).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Relapse after erythroid response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No further treatment required', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study closed due to marketing approval', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lenalidomide', 'description': '10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.8', 'spread': '5.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of MDS', 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '1.44', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'International Prognostic Scoring System (IPSS) Score', 'classes': [{'title': 'Low risk', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Intermediate-1 risk', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Intermediate-2 risk', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'High risk', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The MDS IPSS assesses the severity of MDS based on 3 prognostic factors each assigned a score: the proportion of bone marrow blasts, chromosome changes in the marrow cells (karyotype) and the presence of one or more low blood cell counts (cytopenias). The IPSS score is the sum of the bone marrow blast + karyotype + cytopenia score and ranges from 0 (low risk) to 3.5 (high risk). Prognosis is categorized as Low risk (score = 0), Intermediate-1 (score 0.5 to 1.0), Intermediate-2 (score 1.5 to 2.0) or High risk (score ≥ 2.5).', 'unitOfMeasure': 'participants'}, {'title': 'French-American-British (FAB) classification of MDS', 'classes': [{'title': 'Refractory anemia (RA)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Refractory anemia with ringed sideroblasts (RARS)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Refractory anemia with excess blasts (RAEB)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Chronic myelomonocytic leukemia (CMML)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'RAEB in transformation (RAEB-t)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The French-American-British (FAB) classification of MDS recognizes five subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), or a monocytosis.', 'unitOfMeasure': 'participants'}, {'title': 'World Health Organization Classification of MDS', 'classes': [{'title': 'Refractory anemia (RA)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'RA with ringed sideroblasts (RARS)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Refractory anemia with excess blasts-1 (RAEB-1)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Refractory anemia with excess blasts-2 (RAEB-2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Refractory cytopenia multilineage dysplasia (RCMD)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'RCMD and ringed sideroblasts (RCMD-RS)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'MDS, unclassified (MDS-U)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'MDS associated with isolated del(5q)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The World Health Organization (WHO) classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q.', 'unitOfMeasure': 'participants'}, {'title': 'Bone Marrow Cellularity', 'classes': [{'title': 'Aplastic (0%)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Hypocellular (> 0% to ≤ 30%)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Normocellular (> 30% to ≤ 60%)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Hypercellular (> 60% to ≤ 90%)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Packed (> 90% to ≤ 100%)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Bone marrow cellularity is a measure of the percentage of hematopoietic stem cells relative to fat cells in the bone marrow.', 'unitOfMeasure': 'participants'}, {'title': 'Transfusion Dependency', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2010-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2008-12-17', 'resultsFirstSubmitDate': '2013-09-30', 'studyFirstSubmitQcDate': '2008-12-19', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-30', 'studyFirstPostDateStruct': {'date': '2008-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AE)', 'timeFrame': 'After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).', 'description': 'An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):\n\n* Death;\n* Life-threatening event;\n* Any inpatient hospitalization or prolongation of existing hospitalization;\n* Persistent or significant disability or incapacity;\n* Congenital anomaly or birth defect;\n* Any other important medical event.\n\nThe investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.\n\nThe severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Lenalidomide', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4).'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of Lenalidomide', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).'}, {'measure': 'Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.', 'description': 'Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide', 'timeFrame': 'Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.', 'description': 'Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1.'}, {'measure': 'Terminal Half-life (T1/2) of Lenalidomide', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).'}, {'measure': 'Apparent Volume of Distribution (VzF) of Lenalidomide', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).'}, {'measure': 'Apparent Total Plasma Clearance (CL/F) of Lenalidomide', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).'}, {'measure': 'Apparent Terminal Elimination Rate Constant of Lenalidomide', 'timeFrame': 'Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.', 'description': 'Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4).'}, {'measure': 'Number of Participants With a Erythroid Response', 'timeFrame': 'Response was assessed every 28 days through Week 156.', 'description': 'Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.\n\nA major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin \\< 10 g/dL at Baseline a major response is defined as a \\> 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.\n\nMinor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.'}, {'measure': 'Time to Erythroid Response', 'timeFrame': 'From the first dose of study drug through Week 156', 'description': 'Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response.'}, {'measure': 'Duration of Erythroid Response', 'timeFrame': 'From the first dose of study drug through Week 156', 'description': 'Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response.'}, {'measure': 'Change From Baseline in Hemoglobin Concentration', 'timeFrame': 'Baseline and from Day1 until the maximum observed value (up to 155 weeks)', 'description': 'Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders.'}, {'measure': 'Number of Participants With a Neutrophil Response', 'timeFrame': 'Response was assessed every 28 days through Week 156', 'description': 'Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count \\< 1,500/mm\\^3 is defined as a ≥ 100% increase or a ≥ 500/mm\\^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.\n\nA minor response for participants with a Baseline neutrophil count \\< 1,500/mm\\^3 is defined as a ≥ 100% increase, but an absolute increase \\< 500/mm\\^3, sustained for consecutive 56 days during the treatment period.'}, {'measure': 'Number of Participants With a Platelet Response', 'timeFrame': 'Response was assessed every 28 days through Week 156', 'description': 'Platelet response was determined using the IWG (2000) criteria. Major response in patients with Baseline platelet count \\< 100,000/mm\\^3 is defined as a ≥ 30,000/mm\\^3 increase sustained for consecutive 56 days during the treatment period. In platelet-transfusion-dependent patients at Baseline a major response is defined as stabilization of platelet counts and platelet transfusion independence sustained for consecutive 56 days during the treatment period.\n\nMinor response in patients with Baseline platelet count \\< 100,000/mm\\^3 is defined as a ≥ 50% increase in platelet count with an absolute increase \\> 10,000/mm\\^3 and \\< 30,000/mm\\^3 sustained for consecutive 56 days during the treatment period.'}, {'measure': 'Number of Participants With a Cytogenetic Response', 'timeFrame': 'Response was assessed every 12 weeks through Week 156', 'description': 'Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.\n\nA major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period.'}, {'measure': 'Change From Baseline in Percentage of Bone Marrow Erythroblasts', 'timeFrame': 'Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).', 'description': 'Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.'}, {'measure': 'Percentage of Bone Marrow Myeloblasts', 'timeFrame': 'Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).', 'description': 'Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.'}, {'measure': 'Percentage of Bone Marrow Promyelocytes', 'timeFrame': 'Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).', 'description': 'Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myelodysplastic Syndromes', 'Lenalidomide'], 'conditions': ['Myelodysplastic Syndromes']}, 'referencesModule': {'references': [{'pmid': '22172461', 'type': 'BACKGROUND', 'citation': 'Matsuda A, Taniwaki M, Jinnai I, Harada H, Watanabe M, Suzuki K, Yanagita S, Suzuki T, Yoshida Y, Kimura A, Tsudo M, Tohyama K, Takatoku M, Ozawa K. Morphologic analysis in myelodysplastic syndromes with del(5q) treated with lenalidomide. A Japanese multiinstitutional study. Leuk Res. 2012 May;36(5):575-80. doi: 10.1016/j.leukres.2011.11.011. Epub 2011 Dec 15.'}, {'pmid': '19705057', 'type': 'RESULT', 'citation': 'Harada H, Watanabe M, Suzuki K, Yanagita S, Suzuki T, Yoshida Y, Kimura A, Tsudo M, Matsuda A, Tohyama K, Taniwaki M, Takeshita K, Takatoku M, Ozawa K. Lenalidomide is active in Japanese patients with symptomatic anemia in low- or intermediate-1 risk myelodysplastic syndromes with a deletion 5q abnormality. Int J Hematol. 2009 Oct;90(3):353-360. doi: 10.1007/s12185-009-0400-8. Epub 2009 Aug 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body \\[pharmacokinetics\\]) in Japanese subjects with low- or intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33) abnormality and symptomatic anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must understand and voluntarily sign an informed consent form.\n* Age ≥ 20 years at the time of signing the informed consent form.\n* Must be able to adhere to the study visit schedule and other protocol requirements.\n* Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated with a deletion 5(q31-33) abnormality\n* Symptomatic anemia secondary to MDS defined as:Untransfused Hb level \\< 10.0 g/dL and a Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74 or Transfusion dependent anemia\n\nExclusion Criteria:\n\n* Pregnant or lactating females.\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.\n* Prior therapy with lenalidomide.\n* Patients with any of the following laboratory abnormalities within 14 days of starting study drug: Absolute Neutrophil Count (ANC) \\< 750 cells/μL (0.75 x 10\\^9/L) Platelet count \\< 50,000/μL (50x10\\^9/L) Serum creatinine \\> 2.5 mg/dL Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \\> 3.0 x Upper Limit of Normal (ULN)'}, 'identificationModule': {'nctId': 'NCT00812968', 'briefTitle': 'Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Multicenter, Single-arm Study to Assess the Safety, Pharmacokinetics and Efficacy of Lenalidomide in Japanese Subjects With Low- or Intern=Mediate-1-risk Myelodysplastic Syndromes (MDS) Associated With a Deletion 5 (q31-33) Abnormality and Symptomatic Anemia', 'orgStudyIdInfo': {'id': 'CC-5013-MDS-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lenalidomide', 'description': 'Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).', 'interventionNames': ['Drug: Lenalidomide']}], 'interventions': [{'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['CC-5013'], 'description': 'Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).', 'armGroupLabels': ['Lenalidomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '329-0498', 'city': 'Shimono', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Celgene Clinical Site'}, {'zip': '150-8935', 'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Celgene Clinical Site'}, {'zip': '734-8551', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Celgene Clinical Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '601-1495', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Celgene Clinical Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '543-8555', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Celgene Clinical Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '420-8527', 'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Celgene Clinical Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}], 'overallOfficials': [{'name': 'Masaaki Takatoku, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celgene Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}