(7.6) 18 (5.1)
Metabolism and nutrition disorders
Anorexia 55 (15.6) 34 (9.7)
Hypokalemia 48 (13.6) 21 (6.0)
Hypocalcemia 31 (8.8) 10 (2.9)
Appetite Decreased 24 (6.8) 14 (4.0)
Dehydration 23 (6.5) 15 (4.3)
Hypomagnesaemia 24 (6.8) 10 (2.9)
Investigations
Weight Decreased 69 (19.5) 52 (14.9)
Eye disorders
Blurred vision 61 (17.3) 40 (11.4)
Vascular disorders
Deep vein thrombosis % 33 (9.3) 15 (4.3)
Hypertension 28 (7.9) 20 (5.7)
Hypotension 25 (7.1) 15 (4.3)
Table 4: Grade 3/4 Adverse Reactions Reported in ≥2% Patients and With a ≥1% Difference in Proportion of Patients Between the REVLIMID/dexamethasone and Placebo/dexamethasone groups System Organ Class/ Preferred Term Lenalidomide/Dex#
(n=353)
n (%) Placebo/Dex#
(n=350)
n (%)
Blood and lymphatic system disorders
Neutropenia % 118 (33.4) 12 (3.4)
Thrombocytopenia @ 43 (12.2) 22 (6.3)
Anemia @ 35 (9.9) 20 (5.7)
Leukopenia 14 (4.0) 1 (0.3)
Lymphopenia 10 (2.8) 4 (1.1)
Febrile Neutropenia % 8 (2.3) 0 (0.0)
General disorders and administration site conditions
Fatigue 23 (6.5) 17 (4.9)
Vascular disorders
Deep vein thrombosis % 29 (8.2) 12 (3.4)
Infectionsb and infestations
Pneumonia @ 30 (8.5) 19 (5.4)
Urinary Tract Infection 5 (1.4) 1 (0.3)
Metabolism and nutrition disorders
Hypokalemia 17 (4.8) 5 (1.4)
Hypocalcemia 13 (3.7) 6 (1.7)
Hypophosphatemia 9 (2.5) 0 (0.0)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism@ 14 (4.0) 3 (0.9)
Respiratory Distress @ 4 (1.1) 0 (0.0)
Musculoskeletal and connective tissue disorders
Muscle weakness 20 (5.7) 10 (2.9)
Gastrointestinal disorders
Diarrhea @ 11 (3.1) 4 (1.1)
Constipation 7 (2.0) 1 (0.3)
Nausea @ 6 (1.7) 2 (0.6)
Cardiac disorders
Atrial fibrillation @ 13 (3.7) 4 (1.1)
Tachycardia 6 (1.7) 1 (0.3)
Cardiac Failure Congestive @ 5 (1.4) 1 (0.3)
Nervous System disorders
Syncope 10 (2.8) 3 (0.9)
Dizziness 7 (2.0) 3 (0.9)
Eye Disorders
Manufacturer
Celgene Corporation
Active Ingredients
Source
U.S. National Library of Medicine
DailyMed
Last Updated: 2nd of March 2011
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