Table 7: 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 

Body System
Adverse Reaction REVLIMID/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)
Infections 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
Cataract 6 (1.7) 1 (0.3)
Cataract Unilateral 5 (1.4) 0 (0.0)
Psychiatric Disorder
Depression 10 (2.8) 6 (1.7)

Table 8: Serious Adverse Reactions Reported in ≥1% Patients and With a ≥1% Difference in Proportion of Patients Between the REVLIMID/dexamethasone and Placebo/dexamethasone Groups 

For Tables 6, 7 and 8 above:
@ - adverse reactions in which at least one resulted in a fatal outcome
% - adverse reactions in which at least one was considered to be life threatening (if the outcome of the reaction was death, it is included with death cases)
Median duration of exposure among patients treated with REVLIMID/dexamethasone was 44 weeks while median duration of exposure among patients treated with placebo/dexamethasone was 23 weeks. This should be taken into consideration when comparing frequency of adverse reactions between two treatment groups REVLIMID/dexamethasone vs. placebo/dexamethasone.

Body System
Adverse Reaction REVLIMID/Dex&
(N=353)
n (%) Placebo/Dex&
(N=350)
n (%)
Blood and lymphatic system disorders
Febrile Neutropenia% 6 (1.7) 0 (0.0)
Vascular disorders
Deep vein thrombosis% 26 (7.4) 11 (3.1)
Infections and infestations
Pneumonia@ 33 (9.3) 21 (6.0)
Respiratory, thoracic, and mediastinal disorders
Pulmonary embolism@ 13 (3.7) 3 (0.9)
Cardiac disorders
Atrial fibrillation@ 11 (3.1) 2 (0.6)
Cardiac Failure Congestive@ 5 (1.4) 0 (0.0)
Nervous system disorders
Cerebrovascular accident@ 7 (2.0) 3 (0.9)
Gastrointestinal disorders
Diarrhea @ 6 (1.7) 2 (0.6)
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