( 0.0) 15 ( 5.1) 6 ( 2.1) 0 ( 0.0) 0 ( 0.0)
Pulmonary embolism c d e 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 3 ( 1.0) 0 ( 0.0) 2 ( 0.7) 0 ( 0.0)
Vascular disorders
Deep vein thrombosis*c d % 8 ( 3.6) 2 ( 0.9) 5 ( 2.2) 2 ( 0.9) 7 ( 2.4) 1 ( 0.4) 4 ( 1.4) 1 ( 0.4)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome c d e 5 ( 2.2) 0 ( 0.0) 2 ( 0.9) 0 ( 0.0) 3 ( 1.0) 0 ( 0.0) 1 ( 0.3) 0 ( 0.0)
After At Least One Prior Therapy for MM:
Data were eva luated from 703 patients in two studies who received at least one dose of REVLIMID/dexamethasone (353 patients) or placebo/dexamethasone (350 patients).
In the REVLIMID/dexamethasone treatment group, 269 patients (76%) had at least one dose interruption with or without a dose reduction of REVLIMID compared to 199 patients (57%) in the placebo/dexamethasone treatment group. Of these patients who had one dose interruption with or without a dose reduction, 50% in the REVLIMID/dexamethasone treatment group had at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone treatment group. Most adverse reactions and Grade 3/4 adverse reactions were more frequent in patients who received the combination of REVLIMID/dexamethasone compared to placebo/dexamethasone.
Tables 6, 7, and 8 summarize the adverse reactions reported for REVLIMID/dexamethasone and placebo/dexamethasone groups.
Table 6: Adverse Reactions Reported in ≥5% of Patients and with a ≥2% 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% 149 (42.2) 22 (6.3)
Anemia@ 111 (31.4) 83 (23.7)
Thrombocytopenia@ 76 (21.5) 37 (10.6)
Leukopenia 28 (7.9) 4 (1.1)
Lymphopenia 19 (5.4) 5 (1.4)
General disorders and administration site conditions
Fatigue 155 (43.9) 146 (41.7)
Pyrexia 97 (27.5) 82 (23.4)
Peripheral edema 93 (26.3) 74 (21.1)
Chest Pain 29 ( 8.2) 20 (5.7)
Lethargy 24 ( 6.8) 8 (2.3)
Gastrointestinal disorders
Constipation 143 (40.5) 74 (21.1)
Diarrhea@ 136 (38.5) 96 (27.4)
Nausea@ 92 (26.1) 75 (21.4)
Vomiting@ 43 (12.2) 33 (9.4)
Abdominal Pain@ 35 (9.9) 22 (6.3)
Dry Mouth 25 (7.1) 13 (3.7)
Musculoskeletal and connective tissue disorders
Muscle cramp 118 (33.4) 74 (21.1)
Back pain 91 (25.8) 65 (18.6)
Bone Pain 48 (13.6) 39 (11.1)
Pain in Limb 42 (11.9) 32 (9.1)
Nervous system disorders
Dizziness 82 (23.2) 59 (16.9)
Tremor 75 (21.2) 26 (7.4)
Dysgeusia 54 (15.3) 34 (9.7)
Hypoaesthesia 36 (10.2) 25 (7.1)
Neuropathya 23 (6.5) 13 (3.7)
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 83 (23.5) 60 (17.1)
Nasopharyngitis 62 (17.6) 31 (8.9)
Pharyngitis 48 (13.6) 33 (9.4)
Bronchitis 40 (11.3) 30 (8.6)
Infectionsb and infestations
Upper respiratory tract infection 87 (24.6) 55 (15.7)
Pneumonia@ 48 (13.6) 29 (8.3)
Urinary Tract Infection 30 (8.5) 19 (5.4)
Sinusitis 26 (7.4) 16 (4.6)
Skin and subcutaneous system disorders
Rashc 75 (21.2) 33 (9.4)
Sweating Increased 35 (9.9) 25 (7.1)
Dry Skin 33 (9.3) 14 (4.0)
Pruritus 27 (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
