Pulmonary embolism (PE) was reported as a serious adverse drug reaction including Grade 3/4 (3.7%) at a higher rate in the REVLIMID/dexamethasone group compared to 0.9% in the placebo/dexamethasone group. Discontinuations due to PE adverse reactions were reported at comparable rates between groups.

Other Adverse Events

In these clinical studies of REVLIMID in patients with multiple myeloma, the following adverse drug reactions (ADRs) not described above that occurred at ≥1% rate and of at least twice of the placebo percentage rate were reported:

Blood and lymphatic system disorders: pancytopenia, autoimmune hemolytic anemia

Cardiac disorders: bradycardia, myocardial infarction, angina pectoris

Endocrine disorders: hirsutism

Eye disorders: blindness, ocular hypertension

Gastrointestinal disorders: gastrointestinal hemorrhage, glossodynia

General disorders and administration site conditions: malaise

Investigations: liver function tests abnormal, alanine aminotransferase increased,

Nervous system disorders: cerebral ischemia

Psychiatric disorders: mood swings, hallucination loss of libido

Reproductive system and breast disorders: erectile dysfunction,

Respiratory, thoracic and mediastinal disorders: cough, hoarseness

Skin and subcutaneous tissue disorders: exanthem, skin hyperpigmentation

Table 3:Adverse Reactions Reported in ≥5% of Patients and with a ≥2% 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 %  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)
Neuropathy a  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 
Rash c  75 (21.2) 33 (9.4)
Sweating Increased 35 (9.9) 25 (7.1)
Dry Skin 33 (9.3) 14 (4.0)
Pruritus 27