Table 10: Most Frequently Observed Grade 3 and 4 Adverse Events [1] Regardless of Relationship to Study Drug Treatment

[1] Adverse events with frequency ≥1% in the 10 mg Overall group. Grade 3 and 4 are based on National Cancer Institute Common Toxicity Criteria version 2.
[2]Adverse events are coded using the MedDRA dictionary. A patient with multiple occurrences of an AE is counted only once in the adverse event category.

Adverse Events[2] 10 mg
(N=148) 

Patients with at least one Grade 3/4 AE 131 (88.5) 
Neutropenia 79 (53.4) 
Thrombocytopenia 74 (50.0) 
Pneumonia 11 (7.4) 
Rash 10 (6.8) 
Anemia 9 (6.1) 
Leukopenia 8 (5.4) 
Fatigue 7 (4.7) 
Dyspnea 7 (4.7) 
Back Pain 7 (4.7) 
Febrile Neutropenia 6 (4.1) 
Nausea 6 (4.1) 
Diarrhea 5 (3.4) 
Pyrexia 5 (3.4) 
Sepsis 4 (2.7) 
Dizziness 4 (2.7) 
Granulocytopenia 3 (2.0) 
Chest Pain 3 (2.0) 
Pulmonary Embolism 3 (2.0) 
Respiratory Distress 3 (2.0) 
Pruritus 3 (2.0) 
Pancytopenia 3 (2.0) 
Muscle Cramp 3 (2.0) 
Respiratory Tract Infection 2 (1.4) 
Upper Respiratory Tract Infection 2 (1.4) 
Asthenia 2 (1.4) 
Multi-organ Failure 2 (1.4) 
Epistaxis 2 (1.4) 
Hypoxia 2 (1.4) 
Pleural Effusion 2 (1.4) 
Pneumonitis 2 (1.4) 
Pulmonary Hypertension 2 (1.4) 
Vomiting 2 (1.4) 
Sweating Increased 2 (1.4) 
Arthralgia 2 (1.4) 
Pain in Limb 2 (1.4) 
Headache 2 (1.4) 
Syncope 2 (1.4) 

In other clinical studies of REVLIMID in MDS patients, the following serious adverse events (regardless of relationship to study drug treatment) not described in Table 9 or 10 were reported:

Blood and lymphatic system disorders: warm type hemolytic anemia, splenic infarction, bone marrow depression, coagulopathy, hemolysis, hemolytic anemia, refractory anemia

Cardiac disorders: cardiac failure congestive, atrial fibrillati