Grade 3 or 4 AEs reported in ≥ 5% of patients (double-blind phase; safety population)
| Grade 3 or 4 AEs,* n (%) . | Placebo (n = 67) . | Lenalidomide 5 mg (n = 69) . | Lenalidomide 10 mg (n = 69) . |
|---|---|---|---|
| Patients with ≥ 1 AE | 29 (43.3) | 62 (89.9) | 65 (94.2) |
| Neutropenia | 10 (14.9) | 51 (73.9) | 52 (75.4) |
| Thrombocytopenia | 1 (1.5) | 23 (33.3) | 28 (40.6) |
| Leukopenia | 0 | 9 (13.0) | 6 (8.7) |
| Anemia | 6 (9.0) | 4 (5.8) | 2 (2.9) |
| DVT | 1 (1.5) | 1 (1.4) | 4 (5.8) |
| Grade 3 or 4 AEs,* n (%) . | Placebo (n = 67) . | Lenalidomide 5 mg (n = 69) . | Lenalidomide 10 mg (n = 69) . |
|---|---|---|---|
| Patients with ≥ 1 AE | 29 (43.3) | 62 (89.9) | 65 (94.2) |
| Neutropenia | 10 (14.9) | 51 (73.9) | 52 (75.4) |
| Thrombocytopenia | 1 (1.5) | 23 (33.3) | 28 (40.6) |
| Leukopenia | 0 | 9 (13.0) | 6 (8.7) |
| Anemia | 6 (9.0) | 4 (5.8) | 2 (2.9) |
| DVT | 1 (1.5) | 1 (1.4) | 4 (5.8) |
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.