Table 2.
Adverse Eventsa
| Arm | Grade 1 n (%) |
Grade 2 n (%) |
Grade 3 n (%) |
Grade 4 n (%) |
Grade 5 n (%) |
|
|---|---|---|---|---|---|---|
|
| ||||||
| Haematologic | ||||||
|
| ||||||
| Hemoglobin | Len (n=231) | 15 (6%) | 6 (3%) | 9 (4%) | 2 (1%) | 0 (0%) |
| PBO (n=143) | 3 (2%) | 3 (2%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| CO (n=86) | 1 (1%) | 1 (1%) | 1 (1%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Leukocytes (total WBC) | Len (n=231) | 4 (2%) | 5 (2%) | 28 (12%) | 3 (1%) | 0 (0%) |
| PBO (n=143) | 2 (1%) | 1 (1%) | 1 (1%) | 1 (1%) | 0 (0%) | |
| CO (n=86) | 1 (1%) | 2 (2%) | 9 (10%) | 1 (1%) | 0 (0%) | |
|
| ||||||
| Lymphopenia | Len (n=231) | 2 (1%) | 2 (1%) | 20 (9%) | 1 (0%) | 0 (0%) |
| PBO (n=143) | 1 (1%) | 1 (1%) | 1 (1%) | 1 (1%) | 0 (0%) | |
| CO (n=86) | 1 (1%) | 1 (1%) | 5 (6%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Neutrophils | Len (n=231) | 14 (6%)) | 36 (16%) | 82 (35%) | 34 (15%) | 0 (0%) |
| PBO (n=143) | 12 (8%) | 10 (7%) | 7 (5%) | 4 (3%) | 0 (0%) | |
| CO (n=86) | 8 (9%) | 15 (17%) | 26 (30%) | 4 (5%) | 0 (0%) | |
|
| ||||||
| Platelets | Len (n=231) | 75 (32%) | 33 (14%) | 23 (10%) | 11 (5%) | 0 (0%) |
| PBO (n=143) | 28 (20%) | 3 (2%) | 0 (0%) | 7 (5%) | 0 (0%) | |
| CO (n=86) | 29 (34%) | 8 (9%) | 3 (3%) | 2 (2%) | 0 (0%) | |
|
| ||||||
| Non-Haematologic | ||||||
|
| ||||||
| Conduction abnormality | Len (n=231) | 0 (0%) | 0 (0%) | 1 (0%) | 0 (0%) | 0 (0%) |
| PBO (n=143) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | |
| CO (n=86) | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Fatigue | Len (n=231) | 10 (4%) | 9 (4%) | 0 (0%) | 0 (0%) | 0 (0%) |
| PBO (n=143) | 5 (3%) | 1 (1%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| CO (n=86) | 4 (3%) | 6 (7%) | 0 (0%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Rash | Len (n=231) | 22 (10%) | 22 (10%) | 9 (4%) | 0 (0%) | 0 (0%) |
| PBO (n=143) | 10 (7%) | 7 (5%) | 1 (1%) | 0 (0%) | 0 (0%) | |
| CO (n=86) | 5 (6%) | 4 (5%) | 1 (1%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Diarrhea | Len (n=231) | 54 (23%) | 36 (16%) | 12 (5%) | 0 (0%) | 0 (0%) |
| PBO (n=143) | 15 (10%) | 3 (2%) | 2 (1%) | 0 (0%) | 0 (0%) | |
| CO (n=86) | 9 (10%) | 12 (14%) | 3 (3%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Febrile neutropenia (fever of unknown origin) | Len (n=231) | 2 (1%) | 0 (0%) | 14 (6%) | 1 (0%) | 0 (0%) |
| PBO (n=143) | 1 (1%) | 0 (0%) | 2 (1%) | 1 (1%) | 0 (0%) | |
| CO (n=86) | 1 (1%) | 0 (0%) | 1 (1%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Infection (documented clinically or microbiologically) | Len (n=231) | 1 (0%) | 4 (2%) | 13 (6%) | 2 (1%) | 0 (0%) |
| PBO (n=143) | 0 (0%) | 2 (1%) | 3 (2%) | 0 (0%) | 0 (0%) | |
| CO (n=86) | 0 (0%) | 2 (1%) | 4 (5%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Infection with normal ANC or grade 1 or 2 neutrophils | Len (n=231) | 0 (0%) | 6 (3%) | 13 (6%) | 0 (0%) | 1 (0%) |
| PBO (n=143) | 0 (0%) | 3 (2%) | 3 (2%) | 0 (0%) | 0 (0%) | |
| CO (n=86) | 1 (1%) | 9 (10%) | 1 (1%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Pain | Len (n=231) | 7 (3%) | 4 (2%) | 6 (3%) | 0 (0%) | 0 (0%) |
| PBO (n=143) | 5 (3%) | 2 (1%) | 6 (4%) | 0 (0%) | 0 (0%) | |
| CO (n=86) | 3 (3%) | 10 (12%) | 2 (2%) | 0 (0%) | 0 (0%) | |
|
| ||||||
| Vascular | Len (n=231) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (0%) |
| PBO (n=143) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| CO (n=86) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
a
Adverse events that occurred in at least 10% for grades 1–2, at least 2% for grades 3–4, or any grade 5.
Abbreviations: ANC (absolute neutrophil count); CO (crossover); Len (lenalidomide); PBO (placebo).