TABLE 2.
Adverse Events
| Arm A
|
Arm B
|
|||
|---|---|---|---|---|
| Grade 3 | Grade 4 | Grade 3 | Grade 4 | |
| Hematologic toxicity, n (%) | ||||
| Leukopenia | 3 (7) | 4 (10) | 4 (12) | 1 (3) |
| Anemia | 5 (12) | 0 | 1 (3) | 0 |
| Thrombocytopenia | 1 (2) | 0 | 0 | 0 |
| Neutropenia | 3 (7) | 6 (14) | 3 (9) | 5 (15) |
| Neutropenic fever | 4 (10) | 2 (5) | 3 (9) | 2 (6) |
| Nonhematologic toxicity, n (%) | ||||
| Fatigue | 2 (5) | 0 | 5 (15) | 0 |
| Nausea/vomiting | 7 (17) | 3 (7) | 6 (18) | 0 |
| Diarrhea | 9 (21) | 6 (14) | 4 (12) | 5 (15) |
| Dehydration | 8 (19) | 3 (7) | 6 (18) | 4 (12) |
| Sepsis | 0 | 1 (2)a | 0 | 0 |
| Anorexia/weight loss | 2 (5) | 0 | 3 (9) | 1 (3) |
| Thrombosis | 0 | 3 (7)b | 1 (3) | 1 (3) |
| Cardiac | 1 (2) | 1 (2)c | 0 | 1 (3)c |
| Acute renal failure | 5 (12) | 0 | 0 | 1 (3) |
| Bleeding | 0 | 1 (2)a | 0 | 0 |
a
Includes one patient each with grade 5 toxicity.
b
Includes two patients with grade 5 toxicity.
c
Includes one patient with sudden death in each arm.