Table 3.
Adverse Events of Grade 3 or Greater.*
| Adverse Event | 1-Month Group (N =1488) | 9-Month Group (N =1498) | ||||||
|---|---|---|---|---|---|---|---|---|
| Grade 3 | Grade 4 | Grade 5 | Grades 3–5 | Grade 3 | Grade 4 | Grade 5 | Grades 3–5 | |
| number of patients (percent) | ||||||||
| Targeted adverse event† | 34 | 9 | 1 | 44 (3) | 32 | 20 | 0 | 52 (3) |
| Serious adverse event | 41 | 22 | 12 | 75 (5) | 49 | 25 | 19 | 93 (6) |
| Any systemic event | 101 | 9 | 1 | 111 (7) | 123 | 12 | 0 | 135 (9) |
| Any adverse event | 198 | 47 | 5 | 250 (17) | 213 | 59 | 2 | 274 (18) |
| Hematologic event | 41 | 22 | 0 | 63 (4) | 36 | 21 | 0 | 57 (4) |
| Thrombocytopenia | 0 | 3 | 0 | 3 (<1) | 4 | 1 | 0 | 5 (<1) |
| Anemia | 6 | 14 | 0 | 20 (1) | 8 | 18 | 0 | 26 (2) |
| Neutropenia | 28 | 8 | 0 | 36 (2) | 16 | 2 | 0 | 18 (1) |
| Hepatic event | 19 | 9 | 0 | 28 (2) | 24 | 18 | 0 | 42 (3) |
| Gastrointestinal event | 29 | 1 | 1 | 31 (2) | 22 | 2 | 0 | 24 (2) |
| Dermatologic event | 8 | 0 | 0 | 8 (1) | 11 | 0 | 0 | 11(1) |
| Neurologic event | 12 | 2 | 0 | 14 (1) | 25 | 4 | 1 | 30 (2) |
*
There was a significant between-group difference in neutropenia and in neurologic events (P = 0.02 for both comparisons) at an alpha level of 0.05 with no adjustment for multiple comparisons.
†
Targeted adverse events included nausea and vomiting, rash, drug-associated fever, elevated liver-enzyme levels, and peripheral neuropathy.