Table 5.
Infectious toxicity
| Grade 1 or 2 |
Grade ≥ 3 |
|||
|---|---|---|---|---|
| No. of episodes | No. (%) of patients | No. of episodes | No. (%) of patients | |
| Infections | ||||
| Bacteremia | 0 | 0 | 1 | 1 (2) |
| Pneumonia/bronchitis | 5 | 5 (8) | 7 | 5 (8) |
| URTI | 26 | 18 (30) | 0 | 0 |
| Orodental | 3 | 2 (3) | 0 | 0 |
| Otitis/sinusitis | 8 | 8 (13) | 0 | 0 |
| UTI | 8 | 5 (8) | 1† | 1 (2)† |
| Other infections* | 6 | 5 (8) | 0 | 0 |
| Any infectious event | 56 | 32 (53) | 8 | 6 (10) |
| Neutropenic fever | 1 | 1 (2) | 3 | 3 (5) |
| Febrile, non-neutropenic | 11 | 11 (18) | 1 | 1 (2) |
| Any febrile or infectious event | 68 | 37 (62) | 12 | 8 (13) |
URTI indicates upper respiratory tract infection; and UTI, urinary tract infection.
*
Other infections: conjunctivitis (4), wound infection (1), and perirectal (1).
†
Infection concurrent with respiratory tract infection.