Table 2.
Treatment-relateda adverse events seen in ≥5 % of patients
| Adverse events | Worst CTCAE grade on study, n (%) | ||
|---|---|---|---|
| 1 or 2 | 3 | 4 | |
| Fatigue | 12 (46) | 0 (0) | 0 (0) |
| Nausea | 7 (27) | 1 (4) | 0 (0) |
| Diarrhea | 5 (19) | 1 (4) | 0 (0) |
| Discolored urine | 6 (23) | 0 (0) | 0 (0) |
| Asthenia | 4 (15) | 0 (0) | 0 (0) |
| Increased alkaline phosphatase | 4 (15) | 0 (0) | 0 (0) |
| Anorexia | 4 (15) | 0 (0) | 0 (0) |
| Headache | 4 (15) | 0 (0) | 0 (0) |
| Pyrexia | 3 (12) | 0 (0) | 0 (0) |
| Chills | 2 (8) | 0 (0) | 0 (0) |
| Abdominal pain | 2 (8) | 0 (0) | 0 (0) |
| Constipation | 2 (8) | 0 (0) | 0 (0) |
| Vomiting | 1 (4) | 1 (4) | 0 (0) |
| Increased ALT | 1 (4) | 1 (4) | 0 (0) |
| Increased AST | 1 (4) | 1 (4) | 0 (0) |
| Increased amylase | 2 (8) | 0 (0) | 0 (0) |
| Decreased ejection fraction | 2 (8) | 0 (0) | 0 (0) |
| Exertional dyspnea | 2 (8) | 0 (0) | 0 (0) |
| First degree AV block | 2 (8) | 0 (0) | 0 (0) |
aRelated to retaspimycin HCl, trastuzumab, or both