Table 2.
Drug-related adverse events in each arm.a
| Adverse event | No. (%)
|
|
|---|---|---|
| Any grade | Grade 3 | |
| Arm A, n = 31 | ||
| Any drug-related adverse event | 29 (94) | 15 (48) |
| Diarrhea | 19 (61) | 5 (16) |
| Nausea | 18 (58) | 3 (10) |
| Fatigue | 15 (48) | 2 (6) |
| Vomiting | 12 (39) | 4 (13) |
| Anorexia | 9 (29) | 2 (6) |
| Edema in limbs | 5 (16) | 1 (3) |
| Transaminitis | 5 (16) | 0 (0) |
| Dysgeusia | 4 (13) | 0 (0) |
| Anemia | 3 (10) | 0 (0) |
| Creatinine increase | 3 (10) | 2 (6) |
| Rash | 3 (10) | 1 (3) |
| Abdominal pain | 2 (6) | 2 (6) |
| Blurred vision | 2 (6) | 1 (3) |
| Constipation | 2 (6) | 0 (0) |
| Dyspnea | 2 (6) | 1 (3) |
| Hypercalcemia | 2 (6) | 1 (3) |
| Leukopenia | 2 (6) | 0 (0) |
| Light sensitivity | 2 (6) | 0 (0) |
| Arm B, n = 30 | ||
| Any drug-related adverse event | 29 (97) | 11 (37) |
| Fatigue | 16 (53) | 3 (10) |
| Nausea | 13 (43) | 1 (3) |
| Diarrhea | 11 (37) | 0 (0) |
| Anorexia | 9 (30) | 1 (3) |
| Vomiting | 9 (30) | 1 (3) |
| Dyspnea | 6 (20) | 3 (10) |
| Anemia | 4 (13) | 0 (0) |
| Constipation | 4 (13) | 0 (0) |
| Creatinine increase | 4 (13) | 2 (7) |
| Neuropathy | 4 (13) | 0 (0) |
| Rash | 4 (13) | 0 (0) |
| Thrombocytopenia | 3 (10) | 0 (0) |
| Edema in limbs | 2 (7) | 0 (0) |
| Headache | 2 (7) | 0 (0) |
| Leukopenia | 2 (7) | 0 (0) |
a
Adverse events of any grade that occurred in more than 5% of the arm. For drug-related adverse events that occurred in less than 5% of patients in each arm, see Supplementary Table 2. There were no grade 4 adverse events in either arm.