Table 2.
Safety results.
| TEAEs >10% of patients | N = 44 | |
|---|---|---|
| Any Grade | Grade ≥3 | |
| Diarrhea | 36 (81.8) | 4 (9.1) |
| Fatiguea | 28 (63.6) | 5 (11.4) |
| Decreased appetite | 24 (54.5) | 1 (2.3) |
| Nausea | 21 (47.7) | 0 (0.0) |
| Neutropeniaa | 17 (38.6) | 11 (25.0) |
| Anemia | 16 (36.4) | 5 (11.4) |
| Vomiting | 16 (36.4) | 0 (0.0) |
| Constipation | 9 (20.5) | 0 (0.0) |
| Blood creatinine increased | 8 (18.2) | 0 (0.0) |
| Thrombocytopeniaa | 8 (18.2) | 2 (4.5) |
| Back pain | 7 (15.9) | 0 (0.0) |
| Pyrexia | 7 (15.9) | 1 (2.3) |
| Edema peripheral | 6 (13.6) | 0 (0.0) |
| Arthralgia | 5 (11.4) | 0 (0.0) |
| TRAEs >10% of patients | N = 44 | |
| Any grade | Grade 3 b | |
| Diarrhea | 35 (79.5) | 3 (6.8) |
| Decreased appetite | 23 (52.3) | 1 (2.3) |
| Fatiguea | 22 (50.0) | 3 (6.8) |
| Nausea | 19 (43.2) | 0 (0.0) |
| Neutropeniaa | 15 (34.1) | 10 (22.7) |
| Vomiting | 15 (34.1) | 0 (0.0) |
| Anemia | 13 (29.5) | 3 (6.8) |
| Thrombocytopeniaa | 7 (15.9) | 1 (2.3) |
| Blood creatinine increased | 5 (11.4) | 0 (0.0) |
aConsolidated terms: fatigue, fatigue and asthenia; neutropenia, neutropenia and neutrophil count decreased; thrombocytopenia, thrombocytopenia, and platelet count decreased.
bNo Grade 4 or 5 TRAEs (as assessed by investigators) were reported.