Overall incidence of selected treatment-emergent AEs and laboratory abnormalities in ≥10% of patients
| . | N = 54 . | |
|---|---|---|
| AE, n (%) . | Any grade* . | Grade ≥3 . |
| Fatigue | 17 (31.5) | 1 (1.9) |
| Diarrhea | 16 (29.6) | 3 (5.6) |
| Pyrexia | 15 (27.8) | 2 (3.7) |
| Cough | 13 (24.1) | 2 (3.7) |
| Back pain | 12 (22.2) | 0 |
| Rash | 12 (22.2) | 0 |
| URI | 12 (22.2) | 0 |
| Pneumonia | 12 (22.2) | 11 (20.4) |
| Night sweats | 10 (18.5) | 0 |
| Chills | 9 (16.7) | 0 |
| Neutropenic fever | 6 (11.1) | 6 (11.1) |
| Laboratory abnormality, n (%) | ||
| ANC, decreased | 31 (57.4) | 23 (42.6) |
| Hb, decreased | 20 (37.0) | 6 (11.1) |
| Platelets, decreased | 16 (29.6) | 9 (16.7) |
| AP, increased | 18 (33.3) | 0 |
| GGT, increased | 11 (20.4) | 1 (1.9) |
| AST, increased | 13 (24.1) | 1 (1.9) |
| ALT, increased | 10 (18.5) | 1 (1.9) |
| Glucose, increased | 25 (46.3) | 3 (5.6) |
| Glucose, decreased | 14 (25.9) | 2 (3.7) |
| . | N = 54 . | |
|---|---|---|
| AE, n (%) . | Any grade* . | Grade ≥3 . |
| Fatigue | 17 (31.5) | 1 (1.9) |
| Diarrhea | 16 (29.6) | 3 (5.6) |
| Pyrexia | 15 (27.8) | 2 (3.7) |
| Cough | 13 (24.1) | 2 (3.7) |
| Back pain | 12 (22.2) | 0 |
| Rash | 12 (22.2) | 0 |
| URI | 12 (22.2) | 0 |
| Pneumonia | 12 (22.2) | 11 (20.4) |
| Night sweats | 10 (18.5) | 0 |
| Chills | 9 (16.7) | 0 |
| Neutropenic fever | 6 (11.1) | 6 (11.1) |
| Laboratory abnormality, n (%) | ||
| ANC, decreased | 31 (57.4) | 23 (42.6) |
| Hb, decreased | 20 (37.0) | 6 (11.1) |
| Platelets, decreased | 16 (29.6) | 9 (16.7) |
| AP, increased | 18 (33.3) | 0 |
| GGT, increased | 11 (20.4) | 1 (1.9) |
| AST, increased | 13 (24.1) | 1 (1.9) |
| ALT, increased | 10 (18.5) | 1 (1.9) |
| Glucose, increased | 25 (46.3) | 3 (5.6) |
| Glucose, decreased | 14 (25.9) | 2 (3.7) |
ALT, alanine aminotransferase; AP, alkaline phosphatase; AST, aspartate aminotransferase; GGT, γ-glutamyltransferase.
The severity of AEs was graded using CTCAE (version 3.0).