Treatment-emergent AEs and laboratory abnormalities (N = 186)
. | Any grade, n (%) . | At least grade 3, n (%) . |
---|---|---|
AE (at least 15% nonhematologic AEs in any grade) | ||
Fatigue | 99 (53.2) | 19 (10.2) |
Nausea | 84 (45.2) | 7 (3.8) |
Diarrhea | 72 (38.7) | 3 (1.6) |
Decreased appetite | 46 (24.7) | 2 (1.1) |
Constipation | 44 (23.7) | 3 (1.6) |
Cough | 39 (21) | 1 (0.5) |
Headache | 39 (21) | 1 (0.5) |
Dizziness | 37 (19.9) | 1 (0.5) |
Pyrexia | 36 (19.4) | 3 (1.6) |
Vomiting | 34 (18.3) | 2 (1.1) |
Dyspnea | 29 (15.6) | 12 (6.5) |
Insomnia | 29 (15.6) | 0 (0) |
SAE (at least 2%) | ||
Dyspnea | 8 (4.3) | |
Pneumonia | 8 (4.3) | |
Febrile neutropenia | 6 (3.2) | |
Dehydration | 5 (2.7) | |
Pyrexia | 4 (2.2) | |
Laboratory abnormality | ||
Neutropenia | 61 (32.8) | 27 (14.5) |
Anemia | 71 (38.2) | 15 (8.1) |
Thrombocytopenia | 16 (8.6) | 5 (2.7) |
Total bilirubin | 60 (32.3) | 7 (3.8) |
Increased ALT | 68 (36.6) | 24 (12.9) |
Increased AST | 61 (32.8) | 19 (10.2) |
. | Any grade, n (%) . | At least grade 3, n (%) . |
---|---|---|
AE (at least 15% nonhematologic AEs in any grade) | ||
Fatigue | 99 (53.2) | 19 (10.2) |
Nausea | 84 (45.2) | 7 (3.8) |
Diarrhea | 72 (38.7) | 3 (1.6) |
Decreased appetite | 46 (24.7) | 2 (1.1) |
Constipation | 44 (23.7) | 3 (1.6) |
Cough | 39 (21) | 1 (0.5) |
Headache | 39 (21) | 1 (0.5) |
Dizziness | 37 (19.9) | 1 (0.5) |
Pyrexia | 36 (19.4) | 3 (1.6) |
Vomiting | 34 (18.3) | 2 (1.1) |
Dyspnea | 29 (15.6) | 12 (6.5) |
Insomnia | 29 (15.6) | 0 (0) |
SAE (at least 2%) | ||
Dyspnea | 8 (4.3) | |
Pneumonia | 8 (4.3) | |
Febrile neutropenia | 6 (3.2) | |
Dehydration | 5 (2.7) | |
Pyrexia | 4 (2.2) | |
Laboratory abnormality | ||
Neutropenia | 61 (32.8) | 27 (14.5) |
Anemia | 71 (38.2) | 15 (8.1) |
Thrombocytopenia | 16 (8.6) | 5 (2.7) |
Total bilirubin | 60 (32.3) | 7 (3.8) |
Increased ALT | 68 (36.6) | 24 (12.9) |
Increased AST | 61 (32.8) | 19 (10.2) |