Table 2.
Adverse Events and Serious Adverse Events in the 116 Study Patients.
| Event | Any Grade | Grade 3 or 4 |
|---|---|---|
| no. of patients (%) | ||
| Adverse event* | ||
| Any | 115 (99) | 96 (83) |
| Diarrhea | 60 (52) | 2 (2) |
| Upper respiratory tract infection | 56 (48) | 1 (1) |
| Nausea | 55 (47) | 2 (2) |
| Neutropenia | 52 (45) | 48 (41) |
| Fatigue | 46 (40) | 4 (3) |
| Cough | 35 (30) | 0 |
| Pyrexia | 30 (26) | 1 (1) |
| Anemia | 29 (25) | 14 (12) |
| Headache | 28 (24) | 1 (1) |
| Constipation | 24 (21) | 1 (1) |
| Thrombocytopenia | 24 (21) | 14 (12) |
| Arthralgia | 21 (18) | 1 (1) |
| Vomiting | 21 (18) | 2 (2) |
| Peripheral edema | 18 (16) | 0 |
| Hyperglycemia | 17 (15) | 10 (9) |
| Serious adverse event† | ||
| Any | 52 (45) | |
| Febrile neutropenia | 7 (6) | |
| Pneumonia | 5 (4) | |
| Upper respiratory tract infection | 4 (3) | |
| Immune thrombocytopenia | 3 (3) | |
| Tumor lysis syndrome | 3 (3) | |
| Diarrhea | 2 (2) | |
| Fluid overload | 2 (2) | |
| Hyperglycemia | 2 (2) | |
| Prostate cancer | 2 (2) | |
| Pyrexia | 2 (2) | |
*
Listed are adverse events that were reported in at least 15% of the patients. Preexisting grade 1 or 2 laboratory abnormalities are not reported, unless the grade increased during the study.
†
Listed are serious adverse events that were reported in at least two patients. Excluded are serious adverse events that were related to disease progression in two patients.