Summary of adverse events
| Event, n (%) . | Any grade (N = 66)* . | Grade 3/4 (N = 66)* . |
|---|---|---|
| Any adverse event | 66 (100) | 45 (68) |
| Nonhematologic adverse events | ||
| Nausea | 31 (47) | 2 (3) |
| Diarrhea | 24 (36) | 2 (3) |
| Fatigue | 18 (27) | 3 (5) |
| Back pain | 14 (21) | 5 (8) |
| Vomiting | 14 (21) | 2 (3) |
| Hematologic adverse events | ||
| Thrombocytopenia | 21 (32) | 17 (26) |
| Neutropenia | 18 (27) | 14 (21) |
| Anemia | 15 (23) | 9 (14) |
| Leukopenia | 15 (23) | 9 (14) |
| Lymphopenia | 12 (18) | 10 (15) |
| Serious adverse event† | Total | |
| Any serious adverse event | 21 (32) | |
| Pneumonia | 5 (8) | |
| Sepsis | 3 (5) | |
| Cough | 2 (3) | |
| Hypotension | 2 (3) | |
| Pain | 2 (3) | |
| Pyrexia | 2 (3) | |
| Event, n (%) . | Any grade (N = 66)* . | Grade 3/4 (N = 66)* . |
|---|---|---|
| Any adverse event | 66 (100) | 45 (68) |
| Nonhematologic adverse events | ||
| Nausea | 31 (47) | 2 (3) |
| Diarrhea | 24 (36) | 2 (3) |
| Fatigue | 18 (27) | 3 (5) |
| Back pain | 14 (21) | 5 (8) |
| Vomiting | 14 (21) | 2 (3) |
| Hematologic adverse events | ||
| Thrombocytopenia | 21 (32) | 17 (26) |
| Neutropenia | 18 (27) | 14 (21) |
| Anemia | 15 (23) | 9 (14) |
| Leukopenia | 15 (23) | 9 (14) |
| Lymphopenia | 12 (18) | 10 (15) |
| Serious adverse event† | Total | |
| Any serious adverse event | 21 (32) | |
| Pneumonia | 5 (8) | |
| Sepsis | 3 (5) | |
| Cough | 2 (3) | |
| Hypotension | 2 (3) | |
| Pain | 2 (3) | |
| Pyrexia | 2 (3) | |
Reported events of neutropenia include the preferred terms of neutropenia and decreased neutrophil counts, thrombocytopenia includes the preferred terms of thrombocytopenia and decreased platelet counts, and leukopenia includes leukopenia and decreased white blood cells.
Adverse events for 20% or more of patients for any grade event or for 10% or more with grade 3/4 adverse events are listed.
Serious adverse events in 2% or more of patients are listed.