Table 2.
Adverse event | All events | Grade ≥3 | Special considerations |
---|---|---|---|
Hematologic | |||
Neutropenia | 347 (94%) | 303 (82%) | More common age ≥65; consider G-CSF prophylaxis |
Leukopenia | 355 (96%) | 253 (68%) | |
Anemia | 361 (97%) | 39 (11%) | |
Thrombocytopenia | 176 (47%) | 15 (4%) | |
Nonhematologic | |||
Diarrhea | 173 (47%) | 23 (6%) | More common age ≥75 and prior radiotherapy |
Fatigue | 136 (37%) | 18 (5%) | |
Back pain | 60 (16%) | 14 (4%) | |
Nausea | 127 (34%) | 7 (2%) | |
Vomiting | 84 (23%) | 7 (2%) | |
Hematuria | 62 (17%) | 7 (2%) | |
Abdominal pain | 43 (12%) | 7 (2%) | |
Dyspnea | 44 (12%) | 5 (1%) | |
Constipation | 76 (20%) | 4 (1%) | |
Pyrexia | 45 (12%) | 4 (1%) | |
Arthralgia | 39 (11%) | 4 (1%) | |
Postmarket reporting (frequency not determined) | |||
Colitis, enterocolitis, gastritis, neutropenic enterocolitis, gastrointestinal hemorrhage and perforation, ileus and intestinal obstruction |
G-CSF, granulocyte colony stimulating factor.