Drug-related hematologic laboratory abnormalities, nonhematologic adverse events (frequency > 10%), events associated with fluid retention (any frequency), and biochemical abnormalities (frequency > 10%) (N = 321)
| . | All grades . | Grades 3/4 . |
|---|---|---|
| Hematologic laboratory abnormalities,* n/N† (%) | ||
| Anemia | 169/318 (53) | 34/318 (11) |
| Neutropenia | 168/316 (53) | 98/316 (31) |
| Thrombocytopenia | 184/319 (58) | 95/319 (30) |
| Nonhematologic adverse events, n (%) (N = 321) | ||
| Rash | 99 (31) | 6 (2) |
| Pruritus | 84 (26) | 3 (< 1) |
| Nausea | 79 (25) | 3 (< 1) |
| Fatigue | 65 (20) | 4 (1) |
| Headache | 57 (18) | 5 (2) |
| Diarrhea | 39 (12) | 6 (2) |
| Vomiting | 41 (13) | 2 (< 1) |
| Constipation | 43 (13) | 1 (< 1) |
| Drug-related adverse events associated with fluid retention and bleeding, n (%) (N = 321) | ||
| Peripheral edema | 20 (6) | 0 |
| Pericardial effusion | 2 (< 1) | 1 (< 1) |
| Pleural effusion | 4 (1) | 1 (< 1) |
| Pulmonary edema | 1 (< 1) | 1 (< 1) |
| CNS bleeding | 1 (< 1) | 1 (< 1) |
| GI bleeding | 3 (< 1) | 1 (< 1) |
| Biochemical laboratory abnormalities,* n/N† (%) | ||
| Lipase elevation | 140/301 (47) | 54/301 (18) |
| Hypophosphatemia | 167/301 (56) | 51/301 (17) |
| Hyperglycemia | 218/311 (70) | 38/311 (12) |
| Bilirubin elevation (total) | 226/316 (72) | 23/316 (7) |
| ALT elevation | 218/318 (69) | 13/318 (4) |
| AST elevation | 173/316 (55) | 8/316 (3) |
| Hypocalcemia | 160/315 (51) | 5/315 (2) |
| Creatinine | 77/317 (24) | 4/317 (1) |
| Hypomagnesemia | 48/289 (17) | 1/289 (< 1) |
| . | All grades . | Grades 3/4 . |
|---|---|---|
| Hematologic laboratory abnormalities,* n/N† (%) | ||
| Anemia | 169/318 (53) | 34/318 (11) |
| Neutropenia | 168/316 (53) | 98/316 (31) |
| Thrombocytopenia | 184/319 (58) | 95/319 (30) |
| Nonhematologic adverse events, n (%) (N = 321) | ||
| Rash | 99 (31) | 6 (2) |
| Pruritus | 84 (26) | 3 (< 1) |
| Nausea | 79 (25) | 3 (< 1) |
| Fatigue | 65 (20) | 4 (1) |
| Headache | 57 (18) | 5 (2) |
| Diarrhea | 39 (12) | 6 (2) |
| Vomiting | 41 (13) | 2 (< 1) |
| Constipation | 43 (13) | 1 (< 1) |
| Drug-related adverse events associated with fluid retention and bleeding, n (%) (N = 321) | ||
| Peripheral edema | 20 (6) | 0 |
| Pericardial effusion | 2 (< 1) | 1 (< 1) |
| Pleural effusion | 4 (1) | 1 (< 1) |
| Pulmonary edema | 1 (< 1) | 1 (< 1) |
| CNS bleeding | 1 (< 1) | 1 (< 1) |
| GI bleeding | 3 (< 1) | 1 (< 1) |
| Biochemical laboratory abnormalities,* n/N† (%) | ||
| Lipase elevation | 140/301 (47) | 54/301 (18) |
| Hypophosphatemia | 167/301 (56) | 51/301 (17) |
| Hyperglycemia | 218/311 (70) | 38/311 (12) |
| Bilirubin elevation (total) | 226/316 (72) | 23/316 (7) |
| ALT elevation | 218/318 (69) | 13/318 (4) |
| AST elevation | 173/316 (55) | 8/316 (3) |
| Hypocalcemia | 160/315 (51) | 5/315 (2) |
| Creatinine | 77/317 (24) | 4/317 (1) |
| Hypomagnesemia | 48/289 (17) | 1/289 (< 1) |
CNS indicates central nervous system; GI, gastrointestinal tract; ALT, alanine aminotransferase; and AST, aspartate aminotransferase.
Most frequent newly occurring or worsening regardless of causality.
Total number of patients with available data at baseline and after baseline who had less than grade 4 at baseline.