Nonhematologic and hematologic AEs in patients treated at 12 μg/kg per day (safety population; N = 36)
| Event term, n (%) . | Any grade . | Grade 1-2 . | Grade 3-4 . |
|---|---|---|---|
| Nonhematologic TEAEs (any grade occurring in ≥20% of patients) . | |||
| Hypoalbuminemia | 17 (47) | 16 (44) | 1 (3) |
| Nausea | 15 (42) | 15 (42) | 0 |
| Dyspnea | 14 (39) | 10 (28) | 4 (11) |
| Peripheral edema∗ | 13 (36) | 12 (33) | 1 (3) |
| Decreased appetite∗ | 13 (36) | 13 (36) | 0 |
| Dizziness | 12 (33) | 12 (33) | 0 |
| Fatigue∗ | 12 (33) | 10 (28) | 2 (6) |
| Pyrexia | 12 (33) | 9 (25) | 3 (8) |
| Abdominal pain | 10 (28) | 8 (22) | 2 (6) |
| Chills | 10 (28) | 10 (28) | 0 |
| Constipation | 10 (28) | 10 (28) | 0 |
| Headache | 10 (28) | 10 (28) | 0 |
| Hypotension | 10 (28) | 9 (25) | 1 (3) |
| Vomiting | 10 (28) | 10 (28) | 0 |
| Diarrhea | 9 (25) | 7 (19) | 2 (6) |
| ALT increased | 8 (22) | 8 (22) | 0 |
| Confusional state∗ | 8 (22) | 7 (19) | 1 (3) |
| Hypokalemia | 8 (22) | 7 (19) | 1 (3) |
| Tachycardia∗ | 8 (22) | 7 (19) | 1 (3) |
| Weight increased | 8 (22) | 8 (22) | 0 |
| Selected hematologic TEAEs | |||
| Thrombocytopenia∗ | 10 (28) | 3 (8) | 7 (19) |
| Anemia | 8 (22) | 0 | 8 (22) |
| Febrile neutropenia | 2 (6) | 1 (3) | 1 (3) |
| Leukopenia∗ | 2 (6) | 2 (6) | 0 |
| Neutropenia∗ | 1 (3) | 1 (3) | 0 |
| Treatment-related hematologic AEs | |||
| Thrombocytopenia∗ | 5 (14) | 2 (6) | 3 (8) |
| Anemia | 2 (6) | 0 | 2 (6) |
| Febrile neutropenia | 1 (3) | 0 | 1 (3) |
| Leukopenia∗ | 1 (3) | 1 (3) | 0 |
| Neutropenia∗ | 1 (3) | 1 (3) | 0 |
| Event term, n (%) . | Any grade . | Grade 1-2 . | Grade 3-4 . |
|---|---|---|---|
| Nonhematologic TEAEs (any grade occurring in ≥20% of patients) . | |||
| Hypoalbuminemia | 17 (47) | 16 (44) | 1 (3) |
| Nausea | 15 (42) | 15 (42) | 0 |
| Dyspnea | 14 (39) | 10 (28) | 4 (11) |
| Peripheral edema∗ | 13 (36) | 12 (33) | 1 (3) |
| Decreased appetite∗ | 13 (36) | 13 (36) | 0 |
| Dizziness | 12 (33) | 12 (33) | 0 |
| Fatigue∗ | 12 (33) | 10 (28) | 2 (6) |
| Pyrexia | 12 (33) | 9 (25) | 3 (8) |
| Abdominal pain | 10 (28) | 8 (22) | 2 (6) |
| Chills | 10 (28) | 10 (28) | 0 |
| Constipation | 10 (28) | 10 (28) | 0 |
| Headache | 10 (28) | 10 (28) | 0 |
| Hypotension | 10 (28) | 9 (25) | 1 (3) |
| Vomiting | 10 (28) | 10 (28) | 0 |
| Diarrhea | 9 (25) | 7 (19) | 2 (6) |
| ALT increased | 8 (22) | 8 (22) | 0 |
| Confusional state∗ | 8 (22) | 7 (19) | 1 (3) |
| Hypokalemia | 8 (22) | 7 (19) | 1 (3) |
| Tachycardia∗ | 8 (22) | 7 (19) | 1 (3) |
| Weight increased | 8 (22) | 8 (22) | 0 |
| Selected hematologic TEAEs | |||
| Thrombocytopenia∗ | 10 (28) | 3 (8) | 7 (19) |
| Anemia | 8 (22) | 0 | 8 (22) |
| Febrile neutropenia | 2 (6) | 1 (3) | 1 (3) |
| Leukopenia∗ | 2 (6) | 2 (6) | 0 |
| Neutropenia∗ | 1 (3) | 1 (3) | 0 |
| Treatment-related hematologic AEs | |||
| Thrombocytopenia∗ | 5 (14) | 2 (6) | 3 (8) |
| Anemia | 2 (6) | 0 | 2 (6) |
| Febrile neutropenia | 1 (3) | 0 | 1 (3) |
| Leukopenia∗ | 1 (3) | 1 (3) | 0 |
| Neutropenia∗ | 1 (3) | 1 (3) | 0 |
ALT, alanine aminotransferase.
Aggregated events by United States Food and Drug Administration Medical Dictionary for Regulatory Activities analysis of selected TEAEs.