Nonhematologic and hematologic TEAEs occurring in 20% or more of patients treated at 12 μg/kg per day
| TEAE . | Any grade, n (%) . | Grade 1-2, n (%) . | Grade 3-4, n (%) . |
|---|---|---|---|
| Nonhematologic TEAEs | |||
| Fatigue∗ | 19 (49) | 14 (36) | 5 (13) |
| Hypoalbuminemia | 18 (46) | 18 (46) | 0 |
| Hypokalemia | 17 (44) | 17 (44) | 0 |
| Nausea | 17 (44) | 15 (39) | 2 (5) |
| Decreased appetite∗ | 17 (44) | 16 (41) | 1 (3) |
| Back pain | 15 (39) | 14 (36) | 1 (3) |
| Cough | 15 (39) | 15 (39) | 0 |
| Constipation | 14 (36) | 14 (36) | 0 |
| Diarrhea | 14 (36) | 11 (28) | 3 (8) |
| Dyspnea | 13 (33) | 9 (23) | 4 (10) |
| Peripheral edema∗ | 13 (33) | 13 (33) | 0 |
| Weight increased | 12 (31) | 12 (31) | 0 |
| ALT increased | 11 (28) | 9 (23) | 2 (5) |
| Chills | 11 (28) | 11 (28) | 0 |
| Headache | 11 (28) | 11 (28) | 0 |
| Pyrexia | 11 (28) | 11 (28) | 0 |
| Tachycardia∗ | 11 (28) | 10 (26) | 1 (3) |
| Acute kidney injury | 10 (26) | 7 (18) | 3 (8) |
| Dizziness | 10 (26) | 9 (23) | 1 (3) |
| Vomiting | 10 (26) | 10 (26) | 0 |
| AST increased | 9 (23) | 6 (15) | 3 (8) |
| Blood creatinine increased | 9 (23) | 8 (21) | 1 (3) |
| CLS | 9 (23) | 4 (10) | 5 (13) |
| Hypotension | 9 (23) | 5 (13) | 4 (10) |
| Insomnia | 9 (23) | 9 (23) | 0 |
| Pneumonia | 9 (23) | 2 (5) | 5 (13) |
| Arthralgia | 8 (21) | 8 (21) | 0 |
| Hyperglycemia | 8 (21) | 5 (13) | 3 (8) |
| Neck pain | 8 (21) | 8 (21) | 0 |
| Hematologic TEAEs | |||
| Anemia | 17 (44) | 5 (13) | 12 (31) |
| Thrombocytopenia∗ | 15 (39) | 3 (8) | 12 (31) |
| Leukocytosis | 12 (31) | 6 (15) | 6 (15) |
| TEAE . | Any grade, n (%) . | Grade 1-2, n (%) . | Grade 3-4, n (%) . |
|---|---|---|---|
| Nonhematologic TEAEs | |||
| Fatigue∗ | 19 (49) | 14 (36) | 5 (13) |
| Hypoalbuminemia | 18 (46) | 18 (46) | 0 |
| Hypokalemia | 17 (44) | 17 (44) | 0 |
| Nausea | 17 (44) | 15 (39) | 2 (5) |
| Decreased appetite∗ | 17 (44) | 16 (41) | 1 (3) |
| Back pain | 15 (39) | 14 (36) | 1 (3) |
| Cough | 15 (39) | 15 (39) | 0 |
| Constipation | 14 (36) | 14 (36) | 0 |
| Diarrhea | 14 (36) | 11 (28) | 3 (8) |
| Dyspnea | 13 (33) | 9 (23) | 4 (10) |
| Peripheral edema∗ | 13 (33) | 13 (33) | 0 |
| Weight increased | 12 (31) | 12 (31) | 0 |
| ALT increased | 11 (28) | 9 (23) | 2 (5) |
| Chills | 11 (28) | 11 (28) | 0 |
| Headache | 11 (28) | 11 (28) | 0 |
| Pyrexia | 11 (28) | 11 (28) | 0 |
| Tachycardia∗ | 11 (28) | 10 (26) | 1 (3) |
| Acute kidney injury | 10 (26) | 7 (18) | 3 (8) |
| Dizziness | 10 (26) | 9 (23) | 1 (3) |
| Vomiting | 10 (26) | 10 (26) | 0 |
| AST increased | 9 (23) | 6 (15) | 3 (8) |
| Blood creatinine increased | 9 (23) | 8 (21) | 1 (3) |
| CLS | 9 (23) | 4 (10) | 5 (13) |
| Hypotension | 9 (23) | 5 (13) | 4 (10) |
| Insomnia | 9 (23) | 9 (23) | 0 |
| Pneumonia | 9 (23) | 2 (5) | 5 (13) |
| Arthralgia | 8 (21) | 8 (21) | 0 |
| Hyperglycemia | 8 (21) | 5 (13) | 3 (8) |
| Neck pain | 8 (21) | 8 (21) | 0 |
| Hematologic TEAEs | |||
| Anemia | 17 (44) | 5 (13) | 12 (31) |
| Thrombocytopenia∗ | 15 (39) | 3 (8) | 12 (31) |
| Leukocytosis | 12 (31) | 6 (15) | 6 (15) |
Data are for the safety population (n = 39).
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Aggregated events by US Food and Drug Administration Medical Dictionary for Regulatory Activities analysis of selected TEAEs.