Most commonly reported (≥10% in any cohort) nonhematologic treatment-related adverse events∗
| Type of AE . | Cohort 1a: 25 mg/m2 MWF (n = 33) . | Cohort 1b: 37.5 mg/m2 MWF (n = 83) . | Cohort 1c: 25/25/50 mg/m2 MWF (n = 51) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| Nausea | 7 (21) | 1 (3) | 20 (24) | 6 (7) | 13 (25) | 2 (4) |
| Vomiting | 7 (21) | 0 | 22 (27) | 3 (4) | 10 (20) | 1 (2) |
| ALT increased | 2 (6) | 2 (6) | 14 (17) | 8 (10) | 8 (16) | 3 (6) |
| Decreased appetite | 3 (9) | 1 (3) | 12 (14) | 3 (4) | 8 (16) | 1 (2) |
| Fatigue | 3 (9) | 1 (3) | 17 (20) | 0 | 2 (4) | 0 |
| AST increased | 2 (6) | 0 | 12 (14) | 4 (5) | 3 (6) | 0 |
| Abdominal pain | 2 (6) | 0 | 9 (11) | 2 (2) | 6 (12) | 0 |
| Febrile neutropenia | 2 (6) | 2 (6) | 11 (13) | 11 (13) | 2 (4) | 2 (4) |
| Hyperglycemia | 3 (9) | 1 (3) | 5 (6) | 2 (2) | 6 (12) | 2 (4) |
| Treatment-related AEs of special interest | ||||||
| Allergic reaction† | 2 (6) | 2 (6) | 11 (13) | 6 (7) | 3 (6) | 1 (2) |
| Pancreatitis‡ | 0 | 0 | 6 (7) | 6 (7) | 6 (12) | 4 (8) |
| Thrombosis§ | 0 | 0 | 2 (2) | 2 (2) | 0 | 0 |
| Type of AE . | Cohort 1a: 25 mg/m2 MWF (n = 33) . | Cohort 1b: 37.5 mg/m2 MWF (n = 83) . | Cohort 1c: 25/25/50 mg/m2 MWF (n = 51) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| Nausea | 7 (21) | 1 (3) | 20 (24) | 6 (7) | 13 (25) | 2 (4) |
| Vomiting | 7 (21) | 0 | 22 (27) | 3 (4) | 10 (20) | 1 (2) |
| ALT increased | 2 (6) | 2 (6) | 14 (17) | 8 (10) | 8 (16) | 3 (6) |
| Decreased appetite | 3 (9) | 1 (3) | 12 (14) | 3 (4) | 8 (16) | 1 (2) |
| Fatigue | 3 (9) | 1 (3) | 17 (20) | 0 | 2 (4) | 0 |
| AST increased | 2 (6) | 0 | 12 (14) | 4 (5) | 3 (6) | 0 |
| Abdominal pain | 2 (6) | 0 | 9 (11) | 2 (2) | 6 (12) | 0 |
| Febrile neutropenia | 2 (6) | 2 (6) | 11 (13) | 11 (13) | 2 (4) | 2 (4) |
| Hyperglycemia | 3 (9) | 1 (3) | 5 (6) | 2 (2) | 6 (12) | 2 (4) |
| Treatment-related AEs of special interest | ||||||
| Allergic reaction† | 2 (6) | 2 (6) | 11 (13) | 6 (7) | 3 (6) | 1 (2) |
| Pancreatitis‡ | 0 | 0 | 6 (7) | 6 (7) | 6 (12) | 4 (8) |
| Thrombosis§ | 0 | 0 | 2 (2) | 2 (2) | 0 | 0 |
Data are given as number (percentage) of patients.
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Treatment-related AEs were reported as Medical Dictionary for Regulatory Activities (version 22.1) preferred terms.
Includes drug hypersensitivity, anaphylactic reaction, hypersensitivity, infusion-related reaction, rash maculopapular, rash, urticaria, and rash erythematous.
Includes pancreatitis and acute pancreatitis. Reporting of pancreatitis by the preferred terms “pancreatitis” or “acute pancreatitis” was assigned by the investigator. However, there was no clear distinction between the 2 preferred terms.
Includes superior sagittal sinus thrombosis, pulmonary embolism, and jugular vein thrombosis.