Table 3.
Non-hematologic adverse events by grade
Decitabine 5-day schedule (n=28) | Decitabine 10-day schedule (n=43) | |||||||
---|---|---|---|---|---|---|---|---|
Parameter | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 |
Acute kidney injury | 5 (18) | 0 | 0 | 0 | 1 (2) | 2 (5) | 1 (2) | 0 |
Altered mental status | 1 (4) | 0 | 0 | 0 | 1 (2) | 2 (5) | 0 | 0 |
Anorexia | 0 | 1 (4) | 0 | 0 | 2 (5) | 0 | 0 | 0 |
Cholecystitis | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Constipation | 2 (7) | 0 | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Diarrhea | 2 (7) | 1 (4) | 0 | 0 | 1 (2) | 0 | 0 | 0 |
Dysphagia | 0 | 1 (4) | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Fatigue | 3 (11) | 2 (7) | 0 | 0 | 4 (9) | 2 (5) | 0 | 0 |
Febrile neutropenia | 0 | 7 (25) | 0 | 1 (4) | 0 | 12 (28) | 2 (5) | 0 |
Hearing loss | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 |
Hemorrhage | 1 (4) | 0 | 1 (4) | 1 (4) | 0 | 1 (2) | 0 | 0 |
Hyperglycemia | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Hypoglycemia | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Hyponatremia | 0 | 0 | 0 | 0 | 0 | 2 (5) | 0 | 0 |
Hypotension | 0 | 1 (4) | 0 | 0 | 1 (2) | 2 (5) | 0 | 0 |
Increased bilirubin | 1 (4) | 1 (4) | 0 | 0 | 0 | 0 | 0 | 0 |
Infection | 1 (4) | 4 (14) | 1 (4) | 1 (4) | 3 (7) | 16 (37) | 0 | 6 (14) |
Myocardial infarction | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Nausea | 1 (4) | 1 (4) | 0 | 0 | 4 (9) | 0 | 0 | 0 |
Pain | 1 (4) | 1 (4) | 0 | 0 | 8 (19) | 2 (5) | 0 | 0 |
Pleural effusion | 0 | 2 (7) | 0 | 0 | 0 | 0 | 0 | 0 |
Syncope | 0 | 1 (4) | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Transient ischemic attack | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 0 |
Venous thromboembolism | 0 | 1 (4) | 0 | 0 | 1 (2) | 0 | 0 | 0 |
Data are n (%). Any grade 1–2 adverse event occuring in ≥10% of patients in either arm, and all grade 3, 4, and 5 adverse events are listed.