Table 4 Non-hematologic adverse events observed in either cohort (AML and MDS/CMML), regardless of causality
Parameter | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 |
|---|---|---|---|---|
Acute coronary syndrome | 0 | 0 | 1 (2%) | 0 |
Acute kidney injury | 0 | 1 (2%) | 1 (2%) | 0 |
Anorexia | 2 (5%) | 1 (2%) | 0 | 0 |
Atrial fibrillation | 0 | 1 (2%) | 0 | 0 |
Cholecystitis | 0 | 2 (5%) | 0 | 0 |
Dehydration | 0 | 1 (2%) | 0 | 0 |
Delirium | 0 | 1 (2%) | 0 | 0 |
Disease progression | 0 | 0 | 0 | 1 (2%) |
Enterocolitis | 0 | 3 (8%) | 0 | 0 |
Fatigue | 4 (10%) | 0 | 0 | 0 |
Febrile neutropenia | 0 | 9 (23%) | 1 (2%) | 0 |
Fluid overload | 0 | 1 (2%) | 0 | 0 |
Generalized muscle weakness | 0 | 1 (2%) | 0 | 0 |
Gastrointestinal hemorrhage | 0 | 0 | 0 | 1 (2%) |
Hyperglycemia | 0 | 3 (8%) | 0 | 0 |
Hypokalemia | 0 | 2 (5%) | 0 | 0 |
Hypophosphatemia | 6 (15%) | 9 (23%) | 0 | 0 |
Hyponatremia | 0 | 1 (2%) | 0 | 0 |
Hypotension | 1 (2%) | 1 (2%) | 0 | 0 |
Increased ALT/AST | 4 (10%) | 3 (8%) | 1 (2%) | 0 |
Increased bilirubin | 2 (5%) | 3 (8%) | 0 | 0 |
Infection | 0 | 16 (35%) | 0 | 1 (2%) |
Insomnia | 0 | 1 (2%) | 0 | 0 |
Intracranial hemorrhage | 0 | 0 | 1 (2%) | 0 |
Multi-organ failure | 0 | 0 | 0 | 1 (2%) |
Nausea/vomiting | 4 (10%) | 2 (6%) | 0 | 0 |
Oral mucositis | 1 (2%) | 1 (2%) | 0 | 0 |
Pain (extremities/back) | 0 | 3 (8%) | 0 | 0 |
Pneumonitis | 0 | 2 (5%) | 0 | 0 |
Rash (acneiform) | 0 | 1 (2%) | 0 | 0 |
Sepsis | 0 | 0 | 2 (5%) | 0 |
Small bowel obstruction | 0 | 2 (5%) | 0 | 0 |
Stroke | 0 | 0 | 0 | 1 (2%) |
Sudden death | 0 | 0 | 0 | 2 (5%) |
Syncope | 0 | 1 (2%) | 0 | 0 |