Table 2.
Grade 3/4 TEAEs occurring in >5% of all patients (N = 47), including possible relationship to study drugs
| n (%) | Possible relationship to study drug, n (%) | ||
|---|---|---|---|
| Venetoclax or Navitoclax | Chemotherapy | ||
| Any | 46 (97.9) | 35 (74.5) | 28 (59.6) |
| Hematologic | |||
| Febrile neutropenia | 22 (46.8) | 9 (19.1) | 4 (8.5) |
| Neutropeniaa | 18 (38.3) | 15 (31.9) | 8 (17.0) |
| Anemiaa | 9 (19.1) | 4 (8.5) | 0 |
| Thrombocytopeniaa | 12 (25.5) | 10 (21.3) | 1 (2.1) |
| Leukopeniaa | 8 (17.0) | 5 (10.6) | 2 (4.3) |
| Nonhematologic | |||
| Hypokalemia | 11 (23.4) | 1 (2.1) | 2 (4.3) |
| ALT increased | 9 (19.1) | 2 (4.3) | 3 (6.4) |
| Hyperbilirubinemiaa | 9 (19.1) | 2 (4.3) | 6 (12.8) |
| Sepsis | 9 (19.1) | 2 (4.3) | 1 (2.1) |
| Pneumonia | 7 (14.9) | 1 (2.1) | 1 (2.1) |
| AST increased | 6 (12.8) | 1 (2.1) | 2 (4.3) |
| Hyperglycemia | 6 (12.8) | 0 | 4 (8.5) |
| Hyponatremia | 6 (12.8) | 0 | 0 |
| Diarrhea | 5 (10.6) | 1 (2.1) | 0 |
| Back pain | 4 (8.5) | 0 | 0 |
| Hypotension | 4 (8.5) | 0 | 0 |
| Sinus tachycardia | 4 (8.5) | 0 | 0 |
| Vomiting | 4 (8.5) | 3 (6.4) | 2 (4.3) |
| Abdominal pain | 3 (6.4) | 0 | 1 (2.1) |
| Bacteremia | 3 (6.4) | 0 | 0 |
| Bone pain | 3 (6.4) | 0 | 0 |
| Hypocalcemia | 3 (6.4) | 1 (2.1) | 0 |
| Respiratory failure | 3 (6.4) | 0 | 0 |
a
Combined preferred terms are presented for neutropenia (neutropenia and neutrophil count decreased), anemia (anemia and hemoglobin decreased), thrombocytopenia (thrombocytopenia and platelet count decreased), leukopenia (leukopenia and white blood cell count decreased), and hyperbilirubinemia (hyperbilirubinemia and blood bilirubin increased).
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; TEAE, treatment-emergent adverse event.