Table 3.
Treatment-emergent adverse events reported with 10-day decitabine and venetoclax, regardless of attribution.
| Treatment-emergent adverse events | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 |
|---|---|---|---|---|
| Infection with ANC <1∙0 ×109/L | 0 (0) | 77 (46) | 2 (1) | 5 (3) |
| Renal Failure | 0 (0) | 0 (0) | 2 (1) | 1 (1) |
| Tumor lysis syndrome | 0 (0) | 3 (2) | 1 (1) | 0 (0) |
| Fever (ANC >1.0 × 109/L) | 0 (0) | 0 (0) | 1 (1) | 0 (0) |
| Hemorrhage, CNS | 0 (0) | 0 (0) | 1 (1) | 0 (0) |
| Febrile neutropenia (ANC <1∙0 ×109/L) | 0 (0) | 49 (2) | 0 (0) | 0 (0) |
| Infection with ANC >1∙0 ×109/L | 2 (1) | 11 (7) | 0 (0) | 0 (0) |
| Hyperbilirubinemia | 0 (0) | 3 (2) | 0 (0) | 0 (0) |
| Diarrhea | 8 (5) | 2 (1) | 0 (0) | 0 (0) |
| Colitis | 0 (0) | 2 (1) | 0 (0) | 0 (0) |
| Mucositis | 11 (7) | 1 (1) | 0 (0) | 0 (0) |
| ALT elevation | 1 (1) | 1 (1) | 0 (0) | 0 (0) |
| Fatigue | 1 (1) | 1 (1) | 0 (0) | 0 (0) |
| Cardiac ischemia | 0 (0) | 1 (1) | 0 (0) | 0 (0) |
| Cough | 0 (0) | 1 (1) | 0 (0) | 0 (0) |
| Esophagitis | 0 (0) | 1 (1) | 0 (0) | 0 (0) |
| Fracture | 0 (0) | 1 (1) | 0 (0) | 0 (0) |
| Muscle weakness | 0 (0) | 1 (1) | 0 (0) | 0 (0) |
| Nausea | 10 (6) | 0 (0) | 0 (0) | 0 (0) |
Results reported as n (%). Reported are adverse events which occurred in at least 10% of the patients or with at least 1 grade 3/4 event; ANC = absolute neutrophil count. ALT = alanine aminotransferase. There were 6 grade 5 adverse events including 5 infections with grade 3/4 neutropenia which were treatment related, and 1 grade 5 renal failure due to acute tubular necrosis which was unrelated to study regimen.