Safety results (regardless of causality)
| . | Guadecitabine (n = 401) . | TC (n = 392) . |
|---|---|---|
| Any AE | 393 (98) | 387 (99) |
| AE leading to discontinuation of study treatment | 41 (10) | 26 (7) |
| Any serious AE | 325 (81) | 296 (76) |
| Death (due to AE) | 115 (29) | 117 (30) |
| Any grade ≥3 AE | 367 (92) | 343 (88) |
| Grade ≥3 AEs in >10% of patients (either group) | ||
| Febrile neutropenia | 136 (34) | 104 (27)∗ |
| Pneumonia | 118 (29) | 77 (20)∗ |
| Thrombocytopenia | 114 (28) | 92 (23) |
| Neutropenia | 110 (27) | 81 (21)∗ |
| Anemia | 81 (20) | 70 (18) |
| Sepsis | 61 (15) | 47 (12) |
| . | Guadecitabine (n = 401) . | TC (n = 392) . |
|---|---|---|
| Any AE | 393 (98) | 387 (99) |
| AE leading to discontinuation of study treatment | 41 (10) | 26 (7) |
| Any serious AE | 325 (81) | 296 (76) |
| Death (due to AE) | 115 (29) | 117 (30) |
| Any grade ≥3 AE | 367 (92) | 343 (88) |
| Grade ≥3 AEs in >10% of patients (either group) | ||
| Febrile neutropenia | 136 (34) | 104 (27)∗ |
| Pneumonia | 118 (29) | 77 (20)∗ |
| Thrombocytopenia | 114 (28) | 92 (23) |
| Neutropenia | 110 (27) | 81 (21)∗ |
| Anemia | 81 (20) | 70 (18) |
| Sepsis | 61 (15) | 47 (12) |
Febrile neutropenia, pneumonia, and neutropenia: P < .05.