Table 4.
Treatment-Emergent Serious Adverse Events in ≥ 5% of Patients in Any Group (2009 clinical cutoff)
| Adverse Event | TC |
Decitabine (n = 238) |
||||||
|---|---|---|---|---|---|---|---|---|
| Supportive Care (n = 29) |
Cytarabine (n = 208) |
Total TC (n = 237) |
||||||
| No. | % | No. | % | No. | % | No. | % | |
| Any serious adverse event | 12 | 41 | 150 | 72 | 162 | 68 | 190 | 80 |
| Febrile neutropenia | 0 | 0 | 33 | 16 | 33 | 14 | 57 | 24 |
| Thrombocytopenia | 0 | 0 | 11 | 5 | 11 | 5 | 21 | 9 |
| Anemia | 0 | 0 | 12 | 6 | 12 | 5 | 15 | 6 |
| Neutropenia | 0 | 0 | 7 | 3 | 7 | 3 | 15 | 6 |
| Pneumonia | 3 | 10 | 33 | 16 | 36 | 15 | 48 | 20 |
| Sepsis | 1 | 3 | 9 | 4 | 10 | 4 | 15 | 6 |
| Septic shock | 0 | 0 | 8 | 4 | 8 | 3 | 15 | 6 |
| Bronchopneumonia | 3 | 10 | 9 | 4 | 12 | 5 | 9 | 4 |
| Disease progression | 2 | 7 | 29 | 14 | 31 | 13 | 27 | 11 |
| Pyrexia | 2 | 7 | 18 | 9 | 20 | 8 | 23 | 10 |
| General physical health deterioration | 1 | 3 | 13 | 6 | 14 | 6 | 15 | 6 |
Abbreviation: TC, treatment choice.