Table 1.
Clinical data
| Characteristic | Number of infection‐related SAEs | Totals | |||
|---|---|---|---|---|---|
| 0 | 1 | 2 | >2 | ||
| Gender | |||||
| Male | 12 | 18 | 8 | 12 | 50 |
| Female | 2 | 16 | 8 | 9 | 35 |
| Age | |||||
| <40 | 0 | 1 | 0 | 1 | 2 |
| 40–60 | 0 | 4 | 2 | 1 | 7 |
| >60 | 14 | 29 | 14 | 19 | 76 |
| Performance status | |||||
| 0 | 5 | 11 | 6 | 4 | 26 |
| 1 | 5 | 13 | 9 | 13 | 40 |
| 2 | 4 | 9 | 1 | 4 | 18 |
| Unknown | 0 | 1 | 0 | 0 | 1 |
| Disease | |||||
| AML | 13 | 19 | 11 | 15 | 58 |
| MDS | 1 | 15 | 5 | 6 | 27 |
| Response | |||||
| CR | 2 | 4 | 1 | 2 | 9 |
| CRi/mCR | 5 | 13 | 8 | 10 | 36 |
| PR/SD/PD | 3 | 11 | 5 | 8 | 27 |
| Not evaluable | 4 | 6 | 2 | 1 | 13 |
| Cycles completed | |||||
| <1 | 4 | 4 | 2 | 1 | 11 |
| 1 | 2 | 8 | 3 | 2 | 15 |
| 2 | 4 | 8 | 6 | 4 | 22 |
| 3 | 0 | 4 | 3 | 4 | 11 |
| >3 | 4 | 10 | 2 | 10 | 26 |
| Total | 14 | 34 | 16 | 21 | 85 |
AML, acute myeloid leukemia; MDS, myelodysplastic syndromes; SAEs, significant adverse events.