Table 5.
Grade 3 to 4 TEAEs occurring in ≥10% of patients in any treatment group (by decreasing frequency in the azacitidine arm)
| Preferred term* | Azacitidine (n = 236) | Individual CCR arms | ||||||
|---|---|---|---|---|---|---|---|---|
| BSC only (n = 40) | LDAC (n = 153) | IC (n = 42) | ||||||
| No. | % | No. | % | No. | % | No. | % | |
| Febrile neutropenia | 66 | 28.0 | 11 | 27.5 | 46 | 30.1 | 13 | 31.0 |
| Neutropenia | 62 | 26.3 | 2 | 5.0 | 38 | 24.8 | 14 | 33.3 |
| Thrombocytopenia | 56 | 23.7 | 2 | 5.0 | 42 | 27.5 | 9 | 21.4 |
| Pneumonia | 45 | 19.1 | 2 | 5.0 | 29 | 19.0 | 2 | 4.8 |
| Anemia | 37 | 15.7 | 2 | 5.0 | 35 | 22.9 | 6 | 14.3 |
| Leukopenia | 16 | 6.8 | 0 | 13 | 8.5 | 6 | 14.3 | |
| Hypokalemia | 12 | 5.1 | 1 | 2.5 | 10 | 6.5 | 7 | 16.7 |
TEAEs were coded by using the Medical Dictionary for Regulatory Activities and were graded for severity by using the National Cancer Institute’s Common Toxicity Criteria for Adverse Events v4.0.
*
To be considered treatment-emergent, an AE must have been a new occurrence or the worsening of a preexisting AE.