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 |
| 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.