Table 3.
Treatment-emergent AEs in the safety populationa
| Ivosidenib + Azacitidine N=71 |
Placebo + Azacitidine N=73 |
|||
|---|---|---|---|---|
| Adverse Eventb | All Grades n (%) |
Grade ≥3 n (%) |
All Grades n (%) |
Grade ≥3 n (%) |
| Nausea | 30 (42) | 2 (3) | 28 (38) | 3 (4) |
| Vomiting | 29 (41) | 0 | 20 (27) | 1 (1) |
| Arthralgia | 21 (30) | 3 (4) | 6 (8) | 1 (1) |
| Electrocardiogram QT prolonged | 14 (20) | 7 (10) | 5 (7) | 2 (3) |
| Dyspnea | 14 (20) | 2 (3) | 11 (15) | 4 (5) |
| Insomnia | 13 (18) | 1 (1) | 9 (12) | 0 |
| Differentiation Syndrome | 11 (15) | 7 (10) | 6 (8) | 6 (8) |
| Hematoma | 11 (15) | 0 | 3 (4) | 0 |
| Leukocytosis | 9 (13) | 0 | 1 (1) | 0 |
| Hypertension | 9 (13) | 3 (4) | 6 (8) | 4 (5) |
| Headache | 8 (11) | 0 | 2 (3) | 0 |
a
N = 144 adults with newly diagnosed IDH1-mutated AML treated with ivosidenib + azacitidine or placebo + azacitidine.
b
Includes grouped terms. See Supplementary Table S1 for further information.
Source: U.S. Food and Drug Administration.