AEs in the safety population
| Event, n (%) . | Ivosidenib + azacitidine n = 72 . | Placebo + azacitidine n = 74 . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Hematologic AEs (in ≥10% of patients in either arm) | ||||
| Anemia | 24 (33.3) | 19 (26.4) | 23 (31.1) | 20 (27.0) |
| Neutropenia | 22 (30.6) | 22 (30.6) | 16 (21.6) | 16 (21.6) |
| Thrombocytopenia | 21 (29.2) | 18 (25.0) | 14 (18.9) | 14 (18.9) |
| Febrile neutropenia | 20 (27.8) | 20 (27.8) | 25 (33.8) | 25 (33.8) |
| Decreased platelet count | 10 (13.9) | 8 (11.1) | 6 (8.1) | 6 (8.1) |
| Decreased neutrophil count | 9 (12.5) | 9 (12.5) | 5 (6.8) | 5 (6.8) |
| Leukocytosis | 8 (11.1) | 0 | 2 (2.7) | 1 (1.4) |
| Nonhematologic AEs (in ≥20% of patients in either arm) | ||||
| Nausea | 32 (44.4) | 2 (2.8) | 29 (39.2) | 3 (4.1) |
| Vomiting | 30 (41.7) | 0 | 20 (27.0) | 1 (1.4) |
| Pyrexia | 27 (37.5) | 2 (2.8) | 32 (43.2) | 2 (2.7) |
| Diarrhea | 26 (36.1) | 1 (1.4) | 29 (39.2) | 6 (8.1) |
| Constipation | 23 (31.9) | 0 | 39 (52.7) | 1 (1.4) |
| Pneumonia | 17 (23.6) | 16 (22.2) | 24 (32.4) | 22 (29.7) |
| Electrocardiogram QT prolonged | 16 (22.2) | 8 (11.1) | 5 (6.8) | 2 (2.7) |
| Decreased appetite | 13 (18.1) | 1 (1.4) | 21 (28.4) | 6 (8.1) |
| Asthenia | 12 (16.7) | 0 | 25 (33.8) | 6 (8.1) |
| Hypokalemia | 11 (15.3) | 2 (2.8) | 21 (28.4) | 7 (9.5) |
| Peripheral edema | 9 (12.5) | 0 | 17 (23.0) | 1 (1.4) |
| Any infection | 25 (34.7) | 16 (22.2) | 38 (51.4) | 23 (31.1) |
| Any bleeding | 31 (43.1) | 5 (6.9) | 23 (31.1) | 6 (8.1) |
| AEs of special interest | ||||
| QT prolongation | 21 (29.2) | 9 (12.5) | 9 (12.2) | 3 (4.1) |
| Differentiation syndrome | 10 (13.9) | 3 (4.2) | 6 (8.1) | 3 (4.1) |
| Leukocytosis | 9 (12.5) | 0 | 2 (2.7) | 1 (1.4) |
| Event, n (%) . | Ivosidenib + azacitidine n = 72 . | Placebo + azacitidine n = 74 . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Hematologic AEs (in ≥10% of patients in either arm) | ||||
| Anemia | 24 (33.3) | 19 (26.4) | 23 (31.1) | 20 (27.0) |
| Neutropenia | 22 (30.6) | 22 (30.6) | 16 (21.6) | 16 (21.6) |
| Thrombocytopenia | 21 (29.2) | 18 (25.0) | 14 (18.9) | 14 (18.9) |
| Febrile neutropenia | 20 (27.8) | 20 (27.8) | 25 (33.8) | 25 (33.8) |
| Decreased platelet count | 10 (13.9) | 8 (11.1) | 6 (8.1) | 6 (8.1) |
| Decreased neutrophil count | 9 (12.5) | 9 (12.5) | 5 (6.8) | 5 (6.8) |
| Leukocytosis | 8 (11.1) | 0 | 2 (2.7) | 1 (1.4) |
| Nonhematologic AEs (in ≥20% of patients in either arm) | ||||
| Nausea | 32 (44.4) | 2 (2.8) | 29 (39.2) | 3 (4.1) |
| Vomiting | 30 (41.7) | 0 | 20 (27.0) | 1 (1.4) |
| Pyrexia | 27 (37.5) | 2 (2.8) | 32 (43.2) | 2 (2.7) |
| Diarrhea | 26 (36.1) | 1 (1.4) | 29 (39.2) | 6 (8.1) |
| Constipation | 23 (31.9) | 0 | 39 (52.7) | 1 (1.4) |
| Pneumonia | 17 (23.6) | 16 (22.2) | 24 (32.4) | 22 (29.7) |
| Electrocardiogram QT prolonged | 16 (22.2) | 8 (11.1) | 5 (6.8) | 2 (2.7) |
| Decreased appetite | 13 (18.1) | 1 (1.4) | 21 (28.4) | 6 (8.1) |
| Asthenia | 12 (16.7) | 0 | 25 (33.8) | 6 (8.1) |
| Hypokalemia | 11 (15.3) | 2 (2.8) | 21 (28.4) | 7 (9.5) |
| Peripheral edema | 9 (12.5) | 0 | 17 (23.0) | 1 (1.4) |
| Any infection | 25 (34.7) | 16 (22.2) | 38 (51.4) | 23 (31.1) |
| Any bleeding | 31 (43.1) | 5 (6.9) | 23 (31.1) | 6 (8.1) |
| AEs of special interest | ||||
| QT prolongation | 21 (29.2) | 9 (12.5) | 9 (12.2) | 3 (4.1) |
| Differentiation syndrome | 10 (13.9) | 3 (4.2) | 6 (8.1) | 3 (4.1) |
| Leukocytosis | 9 (12.5) | 0 | 2 (2.7) | 1 (1.4) |