Nonhematologic TEAEs of any grade reported in >20% of patients in any treatment group, and the corresponding frequencies of grade ≥3 events, during the induction and consolidation periods, regardless of attribution
| TEAE, n (%) . | Induction period . | Consolidation period . | ||||||
|---|---|---|---|---|---|---|---|---|
| Ivosidenib 500 mg + chemotherapy, n = 60 . | Enasidenib 100 mg + chemotherapy, n = 93 . | Ivosidenib 500 mg + chemotherapy, n = 35 . | Enasidenib 100 mg + chemotherapy, n = 46 . | |||||
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| Any TEAE | 60 (100.0) | 58 (96.7) | 92 (98.9) | 87 (93.5) | 35 (100.0) | 34 (97.1) | 45 (97.8) | 41 (89.1) |
| Diarrhea | 43 (71.7) | 1 (1.7) | 55 (59.1) | 5 (5.4) | 7 (20.0) | 0 | 17 (37.0) | 0 |
| Nausea | 33 (55.0) | 0 | 50 (53.8) | 2 (2.2) | 11 (31.4) | 0 | 15 (32.6) | 1 (2.2) |
| Rash* | 33 (55.0) | 3 (5.0) | 51 (54.8) | 13 (14.0) | 12 (34.3) | 1 (2.9) | 13 (28.3) | 1 (2.2) |
| Decreased appetite | 32 (53.3) | 5 (8.3) | 31 (33.3) | 3 (3.2) | 4 (11.4) | 0 | 11 (23.9) | 1 (2.2) |
| Vomiting | 21 (35.0) | 0 | 31 (33.3) | 1 (1.1) | 9 (25.7) | 1 (2.9) | 10 (21.7) | 0 |
| Stomatitis | 20 (33.3) | 3 (5.0) | 23 (24.7) | 4 (4.3) | 4 (11.4) | 0 | 9 (19.6) | 4 (8.7) |
| Fatigue | 19 (31.7) | 0 | 24 (25.8) | 2 (2.2) | 5 (14.3) | 0 | 9 (19.6) | 2 (4.3) |
| Hypokalemia | 17 (28.3) | 7 (11.7) | 29 (31.2) | 9 (9.7) | 3 (8.6) | 1 (2.9) | 11 (23.9) | 4 (8.7) |
| Pyrexia | 16 (26.7) | 4 (6.7) | 31 (33.3) | 2 (2.2) | 8 (22.9) | 1 (2.9) | 13 (28.3) | 0 |
| Constipation | 14 (23.3) | 0 | 25 (26.9) | 0 | 6 (17.1) | 0 | 13 (28.3) | 0 |
| Hypophosphatemia | 14 (23.3) | 10 (16.7) | 20 (21.5) | 12 (12.9) | 0 | 0 | 7 (15.2) | 4 (8.7) |
| Edema peripheral | 14 (23.3) | 0 | 37 (39.8) | 0 | 2 (5.7) | 0 | 13 (28.3) | 0 |
| Abdominal pain | 13 (21.7) | 2 (3.3) | 19 (20.4) | 0 | 4 (11.4) | 0 | 8 (17.4) | 1 (2.2) |
| Aspartate aminotransferase increased | 13 (21.7) | 4 (6.7) | 18 (19.4) | 4 (4.3) | 1 (2.9) | 0 | 6 (13.0) | 2 (4.3) |
| Electrocardiogram QT prolonged† | 16 (26.7) | 6 (10.0) | 11 (11.8) | 7 (7.5) | 3 (8.6) | 1 (2.9) | 7 (15.2) | 3 (6.5) |
| Alanine aminotransferase increased | 11 (18.3) | 4 (6.7) | 22 (23.7) | 5 (5.4) | 2 (5.7) | 1 (2.9) | 6 (13.0) | 2 (4.3) |
| Cough | 11 (18.3) | 0 | 22 (23.7) | 1 (1.1) | 3 (8.6) | 0 | 9 (19.6) | 0 |
| Headache | 10 (16.7) | 0 | 29 (31.2) | 0 | 6 (17.1) | 1 (2.9) | 8 (17.4) | 0 |
| Hypoalbuminemia | 10 (16.7) | 3 (5.0) | 21 (22.6) | 5 (5.4) | 1 (2.9) | 1 (2.9) | 3 (6.5) | 0 |
| Blood bilirubin increased‡ | 11 (18.3) | 4 (6.7) | 46 (49.5) | 15 (16.1) | 2 (5.7) | 1 (2.9) | 13 (28.3) | 5 (10.9) |
| Hypocalcemia | 9 (15.0) | 3 (5.0) | 24 (25.8) | 6 (6.5) | 2 (5.7) | 1 (2.9) | 6 (13.0) | 2 (4.3) |
| TEAE, n (%) . | Induction period . | Consolidation period . | ||||||
|---|---|---|---|---|---|---|---|---|
| Ivosidenib 500 mg + chemotherapy, n = 60 . | Enasidenib 100 mg + chemotherapy, n = 93 . | Ivosidenib 500 mg + chemotherapy, n = 35 . | Enasidenib 100 mg + chemotherapy, n = 46 . | |||||
| All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | All grades . | Grade ≥3 . | |
| Any TEAE | 60 (100.0) | 58 (96.7) | 92 (98.9) | 87 (93.5) | 35 (100.0) | 34 (97.1) | 45 (97.8) | 41 (89.1) |
| Diarrhea | 43 (71.7) | 1 (1.7) | 55 (59.1) | 5 (5.4) | 7 (20.0) | 0 | 17 (37.0) | 0 |
| Nausea | 33 (55.0) | 0 | 50 (53.8) | 2 (2.2) | 11 (31.4) | 0 | 15 (32.6) | 1 (2.2) |
| Rash* | 33 (55.0) | 3 (5.0) | 51 (54.8) | 13 (14.0) | 12 (34.3) | 1 (2.9) | 13 (28.3) | 1 (2.2) |
| Decreased appetite | 32 (53.3) | 5 (8.3) | 31 (33.3) | 3 (3.2) | 4 (11.4) | 0 | 11 (23.9) | 1 (2.2) |
| Vomiting | 21 (35.0) | 0 | 31 (33.3) | 1 (1.1) | 9 (25.7) | 1 (2.9) | 10 (21.7) | 0 |
| Stomatitis | 20 (33.3) | 3 (5.0) | 23 (24.7) | 4 (4.3) | 4 (11.4) | 0 | 9 (19.6) | 4 (8.7) |
| Fatigue | 19 (31.7) | 0 | 24 (25.8) | 2 (2.2) | 5 (14.3) | 0 | 9 (19.6) | 2 (4.3) |
| Hypokalemia | 17 (28.3) | 7 (11.7) | 29 (31.2) | 9 (9.7) | 3 (8.6) | 1 (2.9) | 11 (23.9) | 4 (8.7) |
| Pyrexia | 16 (26.7) | 4 (6.7) | 31 (33.3) | 2 (2.2) | 8 (22.9) | 1 (2.9) | 13 (28.3) | 0 |
| Constipation | 14 (23.3) | 0 | 25 (26.9) | 0 | 6 (17.1) | 0 | 13 (28.3) | 0 |
| Hypophosphatemia | 14 (23.3) | 10 (16.7) | 20 (21.5) | 12 (12.9) | 0 | 0 | 7 (15.2) | 4 (8.7) |
| Edema peripheral | 14 (23.3) | 0 | 37 (39.8) | 0 | 2 (5.7) | 0 | 13 (28.3) | 0 |
| Abdominal pain | 13 (21.7) | 2 (3.3) | 19 (20.4) | 0 | 4 (11.4) | 0 | 8 (17.4) | 1 (2.2) |
| Aspartate aminotransferase increased | 13 (21.7) | 4 (6.7) | 18 (19.4) | 4 (4.3) | 1 (2.9) | 0 | 6 (13.0) | 2 (4.3) |
| Electrocardiogram QT prolonged† | 16 (26.7) | 6 (10.0) | 11 (11.8) | 7 (7.5) | 3 (8.6) | 1 (2.9) | 7 (15.2) | 3 (6.5) |
| Alanine aminotransferase increased | 11 (18.3) | 4 (6.7) | 22 (23.7) | 5 (5.4) | 2 (5.7) | 1 (2.9) | 6 (13.0) | 2 (4.3) |
| Cough | 11 (18.3) | 0 | 22 (23.7) | 1 (1.1) | 3 (8.6) | 0 | 9 (19.6) | 0 |
| Headache | 10 (16.7) | 0 | 29 (31.2) | 0 | 6 (17.1) | 1 (2.9) | 8 (17.4) | 0 |
| Hypoalbuminemia | 10 (16.7) | 3 (5.0) | 21 (22.6) | 5 (5.4) | 1 (2.9) | 1 (2.9) | 3 (6.5) | 0 |
| Blood bilirubin increased‡ | 11 (18.3) | 4 (6.7) | 46 (49.5) | 15 (16.1) | 2 (5.7) | 1 (2.9) | 13 (28.3) | 5 (10.9) |
| Hypocalcemia | 9 (15.0) | 3 (5.0) | 24 (25.8) | 6 (6.5) | 2 (5.7) | 1 (2.9) | 6 (13.0) | 2 (4.3) |
TEAE, treatment-emergent adverse event.
Rash includes preferred terms rash, rash maculopapular, rash pruritic, rash erythematous, rash macular, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis bullous, exfoliative rash, skin ulcer, drug eruption, and urticaria.
Electrocardiogram QT prolonged includes ventricular tachycardia, ventricular arrhythmia, cardiac arrest, cardiorespiratory arrest, electrocardiogram QT prolonged, multiple organ dysfunction syndrome, and syncope.
Blood bilirubin increased includes preferred terms of increased blood bilirubin and hyperbilirubinemia.