Table 3.
All TEAEs of all grades (greater than or equal to 20%) and of grade 3 or 4 severity (greater than or equal to 10%); and TEAEs assessed as related to treatment with olutasidenib of all grades (greater than or equal to 5%) and of grade 3 or 4 severity (greater than 1%)
| AE | All TEAEs |
Treatment-related TEAEs |
||
|---|---|---|---|---|
| All grades (≥20%) n (%) | Grade 3 or 4 (≥10%) n (%) | All grades (≥5%) n (%) | Grade 3 or 4 (>1%) n (%) | |
| Patients with any AE | 153 (100) | 129 (84) | 111 (73) | 59 (39) |
| Nausea | 58 (38) | 0 (0) | 35 (23) | 0 (0) |
| Anemia | 40 (26) | 31 (20) | 9 (6) | 7 (5) |
| Constipation | 40 (26) | 0 (0) | 12 (8) | 0 (0) |
| Leukocytosis | 38 (25) | 14 (9) | 20 (13) | 7 (5) |
| Pyrexia | 36 (24) | 1 (1) | 2 (1) | 0 (0) |
| Fatigue | 35 (23) | 2 (1) | 11 (7) | 1 (1) |
| Febrile neutropenia | 33 (22) | 31 (20) | 2 (1) | 2 (1) |
| Dyspnea | 31 (20) | 5 (3) | 5 (3) | 1 (1) |
| Diarrhea | 31 (20) | 2 (1) | 8 (5) | 1 (1) |
| Thrombocytopenia | 30 (20) | 25 (16) | 8 (5) | 6 (4) |
| Hypokalemia | 30 (20) | 9 (6) | 3 (2) | 0 (0) |
| Neutropenia | 20 (13) | 20 (13) | 8 (5) | 8 (5) |
| Decreased appetite | 25 (16) | 3 (2) | 8 (5) | 0 (0) |
| DS | 22 (14) | 13 (8) | 22 (14) | 13 (8) |
| Alanine aminotransferase increased | 18 (12) | 7 (5) | 13 (8) | 4 (3) |
| Aspartate aminotransferase increased | 14 (9) | 4 (3) | 9 (6) | 3 (2) |
| Gamma-glutamyltransferase increased | 10 (7) | 8 (5) | 8 (5) | 7 (5) |
| Hepatic enzyme increased | 7 (5) | 5 (3) | 6 (4) | 5 (3) |
| Tumor lysis syndrome | 4 (3) | 4 (3) | 3 (2) | 3 (2) |
| Deviating liver function test | 3 (2) | 3 (2) | 3 (2) | 3 (2) |