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) |
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) |