Table 1 Treatment-emergent adverse events (TEAEs) in all patients
Olverembatinib 20 mg (n = 3) | Olverembatinib 30 mg (n = 15) | Olverembatinib 40 mg (n = 32) | Olverembatinib 50 mg (n = 16) | Total (n = 66) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
Any grade | Grade 3-5 | Any grade | Grade 3–5 | Any grade | Grade 3–5 | Any grade | Grade 3–5 | Any grade | Grade 3–5 | |
TEAEs, n (%) | 3 (100.0) | 0 | 15 (100.0) | 5 (33.3) | 32 (100.0) | 12 (37.5) | 16 (100.0) | 9 (56.3) | 66 (100.0) | 26 (39.4) |
Terms reported in ≥20% of patients, n (%) | ||||||||||
Leukocyte count increased | 1 (33.3) | 0 | 8 (53.3) | 0 | 15 (46.9) | 0 | 8 (50.0) | 0 | 32 (48.5) | 0 |
Anemia | 1 (33.3) | 0 | 8 (53.3) | 1 (6.7) | 14 (43.8) | 2 (6.3) | 8 (50.0) | 1 (6.3) | 31 (47.0) | 4 (6.1) |
Aspartate aminotransferase increased | 0 | 0 | 7 (46.7) | 0 | 14 (43.8) | 0 | 10 (62.5) | 2 (12.5) | 31 (47.0) | 2 (3.0) |
Hyperuricemia | 2 (66.7) | 0 | 7 (46.7) | 1 (6.7) | 17 (53.1) | 0 | 5 (31.3) | 0 | 31 (47.0) | 1 (1.5) |
Pyrexia | 0 | 0 | 5 (33.3) | 0 | 17 (53.1) | 0 | 6 (37.5) | 0 | 28 (42.4) | 0 |
Constipation | 2 (66.7) | 0 | 5 (33.3) | 0 | 13 (40.6) | 0 | 7 (43.8) | 0 | 27 (40.9) | 0 |
Alanine aminotransferase increased | 0 | 0 | 6 (40.0) | 0 | 13 (40.6) | 0 | 6 (37.5) | 2 (12.5) | 25 (37.9) | 2 (3.0) |
Neutrophil count increased | 1 (33.3) | 0 | 6 (40.0) | 0 | 12 (37.5) | 0 | 6 (37.5) | 0 | 25 (37.9) | 0 |
Fatigue | 0 | 0 | 4 (26.7) | 0 | 11 (34.4) | 1 (3.1) | 5 (31.3) | 0 | 20 (30.3) | 1 (1.5) |
Melanocytic nevus | 0 | 0 | 3 (20.0) | 0 | 10 (31.3) | 0 | 4 (25.0) | 0 | 17 (25.8) | 0 |
Abdominal pain | 0 | 0 | 5 (33.3) | 1 (6.7) | 7 (21.9) | 0 | 3 (18.8) | 0 | 15 (22.7) | 1 (1.5) |
C-reactive protein increased | 0 | 0 | 3 (20.0) | 0 | 8 (25.0) | 0 | 4 (25.0) | 0 | 15 (22.7) | 0 |
Hypoalbuminemia | 0 | 0 | 4 (26.7) | 0 | 5 (15.6) | 0 | 5 (31.3) | 0 | 14 (21.2) | 0 |
