Table 2.
Treatment‐related adverse events of any grade (≥20% in the total population) and grade ≥3
|
20 mg BID (n = 4) |
40 mg BID (n = 4) |
60 mg BID (n = 7) |
Total (N = 15) |
|||||
|---|---|---|---|---|---|---|---|---|
| All Grades | Grade ≥3 | All Grades | Grade ≥3 | All Grades | Grade ≥3 | All Grades | Grade ≥3 | |
| Asthenia | 3 (75.0) | 0 | 4 (100.0) | 0 | 5 (71.4) | 0 | 12 (80.0) | 0 |
| Nausea | 4 (100.0) | 0 | 3 (75.0) | 0 | 5 (71.4) | 1 (14.3) | 12 (80.0) | 1 (7) |
| Decreased white blood cell count | 2 (50.0) | 0 | 3 (75.0) | 0 | 5 (71.4) | 2 (28.6) | 10 (66.7) | 2 (13) |
| Decreased appetite | 3 (75.0) | 0 | 3 (75.0) | 0 | 3 (42.9) | 0 | 9 (60.0) | 0 |
| Decreased neutrophil count | 1 (25.0) | 0 | 3 (75.0) | 0 | 4 (57.1) | 2 (28.6) | 8 (53.3) | 2 (13) |
| Decreased hemoglobin | 0 | 0 | 1 (25.0) | 0 | 5 (71.4) | 3 (42.9) | 6 (40.0) | 3 (20) |
| Increased conjugated bilirubin | 1 (25.0) | 0 | 1 (25.0) | 0 | 2 (28.6) | 0 | 4 (26.7) | 0 |
| Prolonged electrocardiogram QT a | 1 (25.0) | 1 (25.0) | 1 (25.0) | 0 | 2 (28.6) | 0 | 4 (26.7) | 1 (7) |
| Vomiting | 1 (25.0) | 0 | 1 (25.0) | 0 | 2 (28.6) | 1 (14.3) | 4 (26.7) | 1 (7) |
| Decreased platelet count | 0 | 0 | 0 | 0 | 3 (42.9) | 1 (14.3) | 3 (20.0) | 1 (7) |
| Diarrhea | 0 | 0 | 1 (25.0) | 0 | 2 (28.6) | 0 | 3 (20.0) | 0 |
| Increased GGT | 1 (25.0) | 0 | 1 (25.0) | 0 | 1 (14.3) | 0 | 3 (20.0) | 0 |
| Somnolence | 1 (25.0) | 0 | 1 (25.0) | 0 | 1 (14.3) | 0 | 3 (20.0) | 0 |
| Tachycardia | 0 | 0 | 1 (25.0) | 0 | 2 (28.6) | 0 | 3 (20.0) | 0 |
Data presented as n (%).
Abbreviations: BID, twice daily; GGT, gamma‐glutamyl transferase.
a
Three patients had QTcF 450–480 ms without clinical sequelae, and one patient had QTcF ≥500 ms (grade 3 QT prolongation).