QTc prolongations with quizartinib (safety population)
| . | Quizartinib 30-mg group* (n = 38) . | Quizartinib 60-mg group† (n = 36) . |
|---|---|---|
| Maximum value of QTcF, n (%), ms‡ | ||
| ≥450 to ≤480 | 16 (42.1) | 17 (47.2) |
| >480 to ≤500 | 2 (5.3) | 5 (13.9) |
| >500 | 2 (5.3) | 1 (2.8) |
| Maximum change from baseline in QTcF, n (%), ms‡ | ||
| >30 to ≤60 | 18 (47.4) | 15 (41.7) |
| >60 | 2 (5.3) | 7 (19.4) |
| . | Quizartinib 30-mg group* (n = 38) . | Quizartinib 60-mg group† (n = 36) . |
|---|---|---|
| Maximum value of QTcF, n (%), ms‡ | ||
| ≥450 to ≤480 | 16 (42.1) | 17 (47.2) |
| >480 to ≤500 | 2 (5.3) | 5 (13.9) |
| >500 | 2 (5.3) | 1 (2.8) |
| Maximum change from baseline in QTcF, n (%), ms‡ | ||
| >30 to ≤60 | 18 (47.4) | 15 (41.7) |
| >60 | 2 (5.3) | 7 (19.4) |
Quizartinib 30 mg and 60 mg are equivalent to 26.5 mg and 53 mg free base, respectively.
30-mg starting dose with permitted escalation to 60 mg for lack of or loss of initial response.
60-mg starting dose with permitted escalation to 90 mg for lack of or loss of initial response.
Criteria for maximum QTcF duration and maximum QTcF change from baseline are not mutually exclusive (ie, the same patient could have met either or both criteria).