Table 5.
Treatment-related TEAEs (all grades) reported in ≥10% of patients per dose group (safety population)
| Treatment-related TEAE by preferred term* | Quizartinib 30-mg group, n (%)† (n = 38) | Quizartinib 60-mg group, n (%)‡ (n = 36) | Total, n (%) (n = 74) |
|---|---|---|---|
| Overall | 30 (78.9) | 29 (80.6) | 59 (79.7) |
| Anemia | 8 (21.1) | 7 (19.4) | 15 (20.3) |
| Nausea | 4 (10.5) | 8 (22.2) | 12 (16.2) |
| Fatigue | 5 (13.2) | 4 (11.1) | 9 (12.2) |
| Febrile neutropenia | 4 (10.5) | 4 (11.1) | 8 (10.8) |
| Diarrhea | 4 (10.5) | 4 (11.1) | 8 (10.8) |
| Electrocardiogram QT prolonged | 2 (5.3) | 5 (13.9) | 7 (9.5) |
| Thrombocytopenia | 4 (10.5) | 2 (5.6) | 6 (8.1) |
| Abdominal pain | 2 (5.3) | 4 (11.1) | 6 (8.1) |
| Neutropenia | 1 (2.6) | 4 (11.1) | 5 (6.8) |
| Vomiting | 1 (2.6) | 4 (11.1) | 5 (6.8) |
| Dysgeusia | 4 (10.5) | 1 (2.8) | 5 (6.8) |
| Dyspepsia | 4 (10.5) | 0 | 4 (5.4) |
Quizartinib 30 mg and 60 mg are equivalent to 26.5 mg and 53 mg free base, respectively.
*
Patients may have more than 1 treatment-related TEAE per preferred term. Patients are counted once per preferred term.
†
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.