Table 5 Summary of most frequent all-grade TEAEs that occurred in ≥ 20% of patients in quizartinib arm of QuANTUM-First or in All AML Pool (safety analysis set)
TEAEs of all grades, n (%) | All AML Pool [54]a | |||||
|---|---|---|---|---|---|---|
Quizartinib (n = 265) | Placebo (n = 268) | Quizartinib < 30 mg (n = 30) | Quizartinib 30–60 mg (n = 669) | Quizartinib > 60 mg (n = 382) | Total quizartinib (N = 1081) | |
Any TEAE | 264 (99.6) | 265 (98.9) | 29 (96.7) | 664 (99.3) | 380 (99.5) | 1073 (99.3) |
Nausea | 90 (34.0) | 84 (31.3) | 13 (43.3) | 272 (40.7) | 199 (52.1) | 484 (44.8) |
Febrile neutropenia | 117 (44.2) | 113 (42.2) | 7 (23.3) | 260 (38.9) | 151 (39.5) | 418 (38.7) |
Pyrexia | 112 (42.3) | 109 (40.7) | 8 (26.7) | 258 (38.6) | 120 (31.4) | 386 (35.7) |
Diarrhea | 98 (37.0) | 94 (35.1) | 11 (36.7) | 220 (32.9) | 152 (39.8) | 383 (35.4) |
Vomiting | 65 (24.5) | 53 (19.8) | 8 (26.7) | 195 (29.1) | 148 (38.7) | 351 (32.5) |
Hypokalemia | 93 (35.1) | 96 (35.8) | 8 (26.7) | 205 (30.6) | 71 (18.6) | 284 (26.3) |
Anemia | 29 (10.9) | 19 (7.1) | 6 (20.0) | 165 (24.7) | 113 (29.6) | 284 (26.3) |
Fatigue | 29 (10.9) | 23 (8.6) | 2 (6.7) | 136 (20.3) | 133 (34.8) | 271 (25.1) |
ECG QT prolonged | 36 (13.6) | 11 (4.1) | 3 (10.0) | 133 (19.9) | 106 (27.7) | 242 (22.4) |
Decreased appetite | 46 (17.4) | 36 (13.4) | 7 (23.3) | 122 (18.2) | 98 (25.7) | 227 (21.0) |
Headache | 73 (27.5) | 53 (19.8) | 5 (16.7) | 157 (23.5) | 56 (14.7) | 218 (20.2) |
Edema peripheral | 30 (11.3) | 37 (13.8) | 6 (20.0) | 105 (15.7) | 104 (27.2) | 215 (19.9) |
Constipation | 56 (21.1) | 69 (25.7) | 4 (13.3) | 131 (19.6) | 74 (19.4) | 209 (19.3) |
Cough | 50 (18.9) | 44 (16.4) | 5 (16.7) | 132 (19.7) | 70 (18.3) | 207 (19.1) |
Rash | 69 (26.0) | 66 (24.6) | 4 (13.3) | 129 (19.3) | 51 (13.4) | 184 (17.0) |
Pneumonia | 39 (14.7) | 41 (15.3) | 4 (13.3) | 101 (15.1) | 78 (20.4) | 183 (16.9) |
Neutropenia | 54 (20.4) | 27 (10.1) | 2 (6.7) | 128 (19.1) | 43 (11.3) | 173 (16.0) |
Stomatitis | 57 (21.5) | 56 (20.9) | 7 (23.3) | 111 (16.6) | 23 (6.0) | 141 (13.0) |
Dysgeusia | 9 (3.4) | 5 (1.9) | 4 (13.3) | 40 (6.0) | 81 (21.2) | 125 (11.6) |