Table 2.
Summary of all‐cause AEs in patients initiated with avapritinib 300 mg or 400 mg
| Avapritinib 300 mg (n = 167) | Avapritinib 400 mg (n = 50) | |||
|---|---|---|---|---|
| AEs | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| Patients with AEs, n (%) | 166 (99.4) | 121 (72.5) | 49 (98.0) | 42 (84.0) |
| Nausea | 103 (61.7) | 2 (1.2) | 38 (76.0) | 3 (6.0) |
| Fatigue | 88 (52.7) | 10 (6.0) | 35 (70.0) | 17 (34.0) |
| Anemia | 87 (52.1) | 51 (30.5) | 26 (52.0) | 17 (34.0) |
| Diarrhea | 70 (41.9) | 8 (4.8) | 20 (40.0) | 3 (6.0) |
| Periorbital edema | 64 (38.3) | 2 (1.2) | 26 (52.0) | 0 (0) |
| Decreased appetite | 61 (36.5) | 4 (2.4) | 21 (42.0) | 3 (6.0) |
| Vomiting | 58 (34.7) | 4 (2.4) | 27 (54.0) | 1 (2.0) |
| Increased lacrimation | 51 (30.5) | 0 (0) | 21 (42.0) | 0 (0) |
| Peripheral edema | 45 (26.9) | 1 (<1.0) | 18 (36.0) | 1 (2.0) |
| Memory impairment | 45 (26.9) | 1 (<1.0) | 20 (40.0) | 1 (2.0) |
| Abdominal pain | 41 (24.6) | 11 (6.6) | 10 (20.0) | 1 (2.0) |
| Constipation | 38 (22.8) | 3 (1.8) | 13 (26.0) | 0 (0) |
| Face edema | 38 (22.8) | 0 (0) | 14 (28.0) | 1 (2.0) |
| Blood bilirubin increased | 37 (22.2) | 8 (4.8) | 10 (20.0) | 1 (2.0) |
| Hair color changes | 33 (19.8) | 0 (0) | 14 (28.0) | 1 (2.0) |
| Hypokalemia | 30 (18.0) | 7 (4.2) | 7 (14.0) | 2 (4.0) |
| Dysgeusia | 30 (18.0) | 0 (0) | 5 (10.0) | 0 (0) |
| Dizziness | 27 (16.2) | 1 (<1.0) | 21 (42.0) | 0 (0) |
| Dyspnea | 27 (16.2) | 4 (2.4) | 12 (24.0) | 2 (4.0) |
| Headache | 27 (16.2) | 1 (<1.0) | 10 (20.0) | 0 (0) |
| Dyspepsia | 27 (16.2) | 0 (0) | 7 (14.0) | 0 (0) |
| Weight decreased | 27 (16.2) | 2 (1.2) | 6 (12.0) | 0 (0) |
| Hypophosphatemia | 24 (14.4) | 8 (4.8) | 8 (16.0) | 3 (6.0) |
| Pyrexia | 22 (13.2) | 0 (0) | 10 (20.0) | 1 (2.0) |
| AST increased | 21 (12.6) | 0 (0) | 12 (24.0) | 1 (2.0) |
| Alopecia | 19 (11.4) | — | 10 (20.0) | — |
| Rash | 18 (10.8) | 1 (<1.0) | 10 (20.0) | 0 (0) |
| Cough | 14 (8.4) | 0 (0) | 9 (18.0) | 0 (0) |
| Upper respiratory tract infection | 13 (7.8) | 0 (0) | 8 (16.0) | 0 (0) |
| Feeling cold | 8 (4.8) | 0 (0) | 9 (18.0) | 0 (0) |
| Cognitive effects | 67 (40.1) | 5 (3.0) | 25 (50.0) | 4 (8.0) |
| Memory impairment | 45 (26.9) | 1 (<1.0) | 20 (40.0) | 1 (2.0) |
| Cognitive disorder | 21 (12.6) | 1 (<1.0) | 3 (6.0) | 1 (2.0) |
| Confusional state | 11 (6.6) | 2 (1.2) | 5 (10.0) | 2 (4.0) |
| Encephalopathy | 1 (<1.0) | 1 (<1.0) | 2 (4.0) | 1 (2.0) |
| Intracranial bleeding | 4 (2.4) | 2 (1.2) | 0 (0) | 0 (0) |
| Intracranial hemorrhage | 3 (1.8) | 2 (1.2) | 0 (0) | 0 (0) |
| Subdural hematoma | 1 (<1.0) | 0 (0) | 0 (0) | 0 (0) |
| Cerebral hemorrhage | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Serious AEs, n (%) | 93 (55.7) | — | 29 (58.0) | — |
| AE leading to dose interruption, n (%) | 110 (65.9) | — | 34 (68.0) | — |
| AE leading to dose reduction, n (%) | 75 (44.9) | — | 33 (66.0) | — |
| AE leading to treatment discontinuation, n (%) | 28 (16.8) | — | 9 (18.0) | — |
| Treatment‐related AE leading to discontinuation, n (%) | 16 (9.6) | — | 6 (12.0) | — |
The cutoff date for these analyses was April 2, 2019.
a
Preferred Terms for any‐grade AEs reported in ≥15% of patients in either dose group.
Abbreviations: AE, adverse event; AST, aspartate aminotransferase.