Table 2 Adverse events
From: Safety and efficacy of avapritinib in advanced systemic mastocytosis: the phase 1 EXPLORER trial
All patients (n = 86) | AdvSM safety population (n = 69) | |||
|---|---|---|---|---|
Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
Non-hematologic AEs in ≥15% patients, n (%) | ||||
Periorbital edema | 59 (69) | 2 (2) | 45 (65) | 1 (1) |
Diarrhea | 39 (45) | 1 (1) | 30 (43) | 0 |
Nausea | 38 (44) | 3 (3) | 29 (42) | 3 (4) |
Fatigue | 35 (41) | 8 (9) | 24 (35) | 7 (10) |
Peripheral edema | 34 (40) | 0 | 31 (45) | 0 |
Vomiting | 31 (36) | 4 (5) | 22 (32) | 3 (4) |
Arthralgia | 24 (28) | 3 (3) | 18 (26) | 2 (3) |
Hair color changes | 22 (26) | 1 (1) | 13 (19) | 1 (1) |
Decreased appetite | 20 (23) | 1 (1) | 15 (22) | 1 (1) |
Memory impairment | 20 (23) | 0 | 14 (20) | 0 |
Dizziness | 19 (22) | 2 (2) | 14 (20) | 1 (1) |
Constipation | 19 (22) | 1 (1) | 14 (20) | 1 (1) |
Abdominal pain | 19 (22) | 1 (1) | 13 (19) | 0 |
Headache | 18 (21) | 1 (1) | 11 (16) | 1 (1) |
Hypokalemia | 18 (21) | 3 (3) | 14 (20) | 2 (3) |
Upper respiratory tract infection | 16 (19) | 1 (1) | 12 (17) | 1 (1) |
Dysgeusia | 16 (19) | 0 | 10 (14) | 0 |
Pruritus | 16 (19) | 0 | 11 (16) | 0 |
Dyspnea | 15 (17) | 0 | 12 (17) | 0 |
Epistaxis | 14 (16) | 0 | 13 (19) | 0 |
Pain in extremity | 14 (16) | 0 | 12 (17) | 0 |
Cough | 14 (16) | 0 | 10 (14) | 0 |
Cognitive disorder | 13 (15) | 1 (1) | 8 (12) | 1 (1) |
Hypoesthesia | 13 (15) | 0 | 8 (12) | 0 |
Insomnia | 13 (15) | 1 (1) | 10 (14) | 2 (3) |
Urinary tract infection | 13 (15) | 1 (1) | 9 (13) | 1 (1) |
Hematologic AEs ≥15% patients, n (%) | ||||
Anemia | 47 (55) | 26 (30) | 40 (58) | 25 (36) |
Thrombocytopenia | 33 (44) | 29 (34) | 35 (51) | 28 (41) |
Neutropenia | 17 (20) | 13 (15) | 15 (22) | 13 (19) |
