TEAE Occurring in >20% of Patients, n (%)a | Exposure <12 Months (n = 48) | Exposure ≥12 Months (n = 56) | ||
---|---|---|---|---|
Any Grade | Grade ≥ 3b | Any Grade | Grade ≥ 3b | |
Any AE | 48 (100.0) | 27 (56.3) | 56 (100.0) | 31 (55.4) |
Muscle spasms | 25 (52.1) | 2 (4.2) | 49 (87.5) | 4 (7.1) |
Alopecia | 24 (50.0) | NA | 45 (80.4) | NA |
Dysgeusia | 20 (41.7) | NA | 38 (67.9) | NA |
Weight decreased | 18 (37.5) | 0 | 36 (64.3) | 9 (16.1) |
Fatigue | 17 (35.4) | 4 (8.3) | 28 (50.0) | 1 (1.8) |
Nausea | 11 (22.9) | 0 | 23 (41.1) | 0 |
Decreased appetite | 15 (31.3) | 2 (4.2) | 14 (25.0) | 1 (1.8) |
Diarrhea | 10 (20.8) | 0 | 18 (32.1) | 3 (5.4) |
Constipation | 10 (20.8) | 0 | 10 (17.9) | 0 |
Cough | 8 (16.7) | 0 | 12 (21.4) | 0 |
Arthralgia | 5 (10.4) | 0 | 12 (21.4) | 1 (1.8) |