Table 2.
TEAEs occurring in >10% of patients with GIST in the 150 mg IPDE period
| Preferred term, n (%) | Ripretinib 150 mg QD period (n = 67) | Ripretinib 150 mg IPDE perioda (n = 67) | ||
|---|---|---|---|---|
| All grades | Grade 3/4 | All grades | Grade 3/4 | |
| Diarrhea | 13 (19.4) | 1 (1.5) | 19 (28.4) | 1 (1.5) |
| Abdominal pain | 15 (22.4) | 0 | 18 (26.9) | 7 (10.4) |
| Nausea | 24 (35.8) | 0 | 17 (25.4) | 0 |
| Decreased appetite | 11 (16.4) | 0 | 16 (23.9) | 1 (1.5) |
| Anemia | 3 (4.5) | 0 | 15 (22.4) | 4 (6.0) |
| Fatigue | 23 (34.3) | 0 | 14 (20.9) | 2 (3.0) |
| PPES | 24 (35.8) | 0 | 12 (17.9) | 0 |
| Alopecia | 41 (61.2) | 0 | 11 (16.4) | 0 |
| Vomiting | 9 (13.4) | 0 | 11 (16.4) | 0 |
| Weight decreased | 19 (28.4) | 0 | 11 (16.4) | 0 |
| Muscle spasms | 19 (28.4) | 0 | 10 (14.9) | 0 |
| Dyspnea | 5 (7.5) | 0 | 9 (13.4) | 2 (3.0) |
| Back pain | 10 (14.9) | 0 | 7 (10.4) | 0 |
| Headache | 8 (11.9) | 0 | 7 (10.4) | 1 (1.5) |
| Myalgia | 33 (49.3) | 0 | 7 (10.4) | 0 |
| Oedema peripheral | 5 (7.5) | 0 | 7 (10.4) | 1 (1.5) |
| Rash | 13 (19.4) | 0 | 7 (10.4) | 0 |
a
Only includes TEAEs that are new or worsening.
GIST, gastrointestinal stromal tumor; IPDE, intrapatient dose escalation; PPES, palmar-plantar erythrodysesthesia syndrome; QD, once daily; TEAE, treatment-emergent adverse event.