Table 2.
Treatment‐emergent adverse events reported in >10% of patients with advanced GISTs receiving ripretinib IPDE to 150 mg b.i.d
Preferred term, n (%) | Ripretinib 150 mg QD period (n = 43) | Ripretinib 150 mg b.i.d. period (n = 43) a | ||
---|---|---|---|---|
All grades | Grade 3–4 | All grades | Grade 3–4 | |
Abdominal pain | 18 (42) | 2 (5) | 13 (30) | 3 (7) |
Decreased appetite | 13 (30) | 1 (2) | 11 (26) | 2 (5) |
Anemia | 5 (12) | 1 (2) | 10 (23) | 6 (14) |
Nausea | 13 (30) | 1 (2) | 10 (23) | 1 (2) |
Blood bilirubin increased | 8 (19) | 0 | 8 (19) | 0 |
Constipation | 16 (37) | 0 | 8 (19) | 0 |
Diarrhea | 11 (26) | 0 | 7 (16) | 0 |
Fatigue | 19 (44) | 1 (2) | 7 (16) | 2 (5) |
Myalgia | 15 (35) | 1 (2) | 7 (16) | 0 |
Palmar‐plantar erythrodysesthesia syndrome | 8 (19) | 0 | 7 (16) | 1 (2) |
Alopecia | 26 (60) | — | 6 (14) | — |
Asthenia | 7 (16) | 0 | 6 (14) | 1 (2) |
Dyspnea | 4 (9) | 0 | 6 (14) | 1 (2) |
Vomiting | 7 (16) | 1 (2) | 6 (14) | 1 (2) |
Muscle spasms | 6 (14) | 0 | 5 (12) | 0 |
Edema peripheral | 7 (16) | 0 | 5 (12) | 0 |
Weight loss | 9 (21) | 0 | 5 (12) | 0 |
—indicates that no data were captured per adverse event grade ratings.
Data represent new or worsening TEAEs in the ripretinib 150 mg b.i.d. period. The ongoing TEAEs from the ripretinib 150 mg QD period were not included if they remained at the same or lower grade.
Abbreviations: GIST, gastrointestinal stromal tumor; QD, once daily; TEAEs, treatment‐emergent adverse events.