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- All 25 patients experienced at least one adverse event (TEAE) during treatment of any level
- Fifty-eight enrolled patients (97%) experienced at least one TEAE of any grade
.
The most common (≥20%) are diarrhea (67%), nausea (57%), fatigue (48%), high blood pressure (40%), decreased appetite (37%), vomiting (37%), abdominal pain (35%) ), constipation (33%), elevated ALT (30%), urinary tract infection (27%), elevated AST (20%), dysphonia (20%), headache (20%), and erythema paresthesias in the palms and toes Syndrome (20%) - 41 patients (68%) experienced at least one TEAE of grade 3 and above, the most common (≥5%) were hypertension (18%) and abdominal pain (12%)
- 42 patients (70%) experienced at least 1 serious TEAE
- Twenty-three patients (38%) discontinued the trial treatment due to TEAE, of which 9 (15%) discontinued the treatment with Bezan® and 14 (23%) discontinued the treatment with sitravatinib
- Fifty patients (83%) and 30 patients (50%) respectively experienced interruption or reduction of sitravatinib dose
- 4 patients died due to TEAE, all of which were deemed unrelated to the trial treatment
- Among the 53 patients included in the effectiveness evaluation, the confirmed ORR was 26% (95% CI: 15.
3, 40.
3), of which 14 patients achieved PR and DCR was 77% (95% CI: 63.
8, 87.
7) - The median DoR was 4.
7 months (95% CI: 2.
8, failed to assess) - The median PFS and OS were 4.
1 months (95% CI: 4.
0, 5.
1) and 12.
9 months (95% CI: 6.
3, 17.
2), respectively
- Fifty-eight enrolled patients (97%) experienced at least one TEAE of any grade
