Nebenwirkungen · Tevimbra
Tevimbra 100 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 18
HOS-150256 · Präparat HOS-100272
Among ADA-evaluable patients receiving 200 mg once every 3 weeks monotherapy or in combination with chemotherapies (including adjuvant 400 mg once every 6 weeks in resectable NSCLC) the following rates of adverse events (AEs) have been observed for the ADA-positive population compared to the ADA-negative population, respectively: Grade ≥3 AEs 52.5% vs. 42.1%, serious adverse events (SAEs) 39.0% vs. 31.8%, AEs leading to tislelizumab treatment discontinuation 12.3% vs 11.4% (for monotherapy); Grade ≥ 3 AEs 80.0% vs. 78.6%, SAEs 43.3% vs. 41.0%, AEs leading to tislelizumab treatment discontinuation 13.6% vs 13.5% (for combination therapy). Patients who developed treatment-emergent ADAs tended to have overall poorer health and disease characteristics at baseline which can confound the interpretation of the safety analysis. Available data do not allow firm conclusions to be drawn on possible patterns of adverse drug reactions.
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