Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Jemperli

JEMPERLI 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-145347 · Präparat HOS-099336

Adverse reactions reported in clinical trials of dostarlimab as a monotherapy or in combination with chemotherapy are listed in Table 4 by system organ class and by frequency. Unless otherwise stated, the frequencies of adverse reactions listed in the dostarlimab monotherapy column are based on all-cause adverse event frequency identified in 605 patients with advanced or recurrent solid tumours from the GARNET study exposed to dostarlimab monotherapy for a median duration of treatment of 24 weeks (range: 1 week to 229 weeks). Unless otherwise stated, the frequencies of adverse reactions listed in the dostarlimab in combination with chemotherapy column are based on all-cause adverse event frequency identified in 241 patients with primary advanced or recurrent EC from the RUBY study exposed to dostarlimab in combination with carboplatin and paclitaxel for a median duration of treatment of 43 weeks (range: 3 to 193 weeks). For additional safety information when dostarlimab is administered in combination with carboplatin and paclitaxel, refer to the respective Prescribing Information for the combination products.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.