Nebenwirkungen · Tagrisso
TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14
HOS-135440 · Präparat HOS-097706
In the ADAURA, FLAURA, FLAURA2, LAURA and AURA studies (TAGRISSO monotherapy; N=1956), diarrhoea was reported in 46% of patients of which 36% were Grade 1 events, 8. 1% Grade 2 and 1.5% were Grade 3; no Grade 4 or 5 events were reported. Dose reduction was required in 0.6% of patients and dose interruption in 1.9%. Four events (0.2%) led to discontinuation. In ADAURA, FLAURA, FLAURA2 (monotherapy arm) and AURA3 the median time to onset was 22 days, 19 days, 22 days and 22 days, respectively, and the median duration of the Grade 2 events was 11 days, 19 days, 17 days and 6 days, respectively. In patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, diarrhoea was reported in 43% of patients versus 41% of patients in monotherapy, most of these diarrhoea events were Grade 1 and Grade 2 events.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-18T16:00:00Z · SHA-256 36d1f10f3b323cac93ed4124915e050ad98541d8f140829a41c0c4e0ad3343cb · Passage 6b1c66dc4bcd5d0a882476f7e6ef50ec7d1acff8f532a382d4165b2400f85628 · Zeichen 15163–16004 im Abschnitt