Nebenwirkungen · Tremfya
Tremfya 45 mg/0.45 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6–7
HOS-137280 · Präparat HOS-098012
6 Table 3: Frequency of patients with transaminase increases post-baseline in two Phase III psoriatic arthritis clinical studies Through Week 24a Through 1 yearb Placebo guselkumab guselkumab guselkumab guselkumab N=370c 100 mg q8w 100 mg q4w 100 mg q8w 100 mg q4w N=373c N=371c N=373c N=371c ALT >1 to ≤3 x ULN 30.0% 28.2% 35.0% 33.5% 41.2% >3 to ≤ 5 x ULN 1.4% 1.1% 2.7% 1.6% 4.6% >5 x ULN 0.8% 0.8% 1.1% 1.1% 1.1% AST >1 to ≤3 x ULN 20.0% 18.8% 21.6% 22.8% 27.8% >3 to ≤ 5 x ULN 0.5% 1.6% 1.6% 2.9% 3.8% >5 x ULN 1.1% 0.5% 1.6% 0.5% 1.6% a placebo-controlled period. b patients randomised to placebo at baseline and crossed over to guselkumab are not included. c number of patients with at least one post-baseline assessment for the specific laboratory test within the time period.
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 2026-03-23T16:31:00Z · SHA-256 039a821487750437322e4aaaaa4a6ce804d9bf8a0433b6d64d8e85ad2e523477 · Passage 03fbebebbbf5af46efa6381672234596375d93e90dfc6153b291bcfa01d3b4cf · Zeichen 3711–5231 im Abschnitt