Nebenwirkungen · Tremfya
Tremfya 200 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 145
HOS-137432 · Präparat HOS-098012
Table 2: 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.
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