Nebenwirkungen · Kaftrio
Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets Kaftrio 75 mg/50 mg/100 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-145656 · Präparat HOS-099389
Safety data from the following studies were consistent with the safety data observed in study 445-102. • A 4-week, randomised, double-blind, active-controlled study in 107 patients aged 12 years and older (study 445-103). • A 192-week, open-label safety and efficacy study (study 445-105) in 506 patients who rolled over from studies 445-102 and 445-103. • An 8-week, randomised, double-blind, active-controlled study in 258 patients aged 12 years and older (study 445-104). • A 24-week, open-label study (study 445-106) in 66 patients aged 6 to less than 12 years. • A 24-week, randomised, placebo-controlled study (study 445-116) in 121 patients aged 6 to less than 12 years.
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Version 2026-08-19T16:15:00Z · SHA-256 04121cac1535ad5982d6257c33a1777a08c5914a9fce488aee1208cd9e01ad69 · Passage 0ea071294141d956d2ef93d955491f8a274a4d6c1f71850b9d50f40c7891e1eb · Zeichen 4584–5305 im Abschnitt