Nebenwirkungen · Etcamah
Etcamah 75 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-153290 · Präparat HOS-100955
Visual effects Of the 40.7% patients who reported visual effects, the majority (92.5%) experienced CTCAE Grade 1 adverse reactions, while 6.5% patients experienced CTCAE Grade 2 adverse reactions and 0.9% CTCAE Grade 3 adverse reaction (photopsia) occurred. The most common visual effect was photopsia (24.0%). The median time to the onset of the first visual effect was 9 days. Visual effects ADRs were typically intermittent, of brief duration, and not continuous throughout the day. Visual effects were reported not to worsen over time in patients. Ophthalmological review of patients reporting visual effects showed no evidence of structural effects on the eye or clinically meaningful changes in visual acuity attributed to Etcamah (see section 5.1).
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 2026-07-21T14:07:16Z · SHA-256 b50ea6ed7223cee8c2b96a46475d89e0843fb8c57083f80f60c2957e00e303a8 · Passage a59d9a66bcd9fc189ecf0c5a1420b3852e71ba1a6c9644726c5931f6100ac2ea · Zeichen 9470–10225 im Abschnitt