Nebenwirkungen · Relvar Ellipta
Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed · Abschnitt 4.8 · PDF-Seite 33
HOS-128433 · Präparat HOS-096557
In an integrated analysis of the two replicate one year studies in moderate to severe COPD (mean predicted post-bronchodilator screening FEV1 of 45%, standard deviation (SD) 13%) with an exacerbation in the preceding year (n = 3255), the number of pneumonia events per 1000 patient years was 97.9 with FF/VI 184/22 micrograms, 85.7 in the FF/VI 92/22 micrograms and 42.3 in the VI 22 micrograms group. For severe pneumonia the corresponding number of events per 1000 patient years were 33.6, 35.5, and 7.6 respectively, while for serious pneumonia the corresponding events per 1000 patient years were 35.1 for FF/VI 184/22 micrograms, 42.9 with FF/VI 92/22 micrograms, 12.1 with VI 22 micrograms. Finally, the exposure-adjusted cases of fatal pneumonia were 8.8 for FF/VI 184/22 micrograms versus 1.5 for FF/VI 92/22 micrograms and 0 for VI 22 micrograms.
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Version 2025-04-10T11:43:00Z · SHA-256 ae80777ab6b52d24a5268a5989d61a006f952cc42bf17fad0fcab526c332f7e3 · Passage 299d2b8ce164f3365119d6bdb8a7d93aef0079384a0ad440c2c35671d4da7bdf · Zeichen 3617–4472 im Abschnitt