Nebenwirkungen · Baraclude
Baraclude 0.5 mg film-coated tablets Baraclude 1 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9
HOS-114614 · Präparat HOS-094121
Experience in patients with decompensated liver disease: the safety profile of entecavir in patients with decompensated liver disease was assessed in a randomized open-label comparative study in which patients received treatment with entecavir 1 mg/day (n = 102) or adefovir dipivoxil 10 mg/day (n = 89) (study 048). Relative to the adverse reactions noted in section b. Tabulated list of adverse reactions, one additional adverse reaction [decrease in blood bicarbonate (2%)] was observed in entecavir-treated patients through week 48. The on-study cumulative death rate was 23% (23/102), and causes of death were generally liver-related, as expected in this population. The on-study cumulative rate of hepatocellular carcinoma (HCC) was 12% (12/102). Serious adverse events were generally liver-related, with an on-study cumulative frequency of 69%. Patients with high baseline CTP score were at higher risk of developing serious adverse events (see section 4.4).
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Version 2025-12-03T16:10:00Z · SHA-256 5288f9187061003c75d2d5158a207cf313073c14cbda3e6d995b2fa35b53697e · Passage a0a387e681e4f081cc3e7341fa0daa514a2ea37d31e88f9d9c162fd22978c7fb · Zeichen 5963–6928 im Abschnitt