Nebenwirkungen · Koselugo
Koselugo 10 mg hard capsules Koselugo 25 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9
HOS-145451 · Präparat HOS-099352
Tabulated list of adverse reactions Table 5 presents the adverse reactions identified in the paediatric and adult population with NF1 who have inoperable PN and also in adult patients with multiple tumour types (see footnote to Table 5). The frequency is determined from the paediatric pool (N = 126) and adult patients (N = 137) as defined above. Adverse drug reactions (ADRs) are organised by MedDRA system organ class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from available data), including isolated reports.
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