Nebenwirkungen · Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
Lenalidomide Krka d.d. Novo mesto 2.5 mg hard capsules Lenalidomide Krka d.d. Novo mesto 5 mg hard capsules Lenalidomide Krka d.d. Novo mesto 7.5 mg hard capsules Lenalidomide Krka d.d. Novo mesto 10 mg hard capsules Lenalidomide Krka d.d. Novo mesto 15 mg hard capsules Lenalidomide Krka d.d. Novo mesto 20 mg hard capsules Lenalidomide Krka d.d. Novo mesto 25 mg hard capsules · Abschnitt 4.8 · PDF-Seite 30
HOS-148817 · Präparat HOS-099972
Common Weight decreased, Blood Bilirubin increased ^see section 4.8 description of selected adverse reactions Algorithm applied for follicular lymphoma: Controlled– Phase 3 trial: - NHL-007 ADRs- All treatment-emergent AEs with ≥ 5.0% of subjects in lenalidomide/rituximab arm and at least 2.0% higher frequency (%) in Len arm compared to control arm - (Safety population) - NHL-007 Gr 3/4 ADRs- All Grades 3 or Grade 4 treatment-emergent AEs with at least 1.0% subjects in lenalidomide/rituximab arm and at least 1.0% higher frequency in lenalidomide arm compared to control arm - (safety population) - NHL-007 Serious ADRs- All serious treatment-emergent AEs with at least 1.0% subjects in lenalidomide/rituximab arm and at least 1.0% higher frequency in lenalidomide/rituximab arm compared to control arm - (safety population) FL single arm - phase 3 trial: - NHL-008 ADRs- All treatment-emergent adverse events with ≥ 5.0% of subjects - NHL-008 Gr 3/4 ADRs- All Grade 3/4 treatment-emergent adverse events reported in ≥ 1.0% of subjects - NHL-008 Serious ADRs- All serious treatment-emergent adverse events reported in ≥ 1.0% of subjects ◊Adverse events reported as serious in follicular lymphoma clinical trials + Applies to serious adverse drug reactions only * Rash includes PT of rash and rash maculo-papular **Leucopenia includes PT leucopenia and white blood cell count decreased ***Lymphopenia includes PT lymphopenia and lymphocyte count decreased
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Version 2021-12-17T12:56:00Z · SHA-256 9b15721a878f6b48caf8691524d0cc634862d39053d4ce108521191ff1511e31 · Passage 5d52182f864d430f63f1210c0a6fe0c659e262ba5f48f6448f62061674a4ad94 · Zeichen 30419–32069 im Abschnitt