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Vizimpro · 4.8 · Dacomitinib Gefitinib (N=227) (N=224) Adverse Reactionsa All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Eintrag öffnenVizimpro · 4.8 · Dacomitinib Gefitinib (N=227) (N=224) Adverse Reactionsa All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Eintrag öffnenVizimpro · 4.8 · Description of selected adverse reactions
Eintrag öffnenVizimpro · 4.8 · Diarrhoea Diarrhoea was the most frequently reported adverse reaction in patients receiving Vizimpro (88.6%) a
Eintrag öffnenVizimpro · 4.8 · Interstitial lung disease (ILD)/Pneumonitis ILD/pneumonitis adverse reactions were reported in 2.7% of patient
Eintrag öffnenVizimpro · 4.8 · Metabolism and nutrition disorders Decreased appetite Dehydration Hypokalaemiaa Nervous system disorders Dysge
Eintrag öffnenVizimpro · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenVizimpro · 4.8 · Serious adverse reactions were reported in 6.7% of patients treated with dacomitinib. The most frequently (≥ 1
Eintrag öffnenVizimpro · 4.8 · Skin-related adverse reactions Rash, erythematous and exfoliative skin condition adverse reactions were report
Eintrag öffnenVizimpro · 4.8 · Summary of safety profile
Eintrag öffnenVizimpro · 4.8 · System organ class Very common Common
Eintrag öffnenVizimpro · 4.8 · System organ class Very common Common h Nail disorder includes the following PTs: Ingrowing nail, Nail bed ble
Eintrag öffnenVizimpro · 4.8 · Table 3 presents adverse reactions for Vizimpro. Adverse reactions are listed according to system organ class
Eintrag öffnenVizimpro · 4.8 · Table 3. Adverse reactions reported in dacomitinib clinical studies (N=255)
Eintrag öffnenVizimpro · 4.8 · Table 4. Very common adverse reactions in Phase 3 Study ARCHER 1050 (N=451)
Eintrag öffnenVizimpro · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenVizimpro · 4.8 · The median duration of treatment with Vizimpro across the pooled data set was 66.7 weeks.
Eintrag öffnenVizimpro · 4.8 · The median time to the first episode of any grade ILD/pneumonitis was 16 weeks and the median time to the wors
Eintrag öffnenVizimpro · 4.8 · The median time to the first episode of any grade diarrhoea was 1 week and the median time to the worst episod
Eintrag öffnenVizimpro · 4.8 · The median time to the first episode of any grade of transaminases increased was approximately 12 weeks and th
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