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Balversa · 4.8 · Abnormal laboratory findings Abnormal laboratory findings (other than hyperphosphataemia, which is described s
Eintrag öffnenBalversa · 4.8 · Adverse reactions leading to dose reduction occurred in 59.7% of patients. Stomatitis (15.4%), palmar-plantar
Eintrag öffnenBalversa · 4.8 · Adverse reactions leading to treatment discontinuation occurred in 19.4% of patients. Detachment of retinal pi
Eintrag öffnenBalversa · 4.8 · Adverse reactions observed during clinical studies are listed below in Table 6 by frequency category. Frequenc
Eintrag öffnenBalversa · 4.8 · Central serous retinopathy (CSR) Adverse reactions of CSR were reported in 31.5% of patients with a median tim
Eintrag öffnenBalversa · 4.8 · Description of selected adverse reactions
Eintrag öffnenBalversa · 4.8 · Gastrointestinal disorders Gastrointestinal disorders were reported in 83.9% of patients. The most commonly re
Eintrag öffnenBalversa · 4.8 · Hyperphosphataemia and soft tissue mineralisation Erdafitinib can cause hyperphosphataemia. Increases in phosp
Eintrag öffnenBalversa · 4.8 · Hypophosphataemia Erdafitinib can cause hypophosphataemia. Hypophosphataemia occurred in 5.6% of patients. Hyp
Eintrag öffnenBalversa · 4.8 · Nail disorders Nail disorders were reported in 62.6% of patients. The most commonly reported events included o
Eintrag öffnenBalversa · 4.8 · Other eye disorders Eye disorders (other than central serous retinopathy) were reported in 36.3% of patients.
Eintrag öffnenBalversa · 4.8 · Paediatric population Growth acceleration and epiphysiolysis of the femoral head have been reported in paediat
Eintrag öffnenBalversa · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenBalversa · 4.8 · Skin disorders Skin disorders were reported in 54.5% of patients. The most commonly reported events were dry s
Eintrag öffnenBalversa · 4.8 · Summary of the safety profile The most common adverse reactions were hyperphosphataemia (78.5%), diarrhoea (55
Eintrag öffnenBalversa · 4.8 · Table 6: Adverse reactions identified in clinical studies System organ class Frequency Adverse reaction Endocr
Eintrag öffnenBalversa · 4.8 · Tabulated list of adverse reactions The safety profile is based on pooled data from 479 locally advanced unres
Eintrag öffnenBalversa · 4.8 · Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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