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Rubraca · 4.8 Undesirable effects · 1
Eintrag öffnenRubraca · 4.8 · 10 Reporting of suspected adverse reactions
Eintrag öffnenRubraca · 4.8 · 8 Immune system disorders Common Uncommon Hypersensitivity c Hypersensitivity c Metabolism and nutrition Very
Eintrag öffnenRubraca · 4.8 · 9 to at least one dose of oral rucaparib in all clinical studies). In the placebo-controlled Phase 3 studies,
Eintrag öffnenRubraca · 4.8 · Adverse reactions that most commonly led to dose reduction or interruption were anaemia (23%), fatigue/astheni
Eintrag öffnenRubraca · 4.8 · Description of selected adverse reactions
Eintrag öffnenRubraca · 4.8 · Elderly In patients ≥ 75 years old, frequencies of some adverse reactions increased: increased blood creatinin
Eintrag öffnenRubraca · 4.8 · Elevations in serum creatinine Increases in serum creatinine, predominantly mild to moderate (CTCAE Grade 1 or
Eintrag öffnenRubraca · 4.8 · Gastrointestinal toxicities Vomiting and nausea were reported in 37% and 68% of patients, respectively, and we
Eintrag öffnenRubraca · 4.8 · Haematological toxicity Haematological adverse reactions of all CTCAE Grades of anaemia, thrombocytopenia and
Eintrag öffnenRubraca · 4.8 · Increases in serum aminotransferases (AST/ALT) Events related to increases in alanine aminotransferase (ALT) o
Eintrag öffnenRubraca · 4.8 · Myelodysplastic syndrome/Acute myeloid leukaemia MDS/AML are serious adverse reactions that occur uncommonly (
Eintrag öffnenRubraca · 4.8 · No studies have been conducted to investigate the pharmacokinetics of rucaparib in paediatric patients.
Eintrag öffnenRubraca · 4.8 · Paediatric population
Eintrag öffnenRubraca · 4.8 · Patients with Renal Impairment In patients with moderate renal impairment (CLcr of 30-59 mL/min), frequencies
Eintrag öffnenRubraca · 4.8 · Photosensitivity Photosensitivity was reported in 10% of patients as low grade skin reactions (CTCAE Grade 1 o
Eintrag öffnenRubraca · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenRubraca · 4.8 · Summary of the safety profile
Eintrag öffnenRubraca · 4.8 · Table 3. Tabulated list of adverse reactions by MedDRA system organ class Adverse reactions MedDRA system orga
Eintrag öffnenRubraca · 4.8 · Tabulated list of adverse reactions
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