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Lynparza · 4.8 · 13 Adverse reactions MedDRA Frequency of All CTCAE grades Frequency of CTCAE grade 3 System Organ and above Cl
Eintrag öffnenLynparza · 4.8 · 15 Myelodysplastic syndrome/Acute myeloid leukaemia MDS/AML are serious adverse reactions that occurred uncomm
Eintrag öffnenLynparza · 4.8 · 16 In first-line ovarian cancer maintenance treatment, patients experienced nausea events (77% on olaparib, 38
Eintrag öffnenLynparza · 4.8 · Baseline testing, followed by monthly monitoring of complete blood counts is recommended for the first 12 mont
Eintrag öffnenLynparza · 4.8 · Description of selected adverse reactions
Eintrag öffnenLynparza · 4.8 · For patients receiving Lynparza in combination with durvalumab following treatment with durvalumab in combinat
Eintrag öffnenLynparza · 4.8 · Gastrointestinal toxicities Nausea was generally reported very early, with first onset within the first month
Eintrag öffnenLynparza · 4.8 · General Very common Common disorders and Fatigue (including asthenia) Fatigue (including asthenia) administrat
Eintrag öffnenLynparza · 4.8 · Haematological toxicity Anaemia and other haematological toxicities were generally low grade (CTCAE grade 1 or
Eintrag öffnenLynparza · 4.8 · In patients with BRCAm platinum-sensitive relapsed ovarian cancer who had received at least two prior lines of
Eintrag öffnenLynparza · 4.8 · MedDRA SOC MedDRA Term CIOMS descriptor/ Frequency of CTCAE Overall Frequency grade 3 and above (All CTCAE gra
Eintrag öffnenLynparza · 4.8 · Other laboratory findings In clinical studies with Lynparza the incidence of CTCAE grade ≥2 shifts (elevations
Eintrag öffnenLynparza · 4.8 · Other special populations Limited safety data are available in non-Caucasian patients.
Eintrag öffnenLynparza · 4.8 · Paediatric population No new safety signals were observed in the study population relative to the known safety
Eintrag öffnenLynparza · 4.8 · Patients with significant cardiovascular disease were excluded. Please refer to the product information for ab
Eintrag öffnenLynparza · 4.8 · Pure Red Cell Aplasia Pure Red Cell Aplasia (PRCA) has been reported when Lynparza has been used in combinatio
Eintrag öffnenLynparza · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenLynparza · 4.8 · Summary of the safety profile Lynparza has been associated with adverse reactions generally of mild or moderat
Eintrag öffnenLynparza · 4.8 · Table 2 Additional adverse drug reaction reported in a clinical trial with Lynparza in combination with durval
Eintrag öffnenLynparza · 4.8 · Tabulated list of adverse reactions The safety profile is based on pooled data from 4499 patients with solid t
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