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Akeega · 4.8 · 11 Endocrine disorders not known adrenal insufficiency8 Metabolism and nutrition very common decreased appetit
Eintrag öffnenAkeega · 4.8 · 12 16 Includes systolic hypertension 17 Includes dyspnoea exertional 18 Includes abdominal pain upper, abdomin
Eintrag öffnenAkeega · 4.8 · 13 Cardiac events The incidence of treatment-emergent adverse events (TEAEs) of cardiac disorder (all grades)
Eintrag öffnenAkeega · 4.8 · Anaemia Anaemia was the most frequent adverse reaction (51.9%) and most commonly observed Grade 3-4 event (29.
Eintrag öffnenAkeega · 4.8 · Description of selected adverse reactions The selected adverse reactions described below are based on pooled d
Eintrag öffnenAkeega · 4.8 · Haematological toxicities Haematological toxicities (anaemia, thrombocytopenia and neutropenia) including labo
Eintrag öffnenAkeega · 4.8 · Hepatobiliary disorders common hyperbilirubinaemia uncommon hepatic failure, hepatitis19 Skin and subcutaneous
Eintrag öffnenAkeega · 4.8 · Hepatotoxicity The overall incidence of hepatotoxicity was similar for the niraparib plus AAP (13.6%) and plac
Eintrag öffnenAkeega · 4.8 · Hypertension Hypertension is an adverse reaction for both components of Akeega and patients with uncontrolled
Eintrag öffnenAkeega · 4.8 · Hypertension was reported in 40.6% of patients of whom 22.9% had Grade ≥ 3. The median time to onset of hypert
Eintrag öffnenAkeega · 4.8 · In the MAGNITUDE and AMPLITUDE studies, the following haematological parameters were inclusion criteria: absol
Eintrag öffnenAkeega · 4.8 · Neutropenia Neutropenia was reported in 19.7% of patients with Grade 3-4 neutropenia reported in 8.4% of patie
Eintrag öffnenAkeega · 4.8 · Patients should have blood pressure controlled before initiating Akeega and blood pressure should be monitored
Eintrag öffnenAkeega · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenAkeega · 4.8 · Summary of the safety profile The overall safety profile of Akeega is based on pooled data from two clinical P
Eintrag öffnenAkeega · 4.8 · Table 3: Adverse reactions identified in clinical studies System Organ Class Frequency Adverse reaction Infect
Eintrag öffnenAkeega · 4.8 · Tabulated list of adverse reactions Adverse reactions observed during clinical studies are listed below by fre
Eintrag öffnenAkeega · 4.8 · The incidence of cardiac failure (grouped term) was 4.7% in the niraparib plus AAP arm vs 1.8% in placebo plus
Eintrag öffnenAkeega · 4.8 · The incidence of ischaemic heart disease (grouped term) was 5.4% in the niraparib plus AAP arm vs 5.0% in the
Eintrag öffnenAkeega · 4.8 · Thrombocytopenia Thrombocytopenia was reported in 20.9% of treated patients while 7.5% of patients experienced
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