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Evrenzo · 4.8 · Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1
Eintrag öffnenEvrenzo · 4.8 · Hepatobiliary disorders Uncommon Hyperbilirubinaemia
Eintrag öffnenEvrenzo · 4.8 · In CKD patients not on dialysis, pulmonary embolism was observed in 0.4% (0.2 patients with events per 100 pat
Eintrag öffnenEvrenzo · 4.8 · In CKD patients not on dialysis, the overall incidence of Ischaemic central nervous system vascular conditions
Eintrag öffnenEvrenzo · 4.8 · In CKD patients on dialysis, seizures occurred in 2.0% (1.2 patients with events per 100 patient years of expo
Eintrag öffnenEvrenzo · 4.8 · In CKD patients on dialysis, the overall incidence of events from Ischaemic central nervous system vascular co
Eintrag öffnenEvrenzo · 4.8 · In CKD patients on dialysis, vascular access thrombosis was observed in 12.8% (7.6 patients with events per 10
Eintrag öffnenEvrenzo · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenEvrenzo · 4.8 · Seizures In CKD patients not on dialysis, seizures occurred in 1.1% (0.6 patients with events per 100 patient
Eintrag öffnenEvrenzo · 4.8 · Sepsis In CKD patients not on dialysis, sepsis was observed in 2.1% (1.3 patients with events per 100 patient
Eintrag öffnenEvrenzo · 4.8 · Skin and subcutaneous tissue Not known Dermatitis Exfoliative disorders Generalised (DEG) General disorders an
Eintrag öffnenEvrenzo · 4.8 · Skin reactions Dermatitis exfoliative generalised, part of severe cutaneous adverse reactions (SCARs), has bee
Eintrag öffnenEvrenzo · 4.8 · Summary of the safety profile
Eintrag öffnenEvrenzo · 4.8 · Table 3. Adverse reactions MedDRA System organ class Frequency category Adverse reaction (SOC) Infections and
Eintrag öffnenEvrenzo · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenEvrenzo · 4.8 · The most frequent (≥ 1%) serious adverse reactions associated with roxadustat were sepsis (3.4%), hyperkalaemi
Eintrag öffnenEvrenzo · 4.8 · The most frequent (≥ 10%) adverse reactions associated with roxadustat are hypertension (13.9%), vascular acce
Eintrag öffnenEvrenzo · 4.8 · The safety of Evrenzo was evaluated in 3542 non-dialysis dependent (NDD) and 3353 dialysis dependent (DD) pati
Eintrag öffnenEvrenzo · 4.8 · Thrombotic vascular events In CKD patients not on dialysis, DVT events were uncommon, occurring in 1.0% (0.6 p
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