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Jivi · 4.8 · No clinical immune response to PEG resulting in loss of drug efficacy or hypersensitivity was observed from th
Eintrag öffnenJivi · 4.8 · Overall, in all studies 75 patients, 39 of them below 12 years of age, were observed for a treatment duration
Eintrag öffnenJivi · 4.8 · Paediatric population in the PROTECT Kids study In the completed clinical study with 73 paediatric PTPs < 12 y
Eintrag öffnenJivi · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenJivi · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenJivi · 4.8 · Summary of the safety profile
Eintrag öffnenJivi · 4.8 · Table 2: Frequency of adverse drug reactions in clinical studies
Eintrag öffnenJivi · 4.8 · The median number of exposure days to Jivi per patient was 195 (min-max: 1-698) for all patients in the clinic
Eintrag öffnenJivi · 4.8 · The most frequently reported adverse reactions in clinical studies in PTPs were headache, cough and pyrexia.
Eintrag öffnenJivi · 4.8 · The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level
Eintrag öffnenJivi · 4.8 · There was no change in the safety profile during the PROTECT VIII and the PROTECT Kids extension studies.
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