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Jascayd · 4.8 Undesirable effects · 1
Eintrag öffnenJascayd · 4.8 · Description of selected adverse reactions
Eintrag öffnenJascayd · 4.8 · Diarrhoea
Eintrag öffnenJascayd · 4.8 · Diarrhoea was the most common adverse reaction associated with treatment discontinuation and occurred most fre
Eintrag öffnenJascayd · 4.8 · Diarrhoea was the most common adverse reaction associated with treatment discontinuation and occurred most fre
Eintrag öffnenJascayd · 4.8 · Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100),
Eintrag öffnenJascayd · 4.8 · IPF (FIBRONEER-IPF) PPF (FIBRONEER-ILD) Placeb Nerandomilas Nerandomilas Placeb Nerandomilas Nerandomilas o t
Eintrag öffnenJascayd · 4.8 · In clinical trials, weight decrease started after the second week of treatment and stabilised after 12 weeks o
Eintrag öffnenJascayd · 4.8 · In most patients treated with nerandomilast, diarrhoea was of mild to moderate intensity and generally occurre
Eintrag öffnenJascayd · 4.8 · In patients treated in the FIBRONEER-ILD trial, without background nintedanib treatment, severe diarrhoea was
Eintrag öffnenJascayd · 4.8 · In patients treated in the FIBRONEER-IPF trial, without background IPF treatment, severe diarrhoea was not rep
Eintrag öffnenJascayd · 4.8 · In the FIBRONEER-ILD trial, the mean absolute change in body weight from baseline to week 52 was -3.2 kg for p
Eintrag öffnenJascayd · 4.8 · In the FIBRONEER-IPF trial, the mean absolute change in body weight from baseline to week 52 was -2.6 kg for p
Eintrag öffnenJascayd · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenJascayd · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenJascayd · 4.8 · Summary of the safety profile
Eintrag öffnenJascayd · 4.8 · System Organ Class Adverse reactions Frequency category IPFb PPF Metabolism and nutrition disorders Decreased
Eintrag öffnenJascayd · 4.8 · Table 1 shows the frequencies of adverse reactions based on 52-week data from two randomised, placebo-controll
Eintrag öffnenJascayd · 4.8 · Table 1. Adverse reactions
Eintrag öffnenJascayd · 4.8 · Table 2. Frequencies of diarrhoea by background treatment subgroups over 52 weeks in the FIBRONEER-IPF trial (
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