Nebenwirkungen · Faslodex
Faslodex 250 mg solution for injection. · Abschnitt 4.8 · PDF-Seite 5–6
HOS-112840 · Präparat HOS-093769
5 a Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed due to the underlying disease. b The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral. c The event was not observed in major clinical studies (CONFIRM, FINDER 1, FINDER 2, NEWEST). The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate. This is calculated as 3/560 (where 560 is the number of patients in the major clinical studies), which equates to a frequency category of ‘uncommon’. d Includes: arthralgia, and less frequently musculoskeletal pain, myalgia and pain in extremity. e Frequency category differs between pooled safety dataset and FALCON. f ADR was not observed in FALCON.
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