Nebenwirkungen · Signifor
Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-213427 · Präparat HOS-155106
The data described below reflect exposure of 162 Cushing’s disease patients to Signifor in the phase III study. At study entry patients were randomised to receive twice-daily doses of either 0.6 mg or 0.9 mg Signifor. The mean age of patients was approximately 40 years and the majority of patients (77.8%) were female. Most (83.3%) patients had persistent or recurrent Cushing’s disease and few (≤5%) in either treatment group had received previous pituitary irradiation. The median exposure to the treatment up to the cut-off date of the primary efficacy and safety analysis was 10.37 months (0.03-37.8), with 66.0% of patients having at least six months’ exposure.
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