An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.
Participants who completed the main FE200486 CS12 study initially continued with the same
dose in the FE200486 CS12A extension study. After a protocol amendment all study
participants were treated with 160 mg (40 mg/mL).
The data include data from the participants who participated in both the main study
(FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.
Clinical Development Support
Belgium: Federal Agency for Medicines and Health Products, FAMHP