Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Official Title

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

Summary:

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centres for doctor's visits as often as they did in the previous study.

Trial Description

Primary Outcome:

• Incidence of Treatment-emergent adverse events (TEAEs)
• Incidence of Treatment-emergent serious adverse events (TESAEs)
• Incidence of drug-related TEAEs
• Incidence of drug-related TESAEs

• Number of dose modifications

View this trial on ClinicalTrials.gov