Study type

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

DAROLUTAMIDE

Medical condition to be studied

Prostate cancer
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

800
Study design details

Main study objective

To describe the safety of darolutamide in patients with nmCRPC, including the incidence of TEAEs in the real-world setting.

Outcomes

Occurrence of treatment-emergent adverse events (TEAEs) Reasonable causal relationship between darolutamide and an adverse event (AE) Action taken related to darolutamide treatment, Subject's demographics and characteristics, Dosage and dose modification, Initiation and termination dates, Reasons for ending treatment and/or observation/follow-up and discontinuations or changes of treatments, Metastasis-Free Survival, Time to Symptomatic Skeletal Event, Time to Prostate-Specific Antigen progression, Survival rate, Imaging exams, Prior and post darolutamide treatment

Data analysis plan

Statistical analyses will be of an exploratory and descriptive nature. The study is not aimed to test predefined hypotheses. All variables will be analyzed descriptively with appropriate statistical methods: categorical variables by frequency tables (absolute and relative frequencies) and continuous variables by sample statistics (i.e. mean, standard deviation, minimum, median, quartiles, and maximum). Continuous variables will be described by absolute value and as change from baseline per analysis time point, if applicable. Patients who took at least one dose of darolutamide will be included in the safety analysis set (SAF). Patients who took at least one dose of darolutamide, did not violate a major inclusion/exclusion criterion, and had at least one post-baseline assessment after receiving darolutamide will be included in the full analysis set (FAS). Safety data will be analyzed on the SAF, effectiveness data on the FAS.