- CSR Summary Not Yet Available
- NCT00474383
- Primary Citation
- Data Specification Not Available
Trial Information
Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaCancers and Other NeoplasmsEnrollment47% FemaleN/A% WhiteN/A
Product ClassHormonesSponsor Protocol NumberCOU-AA-003Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)67
Supporting Documentation
- Collected Datasets Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2023-5236 : Understanding the Symptom Experience of Abiraterone and the Effect on Quality of Life for Men with metastatic Prostate Cancer.
- 2023-5198 : Evaluation of G-computation and conformal prediction to provide early signs of efficacy in single arm trial with time to event outcomes
- 2022-5125 : Risk of therapy-related adverse events in men on abiraterone or enzalutamide, a meta-analysis of clinical trial data
- 2020-4189 : Design and validation of an external control arm using prior clinical trials and real-world data
- 2019-3999 : Psychiatric Symptoms as Adverse Events of Abiraterone / Prednisolone Therapy: Systematic Review and Meta-Analysis