- NCT00924469
- Primary Citation Not Available
- Data Specification Not Available
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Trial Information
Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaCancers and Other NeoplasmsEnrollment58% FemaleN/A% WhiteN/A
Product ClassHormonesSponsor Protocol NumberCOU-AA-201-DFCIData PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)59
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2022-5125 : Risk of therapy-related adverse events in men on abiraterone or enzalutamide, a meta-analysis of clinical trial data
- 2022-4974 : Association between adverse events and change in quality-of-life scores in phase II-III cancer clinical trials
- 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
- 2017-1861 : TESTING - Ginger