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NCT01795703
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Primary Citation
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Data Specification
Not Available
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Trial Information
Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassEndocrine TherapyPharmacological SubgroupHormone Antagonists and Related AgentsChemical SubgroupOther Hormone Antagonists and Related AgentsCondition StudiedNeoplasms, Prostatic
Sponsor Protocol NumberJNJ-212082-JPN-202Enrollment47Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)72% WhiteN/A
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
- 2022-5106 : Assessing the Androgen indifferent prostate cancer patients response to novel antiandrogen-based regimen or taxanes
- 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