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Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaCancers and Other NeoplasmsEnrollment1195% FemaleN/A% White93%
Product ClassHormonesSponsor Protocol NumberCOU-AA-301Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)69
- 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
- The Impact of Dose Timing on the Efficacy and Safety of Abiraterone Acetate plus Prednisone in Men with Advanced Prostate Cancer
- Understanding the Symptom Experience of Abiraterone and the Effect on Quality of Life for Men with metastatic Prostate Cancer.
- Evaluation of G-computation and conformal prediction to provide early signs of efficacy in single arm trial with time to event outcomes
- The association between antibiotics exposure and outcomes in men with prostate cancer
- Improving Outcome in Advanced Prostate Cancer: a Pooled Analysis of Randomized Controlled Trials
- Risk of therapy-related adverse events in men on abiraterone or enzalutamide, a meta-analysis of clinical trial data
- Assessing the Androgen indifferent prostate cancer patients response to novel antiandrogen-based regimen or taxanes
- An evaluation of the performance of two population-adjusted indirect comparison methods in anchored and unanchored settings
- Overall Survival and Radiographic Progression Free Survival difference among Asian, White and Black mCRPC patients treated with Abiraterone
- Development of a prognostic calculator for patients with metastatic prostate cancer undergoing treatment with androgen receptor axis-targeted therapy.
- Association between adverse events and change in quality-of-life scores in phase II-III cancer clinical trials
- The Impact of Second Generation Anti-Androgens on Sexual Function in Men with Advanced Prostate Cancer
- A statistical methodology study to evaluate External Comparator Arm study results versus Randomized Controlled Trials in cancer drug development
- Psychiatric Symptoms as Adverse Events of Abiraterone / Prednisolone Therapy: Systematic Review and Meta-Analysis
- Clinical Significance and Factors Associated with PSA Progression in mCRPC Patients Treated with Abiraterone