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CSR Summary Not Yet Available
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NCT01867710
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Primary Citation
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Data Specification Not Yet 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 Number212082PCR2023Enrollment164Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)69.6% WhiteN/A
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
- 2025-0320 : ANDRO-HEME (Androgen Deprivation and Hematologic Effects in Men): An Individual Participant-Level Meta-Analysis of Clinical Trials
- 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
- 2022-4977 : Clinical Trials dataset for teaching purposes at University College London
- 2021-4841 : The Impact of Second Generation Anti-Androgens on Quality of Life in Men with Advanced Prostate Cancer
- 2021-4821 : Evaluation of a single global item for side effect bother
- 2021-4740 : The Impact of Second Generation Anti-Androgens on Sexual Function in Men with Advanced Prostate Cancer
- 2020-4410 : Predictors of therapeutic and adverse effects of medicines used in the treatment of prostate cancer
- 2020-4189 : Design and validation of an external control arm using prior clinical trials and real-world data
- 2019-4146 : Evaluation of exogenous glucocorticoid potencies
- 2019-3999 : Psychiatric Symptoms as Adverse Events of Abiraterone / Prednisolone Therapy: Systematic Review and Meta-Analysis