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CSR Summary
Not Yet Available
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NCT01946204
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Primary Citation
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Trial Information
Generic NameApalutamideProduct NameERLEADA®Therapeutic AreaCancers and Other NeoplasmsEnrollment1207% FemaleN/A% White66.3%
Product ClassNonsteroidal antiandrogenSponsor Protocol NumberARN-509-003Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)73.9
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
- 2024-0740 : Prognostic Enrichment Efficiency Ratio
- 2023-5534 : Quality tolerance limit and duplicated patient investigation in clinical trials
- 2023-5274 : Statin use and outcomes in patients treated in the SPARTAN, TITAN and ACIS trial
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2023-5187 : The association between antibiotics exposure and outcomes in men with prostate cancer
- 2023-5173 : Improving Outcome in Advanced Prostate Cancer: a Pooled Analysis of Randomized Controlled Trials
- 2023-5137 : Impact of Prior Local Therapy on Outcome in Men with non-metastatic Castrate Resistant Prostate Cancer
- 2022-4942 : External Validation of a Prognostic Model of Metastasis-Free Survival In Men with Nonmetastatic Castration-Resistant Prostate Cancer