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Trial · NCT03150056

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
SECONDARYProstate-specific Antigen (PSA) Response Rate at Week 4Week 4Modified All Treated Population.Percentage of participantsNUMBER
SECONDARYTime to Disease ProgressionUp to 21.3 monthsModified All Treated Population.DaysMEDIAN
SECONDARYRadiographic Progression-free Survival (rPFS)Up to 21.3 montthsModified All Treated Population.DaysMEDIAN
SECONDARYNumber of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance StatusUp to 21.3 monthsAll Treated Population. Only those participants with data available at the indicated time points were analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).Scores on a scaleMEAN
SECONDARYChange From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 HoursBaseline (Pre-dose on Week 1 Day 1) and on Day 1 of Weeks 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61, 73, 85, 97Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).Scores on a scaleMEAN
OTHER_PRE_SPECIFIEDNumber of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the StudyUp to 3 years and 11 monthsAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDNumber of Participants With AEs Leading to Any Dose Reduction or Delays Until End of the StudyUp to 3 years and 11 monthsAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDNumber of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment Until End of the StudyUp to 3 years and 11 monthsAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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