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Trial · NCT03706365

Results by group33

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Radiographic Progression Free Survival (rPFS)Abemaciclib21.9695% Confidence Interval 19.33 to 27.48Months
Radiographic Progression Free Survival (rPFS)Placebo20.2895% Confidence Interval 16.47 to 24.36Months
Time to Prostate-Specific Antigen (PSA) ProgressionAbemaciclib22.1995% Confidence Interval 15.68 to 33.17Months
Time to Prostate-Specific Antigen (PSA) ProgressionPlacebo16.6095% Confidence Interval 12.03 to 20.28Months
Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central ReviewAbemaciclib24.8995% Confidence Interval 21.96 to NAMonths
Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central ReviewPlacebo22.8895% Confidence Interval 19.36 to 31.50Months
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)Abemaciclib45.295% Confidence Interval 34.6 to 55.9percentage of participants
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)Placebo54.895% Confidence Interval 43.4 to 66.2percentage of participants
Duration of Response (DOR)Abemaciclib21.2795% Confidence Interval 16.60 to NAMonths
Duration of Response (DOR)Placebo15.6895% Confidence Interval 11.87 to 39.35Months
Overall Survival (OS)Abemaciclib38.0195% Confidence Interval 30.58 to 46.65Months
Overall Survival (OS)Placebo33.2195% Confidence Interval 29.52 to NAMonths
Time to Symptomatic ProgressionAbemaciclib51.3995% Confidence Interval 27.98 to NAMonths
Time to Symptomatic ProgressionPlacebo35.7495% Confidence Interval 28.44 to NAMonths
Pharmacokinetics (PK): Mean Steady State Exposure of AbemaciclibAbemaciclibC1 D14.79Geometric Coefficient of Variation 157nanogram per milliliter (ng/mL)
Pharmacokinetics (PK): Mean Steady State Exposure of AbemaciclibAbemaciclibC1 D15289Geometric Coefficient of Variation 58.7nanogram per milliliter (ng/mL)
Pharmacokinetics (PK): Mean Steady State Exposure of AbemaciclibAbemaciclibC2 D1253Geometric Coefficient of Variation 65.7nanogram per milliliter (ng/mL)
Pharmacokinetics (PK): Mean Steady State Exposure of AbemaciclibAbemaciclibC2 D15252Geometric Coefficient of Variation 68.4nanogram per milliliter (ng/mL)
Pharmacokinetics (PK): Mean Steady State Exposure of AbemaciclibAbemaciclibC3 D1270Geometric Coefficient of Variation 54.5nanogram per milliliter (ng/mL)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567AbemaciclibC1 D12.90Geometric Coefficient of Variation 87.4ng/mL

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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