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Comparison · NCT03686683-deaths

Treatment Group: Sipuleucel-T vs Control Arm: Active Surveillance: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Treatment Group: Sipuleucel-T vs Control Arm: Active Surveillance: deaths from any cause. Trial comparisons, record NCT03686683-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03686683-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.02810.01530.0509wilson
Risk in group 20.02840.01220.0648wilson
Risk difference, group 1 minus group 2-0.000319-0.03890.0277newcombe hybrid score
Risk ratio, group 1 over group 20.9890.3432.85log
Odds ratio, group 1 over group 20.9880.3332.94log
Number needed to treat, for one fewer death from any cause on Treatment Group: Sipuleucel-T than on Control Arm: Active Surveillance3,130from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Treatment Group: Sipuleucel-T
Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
10356EG000
Group 2Control Arm: Active SurveillanceSubjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.5176EG001

Harm

What it counts
Total, all-cause mortality
Time frame
4 years, 5 months

Source ClinicalTrials.gov

Trial

Title
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
NCT number
NCT03686683
Phases
PHASE3
Conditions
Adenocarcinoma of the Prostate
Interventions
sipuleucel-T
Lead sponsor
Dendreon
Results first posted
2024-10-08

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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