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Comparison · NCT00988208-sae

Docetaxel/Prednisone/Lenalidomide (DPL) vs Docetaxel/ Prednisone/and Placebo (DP): serious adverse events

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. Docetaxel/Prednisone/Lenalidomide (DPL) vs Docetaxel/ Prednisone/and Placebo (DP): serious adverse events. Trial comparisons, record NCT00988208-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00988208-sae

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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 10.5390.4960.581wilson
Risk in group 20.3380.2990.379wilson
Risk difference, group 1 minus group 20.2010.1420.259newcombe hybrid score
Risk ratio, group 1 over group 21.61.381.84log
Odds ratio, group 1 over group 22.291.792.94log
Number needed to harm, for one more participant with a serious adverse event on Docetaxel/Prednisone/Lenalidomide (DPL) than on Docetaxel/ Prednisone/and Placebo (DP)4.973.867.07from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Docetaxel/Prednisone/Lenalidomide (DPL)
Participants received docetaxel 75 mg/m\^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
283525EG000
Group 2Docetaxel/ Prednisone/and Placebo (DP)
Participants received Docetaxel 75 mg/m\^2 by intravenous (IV) administration over 30-60 minutes on Day 1, Prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
176521EG001

Harm

What it counts
Total, serious adverse events
Time frame
From first dose of study treatment to 28 days after the last dose; as of the final analysis cut-off of 20 April 2017; median overall duration of treatment was 22.1 months for DPL and 27.0 months for the DP group

Source ClinicalTrials.gov

Trial

Title
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
NCT number
NCT00988208
Phases
PHASE3
Conditions
Prostate Cancer
Interventions
Lenalidomide, Docetaxel, Prednisone, Placebo
Lead sponsor
Celgene
Results first posted
2013-09-05

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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