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Comparison · NCT02709512-deaths

Drug: ADI-PEG 20 Plus Pem Platinum vs Drug: Placebo Plus Pem Platinum: 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. Drug: ADI-PEG 20 Plus Pem Platinum vs Drug: Placebo Plus Pem Platinum: deaths from any cause. Trial comparisons, record NCT02709512-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02709512-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 10.4960.410.582wilson
Risk in group 20.4920.4060.579wilson
Risk difference, group 1 minus group 20.00406-0.1180.126newcombe hybrid score
Risk ratio, group 1 over group 21.010.7841.3log
Odds ratio, group 1 over group 21.020.6181.67log
Number needed to harm, for one more death from any cause on Drug: ADI-PEG 20 Plus Pem Platinum than on Drug: Placebo Plus Pem Platinum246from 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 1Drug: ADI-PEG 20 Plus Pem Platinum
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study~In Combination With:~Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous~ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication
62125EG000
Group 2Drug: Placebo Plus Pem Platinum
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study~In Combination With:~Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous~Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication
61124EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Treatment-emergent AEs were collected with onset after the first dose of study drug or existing events that worsened after the first dose during the study, approximately 18 months.

Source ClinicalTrials.gov

Trial

Title
Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
NCT number
NCT02709512
Phases
PHASE2, PHASE3
Conditions
Mesothelioma
Interventions
ADI-PEG 20 plus Pem Platinum, Placebo plus Pem Platinum
Lead sponsor
Polaris Group
Results first posted
2023-10-04

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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