Comparison · NCT02709512-sae
Drug: ADI-PEG 20 Plus Pem Platinum vs Drug: Placebo Plus Pem Platinum: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Drug: ADI-PEG 20 Plus Pem Platinum vs Drug: Placebo Plus Pem Platinum: serious adverse events. Trial comparisons, record NCT02709512-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02709512-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.152 | 0.0995 | 0.225 | wilson | |
| Risk in group 2 | 0.161 | 0.107 | 0.236 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00929 | -0.101 | 0.0819 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.942 | 0.529 | 1.68 | log | |
| Odds ratio, group 1 over group 2 | 0.932 | 0.47 | 1.85 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Drug: ADI-PEG 20 Plus Pem Platinum than on Drug: Placebo Plus Pem Platinum | 108 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Drug: 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 | 19 | 125 | EG000 |
| Group 2 | Drug: 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 | 20 | 124 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02709512?tab=results
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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