Comparison · NCT05983367-deaths
Ompenaclid + FOLFIRI + Bevacizumab vs Placebo + FOLFIRI + Bevacizumab: 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
Cite this record
ConductScience Library. Ompenaclid + FOLFIRI + Bevacizumab vs Placebo + FOLFIRI + Bevacizumab: deaths from any cause. Trial comparisons, record NCT05983367-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05983367-deaths
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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 | 0.105 | 0.0417 | 0.241 | wilson | |
| Risk in group 2 | 0.289 | 0.17 | 0.448 | wilson | |
| Risk difference, group 1 minus group 2 | -0.184 | -0.355 | -0.00318 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.364 | 0.127 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.289 | 0.0827 | 1.01 | log | |
| Number needed to treat, for one fewer death from any cause on Ompenaclid + FOLFIRI + Bevacizumab than on Placebo + FOLFIRI + Bevacizumab | 5.43 | 2.82 | 315 | from the risk difference interval |
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 | Ompenaclid + FOLFIRI + Bevacizumab | Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.~Ompenaclid: Ompenaclid (RGX-202-01)~Bevacizumab: Bevacizumab~FOLFIRI regimen: FOLFIRI regimen (irinotecan 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, and then 5-FU 2400 mg/m2 over 46 hours on Days 1 and 15 of each 28-day cycle) | 4 | 38 | EG000 |
| Group 2 | Placebo + FOLFIRI + Bevacizumab | Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.~Placebo: Placebo~Bevacizumab: Bevacizumab~FOLFIRI regimen: FOLFIRI regimen (irinotecan 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, and then 5-FU 2400 mg/m2 over 46 hours on Days 1 and 15 of each 28-day cycle) | 11 | 38 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer
- NCT number
- NCT05983367
- Phases
- PHASE2
- Conditions
- Colorectal Cancer, Metastatic Colon Cancer
- Interventions
- Ompenaclid, Placebo, Bevacizumab, FOLFIRI regimen
- Lead sponsor
- Inspirna, Inc.
- Results first posted
- 2026-02-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05983367?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT05983367-deaths