Comparison · NCT05983367-db9809ec
Ompenaclid + FOLFIRI + Bevacizumab vs Placebo + FOLFIRI + Bevacizumab: Frequency of Adverse Events (AEs)
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. Ompenaclid + FOLFIRI + Bevacizumab vs Placebo + FOLFIRI + Bevacizumab: Frequency of Adverse Events (AEs). Trial comparisons, record NCT05983367-db9809ec. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05983367-db9809ec
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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 | 1 | 0.906 | 1 | wilson | |
| Risk in group 2 | 1 | 0.908 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0941 | 0.0918 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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. | 37 | 37 | OG000 |
| 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. | 38 | 38 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Frequency of Adverse Events (AEs)
- Description
- Percentage of patients with treatment-emergent AEs (TEAE).
- Time frame
- From the signing of informed consent until 30 days (+/- 3 days) after the last dose of study drug (up to approximately 12 months).
- Population
The safety analysis set comprised all patients who received at least one dose of ompenaclid or matching placebo (N=75). One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria.
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.
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