Comparison · NCT03595553-sae
RIDINILAZOLE 200 MG vs VANCOMYCIN 125 MG: 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. RIDINILAZOLE 200 MG vs VANCOMYCIN 125 MG: serious adverse events. Trial comparisons, record NCT03595553-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03595553-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 | 0.0856 | 0.0613 | 0.118 | wilson | |
| Risk in group 2 | 0.0796 | 0.0563 | 0.111 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00599 | -0.034 | 0.0461 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.667 | 1.73 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.643 | 1.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on RIDINILAZOLE 200 MG than on VANCOMYCIN 125 MG | 167 | 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 | RIDINILAZOLE 200 MG | RIDINILAZOLE 200mg bid, coated tablet, oral route of administration. | 32 | 374 | EG000 |
| Group 2 | VANCOMYCIN 125 MG | VANCOMYCIN 125mg qid, hard capsule, oral route of administration. | 30 | 377 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All Serious Adverse Events (SAEs) will be collected from the signing of the informed consent form (ICF) until the D100 End of Study visit. All AEs will be collected from the time and date of first dose of study treatment until the D40 follow-up visit.
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
- NCT number
- NCT03595553
- Phases
- PHASE3
- Conditions
- Clostridioides Difficile Infection
- Interventions
- Ridinilazole, Vancomycin
- Lead sponsor
- Summit Therapeutics
- Results first posted
- 2023-03-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03595553?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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