Comparison · NCT05584657-sae
Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: 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. Sulopenem Etzadroxil/Probenecid vs Amoxicillin/Clavulanate: serious adverse events. Trial comparisons, record NCT05584657-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05584657-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 | 0 | 0.00346 | wilson | |
| Risk in group 2 | 0.00452 | 0.00193 | 0.0105 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00452 | -0.0105 | -0.000199 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Sulopenem Etzadroxil/Probenecid than on Amoxicillin/Clavulanate | 221 | 95 | 5,030 | 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 | Sulopenem Etzadroxil/Probenecid | Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days~Sulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days | 0 | 1,107 | EG000 |
| Group 2 | Amoxicillin/Clavulanate | Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days~Amoxicillin/clavulanate: Oral Augmentin twice daily for 5 days | 5 | 1,107 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 28 days
Source ClinicalTrials.gov
Trial
- Title
- Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
- NCT number
- NCT05584657
- Phases
- PHASE3
- Conditions
- Urinary Tract Infections, Cystitis
- Interventions
- Sulopenem etzadroxil/probenecid, Amoxicillin/clavulanate
- Lead sponsor
- Iterum Therapeutics, International Limited
- Results first posted
- 2024-11-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05584657?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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