Comparison · NCT03354598-sae
Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin: 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 Ciprofloxacin: serious adverse events. Trial comparisons, record NCT03354598-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03354598-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 | 0.0072 | 0.00331 | 0.0156 | wilson | |
| Risk in group 2 | 0.00242 | 0.000663 | 0.00877 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00478 | -0.00267 | 0.0134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.98 | 0.603 | 14.7 | log | |
| Odds ratio, group 1 over group 2 | 2.99 | 0.602 | 14.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sulopenem-etzadroxil/Probenecid than on Ciprofloxacin | 209 | 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 | Sulopenem-etzadroxil/Probenecid | Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days~Sulopenem-Etzadroxil/Probenecid: Treatment of uncomplicated urinary tract infection | 6 | 833 | EG000 |
| Group 2 | Ciprofloxacin | Ciprofloxacin 250 mg PO administered twice daily for 3 days~Ciprofloxacin: Treatment of uncomplicated urinary tract infection | 2 | 827 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the time of informed consent through the final visit, an average of 28 days.
Source ClinicalTrials.gov
Trial
- Title
- Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
- NCT number
- NCT03354598
- Phases
- PHASE3
- Conditions
- Uncomplicated Urinary Tract Infections
- Interventions
- Sulopenem-Etzadroxil/Probenecid, Ciprofloxacin
- Lead sponsor
- Iterum Therapeutics, International Limited
- Results first posted
- 2020-12-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03354598?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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