Comparison · NCT03357614-sae
Sulopenem vs Ertapenem: 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 vs Ertapenem: serious adverse events. Trial comparisons, record NCT03357614-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03357614-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 | 0.0201 | 0.012 | 0.0334 | wilson | |
| Risk in group 2 | 0.0086 | 0.00395 | 0.0186 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0115 | -0.00139 | 0.0256 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.34 | 0.903 | 6.05 | log | |
| Odds ratio, group 1 over group 2 | 2.36 | 0.903 | 6.19 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sulopenem than on Ertapenem | 87 | 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 | Sulopenem 1000 mg IV once daily for a minimum of 5 days, followed by sulopenem-etzadroxil/probenecid 500 mg PO twice daily to complete 7-10 total days of treatment~Sulopenem: Antibiotic therapy for complicated UTI~Sulopenem-Etzadroxil/Probenecid: Antibiotic therapy for complicated UTI | 14 | 697 | EG000 |
| Group 2 | Ertapenem | Ertapenem 1000 mg IV once daily for a minimum of 5 days, followed by ciprofloxacin 500 mg PO twice daily or amoxicillin-clavulanate 500 mg PO twice daily to complete 7-10 total days of treatment~Ertapenem: Antibiotic therapy for complicated UTI~Ciprofloxacin: Antibiotic therapy for complicated UTI~Amoxicillin-clavulanate: Antibiotic therapy for complicated UTI | 6 | 698 | 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
- Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults
- NCT number
- NCT03357614
- Phases
- PHASE3
- Conditions
- Complicated Urinary Tract Infections
- Interventions
- Sulopenem, Sulopenem-Etzadroxil/Probenecid, Ertapenem, Ciprofloxacin, Amoxicillin-clavulanate
- Lead sponsor
- Iterum Therapeutics, International Limited
- Results first posted
- 2020-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03357614?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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