Comparison · NCT01110408-sae
Doripenem vs Cefepime: serious adverse events
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. Doripenem vs Cefepime: serious adverse events. Trial comparisons, record NCT01110408-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01110408-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 | 0.0333 | 0.00591 | 0.167 | wilson | |
| Risk in group 2 | 0.3 | 0.108 | 0.603 | wilson | |
| Risk difference, group 1 minus group 2 | -0.267 | -0.571 | -0.0327 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.111 | 0.013 | 0.951 | log | |
| Odds ratio, group 1 over group 2 | 0.0805 | 0.00723 | 0.895 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Doripenem than on Cefepime | 3.75 | 1.75 | 30.6 | 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 | Doripenem | Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. | 1 | 30 | EG000 |
| Group 2 | Cefepime | Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days. | 3 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approximately 8 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections
- NCT number
- NCT01110408
- Phases
- PHASE3
- Conditions
- Complicated Urinary Tract Infections or Pyelonephritis
- Interventions
- Doripenem, Doripenem placebo, Cefepime, Cefepime placebo, Amoxicillin/clavulanate potassium
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2014-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01110408?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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