Comparison · NCT03830333-sae
Ceftolozane/Tazobactam + Metronidazole vs Meropenem + Placebo: 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. Ceftolozane/Tazobactam + Metronidazole vs Meropenem + Placebo: serious adverse events. Trial comparisons, record NCT03830333-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03830333-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 | 0.0522 | 0.0255 | 0.104 | wilson | |
| Risk in group 2 | 0.0522 | 0.0255 | 0.104 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0582 | 0.0582 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.361 | 2.77 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.341 | 2.93 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Ceftolozane/Tazobactam + Metronidazole | Participants received ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam could be adjusted to 500 mg/250 mg if CrCL was 30 to ≤50 mL/min). | 7 | 134 | EG000 |
| Group 2 | Meropenem + Placebo | Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). | 7 | 134 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately Day 30
Source ClinicalTrials.gov
Trial
- Title
- Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)
- NCT number
- NCT03830333
- Phases
- PHASE3
- Conditions
- Complicated Intra-abdominal Infections
- Interventions
- Ceftolozane/Tazobactam, Metronidazole, Meropenem, Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2021-10-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03830333?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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