Comparison · NCT03182907-sae
Bezlotoxumab vs 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. Bezlotoxumab vs Placebo: serious adverse events. Trial comparisons, record NCT03182907-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03182907-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 | 0.533 | 0.439 | 0.624 | wilson | |
| Risk in group 2 | 0.806 | 0.65 | 0.902 | wilson | |
| Risk difference, group 1 minus group 2 | -0.273 | -0.408 | -0.092 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.661 | 0.521 | 0.84 | log | |
| Odds ratio, group 1 over group 2 | 0.275 | 0.111 | 0.683 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Bezlotoxumab than on Placebo | 3.67 | 2.45 | 10.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Bezlotoxumab | Participants received 10 mg of bezlotoxumab per kg body weight via a single 60-minute (±10 minutes) intravenous (IV) infusion on Day 1. Additionally, participants received background ABD for 10-21 days per institutional guidelines, at the investigator's discretion. | 57 | 107 | EG000 |
| Group 2 | Placebo | Participants received placebo for bezlotoxumab consisting of either 0.9% sodium chloride or 5% dextrose via a single 60-minute (±10 minutes) IV infusion on Day 1. Additionally, participants received background ABD for 10-21 days per institutional guidelines, at the investigator's discretion. | 29 | 36 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 14 months
Source ClinicalTrials.gov
Trial
- Title
- Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
- NCT number
- NCT03182907
- Phases
- PHASE3
- Conditions
- Clostridium Difficile Infection
- Interventions
- Bezlotoxumab, Placebo, Antibacterial drug treatment (ABD)
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-06-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03182907?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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