Comparison · NCT01983683-sae
Cadazolid vs Vancomycin: 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. Cadazolid vs Vancomycin: serious adverse events. Trial comparisons, record NCT01983683-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01983683-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 | 0.119 | 0.0869 | 0.161 | wilson | |
| Risk in group 2 | 0.15 | 0.114 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0308 | -0.0855 | 0.0243 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.795 | 0.528 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.767 | 0.478 | 1.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cadazolid than on Vancomycin | 32.5 | 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 | Cadazolid | oral cadazolid 250 mg twice daily (bid) for 10 days | 35 | 294 | EG000 |
| Group 2 | Vancomycin | oral vancomycin 125 mg 4 times per day (qid) for 10 days | 46 | 307 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
- NCT number
- NCT01983683
- Phases
- PHASE3
- Conditions
- Clostridium Difficile Infection
- Interventions
- Cadazolid, Vancomycin, Cadazolid-matching placebo, Vancomycin-matching placebo
- Lead sponsor
- Actelion
- Results first posted
- 2018-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01983683?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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