Comparison · NCT01142089-sae
Rifamycin SV MMX 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. Rifamycin SV MMX vs Placebo: serious adverse events. Trial comparisons, record NCT01142089-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01142089-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 | 0.0101 | 0.00276 | 0.0359 | wilson | |
| Risk in group 2 | 0.0154 | 0.00272 | 0.0821 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00533 | -0.0725 | 0.0234 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.653 | 0.0602 | 7.09 | log | |
| Odds ratio, group 1 over group 2 | 0.65 | 0.058 | 7.28 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rifamycin SV MMX than on Placebo | 187 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rifamycin SV MMX | Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT) | 2 | 199 | EG001 |
| Group 2 | Placebo | Placebo (two matching tablets) orally twice daily for 3 days (72 hours)~Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours).~Intent To Treat (ITT) | 1 | 65 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The Investigator must completely and promptly record each new AE/SAE that occurs after the first dose of study drug through Visit 4 (i.e., treatment emergent AEs) on the appropriate CRF, even if the relationship of an AE to study drug is assessed by the Investigator to be unlikely or not related. In addition, the investigator must document and follow SAEs that occur from Visit 4 through 30 days after the last dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)
- NCT number
- NCT01142089
- Phases
- PHASE3
- Conditions
- Traveler's Diarrhea
- Interventions
- Placebo, Rifamycin SV MMX
- Lead sponsor
- Cosmo Technologies Ltd
- Results first posted
- 2018-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01142089?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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