Comparison · NCT05857163-sae
Test Group vs Control Group: 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. Test Group vs Control Group: serious adverse events. Trial comparisons, record NCT05857163-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05857163-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 | 0.0057 | 0.00156 | 0.0205 | wilson | |
| Risk in group 2 | 0.00578 | 0.00159 | 0.0208 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0000823 | -0.0157 | 0.0153 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.986 | 0.14 | 6.96 | log | |
| Odds ratio, group 1 over group 2 | 0.986 | 0.138 | 7.04 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Test Group than on Control Group | 12,100 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Test Group | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, BID for 14 days | 2 | 351 | EG000 |
| Group 2 | Control Group | Amoxicillin capsules 1 g + Clarithromycin tablets 500 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Bismuth potassium citrate capsules 240 mg + Rifasutenizol placebo capsules, BID for 14 days | 2 | 346 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 4-6 weeks after the last dose of the study drugs
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection
- NCT number
- NCT05857163
- Phases
- PHASE3
- Conditions
- H.Pylori Infection
- Interventions
Rifasutenizol capsules, Rabeprazole sodium enteric-coated tablets, Amoxicillin Capsules, Clarithromycin placebo tablets, Bismuth potassium citrate placebo capsules, Clarithromycin tablets, Bismuth potassium citrate capsules, Rifasutenizol placebo capsules
- Lead sponsor
- TenNor Therapeutics (Suzhou) Limited
- Results first posted
- 2025-08-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05857163?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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