Comparison · NCT04198363-sae
Vonoprazan 20 mg vs Esomeprazole 20 mg: 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. Vonoprazan 20 mg vs Esomeprazole 20 mg: serious adverse events. Trial comparisons, record NCT04198363-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04198363-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 | 0.0117 | 0.00399 | 0.0339 | wilson | |
| Risk in group 2 | 0.0197 | 0.00844 | 0.0452 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00797 | -0.0347 | 0.0169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.595 | 0.144 | 2.46 | log | |
| Odds ratio, group 1 over group 2 | 0.591 | 0.14 | 2.5 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Vonoprazan 20 mg than on Esomeprazole 20 mg | 126 | 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 | Vonoprazan 20 mg | Vonoprazan 20 mg, tablets, orally, BID given in combination with bismuth-containing quadruple therapy (amoxicillin 1 g capsules, clarithromycin 500 mg tablets, and bismuth potassium citrate 600 mg capsules) orally, BID for 2 weeks. | 3 | 256 | EG000 |
| Group 2 | Esomeprazole 20 mg | Esomeprazole 20 mg, tablets, orally, BID given in combination with bismuth-containing quadruple therapy (amoxicillin 1 g capsules, clarithromycin 500 mg tablets, and bismuth potassium citrate 600 mg capsules) orally, BID for 2 weeks. | 5 | 254 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to approximately 6 weeks
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection
- NCT number
- NCT04198363
- Phases
- PHASE3
- Conditions
- Helicobacter Pylori
- Interventions
- Vonoprazan, Amoxicillin, Clarithromycin, Bismuth Potassium citrate, Esomeprazole
- Lead sponsor
- Takeda
- Results first posted
- 2023-09-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04198363?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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