Comparison · NCT01757275-sae
Esomeprazole vs Cimetidine: 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. Esomeprazole vs Cimetidine: serious adverse events. Trial comparisons, record NCT01757275-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01757275-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 | 0.0455 | 0.0196 | 0.102 | wilson | |
| Risk in group 2 | 0.0476 | 0.0205 | 0.107 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00216 | -0.0666 | 0.0606 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.955 | 0.285 | 3.2 | log | |
| Odds ratio, group 1 over group 2 | 0.952 | 0.268 | 3.39 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Esomeprazole than on Cimetidine | 462 | 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 | Esomeprazole | Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days | 5 | 110 | EG000 |
| Group 2 | Cimetidine | Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days | 5 | 105 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs will be collected from the time of the first administration of IP until the end of study, up to 35 days. SAEs will be collected from signed inform consent until the end of the study, up to 36 days.
Source ClinicalTrials.gov
Trial
- Title
- High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
- NCT number
- NCT01757275
- Phases
- PHASE3
- Conditions
- Bleeding Peptic Ulcer
- Interventions
- Esomeprazole Na, Cimetidine, Esomeprazole Mg
- Lead sponsor
- AstraZeneca
- Results first posted
- 2016-03-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01757275?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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