Comparison · NCT00527787-sae
PN400 (VIMOVO) vs Naproxen: 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. PN400 (VIMOVO) vs Naproxen: serious adverse events. Trial comparisons, record NCT00527787-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00527787-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 | 0.0229 | 0.00984 | 0.0526 | wilson | |
| Risk in group 2 | 0.0278 | 0.0128 | 0.0593 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00484 | -0.0389 | 0.0284 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.826 | 0.256 | 2.67 | log | |
| Odds ratio, group 1 over group 2 | 0.822 | 0.247 | 2.73 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PN400 (VIMOVO) than on Naproxen | 207 | 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 | PN400 (VIMOVO) | Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg | 5 | 218 | EG000 |
| Group 2 | Naproxen | Naproxen 500 mg | 6 | 216 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomization through 6 months
Source ClinicalTrials.gov
Trial
- Title
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
- NCT number
- NCT00527787
- Phases
- PHASE3
- Conditions
- Gastric Ulcer
- Interventions
- PN400 (VIMOVO), Naproxen
- Lead sponsor
- POZEN
- Results first posted
- 2010-12-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00527787?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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