Comparison · NCT00961350-sae
PA32540 vs EC Aspirin: 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. PA32540 vs EC Aspirin: serious adverse events. Trial comparisons, record NCT00961350-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00961350-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 | 0.0606 | 0.0376 | 0.0962 | wilson | |
| Risk in group 2 | 0.0906 | 0.0616 | 0.131 | wilson | |
| Risk difference, group 1 minus group 2 | -0.03 | -0.0766 | 0.0159 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.669 | 0.364 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.648 | 0.336 | 1.25 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PA32540 than on EC Aspirin | 33.4 | 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 | PA32540 | PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD) | 16 | 264 | EG000 |
| Group 2 | EC Aspirin | EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD) | 24 | 265 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Informed consent through 6 months plus 28 days for Serious Adverse Events and Randomization through 6 months for all non-serious adverse events.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
- NCT number
- NCT00961350
- Phases
- PHASE3
- Conditions
- Gastric Ulcer
- Interventions
- PA32540, EC Aspirin 325
- Lead sponsor
- POZEN
- Results first posted
- 2016-01-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00961350?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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