Comparison · NCT00450216-sae
HZT-501 vs Ibuprofen: 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. HZT-501 vs Ibuprofen: serious adverse events. Trial comparisons, record NCT00450216-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00450216-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 | 0.0362 | 0.0241 | 0.0543 | wilson | |
| Risk in group 2 | 0.0435 | 0.0256 | 0.073 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00723 | -0.0391 | 0.0182 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.834 | 0.426 | 1.63 | log | |
| Odds ratio, group 1 over group 2 | 0.827 | 0.411 | 1.67 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on HZT-501 than on Ibuprofen | 138 | 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 | HZT-501 | HZT-501: Ibuprofen 800mg/famotidine 26.6mg | 22 | 607 | EG000 |
| Group 2 | Ibuprofen | Ibuprofen 800mg | 13 | 299 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomization to 28 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
- NCT number
- NCT00450216
- Phases
- PHASE3
- Conditions
- Ulcer
- Interventions
- Ibuprofen/famotidine, Ibuprofen
- Lead sponsor
- Amgen
- Results first posted
- 2011-06-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00450216?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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