Comparison · NCT00613106-sae
HZT-501 (Ibuprofen/Famotidine) 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
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ConductScience Library. HZT-501 (Ibuprofen/Famotidine) vs Ibuprofen: serious adverse events. Trial comparisons, record NCT00613106-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00613106-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 | 0.0227 | 0.00776 | 0.0647 | wilson | |
| Risk in group 2 | 0.0426 | 0.0117 | 0.142 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0198 | -0.121 | 0.0322 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.534 | 0.0921 | 3.1 | log | |
| Odds ratio, group 1 over group 2 | 0.523 | 0.0847 | 3.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on HZT-501 (Ibuprofen/Famotidine) than on Ibuprofen | 50.4 | 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 | HZT-501 (Ibuprofen/Famotidine) | HZT-501: ibuprofen 800mg/famotidine 26.6mg | 3 | 132 | EG000 |
| Group 2 | Ibuprofen | Ibuprofen 800mg | 2 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 32 weeks
Source ClinicalTrials.gov
Trial
- Title
- Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)
- NCT number
- NCT00613106
- Phases
- PHASE3
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain
- Interventions
- HZT-501, Ibuprofen
- Lead sponsor
- Amgen
- Results first posted
- 2011-06-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00613106?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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