Comparison · NCT00361504-sae
Tapentadol (CG5503) vs Oxycodone: 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. Tapentadol (CG5503) vs Oxycodone: serious adverse events. Trial comparisons, record NCT00361504-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00361504-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 | 0.0548 | 0.0417 | 0.0717 | wilson | |
| Risk in group 2 | 0.0404 | 0.0214 | 0.0749 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0145 | -0.0225 | 0.0399 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.677 | 2.72 | log | |
| Odds ratio, group 1 over group 2 | 1.38 | 0.667 | 2.85 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tapentadol (CG5503) than on Oxycodone | 69.2 | 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 | Tapentadol (CG5503) | Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year | 49 | 894 | EG000 |
| Group 2 | Oxycodone | Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year. | 9 | 223 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
- NCT number
- NCT00361504
- Phases
- PHASE3
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee, Lower Back Pain, Pain
- Interventions
- Oxycodone CR, Tapentadol (CG5503) ER
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Results first posted
- 2009-09-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00361504?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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