Comparison · NCT01165281-sae
Tapentadol (JNS024) Extended-release (ER) Oral Tablets vs Oxycodone Controlled-release (CR) Oral Tablets: 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 (JNS024) Extended-release (ER) Oral Tablets vs Oxycodone Controlled-release (CR) Oral Tablets: serious adverse events. Trial comparisons, record NCT01165281-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01165281-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 | 0.464 | 0.391 | 0.54 | wilson | |
| Risk in group 2 | 0.401 | 0.331 | 0.476 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0631 | -0.0418 | 0.166 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.906 | 1.48 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.842 | 1.99 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tapentadol (JNS024) Extended-release (ER) Oral Tablets than on Oxycodone Controlled-release (CR) Oral Tablets | 15.8 | 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 (JNS024) Extended-release (ER) Oral Tablets | Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of \<=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. | 78 | 168 | EG000 |
| Group 2 | Oxycodone Controlled-release (CR) Oral Tablets | Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of \<=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. | 69 | 172 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
- NCT number
- NCT01165281
- Phases
- PHASE3
- Conditions
- Pain
- Interventions
- Oxycodone CR, R331333 (referred to as JNS024 ER or CG5503)
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2014-01-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01165281?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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