Comparison · NCT01309386-sae
Tapentadol ER vs Morphine SR: 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 ER vs Morphine SR: serious adverse events. Trial comparisons, record NCT01309386-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01309386-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 | 0.32 | 0.208 | 0.458 | wilson | |
| Risk in group 2 | 0.32 | 0.208 | 0.458 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.178 | 0.178 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.565 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.432 | 2.32 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 ER | Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion. | 16 | 50 | EG000 |
| Group 2 | Morphine SR | Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion. | 16 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants
- NCT number
- NCT01309386
- Phases
- PHASE3
- Conditions
- Neoplasms
- Interventions
- Tapentadol ER, Morphine SR
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Results first posted
- 2013-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01309386?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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