Comparison · NCT01964378-sae
Cebranopadol vs Morphine Prolonged Release: 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. Cebranopadol vs Morphine Prolonged Release: serious adverse events. Trial comparisons, record NCT01964378-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01964378-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 | 0.215 | 0.133 | 0.33 | wilson | |
| Risk in group 2 | 0.18 | 0.104 | 0.295 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0351 | -0.106 | 0.173 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.588 | 2.43 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.517 | 3.01 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cebranopadol than on Morphine Prolonged Release | 28.5 | 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 | Cebranopadol | Once daily oral administration. 200, 400 or 600 µg film coated tablets. Dosage 200 µg to 1000 µg per day.~Cebranopadol: Participant will take one or two tablet(s) of cebranopadol in the morning and one or two placebo double-dummy morphine-like capsule(s) in the morning and the evening. | 14 | 65 | EG000 |
| Group 2 | Morphine Prolonged Release | Twice daily oral administration. 15, 30 or 45 mg morphine sulfate capsules. Dosage 30 to 150 mg per day.~Morphine Prolonged Release: Participant will take one or two morphine capsule(s) in the morning and in the evening and one or two placebo double-dummy cebranopadol-like tablet(s) in the morning. | 11 | 61 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From first IMP intake up to day of last IMP in Week 6 + 3 weeks follow-up (max. 9 weeks in total). The All-Cause Mortality is reported for the Allocated Set. Serious and non-serious treatment emergent adverse events (i.e. events documented after the first dose of study medication and events which started before treatment and worsened after first dose of study medication) are reported for the Safety Set (all participants with at least one dose of study medication).
Source ClinicalTrials.gov
Trial
- Title
- CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer
- NCT number
- NCT01964378
- Phases
- PHASE3
- Conditions
- Pain, Neoplasms, Chronic Pain
- Interventions
- Cebranopadol, Morphine Prolonged Release
- Lead sponsor
- Tris Pharma, Inc.
- Results first posted
- 2019-12-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01964378?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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