Comparison · NCT01539538-sae
Sufentanil NanoTab PCA System/15 mcg vs Morphine IV PCA: 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. Sufentanil NanoTab PCA System/15 mcg vs Morphine IV PCA: serious adverse events. Trial comparisons, record NCT01539538-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01539538-sae
On this page
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 | 0.0339 | 0.0156 | 0.072 | wilson | |
| Risk in group 2 | 0.0389 | 0.019 | 0.0781 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00499 | -0.0482 | 0.038 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.872 | 0.299 | 2.54 | log | |
| Odds ratio, group 1 over group 2 | 0.867 | 0.286 | 2.63 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sufentanil NanoTab PCA System/15 mcg than on Morphine IV PCA | 200 | 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 | Sufentanil NanoTab PCA System/15 mcg | 6 | 177 | EG000 | |
| Group 2 | Morphine IV PCA | 7 | 180 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
- NCT number
- NCT01539538
- Phases
- PHASE3
- Conditions
- Post-Operative Pain
- Interventions
- Sufentanil NanoTab PCA System/15 mcg, morphine IV PCA
- Lead sponsor
- Talphera, Inc
- Results first posted
- 2014-03-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01539538?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01539538-sae