Comparison · NCT01660763-sae
Sufentanil NanoTab PCA System/15 mcg vs Placebo Sufentanil NanoTab PCA System: 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 Placebo Sufentanil NanoTab PCA System: serious adverse events. Trial comparisons, record NCT01660763-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01660763-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 | 0.0254 | 0.0129 | 0.0493 | wilson | |
| Risk in group 2 | 0.0385 | 0.0151 | 0.0947 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0131 | -0.0707 | 0.0204 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.66 | 0.203 | 2.15 | log | |
| Odds ratio, group 1 over group 2 | 0.651 | 0.192 | 2.21 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sufentanil NanoTab PCA System/15 mcg than on Placebo Sufentanil NanoTab PCA System | 76.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sufentanil NanoTab PCA System/15 mcg | Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours. | 8 | 315 | EG000 |
| Group 2 | Placebo Sufentanil NanoTab PCA System | Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours. | 4 | 104 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs were collected from time of first study drug dose taken through 12 hours after last study drug dose taken.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery
- NCT number
- NCT01660763
- Phases
- PHASE3
- Conditions
- Post Operative Pain
- Interventions
- Sufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System
- Lead sponsor
- Talphera, Inc
- Results first posted
- 2014-02-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01660763?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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