Comparison · NCT01539642-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 NCT01539642-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01539642-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 | 0.00877 | 0.00155 | 0.048 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0621 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00877 | -0.0538 | 0.048 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Sufentanil NanoTab PCA System/15 mcg than on Placebo Sufentanil NanoTab PCA System | 114 | 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 q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours | 1 | 114 | EG000 |
| Group 2 | Placebo Sufentanil NanoTab PCA System | Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours | 0 | 58 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
- NCT number
- NCT01539642
- 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/NCT01539642?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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