Comparison · NCT01474915-sae
Aprepitant vs Ondansetron: 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. Aprepitant vs Ondansetron: serious adverse events. Trial comparisons, record NCT01474915-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01474915-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 | 0.0333 | 0.00919 | 0.114 | wilson | |
| Risk in group 2 | 0.0492 | 0.0169 | 0.135 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0158 | -0.105 | 0.0707 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.678 | 0.117 | 3.91 | log | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.107 | 4.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Aprepitant than on Ondansetron | 63.1 | 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 | Aprepitant | Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction | 2 | 60 | EG000 |
| Group 2 | Ondansetron | Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction | 3 | 61 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting
- NCT number
- NCT01474915
- Phases
- PHASE4
- Conditions
- Postoperative Nausea and Vomiting (PONV), Nausea
- Interventions
- Aprepitant, Ondansetron, Promethazine, Dexamethasone
- Lead sponsor
- Sergio Bergese
- Results first posted
- 2013-12-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01474915?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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