Comparison · NCT00967499-sae
Palonosetron 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. Palonosetron vs Ondansetron: serious adverse events. Trial comparisons, record NCT00967499-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00967499-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 | 0.125 | 0.0586 | 0.247 | wilson | |
| Risk in group 2 | 0.16 | 0.0834 | 0.285 | wilson | |
| Risk difference, group 1 minus group 2 | -0.035 | -0.177 | 0.109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.781 | 0.293 | 2.08 | log | |
| Odds ratio, group 1 over group 2 | 0.75 | 0.239 | 2.35 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Palonosetron than on Ondansetron | 28.6 | 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 | Palonosetron | Participants received a single dose of palonosetron 0.075 mg, intravenously, over a period of 10 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV. | 6 | 48 | EG000 |
| Group 2 | Ondansetron | Participants received a single dose of ondansetron 4 mg, intravenously, over a period of 30 seconds as preoperative antiemetic treatment prior to anesthesia administration on Day 1 (day of surgical procedure). Participants had also received same treatment as rescue medication up to 72 hours post-surgical procedure if experienced PONV. | 8 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From on or after date of first dose of study drug up to and including 30 days after last dose of study drug, or up to approximately 158 days
Source ClinicalTrials.gov
Trial
- Title
- Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)
- NCT number
- NCT00967499
- Phases
- PHASE2
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Ondansetron, Palonosetron
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2021-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00967499?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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