Comparison · NCT01395901-sae
Palonosetron and Placebo to Ondansetron vs Ondansetron and Placebo to Palonosetron: 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 and Placebo to Ondansetron vs Ondansetron and Placebo to Palonosetron: serious adverse events. Trial comparisons, record NCT01395901-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01395901-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 | 0.0121 | 0.00471 | 0.0307 | wilson | |
| Risk in group 2 | 0.0333 | 0.0187 | 0.0587 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0212 | -0.0477 | 0.00239 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.363 | 0.117 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 0.355 | 0.112 | 1.13 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Palonosetron and Placebo to Ondansetron than on Ondansetron and Placebo to Palonosetron | 47.1 | 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 | Palonosetron and Placebo to Ondansetron | Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron | 4 | 331 | EG000 |
| Group 2 | Ondansetron and Placebo to Palonosetron | Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;~* 13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron | 11 | 330 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
- NCT number
- NCT01395901
- Phases
- PHASE3
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Palonosetron, Ondansetron, Placebo to Ondansetron, Placebo to Palonosetron
- Lead sponsor
- Helsinn Healthcare SA
- Results first posted
- 2014-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01395901?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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