Comparison · NCT01500226-sae
Rolapitant + Granisetron + Dexamethasone vs Placebo + Granisetron + Dexamethasone: 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. Rolapitant + Granisetron + Dexamethasone vs Placebo + Granisetron + Dexamethasone: serious adverse events. Trial comparisons, record NCT01500226-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01500226-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 | 0.133 | 0.109 | 0.161 | wilson | |
| Risk in group 2 | 0.153 | 0.128 | 0.182 | wilson | |
| Risk difference, group 1 minus group 2 | -0.02 | -0.0575 | 0.0175 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.869 | 0.668 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 0.849 | 0.625 | 1.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rolapitant + Granisetron + Dexamethasone than on Placebo + Granisetron + Dexamethasone | 50 | 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 | Rolapitant + Granisetron + Dexamethasone | * Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1-2 h before administration of chemotherapy~* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~* Dexamethasone (20 mg orally) about 30 min before chemotherapy~ * 684 subjects were randomized to Rolapitant~ * 670 of those randomized to Rolapitant received rolapitant in C1~ * Safety = 670 Rolapitant | 89 | 670 | EG000 |
| Group 2 | Placebo + Granisetron + Dexamethasone | * Matching placebo 1-2 h before administration of chemotherapy~* Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2-3~* Dexamethasone (20 mg orally) about 30 min before chemotherapy~ * 685 subjects were randomized to control~ * 674 of those who were randomized to control received control in C1~ * Safety = 674 control | 103 | 674 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 6 cycles (median number of cycles=4; median duration of each cycle = 21 days) of treatment
Source ClinicalTrials.gov
Trial
- Title
- Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
- NCT number
- NCT01500226
- Phases
- PHASE3
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Interventions
- Rolapitant, Granisetron, Dexamethasone, Placebo
- Lead sponsor
- Tesaro, Inc.
- Results first posted
- 2015-11-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01500226?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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