Comparison · NCT00375674-sae
Sunitinib vs Placebo: 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. Sunitinib vs Placebo: serious adverse events. Trial comparisons, record NCT00375674-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00375674-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 | 0.219 | 0.176 | 0.269 | wilson | |
| Risk in group 2 | 0.171 | 0.133 | 0.217 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0479 | -0.0151 | 0.111 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.924 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 1.36 | 0.908 | 2.03 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sunitinib than on Placebo | 20.9 | 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 | Sunitinib | Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off. | 67 | 306 | EG000 |
| Group 2 | Placebo | Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off. | 52 | 304 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Cycle 1(Day 1 & Day 28); subsequent cycles (Day 1); end of treatment/withdrawal and 28 days post-treatment, or until all serious or study medication-related toxicities had resolved or were determined to be chronic or stable, whichever was later.
Source ClinicalTrials.gov
Trial
- Title
- A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
- NCT number
- NCT00375674
- Phases
- PHASE3
- Conditions
- Kidney Neoplasms
- Interventions
- Sunitinib malate, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2017-08-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00375674?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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