Comparison · NCT00676650-sae
Sunitinib and Prednisone vs Placebo and Prednisone: 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 and Prednisone vs Placebo and Prednisone: serious adverse events. Trial comparisons, record NCT00676650-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00676650-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 | 0.473 | 0.433 | 0.514 | wilson | |
| Risk in group 2 | 0.302 | 0.251 | 0.357 | wilson | |
| Risk difference, group 1 minus group 2 | 0.172 | 0.103 | 0.236 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.57 | 1.29 | 1.91 | log | |
| Odds ratio, group 1 over group 2 | 2.08 | 1.54 | 2.81 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sunitinib and Prednisone than on Placebo and Prednisone | 5.83 | 4.23 | 9.72 | from the risk difference interval |
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 | Sunitinib and Prednisone | Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. | 275 | 581 | EG000 |
| Group 2 | Placebo and Prednisone | Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution. | 86 | 285 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
- NCT number
- NCT00676650
- Phases
- PHASE3
- Conditions
- Prostatic Neoplasms
- Interventions
- Prednisone, sunitinib, Placebo, Prednisone
- Lead sponsor
- Pfizer
- Results first posted
- 2013-03-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00676650?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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