Comparison · NCT00577382-sae
Cohort A-Sunitinib Intermittent Dosing vs Cohort B-Sunitinib Continuous Dosing: 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. Cohort A-Sunitinib Intermittent Dosing vs Cohort B-Sunitinib Continuous Dosing: serious adverse events. Trial comparisons, record NCT00577382-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00577382-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 | 0.476 | 0.283 | 0.676 | wilson | |
| Risk in group 2 | 0.419 | 0.264 | 0.592 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0568 | -0.202 | 0.31 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.617 | 2.09 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.413 | 3.84 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort A-Sunitinib Intermittent Dosing than on Cohort B-Sunitinib Continuous Dosing | 17.6 | 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 | Cohort A-Sunitinib Intermittent Dosing | Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year. | 10 | 21 | EG000 |
| Group 2 | Cohort B-Sunitinib Continuous Dosing | Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year. | 13 | 31 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AE assessment was ongoing from the start of study drug and up to day 30 post-treatment.
Source ClinicalTrials.gov
Trial
- Title
- SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
- NCT number
- NCT00577382
- Phases
- PHASE2
- Conditions
- Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant Melanoma
- Interventions
- Sunitinib
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2016-12-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00577382?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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