Comparison · NCT00083889-sae
SU011248 vs IFN-α: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. SU011248 vs IFN-α: serious adverse events. Trial comparisons, record NCT00083889-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00083889-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 | 0.453 | 0.404 | 0.504 | wilson | |
| Risk in group 2 | 0.258 | 0.216 | 0.306 | wilson | |
| Risk difference, group 1 minus group 2 | 0.195 | 0.126 | 0.261 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.75 | 1.43 | 2.16 | log | |
| Odds ratio, group 1 over group 2 | 2.38 | 1.74 | 3.25 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SU011248 than on IFN-α | 5.13 | 3.83 | 7.92 | 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 | SU011248 | 50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered. | 170 | 375 | EG000 |
| Group 2 | IFN-α | Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity. | 93 | 360 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
- NCT number
- NCT00083889
- Phases
- PHASE3
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Interferon-alfa, SU011248
- Lead sponsor
- Pfizer
- Results first posted
- 2009-12-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00083889?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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