Comparison · NCT00083889-ca37dda6
SU011248 vs IFN-α: Objective Response, Investigator's Assessment
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. SU011248 vs IFN-α: Objective Response, Investigator's Assessment. Trial comparisons, record NCT00083889-ca37dda6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00083889-ca37dda6
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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 | 0.456 | 0.406 | 0.507 | wilson | |
| Risk in group 2 | 0.12 | 0.0909 | 0.157 | wilson | |
| Risk difference, group 1 minus group 2 | 0.336 | 0.274 | 0.394 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.8 | 2.83 | 5.11 | log | |
| Odds ratio, group 1 over group 2 | 6.15 | 4.24 | 8.92 | log | |
| Number needed to treat, for one more participant with the outcome on SU011248 than on IFN-α | 2.98 | 2.54 | 3.65 | 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. | 171 | 375 | OG000 |
| 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. | 45 | 375 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Objective Response, Investigator's Assessment
- Description
Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study \>= 4 weeks after initial documentation of response.
- Time frame
- Day 28 of each 6-week cycle: duration of treatment phase
- Population
- ITT
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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