Comparison · NCT02684006-sae
Avelumab + Axitinib vs Sunitinib: 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. Avelumab + Axitinib vs Sunitinib: serious adverse events. Trial comparisons, record NCT02684006-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02684006-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 | 0.532 | 0.485 | 0.579 | wilson | |
| Risk in group 2 | 0.378 | 0.334 | 0.424 | wilson | |
| Risk difference, group 1 minus group 2 | 0.154 | 0.0882 | 0.218 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.41 | 1.21 | 1.63 | log | |
| Odds ratio, group 1 over group 2 | 1.87 | 1.43 | 2.45 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Avelumab + Axitinib than on Sunitinib | 6.49 | 4.58 | 11.3 | 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 | Avelumab + Axitinib | Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was of 42 days. | 231 | 434 | EG000 |
| Group 2 | Sunitinib | Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days. | 166 | 439 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
- NCT number
- NCT02684006
- Phases
- PHASE3
- Conditions
- Renal Cell Cancer
- Interventions
- Avelumab (MSB0010718C), Axitinib (AG-013736), Sunitinib
- Lead sponsor
- Pfizer
- Results first posted
- 2024-10-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02684006?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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