Comparison · NCT02952586-sae
Avelumab + Standard of Care Chemotherapy (SOC CRT) vs Placebo + SOC CRT: 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 + Standard of Care Chemotherapy (SOC CRT) vs Placebo + SOC CRT: serious adverse events. Trial comparisons, record NCT02952586-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02952586-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 | 0.529 | 0.476 | 0.581 | wilson | |
| Risk in group 2 | 0.515 | 0.462 | 0.567 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0142 | -0.0599 | 0.0881 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.891 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.786 | 1.43 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Avelumab + Standard of Care Chemotherapy (SOC CRT) than on Placebo + SOC CRT | 70.4 | 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 | Avelumab + Standard of Care Chemotherapy (SOC CRT) | Participants with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) were administered with avelumab 10 milligram per kilogram (mg/kg) intravenous (IV) injection on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin 100 milligram per square meter (mg/m\^2) on Days 1, 22, 43 and intensity-modulated radiation therapy (IMRT) 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received avelumab 10 mg/kg IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term (LT) follow up period every 16 weeks for survival and new systemic anticancer treatment. | 184 | 348 | EG000 |
| Group 2 | Placebo + SOC CRT | Participants with LA SCCHN were administered with placebo IV injection matched to avelumab on Day 1 of the Lead-in Phase (7 days) and on Days 8, 25 and 39 in CRT phase (63 days). In CRT phase participants also received SOC CRT: cisplatin mg/m\^2 on Days 1, 22 and 43 + IMRT 5 days a week. CRT phase was followed by maintenance phase (12 months) in which participants received placebo IV injection every 2 weeks. All participants were followed for safety 30 days after the last study treatment administration or until the time of initiation of new systemic anticancer treatment. If any concern arose participants were followed up on Day 90 via telephone call thereafter in long term follow up period every 16 weeks for survival and new systemic anticancer treatment. | 177 | 344 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to 44 months
Source ClinicalTrials.gov
Trial
- Title
Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)
- NCT number
- NCT02952586
- Phases
- PHASE3
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Avelumab, Chemoradiation
- Lead sponsor
- Pfizer
- Results first posted
- 2021-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02952586?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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