Comparison · NCT00882583-sae
Cohort A vs Cohort B: 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. Cohort A vs Cohort B: serious adverse events. Trial comparisons, record NCT00882583-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00882583-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 | 0.143 | 0.0257 | 0.513 | wilson | |
| Risk in group 2 | 0.417 | 0.193 | 0.68 | wilson | |
| Risk difference, group 1 minus group 2 | -0.274 | -0.562 | 0.159 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.343 | 0.0496 | 2.37 | log | |
| Odds ratio, group 1 over group 2 | 0.233 | 0.021 | 2.59 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort A than on Cohort B | 3.65 | 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 | In both Cohort A and B, there will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy. | 1 | 7 | EG000 |
| Group 2 | Cohort B | In both Cohort A and B, there will be an initial run-in period of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy. | 5 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of treatment to 30 days after completion of RT and last dose of Dasatinib. All-cause mortality was based on 2-year follow-up.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC
- NCT number
- NCT00882583
- Phases
- PHASE1
- Conditions
- Head and Neck Cancer
- Interventions
- Cetuximab, Dasatinib, Cisplatin, Radiation Therapy
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Results first posted
- 2017-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00882583?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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GET https://conductscience.org/api/comparisons/v1/NCT00882583-sae