Comparison · NCT00956007-sae
IMRT vs IMRT Plus Cetuximab: 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. IMRT vs IMRT Plus Cetuximab: serious adverse events. Trial comparisons, record NCT00956007-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00956007-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 | 0.177 | 0.137 | 0.226 | wilson | |
| Risk in group 2 | 0.301 | 0.25 | 0.357 | wilson | |
| Risk difference, group 1 minus group 2 | -0.123 | -0.193 | -0.0528 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.59 | 0.433 | 0.803 | log | |
| Odds ratio, group 1 over group 2 | 0.501 | 0.336 | 0.747 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on IMRT than on IMRT Plus Cetuximab | 8.1 | 5.19 | 18.9 | 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 | IMRT | Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks). | 50 | 282 | EG000 |
| Group 2 | IMRT Plus Cetuximab | Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).~Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT. | 83 | 276 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
Source ClinicalTrials.gov
Trial
- Title
- RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
- NCT number
- NCT00956007
- Phases
- PHASE3
- Conditions
- Head and Neck Cancer
- Interventions
- cetuximab, intensity-modulated radiation therapy
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2024-05-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00956007?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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