Comparison · NCT01302834-sae
IMRT + Cisplatin vs IMRT + 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 + Cisplatin vs IMRT + Cetuximab: serious adverse events. Trial comparisons, record NCT01302834-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01302834-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 | 0.445 | 0.397 | 0.494 | wilson | |
| Risk in group 2 | 0.292 | 0.249 | 0.339 | wilson | |
| Risk difference, group 1 minus group 2 | 0.153 | 0.0858 | 0.218 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.52 | 1.26 | 1.84 | log | |
| Odds ratio, group 1 over group 2 | 1.94 | 1.45 | 2.61 | log | |
| Number needed to harm, for one more participant with a serious adverse event on IMRT + Cisplatin than on IMRT + Cetuximab | 6.54 | 4.59 | 11.7 | 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 + Cisplatin | Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin~Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy. | 177 | 398 | EG000 |
| Group 2 | IMRT + Cetuximab | Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab~Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks~IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy. | 115 | 394 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization to last follow-up. Maximum follow-up was 7.4 years.
Source ClinicalTrials.gov
Trial
- Title
- Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
- NCT number
- NCT01302834
- Phases
- PHASE3
- Conditions
- Head and Neck Cancer, Precancerous Condition
- Interventions
- cetuximab, cisplatin, IMRT
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2020-01-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01302834?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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