Comparison · NCT01256385-sae
Arm A (Cetuximab and Temsirolimus) vs Arm B (Temsirolimus): 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. Arm A (Cetuximab and Temsirolimus) vs Arm B (Temsirolimus): serious adverse events. Trial comparisons, record NCT01256385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01256385-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 | 0.35 | 0.221 | 0.505 | wilson | |
| Risk in group 2 | 0.475 | 0.329 | 0.625 | wilson | |
| Risk difference, group 1 minus group 2 | -0.125 | -0.323 | 0.0876 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.737 | 0.432 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 0.595 | 0.242 | 1.46 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A (Cetuximab and Temsirolimus) than on Arm B (Temsirolimus) | 8 | 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 | Arm A (Cetuximab and Temsirolimus) | Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. | 14 | 40 | EG000 |
| Group 2 | Arm B (Temsirolimus) | Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A. | 19 | 40 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
- NCT number
- NCT01256385
- Phases
- PHASE2
- Conditions
Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Squamous Cell Carcinoma, Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary, Stage IV Hypopharyngeal Squamous Cell Carcinoma, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVA Laryngeal Squamous Cell Carcinoma, Stage IVA Laryngeal Verrucous Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVA Major Salivary Gland Carcinoma, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVA Oral Cavity Verrucous Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Laryngeal Squamous Cell Carcinoma, Stage IVB Laryngeal Verrucous Carcinoma, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Major Salivary Gland Carcinoma, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVB Oral Cavity Verrucous Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Laryngeal Squamous Cell Carcinoma, Stage IVC Laryngeal Verrucous Carcinoma, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVC Major Salivary Gland Carcinoma, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVC Oral Cavity Verrucous Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, Tongue Carcinoma
- Interventions
- Cetuximab, Laboratory Biomarker Analysis, Temsirolimus
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2017-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01256385?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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