Comparison · NCT01744340-sae
Head and Neck vs Colon- Closed as of May 2014: 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. Head and Neck vs Colon- Closed as of May 2014: serious adverse events. Trial comparisons, record NCT01744340-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01744340-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 | 0.625 | 0.306 | 0.863 | wilson | |
| Risk in group 2 | 0.0667 | 0.0119 | 0.298 | wilson | |
| Risk difference, group 1 minus group 2 | 0.558 | 0.164 | 0.803 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 9.38 | 1.31 | 67.1 | log | |
| Odds ratio, group 1 over group 2 | 23.3 | 1.95 | 279 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Head and Neck than on Colon- Closed as of May 2014 | 1.79 | 1.25 | 6.1 | 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 | Head and Neck | Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle | 5 | 8 | EG000 |
| Group 2 | Colon- Closed as of May 2014 | Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle | 1 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected pre-study, within 72 hours of day 1 if each cycle, at day 8 of each cycle, at end of treatment visit and 30 days post last dose of drug.
Source ClinicalTrials.gov
Trial
- Title
- A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer
- NCT number
- NCT01744340
- Phases
- PHASE1, PHASE2
- Conditions
- Head and Neck Cancer, Colon Cancer
- Interventions
- Head and neck, Colon- Closed as of May 2014
- Lead sponsor
- howard safran
- Results first posted
- 2016-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01744340?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01744340-sae