Comparison · NCT01097642-sae
Ixabepilone vs Ixabepilone 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. Ixabepilone vs Ixabepilone Plus Cetuximab: serious adverse events. Trial comparisons, record NCT01097642-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01097642-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 | 0.133 | 0.0374 | 0.379 | wilson | |
| Risk in group 2 | 0.24 | 0.115 | 0.434 | wilson | |
| Risk difference, group 1 minus group 2 | -0.107 | -0.323 | 0.169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.556 | 0.128 | 2.41 | log | |
| Odds ratio, group 1 over group 2 | 0.487 | 0.0848 | 2.8 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ixabepilone than on Ixabepilone Plus Cetuximab | 9.38 | 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 | Ixabepilone | Brand name is Ixempra ®; it is an epothilone B analog used in combination with other chemotherapeutics against cancer.~Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles. | 2 | 15 | EG000 |
| Group 2 | Ixabepilone Plus Cetuximab | Cetuximab, brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor and monoclonal antibody used with Ixabepilone against cancer.~Cetuximab: Cetuximab will be given at 400mg/m\^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m\^2 IV over 60 minutes.~Ixabepilone: Ixabepilone will be given at 40mg/m\^2 IV over 180 minutes on day 1 of each of four 21 day cycles. | 6 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Safety was assessed from time of informed consent signing through 30 days after last treatment dose (an average of 12 weeks).
Source ClinicalTrials.gov
Trial
- Title
- Neo-Adjuvant Study in Triple Negative Breast Cancer Patients
- NCT number
- NCT01097642
- Phases
- PHASE2
- Conditions
- Breast Cancer
- Interventions
- Cetuximab, Ixabepilone
- Lead sponsor
- The Methodist Hospital Research Institute
- Results first posted
- 2021-08-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01097642?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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