Comparison · NCT01196390-sae
Chemoradiation and Trastuzumab vs Chemoradiation: 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. Chemoradiation and Trastuzumab vs Chemoradiation: serious adverse events. Trial comparisons, record NCT01196390-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01196390-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 | 0.537 | 0.437 | 0.634 | wilson | |
| Risk in group 2 | 0.354 | 0.266 | 0.454 | wilson | |
| Risk difference, group 1 minus group 2 | 0.183 | 0.0417 | 0.314 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.52 | 1.09 | 2.11 | log | |
| Odds ratio, group 1 over group 2 | 2.11 | 1.18 | 3.78 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Chemoradiation and Trastuzumab than on Chemoradiation | 5.47 | 3.19 | 24 | 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 | Chemoradiation and Trastuzumab | Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab | 51 | 95 | EG000 |
| Group 2 | Chemoradiation | Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery | 34 | 96 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Day 8, 15, 22, 29, and 36 and completion (day 57) of concurrent chemoradiation, before surgery (5-8 weeks after last radiation treatment), every 4 mos from the end of surgery for 2 years, then annually until study completion. Maximum follow-up at time of analysis was 8.0 years.
Source ClinicalTrials.gov
Trial
- Title
- Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
- NCT number
- NCT01196390
- Phases
- PHASE3
- Conditions
Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Stage IB Esophageal Cancer AJCC v7, Stage IIA Esophageal Cancer AJCC v7, Stage IIB Esophageal Cancer AJCC v7, Stage IIIA Esophageal Cancer AJCC v7, Stage IIIB Esophageal Cancer AJCC v7
- Interventions
- Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Radiation Therapy, Therapeutic Conventional Surgery, Trastuzumab
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-05-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01196390?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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