Comparison · NCT01142388-sae
Arm I (Paclitaxel) vs Arm II (Cixutumumab, Paclitaxel): 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. Arm I (Paclitaxel) vs Arm II (Cixutumumab, Paclitaxel): serious adverse events. Trial comparisons, record NCT01142388-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01142388-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 | 0.525 | 0.375 | 0.671 | wilson | |
| Risk in group 2 | 0.523 | 0.379 | 0.662 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00227 | -0.203 | 0.207 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.668 | 1.51 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.428 | 2.38 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Paclitaxel) than on Arm II (Cixutumumab, Paclitaxel) | 440 | 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 I (Paclitaxel) | Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m\^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV | 21 | 40 | EG000 |
| Group 2 | Arm II (Cixutumumab, Paclitaxel) | Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV | 23 | 44 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed at the end of each cycle (1 cycle=28 days) while on treatment and for 30 days after the end of treatment
Source ClinicalTrials.gov
Trial
- Title
- Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
- NCT number
- NCT01142388
- Phases
- PHASE2
- Conditions
Metastatic Esophageal Adenocarcinoma, Metastatic Esophageal Squamous Cell Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Recurrent Esophageal Adenocarcinoma, Recurrent Esophageal Carcinoma, Recurrent Esophageal Squamous Cell Carcinoma, Recurrent Gastroesophageal Junction Adenocarcinoma, Stage IV Esophageal Cancer AJCC v7
- Interventions
- Cixutumumab, Laboratory Biomarker Analysis, Paclitaxel, Pharmacological Study
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2015-06-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01142388?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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