Comparison · NCT01367002-sae
Carboplatin/Paclitaxel vs Trastuzumab: 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. Carboplatin/Paclitaxel vs Trastuzumab: serious adverse events. Trial comparisons, record NCT01367002-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01367002-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 | 0.214 | 0.102 | 0.395 | wilson | |
| Risk in group 2 | 0.438 | 0.282 | 0.607 | wilson | |
| Risk difference, group 1 minus group 2 | -0.223 | -0.426 | 0.0157 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.49 | 0.218 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.351 | 0.112 | 1.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Carboplatin/Paclitaxel than on Trastuzumab | 4.48 | 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 | Carboplatin/Paclitaxel | Chemotherapy~Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel. | 6 | 28 | EG000 |
| Group 2 | Trastuzumab | Monoclonal antibody~Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab. | 14 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 30 days post treatment (treatment could last as long as 6 years)
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
- NCT number
- NCT01367002
- Phases
- PHASE2
- Conditions
- Endometrial Cancer
- Interventions
- Carboplatin/Paclitaxel, Trastuzumab
- Lead sponsor
- Yale University
- Results first posted
- 2023-04-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01367002?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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