Comparison · NCT00876395-sae
Everolimus+ Paclitaxel+ Trastuzumab vs Placebo+ Paclitaxel+ 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. Everolimus+ Paclitaxel+ Trastuzumab vs Placebo+ Paclitaxel+ Trastuzumab: serious adverse events. Trial comparisons, record NCT00876395-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00876395-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 | 0.367 | 0.324 | 0.411 | wilson | |
| Risk in group 2 | 0.168 | 0.126 | 0.221 | wilson | |
| Risk difference, group 1 minus group 2 | 0.198 | 0.131 | 0.26 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.18 | 1.61 | 2.96 | log | |
| Odds ratio, group 1 over group 2 | 2.86 | 1.94 | 4.22 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Everolimus+ Paclitaxel+ Trastuzumab than on Placebo+ Paclitaxel+ Trastuzumab | 5.04 | 3.85 | 7.64 | 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 | Everolimus+ Paclitaxel+ Trastuzumab | Everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 | 173 | 472 | EG000 |
| Group 2 | Placebo+ Paclitaxel+ Trastuzumab | Placebo of everolimus 10 mg daily in combination with paclitaxel 80mg/m2 weekly on days 1, 8, 15 and trastuzumab 2mg/kg weekly on days 1, 8, 15, 22 | 40 | 238 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until 30 days after Last Patient Last Visit.
Source ClinicalTrials.gov
Trial
- Title
- Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
- NCT number
- NCT00876395
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Everolimus, Placebo, Trastuzumab, Paclitaxel
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2018-12-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00876395?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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