Comparison · NCT00878709-sae
Neratinib vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Neratinib vs Placebo: serious adverse events. Trial comparisons, record NCT00878709-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00878709-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 | 0.0732 | 0.0607 | 0.0879 | wilson | |
| Risk in group 2 | 0.0604 | 0.0491 | 0.074 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0128 | -0.00572 | 0.0314 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.918 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.913 | 1.65 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Neratinib than on Placebo | 78.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Neratinib | Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred. | 103 | 1,408 | EG000 |
| Group 2 | Placebo | Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred. | 85 | 1,408 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose through 28 days after the last dose, up to two years.
Source ClinicalTrials.gov
Trial
- Title
- Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
- NCT number
- NCT00878709
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- neratinib, placebo
- Lead sponsor
- Puma Biotechnology, Inc.
- Results first posted
- 2017-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00878709?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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