Comparison · NCT01808573-sae
Neratinib Plus Capecitabine vs Lapatinib Plus Capecitabine: 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. Neratinib Plus Capecitabine vs Lapatinib Plus Capecitabine: serious adverse events. Trial comparisons, record NCT01808573-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01808573-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 | 0.34 | 0.289 | 0.395 | wilson | |
| Risk in group 2 | 0.299 | 0.251 | 0.352 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0409 | -0.0327 | 0.114 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.902 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 1.21 | 0.859 | 1.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Neratinib Plus Capecitabine than on Lapatinib Plus Capecitabine | 24.5 | 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 | Neratinib Plus Capecitabine | neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle. | 103 | 303 | EG000 |
| Group 2 | Lapatinib Plus Capecitabine | lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle. | 93 | 311 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From time of first dose, through 28 days after last dose, assessed up to 41 months.
Source ClinicalTrials.gov
Trial
- Title
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
- NCT number
- NCT01808573
- Phases
- PHASE3
- Conditions
- HER2+ Metastatic Breast Cancer (MBC)
- Interventions
- neratinib, capecitabine, lapatinib
- Lead sponsor
- Puma Biotechnology, Inc.
- Results first posted
- 2019-12-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01808573?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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