Comparison · NCT00374322-sae
Lapatinib 1500 mg 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
Cite this record
ConductScience Library. Lapatinib 1500 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00374322-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00374322-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 | 0.0629 | 0.052 | 0.076 | wilson | |
| Risk in group 2 | 0.0496 | 0.0399 | 0.0614 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0134 | -0.00277 | 0.0297 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 0.952 | 1.69 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.949 | 1.75 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lapatinib 1500 mg than on Placebo | 74.7 | 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 | Lapatinib 1500 mg | Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal. | 99 | 1,573 | EG000 |
| Group 2 | Placebo | Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal. | 78 | 1,574 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Non-serious adverse events (AEs): collected from start of treatment until up to 5 days after the last dose of study treatment (up to 12 months). SAEs: collected up to any time during the follow-up period post discontinuation of study drug (up to 6 years).
Source ClinicalTrials.gov
Trial
- Title
- Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
- NCT number
- NCT00374322
- Phases
- PHASE3
- Conditions
- Neoplasms, Breast
- Interventions
- lapatinib, placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2014-08-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00374322?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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