Comparison · NCT00073528-sae
Placebo + Letrozole 2.5 mg vs Lapatinib 1500 mg + Letrozole 2.5 mg: 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. Placebo + Letrozole 2.5 mg vs Lapatinib 1500 mg + Letrozole 2.5 mg: serious adverse events. Trial comparisons, record NCT00073528-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00073528-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 | 0.165 | 0.138 | 0.196 | wilson | |
| Risk in group 2 | 0.229 | 0.199 | 0.263 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0643 | -0.108 | -0.0206 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.72 | 0.574 | 0.902 | log | |
| Odds ratio, group 1 over group 2 | 0.664 | 0.502 | 0.878 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Placebo + Letrozole 2.5 mg than on Lapatinib 1500 mg + Letrozole 2.5 mg | 15.6 | 9.3 | 48.5 | 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 | Placebo + Letrozole 2.5 mg | Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. | 103 | 624 | EG000 |
| Group 2 | Lapatinib 1500 mg + Letrozole 2.5 mg | Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. | 150 | 654 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 663.9 weeks (treatment duration ranged from 0.1 to 659.9 weeks).
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
- NCT number
- NCT00073528
- Phases
- PHASE3
- Conditions
- Breast Neoplasms
- Interventions
- Lapatinib, Letrozole, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2012-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00073528?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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GET https://conductscience.org/api/comparisons/v1/NCT00073528-sae