Comparison · NCT00075270-sae
Lapatinib With Paclitaxel vs Placebo With Paclitaxel: 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. Lapatinib With Paclitaxel vs Placebo With Paclitaxel: serious adverse events. Trial comparisons, record NCT00075270-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00075270-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 | 0.352 | 0.299 | 0.408 | wilson | |
| Risk in group 2 | 0.22 | 0.176 | 0.272 | wilson | |
| Risk difference, group 1 minus group 2 | 0.131 | 0.0577 | 0.203 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.6 | 1.22 | 2.09 | log | |
| Odds ratio, group 1 over group 2 | 1.92 | 1.33 | 2.77 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lapatinib With Paclitaxel than on Placebo With Paclitaxel | 7.62 | 4.93 | 17.3 | 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 | Lapatinib With Paclitaxel | Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m\^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. | 103 | 293 | EG000 |
| Group 2 | Placebo With Paclitaxel | Participants received matching placebo orally OD with paclitaxel (175 mg/m\^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal. | 63 | 286 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events (SAEs) and adverse events were collected from the first dose of randomized therapy until 30 days after the last dose of randomized therapy (average of 26 weeks).
Source ClinicalTrials.gov
Trial
- Title
- Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
- NCT number
- NCT00075270
- Phases
- PHASE3
- Conditions
- Neoplasms, Breast
- Interventions
- Paclitaxel, GW572016 (Lapatinib)
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2014-03-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00075270?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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