Comparison · NCT00424255-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
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ConductScience Library. Lapatinib 1500 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00424255-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00424255-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 | 0.484 | 0.432 | 0.537 | wilson | |
| Risk in group 2 | 0.396 | 0.345 | 0.449 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0884 | 0.014 | 0.161 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.22 | 1.03 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 1.43 | 1.06 | 1.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lapatinib 1500 mg than on Placebo | 11.3 | 6.2 | 71.2 | from the risk difference interval |
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 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m\^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner. | 169 | 349 | EG001 |
| Group 2 | Placebo | Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m\^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner. | 133 | 336 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow up of treatment (average of 141 study weeks).
Source ClinicalTrials.gov
Trial
- Title
- Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery
- NCT number
- NCT00424255
- Phases
- PHASE3
- Conditions
- Neoplasms, Head and Neck
- Interventions
- Lapatinib, Chemoradiation, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2014-02-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00424255?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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