Comparison · NCT01523587-sae
Afatinib vs Erlotinib: 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. Afatinib vs Erlotinib: serious adverse events. Trial comparisons, record NCT01523587-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01523587-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 | 0.444 | 0.395 | 0.493 | wilson | |
| Risk in group 2 | 0.443 | 0.395 | 0.492 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00084 | -0.0683 | 0.0699 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.857 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.757 | 1.33 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Afatinib than on Erlotinib | 1,190 | 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 | Afatinib | Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events. | 174 | 392 | EG000 |
| Group 2 | Erlotinib | Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events. | 175 | 395 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
Source ClinicalTrials.gov
Trial
- Title
- LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
- NCT number
- NCT01523587
- Phases
- PHASE3
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- afatinib, erlotinib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2014-11-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01523587?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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