Comparison · NCT01466660-sae
Afatinib vs Gefitinib: 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 Gefitinib: serious adverse events. Trial comparisons, record NCT01466660-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01466660-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 | 0.469 | 0.393 | 0.546 | wilson | |
| Risk in group 2 | 0.403 | 0.329 | 0.48 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0662 | -0.0422 | 0.172 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.906 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 1.31 | 0.84 | 2.04 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Afatinib than on Gefitinib | 15.1 | 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 | Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal. | 75 | 160 | EG000 |
| Group 2 | Gefitinib | Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal. | 64 | 159 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From first drug administration until 28 days after last drug administration, up to 2405 days. For All-Cause Mortality: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
Source ClinicalTrials.gov
Trial
- Title
- LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
- NCT number
- NCT01466660
- Phases
- PHASE2
- Conditions
- Lung Neoplasms
- Interventions
- Afatinib, gefitinib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2017-06-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01466660?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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