Comparison · NCT00656136-sae
Afatinib 50 mg/Day 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. Afatinib 50 mg/Day vs Placebo: serious adverse events. Trial comparisons, record NCT00656136-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00656136-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 | 0.349 | 0.303 | 0.397 | wilson | |
| Risk in group 2 | 0.185 | 0.136 | 0.245 | wilson | |
| Risk difference, group 1 minus group 2 | 0.164 | 0.0884 | 0.233 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.89 | 1.37 | 2.61 | log | |
| Odds ratio, group 1 over group 2 | 2.36 | 1.56 | 3.59 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Afatinib 50 mg/Day than on Placebo | 6.09 | 4.3 | 11.3 | 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 | Afatinib 50 mg/Day | Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0). | 136 | 390 | EG001 |
| Group 2 | Placebo | Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm. | 36 | 195 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the date of first drug intake up to 28 days after the last drug intake for on-treatment adverse events or the last patient out date on 4 October 2013.
Source ClinicalTrials.gov
Trial
- Title
- BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
- NCT number
- NCT00656136
- Phases
- PHASE3
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- placebo, BIBW 2992
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2013-11-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00656136?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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