Comparison · NCT01345669-sae
Afatinib (BIBW 2992) 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
Cite this record
ConductScience Library. Afatinib (BIBW 2992) vs Placebo: serious adverse events. Trial comparisons, record NCT01345669-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01345669-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 | 0.195 | 0.159 | 0.236 | wilson | |
| Risk in group 2 | 0.248 | 0.194 | 0.311 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0529 | -0.125 | 0.0149 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.786 | 0.577 | 1.07 | log | |
| Odds ratio, group 1 over group 2 | 0.735 | 0.493 | 1.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Afatinib (BIBW 2992) than on Placebo | 18.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Afatinib (BIBW 2992) | Patient received Afatinib film-coated tablets with starting dose 40 mg (milligram)/day and escalation to 50 mg/day and/or reduction to 40, 30 or 20 mg/day according to absence or presence of drug-related adverse events (AEs), orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal. | 80 | 411 | EG000 |
| Group 2 | Placebo | Patient received placebo matching Afatinib film-coated tablets with matching Afatinib dosage regimen, orally, once daily for up to 80 weeks or until recurrence / occurrence of second primary tumour, unacceptable side effects, or other reason necessitating withdrawal. | 51 | 206 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first drug administration until 4 weeks after the last drug administration, up to 84 weeks
Source ClinicalTrials.gov
Trial
- Title
- LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy
- NCT number
- NCT01345669
- Phases
- PHASE3
- Conditions
- Head and Neck Neoplasms
- Interventions
- Placebo, Afatinib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2017-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01345669?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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