Comparison · NCT03157089-sae
Afatinib 40 mg + Pembrolizumab 200 mg vs Afatinib 30 mg + Pembrolizumab 200 mg: 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 40 mg + Pembrolizumab 200 mg vs Afatinib 30 mg + Pembrolizumab 200 mg: serious adverse events. Trial comparisons, record NCT03157089-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03157089-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 | 0.333 | 0.138 | 0.609 | wilson | |
| Risk in group 2 | 0.75 | 0.468 | 0.911 | wilson | |
| Risk difference, group 1 minus group 2 | -0.417 | -0.67 | -0.0218 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.444 | 0.187 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.167 | 0.0283 | 0.983 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Afatinib 40 mg + Pembrolizumab 200 mg than on Afatinib 30 mg + Pembrolizumab 200 mg | 2.4 | 1.49 | 45.8 | from the risk difference interval |
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 40 mg + Pembrolizumab 200 mg | 40 milligram (mg) of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles. | 4 | 12 | EG000 |
| Group 2 | Afatinib 30 mg + Pembrolizumab 200 mg | 30 mg of afatinib film-coated tablet, given orally with a glass of water (without food consumption 3 hours (h) prior and 1h post afatinib administration), once daily + pembrolizumab 200 mg, intravenous infusion, once every 3 weeks.~Both afatinib and pembrolizumab were to be given until documented disease progression, or unacceptable adverse events, or other reasons requiring treatment discontinuation, or for up to 35 cycles of 21 days (i.e. the approved pembrolizumab monotherapy duration). In case of early discontinuation of one agent, the other agent could be continued as monotherapy for altogether up to 35 cycles. | 9 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
[Timeframe for All-Cause Mortality]: From Day 1 of study treatment (afatinib or pembrolizumab) administration up to a total of 574 days. [Timeframe for Serious and Other Adverse Events]: From the time of first drug administration till the end of treatment + 30 days residual effect period (REP), up to 558 days.
Source ClinicalTrials.gov
Trial
- Title
- Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung
- NCT number
- NCT03157089
- Phases
- PHASE2
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Afatinib, pembrolizumab
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2021-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03157089?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT03157089-sae