Comparison · NCT03631706-sae
M7824 vs Pembrolizumab: 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. M7824 vs Pembrolizumab: serious adverse events. Trial comparisons, record NCT03631706-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03631706-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 | 0.596 | 0.516 | 0.671 | wilson | |
| Risk in group 2 | 0.401 | 0.327 | 0.481 | wilson | |
| Risk difference, group 1 minus group 2 | 0.195 | 0.0822 | 0.3 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.49 | 1.17 | 1.88 | log | |
| Odds ratio, group 1 over group 2 | 2.2 | 1.39 | 3.48 | log | |
| Number needed to harm, for one more participant with a serious adverse event on M7824 than on Pembrolizumab | 5.14 | 3.33 | 12.2 | 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 | M7824 | Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal. | 90 | 151 | EG000 |
| Group 2 | Pembrolizumab | Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal. | 61 | 152 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Time from first treatment assessed up to approximately 843 days
Source ClinicalTrials.gov
Trial
- Title
- M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT03631706
- Phases
- PHASE3
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- M7824, Pembrolizumab
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Results first posted
- 2022-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03631706?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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