Comparison · NCT02912468-sae
Dupilumab 300 mg 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. Dupilumab 300 mg vs Placebo: serious adverse events. Trial comparisons, record NCT02912468-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02912468-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 | 0.042 | 0.0194 | 0.0885 | wilson | |
| Risk in group 2 | 0.144 | 0.0941 | 0.214 | wilson | |
| Risk difference, group 1 minus group 2 | -0.102 | -0.175 | -0.0338 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.291 | 0.12 | 0.708 | log | |
| Odds ratio, group 1 over group 2 | 0.26 | 0.101 | 0.674 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dupilumab 300 mg than on Placebo | 9.81 | 5.7 | 29.6 | 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 | Dupilumab 300 mg | Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose. | 6 | 143 | EG001 |
| Group 2 | Placebo | Placebo (for dupilumab), 1 SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose. | 19 | 132 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All Adverse Events (AEs) were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of TEAE was up to 36 weeks.
Source ClinicalTrials.gov
Trial
- Title
- A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
- NCT number
- NCT02912468
- Phases
- PHASE3
- Conditions
- Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
- Interventions
- Dupilumab SAR231893 (REGN668), Placebo, Mometasone furoate 50 micrograms
- Lead sponsor
- Sanofi
- Results first posted
- 2019-07-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02912468?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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