Comparison · NCT02379052-sae
Dupilumab 300 mg QW 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. Dupilumab 300 mg QW vs Placebo: serious adverse events. Trial comparisons, record NCT02379052-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02379052-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 | 0.13 | 0.0454 | 0.321 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000139 | 0.138 | wilson | |
| Risk difference, group 1 minus group 2 | 0.13 | -0.0317 | 0.321 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Dupilumab 300 mg QW than on Placebo | 7.67 | 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 | Dupilumab 300 mg QW | Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections. | 3 | 23 | EG001 |
| Group 2 | Placebo | Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections. | 0 | 24 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse event (AE) information was collected from the time the informed consent was signed until the participant's last study visit. Serious adverse event (SAE) information was collected until the event was considered chronic and/or stable.
Source ClinicalTrials.gov
Trial
- Title
- Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)
- NCT number
- NCT02379052
- Phases
- PHASE2
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Dupilumab, Placebo
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2020-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02379052?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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