Comparison · NCT03359356-sae
Dupilumab 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 vs Placebo: serious adverse events. Trial comparisons, record NCT03359356-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03359356-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 | 0.025 | 0.00443 | 0.129 | wilson | |
| Risk in group 2 | 0 | 0 | 0.161 | wilson | |
| Risk difference, group 1 minus group 2 | 0.025 | -0.137 | 0.129 | 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 than on Placebo | 40 | 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 | Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses. | 1 | 40 | EG001 |
| Group 2 | Placebo | Matching placebo in prefilled syringes identical to the dupilumab syringes. 24 weeks of Placebo | 0 | 20 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 48 weeks
Source ClinicalTrials.gov
Trial
- Title
- Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)
- NCT number
- NCT03359356
- Phases
- PHASE2
- Conditions
- Alopecia Areata
- Interventions
- Dupilumab, Placebo
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Results first posted
- 2022-02-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03359356?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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