Comparison · NCT03562377-sae
Tralokinumab 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. Tralokinumab vs Placebo: serious adverse events. Trial comparisons, record NCT03562377-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03562377-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 | 0.028 | 0.00958 | 0.0792 | wilson | |
| Risk in group 2 | 0.028 | 0.00958 | 0.0792 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0544 | 0.0544 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.206 | 4.84 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.197 | 5.07 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tralokinumab | Tralokinumab | 3 | 107 | EG000 |
| Group 2 | Placebo | Placebo | 3 | 107 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs were collected from time of first trial-related activity after the subject had signed the ICF until completion of the clinical trial (defined as the safety follow up visit at Week 30). Non-serious AEs possibly/probably related to IMP and ongoing at the time of trial completion were followed up for 2 weeks or until final outcome, whichever came first. Serious AEs were followed up until final outcome had been established.
Source ClinicalTrials.gov
Trial
- Title
- Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
- NCT number
- NCT03562377
- Phases
- PHASE2
- Conditions
- Atopic Dermatitis
- Interventions
- Tralokinumab, Placebo, Tdap vaccine, Meningococcal vaccine
- Lead sponsor
- LEO Pharma
- Results first posted
- 2021-03-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03562377?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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