Comparison · NCT03881696-sae
Omalizumab vs Placebo for Omalizumab: 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. Omalizumab vs Placebo for Omalizumab: serious adverse events. Trial comparisons, record NCT03881696-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03881696-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 | 0.0333 | 0.013 | 0.0826 | wilson | |
| Risk in group 2 | 0.0167 | 0.00295 | 0.0886 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0167 | -0.058 | 0.0678 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.229 | 17.5 | log | |
| Odds ratio, group 1 over group 2 | 2.03 | 0.222 | 18.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Omalizumab than on Placebo for Omalizumab | 60 | 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 | Omalizumab | Omalizumab | 4 | 120 | EG000 |
| Group 2 | Placebo for Omalizumab | Placebo for Omalizumab | 1 | 60 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Stage 1 treatment-emergent AEs were collected from first administration of study drug through end of Stage 1 (up to 20 weeks) or early termination from the study.
Source ClinicalTrials.gov
Trial
- Title
- Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
- NCT number
- NCT03881696
- Phases
- PHASE3
- Conditions
- Peanut Allergy, Multi-food Allergy
- Interventions
- Omalizumab, Placebo for Omalizumab, Multi-Allergen Oral Immunotherapy, Placebo for Multi-Allergen Oral Immunotherapy, Double-Blind Placebo-Controlled Food Challenge Based Treatment
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2024-06-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03881696?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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