Comparison · NCT03181009-deaths
Group A (300 mg Maintenance Dose) vs Group B (1200 Maintenance Dose): deaths from any cause
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. Group A (300 mg Maintenance Dose) vs Group B (1200 Maintenance Dose): deaths from any cause. Trial comparisons, record NCT03181009-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03181009-deaths
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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 | 0 | 0.114 | wilson | |
| Risk in group 2 | 0 | 0 | 0.114 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.114 | 0.114 | 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 | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Group A (300 mg Maintenance Dose) | After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle. | 0 | 30 | EG000 |
| Group 2 | Group B (1200 Maintenance Dose) | After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.~Omalizumab: All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.~Food Flour Allergens: The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle. | 0 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- 18 weeks
Source ClinicalTrials.gov
Trial
- Title
- Multi OIT to Test Immune Markers After Minimum Maintenance Dose
- NCT number
- NCT03181009
- Phases
- PHASE2
- Conditions
- Food Allergy
- Interventions
- Omalizumab, Food Flour Allergens
- Lead sponsor
- Andrew Long, PharmD
- Results first posted
- 2019-09-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03181009?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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