Comparison · NCT03126227-aa3fbaac
AR101 Powder Provided in Capsules vs Placebo Powder: Frequency of Anaphylaxis as Defined in the Protocol
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. AR101 Powder Provided in Capsules vs Placebo Powder: Frequency of Anaphylaxis as Defined in the Protocol. Trial comparisons, record NCT03126227-aa3fbaac. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03126227-aa3fbaac
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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 | 0.107 | 0.0782 | 0.144 | wilson | |
| Risk in group 2 | 0.0536 | 0.0284 | 0.0987 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0533 | -0.000177 | 0.0984 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.99 | 0.984 | 4.04 | log | |
| Odds ratio, group 1 over group 2 | 2.11 | 0.993 | 4.5 | log | |
| Number needed to treat, for one more participant with the outcome on AR101 Powder Provided in Capsules than on Placebo Powder | 18.8 | 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 | AR101 Powder Provided in Capsules | Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol~AR101: AR101 powder provided in capsules | 36 | 337 | OG000 |
| Group 2 | Placebo Powder | Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.~Placebo: Placebo powder provided in capsules | 9 | 168 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Frequency of Anaphylaxis as Defined in the Protocol
- Description
Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:~1. Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence).~2. Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain).~3. Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or \> 30% drop in systolic BP; Adults: systolic BP \< 90 mm Hg or \> 30% drop from their baseline.
- Time frame
- Approximately 6 months
- Population
- Safety population defined as all subjects who received at least 1 dose of randomized study treatment
Source ClinicalTrials.gov
Trial
- Title
- Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
- NCT number
- NCT03126227
- Phases
- PHASE3
- Conditions
- Peanut Allergy
- Interventions
- AR101, Placebo
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Results first posted
- 2021-11-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03126227?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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