Comparison · NCT02635776-cdf6b4ab
AR101 vs Placebo: Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
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. AR101 vs Placebo: Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC). Trial comparisons, record NCT02635776-cdf6b4ab. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02635776-cdf6b4ab
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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 | 0.672 | 0.623 | 0.718 | wilson | |
| Risk in group 2 | 0.0403 | 0.0173 | 0.0909 | wilson | |
| Risk difference, group 1 minus group 2 | 0.632 | 0.561 | 0.683 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 16.7 | 7.04 | 39.4 | log | |
| Odds ratio, group 1 over group 2 | 48.8 | 19.4 | 122 | log | |
| Number needed to treat, for one more participant with the outcome on AR101 than on Placebo | 1.58 | 1.46 | 1.78 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | AR101 | Study product provided as peanut protein in pull-apart capsules or sachets.~AR101 powder provided in capsules \& sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol | 250 | 372 | OG000 |
| Group 2 | Placebo | Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients~Placebo powder provided in capsules \& sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol | 5 | 124 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
- Description
The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
- Time frame
- 12 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
- NCT number
- NCT02635776
- Phases
- PHASE3
- Conditions
- Peanut Allergy
- Interventions
- AR101 powder provided in capsules & sachets, Placebo powder provided in capsules & sachets
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Results first posted
- 2022-03-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02635776?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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