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This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™ regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years, inclusive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR101 Powder Provided in Capsules | Active Comparator | Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol |
|
| Placebo powder | Placebo Comparator | Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR101 | Biological | AR101 powder provided in capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product. | Approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | |
| Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | Approximately 6 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Medical Research of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34389504 | Derived | Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo Powder |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2017 | Aug 9, 2021 |
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2:1 randomization to AR101 or placebo
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| Placebo |
| Biological |
Placebo powder provided in capsules |
|
| Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | Approximately 6 months |
| Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Approximately 6 months |
| Frequency of Anaphylaxis as Defined in the Protocol | Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:
| Approximately 6 months |
| Frequency of Epinephrine Use as Rescue Medication | Approximately 6 months |
| Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | Approximately 6 months |
| Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 4-11 years included 4 questions for the subject and 3 questions for the parent; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control) | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) |
| Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 12-17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control). | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) |
| Frequency of Adverse Events That Led to Early Withdrawal | Approximately 6 months |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Banner University of Arizona Medical Center | Tucson | Arizona | 85724 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
| Jonathan Corren, M.D., Inc. | Los Angeles | California | 90025 | United States |
| Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy | Los Angeles | California | 90027 | United States |
| Allergy & Asthma Associates of Southern California | Mission Viejo | California | 92691 | United States |
| Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital | Mountain View | California | 94040 | United States |
| Peninsula Research Associates, Inc. | Rolling Hills Estates | California | 90274 | United States |
| Allergy & Asthma Medical Group and Research Center, A.P.C | San Diego | California | 92123 | United States |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | United States |
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| Allergy & Asthma Associates of Santa Clara Valley Research Center | San Jose | California | 95117 | United States |
| UCLA Medical Center, Santa Monica | Santa Monica | California | 90404 | United States |
| Allergy and Asthma Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Asthma & Allergy Associates, PC | Colorado Springs | Colorado | 80907 | United States |
| National Jewish Health | Denver | Colorado | 80206-2761 | United States |
| Colorado Allergy & Asthma Centers | Denver | Colorado | 80230 | United States |
| Children's National Health System | Washington D.C. | District of Columbia | 20010 | United States |
| Sher Allergy Specialists - Center for Cough | Largo | Florida | 33778 | United States |
| Allergy Associates of the Palm Beaches | North Palm Beach | Florida | 33408 | United States |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | United States |
| University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit | Tampa | Florida | 33613 | United States |
| Atlanta Allergy & Asthma Clinic, PA | Marietta | Georgia | 30060 | United States |
| Idaho Allergy and Research | Eagle | Idaho | 83616 | United States |
| Ann & Robert H. Lurie's Children's Hospital of Chicago | Chicago | Illinois | 60611-2605 | United States |
| The University of Chicago Medicine, Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| Sneeze, Wheeze, & Itch Associates, LLC | Normal | Illinois | 61761 | United States |
| Deaconess Clinic Downtown | Evansville | Indiana | 47713 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Family Allergy & Asthma Research Institute | Louisville | Kentucky | 40215 | United States |
| Chesapeake Clinical Research, Inc. | Baltimore | Maryland | 21236 | United States |
| Johns Hopkins Hospital, Pediatric Clinical Research Unit | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System / Michigan Medicine | Ann Arbor | Michigan | 48109 | United States |
| Clinical Research Institute, Inc. | Plymouth | Minnesota | 55441 | United States |
| Children's Mercy on Broadway | Kansas City | Missouri | 64111 | United States |
| Nebraska Medical Research Institute, Inc. | Bellevue | Nebraska | 68123 | United States |
| Atlantic Research Center, LLC | Ocean City | New Jersey | 07712 | United States |
| Princeton Center for Clinical Research | Skillman | New Jersey | 08558 | United States |
| Northwell Health System | Great Neck | New York | 11021 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC) | Chapel Hill | North Carolina | 27599 | United States |
| National Allergy and Asthma Research, LLC | Charleston | North Carolina | 29420 | United States |
| Clinical Research of Charlotte | Charlotte | North Carolina | 28277 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Oklahoma Institute of Allergy and Asthma Clinical Research, LLC | Oklahoma City | Oklahoma | 73131 | United States |
| Columbia Asthma & Allergy Clinic | Clackamas | Oregon | 97015 | United States |
| Baker Allergy, Asthma and Dermatology Research Center | Portland | Oregon | 97223 | United States |
| Children's Hospital of Philadelphia: Allergy/Immunology | Philadelphia | Pennsylvania | 19104 | United States |
| Dell Children's Medical Group / Allergy, Asthma & Immunology Clinic | Austin | Texas | 78723 | United States |
| Children's Health | Dallas | Texas | 75235 | United States |
| Western Sky Medical Research | El Paso | Texas | 79903 | United States |
| Texas Children's Hospital / Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Biogenics Research Institute | San Antonio | Texas | 78229 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| ASTHMA Inc. Clinical Research Center | Seattle | Washington | 98115 | United States |
| Triple A Lab (Hamilton Allergy) | Hamilton | Ontario | L8S 1G5 | Canada |
| McMaster University Medical Center | Hamilton | Ontario | L8S 4K1 | Canada |
| Cheema Research Inc. (CRI) | Mississauga | Ontario | L5A 3V4 | Canada |
| Ottawa Allergy Research Corp. | Ottawa | Ontario | K1G 6C6 | Canada |
| Gordon Sussman Clinical Research | Toronto | Ontario | M4V 1R2 | Canada |
Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product.
Placebo: Placebo powder provided in capsules
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 506 subjects were enrolled. However, only 505 subjects were included in the intent-to-treat (ITT) population. The ITT Population includes all subjects who received at least one dose of randomized study treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo Powder | Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product. Placebo: Placebo powder provided in capsules |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product. | Safety population defined as all subjects who received at least 1 dose of randomized study treatment. | Posted | Count of Participants | Participants | Approximately 6 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Premature Discontinuation of Dosing Due to Adverse Events | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | Safety population defined as all subjects who received at least 1 dose of randomized study treatment. Number of participants analyzed: subjects who discontinued dosing due to chronic/recurrent gastrointestinal adverse events. None of the subjects in Placebo group discontinued dosing due to chronic/recurrent gastrointestinal adverse events. | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Posted | Number | number of events | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Anaphylaxis as Defined in the Protocol | Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:
| Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Posted | Count of Participants | Participants | Approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Epinephrine Use as Rescue Medication | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 4-11 years included 4 questions for the subject and 3 questions for the parent; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control) | Safety population defined as all subjects who received at least 1 dose of randomized study treatment (included subjects ages 4-11 only). The ACT questionnaire was not completed by all subjects and/or parents at all protocol-defined points of collection. | Posted | Mean | Standard Deviation | Change in ACT total score from baseline | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 12-17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control). | Safety population defined as all subjects who received at least 1 dose of randomized study treatment (included subjects ages 12-17 only). The ACT questionnaire was not completed by all subjects and/or parents at all protocol-defined points of collection. | Posted | Mean | Standard Deviation | Change in ACT total score from baseline | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Adverse Events That Led to Early Withdrawal | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Posted | Count of Participants | Participants | Approximately 6 months |
|
|
Approximately 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 337 | 2 | 337 | 334 | 337 |
| EG001 | Placebo Powder | Placebo formulation in pull-apart capsules containing only excipients color-matched to AR101 study product. Placebo: Placebo powder provided in capsules | 1 | 168 | 2 | 168 | 159 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute lymphocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia mycoplasma | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment | Death due to traumatic brain injury sustained in motor vehicle accident |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oral pruritus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lip pruritus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tongue pruritus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics, Inc. | 650-409-5164 | RegulatoryAffairs@aimmune.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2018 | Aug 9, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| 12-17 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Moderate AE |
|
| Severe AE |
|
| Life Threatening AE |
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| Death |
|
| Subjects with at least 1 serious adverse event |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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