Oral Desensitization to Peanut in Peanut Allergic Childre... | NCT02198664

NCT02198664

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARC001 placebo group	Experimental	Subjects who received placebo in study ARC001.	Biological: AR101 - Peanut protein capsule
ARC001 AR101 group	Experimental	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.	Biological: AR101 - Peanut protein capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AR101 - Peanut protein capsule	Biological	Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months	TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).	Up to 90 weeks

Secondary Outcomes

Measure	Description	Time Frame
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC		Up to 36 weeks
The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Director of Regulatory Affairs	Aimmune Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Hospital		Little Rock	Arkansas	72202	United States
UC San Diego

References Module

Citations

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.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 15, 2017	Jul 7, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

ARC001 placebo group

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
BG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00026 BG00121 BG00247

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG0008.5(5.0 to 14.0) BG0018.0(4.0 to 21.0) BG0028.0(4.0 to 21.0)

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

4-17 years

Title	Measurements
	BG00026 BG00120 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00010 BG0017 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

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

Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months

TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).

The Safety Population (those who received any amount of AR101)

Posted

Count of Participants

Participants

Up to 90 weeks

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units	Counts
Participants	OG00026 OG00121

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG00026 OG00121

Any Grade 3 or Higher TEAE

Title	Measurements
	OG000

Secondary

The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC

The Safety Population (those who received any amount of AR101). Only results for the "ARC001 AR101 Group" is reported as only subjects in this group had Up-dosing DBPCFC in ARC002 study.

Posted

Count of Participants

Participants

Up to 36 weeks

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units	Counts
Participants	OG000

Secondary

The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.

The Safety Population (those who received any amount of AR101). Multiple food challenge dose levels were given at each DBPCFC, so results at 300 mg and 600 mg for Maintenance DBPCFC are not expected to match those for Up-dosing DBPCFC.

Posted

Count of Participants

Participants

Up to 60 weeks.

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units	Counts

Secondary

Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein

The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.

Only includes food challenge completer population

Posted

Geometric Mean

Standard Deviation

Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Secondary

Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated

The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs

Only includes food challenge completer population

Posted

Count of Participants

Participants

Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units	Counts

Secondary

Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance

The Safety Population (those who received any amount of AR101)

Posted

Geometric Mean

Standard Deviation

kU/L

Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units	Counts
Participants	OG000

Secondary

Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance

The Safety Population (those who received any amount of AR101)

Posted

Geometric Mean

Standard Deviation

μg/mL

Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units	Counts
Participants

Secondary

Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance

The Safety Population (those who received any amount of AR101)

Posted

Mean

Standard Deviation

millimeter

Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units	Counts
Participants

Secondary

Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC

Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC

Only subjects who completed the food challenge at each challenge dose during the Up-dosing DBPCFC were analyzed

Posted

Count of Participants

Participants

Up to 36 weeks for up-dosing

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units	Counts

Secondary

Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC

Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC

Only subjects who completed the food challenge at each challenge dose during the Maintenance DBPCFC were analyzed

Posted

Count of Participants

Participants

Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg).
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Units

Secondary

Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.

A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.

The Safety Population (those who received any amount of AR101)

Posted

Mean

Standard Deviation

score on a scale

Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)

ID	Title	Description
OG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
OG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ARC001 Placebo Group	Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	0	26	0	26	26	26
EG001	ARC001 AR101 Group	Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)	0	21	1	21	21	21

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaphylactic reaction	Immune system disorders	MedDRA (16.0)	Systematic Assessment		EG0000 affected26 at risk EG0011 affected21 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00015 affected26 at risk EG0019 affected21 at risk
Vomiting	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00015 affected26 at risk EG0018 affected21 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected26 at risk EG0017 affected21 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected26 at risk EG0016 affected21 at risk
Oral pruritus	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected26 at risk EG0012 affected21 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0013 affected21 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0013 affected21 at risk
Lip swelling	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0004 affected26 at risk EG0012 affected21 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0011 affected21 at risk
Constipation	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected26 at risk EG0011 affected21 at risk
Gastritis	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected26 at risk EG0011 affected21 at risk
Lip pruritus	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected26 at risk EG0012 affected21 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG00010 affected26 at risk EG0015 affected21 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0007 affected26 at risk EG0018 affected21 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0004 affected26 at risk EG0015 affected21 at risk
Viral infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0005 affected26 at risk EG0014 affected21 at risk
Gastroenteritis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0015 affected21 at risk
Nasopharyngitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0004 affected26 at risk EG0014 affected21 at risk
Otitis media	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0012 affected21 at risk
Ear infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0002 affected26 at risk EG0012 affected21 at risk
Influenza	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0002 affected26 at risk EG0012 affected21 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG00011 affected26 at risk EG0016 affected21 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0009 affected26 at risk EG0017 affected21 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected26 at risk EG0014 affected21 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected26 at risk EG0015 affected21 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0008 affected26 at risk EG0013 affected21 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected26 at risk EG0015 affected21 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected26 at risk EG0013 affected21 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected26 at risk EG0012 affected21 at risk
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0011 affected21 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected26 at risk EG0011 affected21 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected26 at risk EG0015 affected21 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0005 affected26 at risk EG0015 affected21 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0005 affected26 at risk EG0014 affected21 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected26 at risk EG0013 affected21 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected26 at risk EG0011 affected21 at risk
Pyrexia	General disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected26 at risk EG0016 affected21 at risk
Chest discomfort	General disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected26 at risk EG0012 affected21 at risk
Malaise	General disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected26 at risk EG0012 affected21 at risk
Hypersensitivity	Immune system disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected26 at risk EG0017 affected21 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (16.0)	Systematic Assessment	EG0004 affected26 at risk EG0012 affected21 at risk
Seasonal allergy	Immune system disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected26 at risk EG0013 affected21 at risk
Food allergy	Immune system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected26 at risk EG0013 affected21 at risk
Headache	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0006 affected26 at risk EG0018 affected21 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0011 affected21 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (16.0)	Systematic Assessment	EG0002 affected26 at risk EG0011 affected21 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (16.0)	Systematic Assessment	EG0002 affected26 at risk EG0011 affected21 at risk
Eye pruritus	Eye disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected26 at risk EG0012 affected21 at risk
Ear pruritus	Ear and labyrinth disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0010 affected21 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0010 affected21 at risk
Flushing	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG0003 affected26 at risk EG0010 affected21 at risk

ID	Term
D021183	Peanut Hypersensitivity

Units	Counts
Participants	OG00026 OG00121

ID	Term
D000074924	Nut and Peanut Hypersensitivity
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases