A Randomized, Double-Blind Placebo-Controlled Peanut Subl... | NCT00580606

NCT00580606

Status Module

Sponsor/Collaborators Module

Name	Class
Consortium of Food Allergy Research	OTHER

Oversight Module

Description Module

Detailed Description

Peanut allergy is a common ailment in the United States. Research suggests that the prevalence of peanut allergy in the United States has doubled over the last 5 years. Currently, the only effective treatment for peanut allergy is a peanut-free diet and quick access to self-injectable epinephrine in the event of peanut exposure. The sublingual route is a potential method to administer immunotherapy for the treatment of food allergies. The intent of this study is to induce desensitization and eventually tolerance to peanut protein and evaluate the safety and immunologic effects of daily sublingual immunotherapy (SLIT) for individuals with peanut allergy. The trial will enroll 40 participants. After the first 10 participants between the ages of 18 and 40 are enrolled, safety information will be reviewed. If there are no safety concerns, the study will continue to enroll the remaining participants between the ages of 12 and 40.

This clinical trial will last 172 to 216 weeks. Participants will be randomly assigned to receive peanut SLIT or placebo SLIT. All participants will have an entry oral food challenge (OFC). The treatment group will receive gradual dosing escalations of peanut SLIT and maintenance therapy over a 44-week period, followed by another OFC. Following the OFC, participants will be unblinded, and the placebo group will receive peanut SLIT escalated to a higher maximum dose than the first treatment group. Maintenance therapy will continue for both groups for more than 2 years.

Study visits will occur every 2 weeks during dosing escalations of peanut SLIT, followed by visits gradually spacing out during maintenance to every 12 weeks. At selected visits, a physical examination, skin prick tests, blood and urine collection, and atopic dermatitis and asthma evaluations will occur. Approximately 6 OFCs will be administered to each participant throughout the course of the study. Additionally, 10 participants will be enrolled as control participants who will not receive any study therapy and will only have blood drawn at 3 visits throughout the course of the trial.

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
Low Dose Peanut SLIT (Double Blind to Open Label)	Experimental	Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy.	Drug: Glycerinated peanut allergenic extract
Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)	Placebo Comparator	Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.	Drug: Placebo for peanut extract (glycerin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glycerinated peanut allergenic extract	Drug	Glycerinated peanut extract delivered sublingually.	Low Dose Peanut SLIT (Double Blind to Open Label)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge	Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.	Week 44 (Double Blind Period)

Secondary Outcomes

Measure	Description	Time Frame
Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg	During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.	Week 44 (Double Blind Period)

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Wesley Burks, MD	Duke University	Study Chair
David Fleischer, MD	National Jewish Health	Study Chair
Hugh A. Sampson, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator
Stacie Jones, MD	Arkansas Children's Hospital Research Institute	Principal Investigator
Robert Wood, MD	Johns Hopkins University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas		Little Rock	Arkansas	72202	United States
National Jewish Medical and Research Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17210088	Background	de Leon MP, Rolland JM, O'Hehir RE. The peanut allergy epidemic: allergen molecular characterisation and prospects for specific therapy. Expert Rev Mol Med. 2007 Jan 9;9(1):1-18. doi: 10.1017/S1462399407000208.
17088653	Background	Enrique E, Cistero-Bahima A. Specific immunotherapy for food allergy: basic principles and clinical aspects. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):466-9. doi: 10.1097/01.all.0000246618.41871.a4.

Label	URL
National Institute of Allergy and Infectious Diseases (NIAID)	View source

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	Low Dose Peanut SLIT (Double Blind to Open Label)	Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Low Dose Peanut SLIT (Double Blind to Open Label)	Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
BG001	Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)	Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG00120 BG00240

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG00015 BG00115 BG00230
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00017.2± 7.6 BG00116.5± 3.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0007 BG0016 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	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00020 BG00120 BG002

Atopic Dermatitis Total Score

The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity.

Mean

Standard Deviation

Scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG0001.1± 1.7 BG001

Total IgE

Total amount of serum immunoglobulin E. Individuals who are not allergic may have a total IgE as high as 304 kU/L.

Mean

Standard Deviation

kU/L

Title

Denominators

Categories

Title	Measurements
	BG000407.8± 254.1 BG001330.5± 305.0

Peanut IgE

Amount of serum peanut-specific immunoglobulin E. Individuals with a peanut IgE of <0.35 kUA/L are considered not to be sensitized to peanut.

Mean

Standard Deviation

kUA/L

Title

Denominators

Categories

Title	Measurements
	BG00033.6± 38.1 BG00147.1

Peanut Skin Prick Test Score

This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the peanut wheal (in mm) observed for a skin prick test. Individuals with a peanut skin prick test score of < 3 mm are considered to have a negative result. 1 subject in the Placebo group did not have a value for this measure.

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00014.0± 6.9 BG001

Age at Initial Peanut Allergic Reaction

Two subjects in the Placebo group did not have a value for this measure.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0004.6± 6.9 BG0011.9± 1.5

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

Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge

Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.

The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.

Posted

Number

Percentage of participants

Week 44 (Double Blind Period)

ID	Title	Description
OG000	Low Dose Peanut SLIT (Double Blind)	Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
OG001	Placebo (Double Blind)	Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram

Units	Counts
Participants	OG00020 OG00120

Title

Denominators

Categories

Title	Measurements
	OG00070 OG00115

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Number of participants who successfully consumed 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline OFC was compared using Barnard's Statistic with the null hypothesis that there was no difference between treatment groups.	Barnard's Statistic	The a priori threshold for statistical significance is 0.05.	<0.001	No adjustments were made to the p-value.	Risk Difference (RD)	55			2-Sided	95	22.2	77.6					Superiority or Other

Secondary

Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg

During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.

The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.

Posted

Number

Percentage of participants

Week 44 (Double Blind Period)

ID	Title	Description
OG000	Low Dose Peanut SLIT (Double Blind)	Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
OG001	Placebo (Double Blind)	Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy

Secondary

Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption

Subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included except for 1 subject who refused the crossover Week 44 OFC and could not be evaluated. 4 subjects who discontinued dosing prior to the crossover Week 44 OFC were counted as failures.

Posted

Number

Percentage of participants

Week 44 after initiating crossover open label peanut protein consumption

ID	Title	Description
OG000	High Dose Peanut SLIT Crossover (Open Label)	Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.

Secondary

Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg

During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.

All subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included.

Posted

Number

Percentage of participants

Week 44 after initiating crossover open label peanut protein consumption

ID	Title	Description
OG000	High Dose Peanut SLIT Crossover (Open Label)	Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.

Units

Secondary

Number of Participants With Serious Adverse Events (SAEs)

This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.

The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.

Posted

Number

participants

Baseline through Week 44 (Double Blind Period)

ID	Title	Description
OG000	Low Dose Peanut SLIT (Double Blind)	Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
OG001	Placebo (Double Blind)	Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy

Secondary

Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption

All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.

Posted

Number

participants

Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption

ID	Title	Description
OG000	High Dose Peanut SLIT Crossover (Open Label)	Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.

Secondary

Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder

Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.

All subjects randomized to the Low Dose Peanut SLIT group and all subjects randomized to the Placebo group who crossed over to open label high dose peanut sublingual immunotherapy were included.

Posted

Number

percentage of participants

Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy

ID	Title	Description
OG000	Low Dose Peanut SLIT (Double Blind to Open Label)	Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
OG001

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)	Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy	1	20	19	20
EG001	Placebo Before Week 44 OFC (Double Blind)	Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy	0	20	20	20
EG002	High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)	Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy	0	17	17	17
EG003	Low Dose Peanut SLIT (Double Blind to Open Label)	After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy	1	18	17	18
EG004	Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)	After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy	0	17	15	17

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaphylactic Reaction	Immune system disorders	MedDRA (18.1)	Non-systematic Assessment		EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG0031 events1 affected18 at risk EG0040 events0 affected17 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment		EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG0031 events1 affected18 at risk EG0040 events0 affected17 at risk
Ear pruritus	Ear and labyrinth disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG002114 events1 affected17 at risk EG003
External ear inflammation	Ear and labyrinth disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Conjunctivitis	Eye disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0021 events1 affected17 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Eye pruritus	Eye disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Lacrimation increased	Eye disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Photophobia	Eye disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00053 events7 affected20 at risk EG0011 events1 affected20 at risk EG00233 events6 affected17 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 events2 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0022 events2 affected17 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0014 events3 affected20 at risk EG0020 events0 affected17 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0003 events2 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Food Poisoning	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0021 events1 affected17 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG00010 events2 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Oral disorder	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002,171 events17 affected20 at risk EG00123 events6 affected20 at risk EG0021,579 events16 affected17 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0008 events3 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected20 at risk EG0020 events0 affected17 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected20 at risk EG0022 events2 affected17 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Chills	General disorders	MedDRA (18.1)	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Feeling hot	General disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Influenza like illness	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected20 at risk EG0021 events1 affected17 at risk EG003
Pain	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Pyrexia	General disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0022 events1 affected17 at risk EG003
Allergy to animal	Immune system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Bronchitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0022 events2 affected17 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Cystitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Ear infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0003 events2 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0021 events1 affected17 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Influenza	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0012 events2 affected20 at risk EG0022 events2 affected17 at risk EG003
Kidney infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Laryngitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Meningitis viral	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0006 events4 affected20 at risk EG0017 events5 affected20 at risk EG0027 events3 affected17 at risk EG003
Otitis externa	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Otitis media	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Pneumonia	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Sinusitis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0005 events4 affected20 at risk EG0012 events2 affected20 at risk EG0024 events3 affected17 at risk EG003
Tinea pedis	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0005 events4 affected20 at risk EG0018 events4 affected20 at risk EG0026 events3 affected17 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Viral infection	Infections and infestations	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Cartilage injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0013 events3 affected20 at risk EG0021 events1 affected17 at risk EG003
Lip injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Sports injury	Injury, poisoning and procedural complications	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Muskuloskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Dizziness	Nervous system disorders	MedDRA (18.1)	Systematic Assessment	EG0004 events2 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Headache	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0004 events2 affected20 at risk EG0015 events3 affected20 at risk EG0026 events3 affected17 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Migraine	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Sinus headache	Nervous system disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Depression	Psychiatric disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 events1 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected20 at risk EG0023 events2 affected17 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0011 events1 affected20 at risk EG0022 events2 affected17 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG00065 events3 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0014 events2 affected20 at risk EG0020 events0 affected17 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0008 events4 affected20 at risk EG0011 events1 affected20 at risk EG0024 events2 affected17 at risk EG003
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG00051 events9 affected20 at risk EG0014 events3 affected20 at risk EG00220 events6 affected17 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0003 events3 affected20 at risk EG0013 events2 affected20 at risk EG0021 events1 affected17 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected17 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0005 events2 affected20 at risk EG0011 events1 affected20 at risk EG0027 events3 affected17 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0024 events4 affected17 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0022 events1 affected17 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0023 events2 affected17 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00062 events7 affected20 at risk EG0017 events3 affected20 at risk EG0022 events2 affected17 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (18.1)	Systematic Assessment	EG00024 events7 affected20 at risk EG0012 events1 affected20 at risk EG00234 events6 affected17 at risk EG003
Labial frenectomy	Surgical and medical procedures	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Nasal septal operation	Surgical and medical procedures	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Papilloma excision	Surgical and medical procedures	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Shoulder operation	Surgical and medical procedures	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Tonsillectomy	Surgical and medical procedures	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003
Wisdom teeth removal	Surgical and medical procedures	MedDRA (18.1)	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected17 at risk EG003
Flushing	Vascular disorders	MedDRA (18.1)	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected17 at risk EG003

Refer to the original results published in the Journal of Allergy and Clinical Immunology, Vol 135, Number 5, page 1247 for a full description of the limitations of the current study.

Certain Agreements

ID	Term
D005512	Food Hypersensitivity
D006967	Hypersensitivity
D006969	Hypersensitivity, Immediate
D021183	Peanut Hypersensitivity

ID	Term
D005990	Glycerol

BG0005
BG0015
BG00210

EG0040 events0 affected17 at risk

EG0044 events1 affected14 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0045 events1 affected14 at risk

EG0040 events0 affected17 at risk

EG00416 events2 affected14 at risk

EG0040 events0 affected17 at risk

EG0040 events0 affected14 at risk

EG00411 events1 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected14 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected14 at risk

EG0041,326 events8 affected14 at risk

EG0040 events0 affected17 at risk

EG0040 events0 affected14 at risk

EG0042 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0040 events0 affected14 at risk

EG0040 events0 affected17 at risk

EG0043 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0042 events2 affected17 at risk

EG0041 events1 affected17 at risk

EG0042 events2 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0042 events1 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0047 events4 affected17 at risk

EG0040 events0 affected17 at risk

EG0048 events3 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0043 events1 affected17 at risk

EG0042 events1 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0045 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0040 events0 affected14 at risk

EG00420 events2 affected17 at risk

EG0040 events0 affected17 at risk

EG0042 events2 affected17 at risk

EG0042 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0043 events1 affected14 at risk

EG0040 events0 affected17 at risk

EG0042 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0042 events1 affected17 at risk

EG0043 events2 affected17 at risk

EG0041 events1 affected14 at risk

EG0042 events2 affected17 at risk

EG0041 events1 affected14 at risk

EG004259 events1 affected14 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0047 events3 affected14 at risk

EG0040 events0 affected14 at risk

EG0040 events0 affected17 at risk

EG0040 events0 affected14 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0043 events2 affected14 at risk

EG0040 events0 affected14 at risk

EG0041 events1 affected17 at risk

EG0042 events2 affected17 at risk

EG00415 events3 affected14 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected17 at risk

EG0041 events1 affected17 at risk

EG0040 events0 affected14 at risk

ID	Term
D007154	Immune System Diseases
D000074924	Nut and Peanut Hypersensitivity

ID	Term
D000073999	Triose Sugar Alcohols
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates