PALISADE Follow-on Study (ARC004) | NCT02993107

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1 (Placebo Crossovers)	Other	Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).	Biological: AR101
Group 2 (Active Rollovers)	Other	Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.	Biological: AR101

Name	Type	Description	Arm Group Labels	Other Names
AR101	Biological	AR101 powder provided in capsules & sachets	Group 1 (Placebo Crossovers) Group 2 (Active Rollovers)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)	Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).	Up to 126 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)	The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).	Up to 126 weeks

Eligibility Module

Name	Affiliation	Role
Director of Regulatory Affairs	Aimmune Regulatory Affairs	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner University of Arizona Medical Center		Tucson	Arizona	85724	United States
Arkansas Children's Hospital

PubMed Identifier	Type	Citation	Retractions
36915184	Derived	Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8.
34389504

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group 1 (Placebo Crossovers)	Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).
FG001	Group 2: Cohort 1 (Active Rollovers)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 12, 2018	May 20, 2021

Arm/Group Information

ID	Title	Description
BG000	Group 1 (Placebo Crossovers)	Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks)
BG001	Group 2: Cohort 1 (Active Rollovers)	Received 300 mg/day (once daily, QD) peanut protein for 28 weeks
BG002	Group 2: Cohort 2 (Active Rollovers)	Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks
BG003	Group 2: Cohort 3A (Active Rollovers)	Received 300 mg/day peanut protein for 56 weeks
BG004	Group 2: Cohort 3B (Active Rollovers)	Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)
BG005	Group 2: Cohort 3C (Active Rollovers)	Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weeks, then once weekly (QW) for 28 weeks (total of 84 weeks)
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Age 18-55 years

Title	Measurements
	BG00011 BG0018 BG0022 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039 BG00155 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00013 BG0019 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 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

Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)

Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).

Posted

Count of Participants

Participants

Up to 126 weeks

ID	Title	Description
OG000	Group 1 (Overall)	Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).
OG001	Group 2: Cohort 1 (QD)	Received 300 mg/day (once daily, QD) peanut protein for 28 weeks
OG002	Group 2: Cohort 2 (Overall)	Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks
OG003	Group 2: Cohort 3A (QD)	Received 300 mg/day peanut protein for 56 weeks
OG004	Group 2: Cohort 3B (Overall)	Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)
OG005	Group 2: Cohort 3C (Overall)	Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks)

Units	Counts
Participants	OG000100 OG001109 OG00246 OG003

Title

Denominators

Categories

All AEs

Title	Measurements
	OG00098 OG00190 OG00236 OG003

Secondary

Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)

The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).

Posted

Number

95% Confidence Interval

Percent of participants

Up to 126 weeks

ID	Title	Description
OG000	Group 1 (Placebo Crossovers)	Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks) (age 4-17).
OG001	Group 2: Cohort 1 (Active Rollovers)	Received 300 mg/day (once daily, QD) peanut protein for 28 weeks
OG002	Group 2: Cohort 2 (Active Rollovers)	Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks
OG003	Group 2: Cohort 3A (Active Rollovers)

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1 (Age 4-17 Overall)	Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).	100	0	100	98	100
EG001	Group 2: Cohort 1 (Age 4-17 QD)	Received 300 mg/day (once daily, QD) peanut protein for 28 weeks.	109	1	109	90	109
EG002	Group 2: Cohort 2 (Age 4-17 Overall)	Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks.	46	0	46	36	46
EG003	Group 2: Cohort 3A (Age 4-17 QD)	Received 300 mg/day peanut protein for 56 weeks.	31	0	31	27	31
EG004	Group 2: Cohort 3B (Age 4-17 Overall)	Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks).	31	1	31	28	31
EG005	Group 2: Cohort 3C (Age 4-17 Overall)	Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks).	34	1	34	33	34
EG006	Group 1 (Age 18-55 Overall)	Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).	11	0	11	10	11
EG007	Group 2: Cohort 1 (Age 18-55 QD)	Received 300 mg/day (once daily, QD) peanut protein for 28 weeks.	8	1	8	6	8
EG008	Group 2: Cohort 2 (Age 18-55 Overall)	Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks.	2	0	2	1	2
EG009	Group 2: Cohort 3A (Age 18-55 QD)	Received 300 mg/day peanut protein for 56 weeks.	4	0	4	2	4
EG010	Group 2: Cohort 3B (Age 18-55 Overall)	Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks).	3	0	3	2	3
EG011	Group 2: Cohort 3C (Age 18-55 Overall)	Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks).	2	0	2	2	2

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG0030 affected31 at risk EG0041 affected31 at risk EG0050 affected34 at risk EG0060 affected11 at risk EG0070 affected8 at risk EG0080 affected2 at risk EG0090 affected4 at risk EG0100 affected3 at risk EG0110 affected2 at risk
Intestinal perforation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Streptococcal infection	Infections and infestations	Systematic Assessment	EG0000 affected100 at risk EG0011 affected109 at risk EG0020 affected46 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected100 at risk EG0011 affected109 at risk EG0020 affected46 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0002 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG0030 affected31 at risk EG0041 affected31 at risk EG0052 affected34 at risk EG0061 affected11 at risk EG0070 affected8 at risk EG0080 affected2 at risk EG0090 affected4 at risk EG0100 affected3 at risk EG0110 affected2 at risk
Thalassaemia beta	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0003 affected100 at risk EG0011 affected109 at risk EG0020 affected46 at risk EG003
Ear pruritus	Ear and labyrinth disorders	Systematic Assessment	EG0002 affected100 at risk EG0011 affected109 at risk EG0023 affected46 at risk EG003
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Conjunctivitis allergic	Eye disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Eye pruritus	Eye disorders	Systematic Assessment	EG0008 affected100 at risk EG0015 affected109 at risk EG0024 affected46 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG00017 affected100 at risk EG0016 affected109 at risk EG0025 affected46 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG00038 affected100 at risk EG00111 affected109 at risk EG0027 affected46 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG00031 affected100 at risk EG0019 affected109 at risk EG0026 affected46 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00010 affected100 at risk EG0015 affected109 at risk EG0021 affected46 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Eosinophilic oesophagitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Food poisoning	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Glossitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Lip pruritus	Gastrointestinal disorders	Systematic Assessment	EG00011 affected100 at risk EG0013 affected109 at risk EG0022 affected46 at risk EG003
Lip swelling	Gastrointestinal disorders	Systematic Assessment	EG0008 affected100 at risk EG0013 affected109 at risk EG0024 affected46 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00033 affected100 at risk EG0019 affected109 at risk EG0029 affected46 at risk EG003
Oral discomfort	Gastrointestinal disorders	Systematic Assessment	EG0001 affected100 at risk EG0011 affected109 at risk EG0020 affected46 at risk EG003
Oral pruritus	Gastrointestinal disorders	Systematic Assessment	EG00017 affected100 at risk EG0016 affected109 at risk EG0025 affected46 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	Systematic Assessment	EG0006 affected100 at risk EG0010 affected109 at risk EG0022 affected46 at risk EG003
Swollen tongue	Gastrointestinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Tongue pruritus	Gastrointestinal disorders	Systematic Assessment	EG00011 affected100 at risk EG0013 affected109 at risk EG0021 affected46 at risk EG003
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0005 affected100 at risk EG0010 affected109 at risk EG0021 affected46 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00042 affected100 at risk EG00118 affected109 at risk EG0026 affected46 at risk EG003
Chest discomfort	General disorders	Systematic Assessment	EG0009 affected100 at risk EG0013 affected109 at risk EG0020 affected46 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0009 affected100 at risk EG0010 affected109 at risk EG0021 affected46 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0004 affected100 at risk EG0012 affected109 at risk EG0021 affected46 at risk EG003
Influenza like illness	General disorders	Systematic Assessment	EG0001 affected100 at risk EG0010 affected109 at risk EG0021 affected46 at risk EG003
Malaise	General disorders	Systematic Assessment	EG0006 affected100 at risk EG0010 affected109 at risk EG0022 affected46 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG00024 affected100 at risk EG00120 affected109 at risk EG0024 affected46 at risk EG003
Anaphylactic reaction	Immune system disorders	Systematic Assessment	EG00017 affected100 at risk EG0017 affected109 at risk EG0020 affected46 at risk EG003
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0006 affected100 at risk EG0011 affected109 at risk EG0021 affected46 at risk EG003
Seasonal allergy	Immune system disorders	Systematic Assessment	EG0008 affected100 at risk EG0012 affected109 at risk EG0020 affected46 at risk EG003
Bronchitis	Infections and infestations	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0004 affected100 at risk EG0011 affected109 at risk EG0020 affected46 at risk EG003
Ear infection	Infections and infestations	Systematic Assessment	EG0002 affected100 at risk EG0014 affected109 at risk EG0023 affected46 at risk EG003
Enterobiasis	Infections and infestations	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0005 affected100 at risk EG0012 affected109 at risk EG0021 affected46 at risk EG003
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0009 affected100 at risk EG0017 affected109 at risk EG0021 affected46 at risk EG003
Gastrointestinal viral infection	Infections and infestations	Systematic Assessment	EG0002 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Influenza	Infections and infestations	Systematic Assessment	EG0007 affected100 at risk EG0017 affected109 at risk EG0021 affected46 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG00016 affected100 at risk EG0015 affected109 at risk EG0025 affected46 at risk EG003
Pharyngitis streptococcal	Infections and infestations	Systematic Assessment	EG0004 affected100 at risk EG0015 affected109 at risk EG0025 affected46 at risk EG003
Respiratory tract infection viral	Infections and infestations	Systematic Assessment	EG0001 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Rhinitis	Infections and infestations	Systematic Assessment	EG0006 affected100 at risk EG0011 affected109 at risk EG0020 affected46 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0006 affected100 at risk EG0012 affected109 at risk EG0021 affected46 at risk EG003
Tonsillitis	Infections and infestations	Systematic Assessment	EG0002 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG00023 affected100 at risk EG00120 affected109 at risk EG0026 affected46 at risk EG003
Viral infection	Infections and infestations	Systematic Assessment	EG00010 affected100 at risk EG0019 affected109 at risk EG0021 affected46 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0004 affected100 at risk EG0015 affected109 at risk EG0020 affected46 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 affected100 at risk EG0011 affected109 at risk EG0020 affected46 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected100 at risk EG0011 affected109 at risk EG0021 affected46 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Breath sounds abnormal	Investigations	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Pulmonary physical examination abnormal	Investigations	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Eating disorder symptom	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected100 at risk EG0012 affected109 at risk EG0020 affected46 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 affected100 at risk EG0010 affected109 at risk EG0021 affected46 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG00027 affected100 at risk EG00112 affected109 at risk EG00212 affected46 at risk EG003
Migraine	Nervous system disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Sinus headache	Nervous system disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Anxiety	Psychiatric disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected100 at risk EG0012 affected109 at risk EG0021 affected46 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected100 at risk EG0013 affected109 at risk EG0024 affected46 at risk EG003
Choking	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00044 affected100 at risk EG00116 affected109 at risk EG0028 affected46 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00012 affected100 at risk EG0011 affected109 at risk EG0021 affected46 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00022 affected100 at risk EG0018 affected109 at risk EG0026 affected46 at risk EG003
Nasal oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00023 affected100 at risk EG0017 affected109 at risk EG0024 affected46 at risk EG003
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Pharyngeal paraesthesia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected100 at risk EG0010 affected109 at risk EG0021 affected46 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0007 affected100 at risk EG0013 affected109 at risk EG0023 affected46 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00028 affected100 at risk EG0017 affected109 at risk EG0022 affected46 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00018 affected100 at risk EG0018 affected109 at risk EG0024 affected46 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00032 affected100 at risk EG00115 affected109 at risk EG0029 affected46 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00012 affected100 at risk EG0011 affected109 at risk EG0021 affected46 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00017 affected100 at risk EG0013 affected109 at risk EG0022 affected46 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0007 affected100 at risk EG0012 affected109 at risk EG0021 affected46 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0008 affected100 at risk EG0011 affected109 at risk EG0021 affected46 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00019 affected100 at risk EG0017 affected109 at risk EG0026 affected46 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00014 affected100 at risk EG0016 affected109 at risk EG0021 affected46 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected100 at risk EG0011 affected109 at risk EG0021 affected46 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00037 affected100 at risk EG00116 affected109 at risk EG0026 affected46 at risk EG003
Rhinoplasty	Surgical and medical procedures	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Sclerotherapy	Surgical and medical procedures	Systematic Assessment	EG0000 affected100 at risk EG0010 affected109 at risk EG0020 affected46 at risk EG003
Flushing	Vascular disorders	Systematic Assessment	EG0006 affected100 at risk EG0013 affected109 at risk EG0022 affected46 at risk EG003

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