Safety and Efficacy Study of Viaskin Peanut in Peanut-all... | NCT03211247

Label	Type	Intervention Names
Part A Viaskin Peanut 250 mcg	Experimental	Biological: Part A Viaskin Peanut 250 mcg
Part A Viaskin Peanut 100 mcg	Experimental	Biological: Part A Viaskin Peanut 100 mcg
Part A Placebo	Placebo Comparator	Biological: Part A Placebo
Part B Viaskin Peanut 250 mcg	Experimental	Biological: Part B Viaskin Peanut 250 mcg
Part B Placebo	Placebo Comparator	Biological: Part B Placebo

Name	Type	Description	Arm Group Labels	Other Names
Part A Viaskin Peanut 250 mcg	Biological	Viaskin Peanut 250 mcg, once daily	Part A Viaskin Peanut 250 mcg

Measure	Description	Time Frame
Percentage of Treatment Responders at Month 12	A participant was defined as a treatment responder if the initial eliciting dose (ED) was > 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.	Month 12

Measure	Description	Time Frame
Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model	The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows: If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona Health Science		Tucson	Arizona	85719	United States
Arkansas Children's Hospital

PubMed Identifier	Type	Citation	Retractions
40204253	Derived	Scurlock AM, Fleischer DM, Toit GD, Arends NJT, Pongracic JA, Trujillo J, Turner P, Vogelberg C, Bee KJ, Green TD, Meney J, Bois T, Campbell DE, Sampson HA, Burks AW. Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Aug;135(2):203-210. doi: 10.1016/j.anai.2025.04.002. Epub 2025 Apr 7.
37163622

ID	Title	Description
FG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 15, 2019	Feb 8, 2024

Arm/Group Information

ID	Title	Description
BG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
BG001	Part B Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
BG002	Part A Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
BG003	Part A Viaskin Peanut 100 mcg	Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
BG004	Part A Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
BG005	Total	Total of all reporting groups

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 Treatment Responders at Month 12

A participant was defined as a treatment responder if the initial eliciting dose (ED) was > 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.

The FAS comprised of all participants who were randomized in the study.

Posted

Number

95% Confidence Interval

Percentage of participants

Month 12

ID	Title	Description
OG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
OG001	Part B Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
OG002	Part A Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
OG003	Part A Viaskin Peanut 100 mcg	Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
OG004	Part A Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

Units	Counts
Participants	OG000244 OG001118 OG00221 OG003

Title

Denominators

Categories

Title	Measurements
	OG00067.0(60.93 to 73.01) OG00133.5(24.84 to 42.24) OG00252.4(29.8 to 74.3) OG003

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	Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Farrington-Manning 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Farrignton-Manning 95% CI of the difference in response rates ≥15%.	Wald test		<0.001		Proportion difference	33.4			2-Sided	95	22.36	44.49			The 2-sided Farrington-Manning 95% confidence interval for the difference in response rates was calculated.

Secondary

Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model

The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows:

If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.

The FAS comprised of all participants who were randomized in the study.

Posted

Geometric Least Squares Mean

95% Confidence Interval

milligram (mg)

Month 12

ID	Title	Description
OG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
OG001	Part B Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

Secondary

Change From Baseline in CRD of Peanut Protein to Month 12

The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows:

If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses.

The FAS comprised of all participants who were randomized in the study.

Posted

Median

Inter-Quartile Range

Baseline (Day 1) and Month 12

ID	Title	Description
OG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
OG001	Part B Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

Secondary

ED of Peanut Protein at Month 12 Using ANCOVA Model

The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared using ANCOVA model.

The FAS comprised of all participants who were randomized in the study.

Posted

Geometric Least Squares Mean

95% Confidence Interval

Month 12

ID	Title	Description
OG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
OG001	Part B Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

Secondary

Change From Baseline in ED of Peanut Protein to Month 12

The FAS comprised of all participants who were randomized in the study.

Posted

Median

Inter-Quartile Range

Baseline (Day 1) and Month 12

ID	Title	Description
OG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).
OG001	Part B Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

Secondary

Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge

The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms), with the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=" absent",1=" mild", 2=" moderate" or 3=" severe". For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. Subjective abdominal pain (when graded 2 or 3) was also considered for this analysis.

The FAS comprised of all participants who were randomized in the study. This outcome was measured on Part B subjects only. Therefore subjects from Part A are reported as zero in the outcome measure data table.

Posted

Number

Percentage of participants

Baseline (Day 1) and Month 12

ID	Title	Description
OG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part B Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).	244	21	244	244	244
EG001	Part B Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).	118	3	118	117	118
EG002	Part A Viaskin Peanut 250 mcg	Participants applied 1 new Viaskin Peanut 250 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 250 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).	21	0	21	21	21
EG003	Part A Viaskin Peanut 100 mcg	Participants applied 1 new Viaskin Peanut 100 mcg patch on intact skin for 24 hours daily for up to 12 months. Each patch contained 100 mcg peanut protein extract for epicutaneous administration. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).	20	0	20	20	20
EG004	Part A Placebo	Participants applied 1 new placebo patch on intact skin for 24 hours daily for up to 12 months. The application duration was progressively increased to a duration of 24 ±4 hours daily over a 4-week period (2 hours during the first week, 4 hours during the second week, 8 hours during the third week, 12 hours during the fourth week onwards, and 24 ± 4 hours every day fifth week onwards).	10	0	10	10	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0008 events6 affected244 at risk EG0011 events1 affected118 at risk EG0020 events0 affected21 at risk EG0030 events0 affected20 at risk EG004
Bronchial Hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Bronchitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Metapneumovirus Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Periorbital Cellulitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Respiratory Syncytial Virus Bronchiolitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Respiratory Syncytial Virus Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0002 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Anaphylactic Reaction To Food	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0012 events2 affected118 at risk EG0020 events0 affected21 at risk EG003
Anaphylaxis	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Food Allergy	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Medication Error	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0002 events2 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Aplasia Pure Red Cell	Blood and lymphatic system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Periorbital Edema	Eye disorders	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Application Site Erythema	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002,182 events239 affected244 at risk EG001760 events107 affected118 at risk EG00221 events18 affected21 at risk EG00315 events14 affected20 at risk EG00413 events6 affected10 at risk
Application Site Pruritus	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002,925 events231 affected244 at risk EG001523 events72 affected118 at risk EG00215 events13 affected21 at risk EG003
Application Site Swelling	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0002,044 events177 affected244 at risk EG001278 events46 affected118 at risk EG00215 events7 affected21 at risk EG003
Pyrexia	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG000150 events84 affected244 at risk EG00183 events50 affected118 at risk EG0028 events5 affected21 at risk EG003
Application Site Oedema	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG000504 events58 affected244 at risk EG001105 events21 affected118 at risk EG0020 events0 affected21 at risk EG003
Application Site Urticaria	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG000152 events68 affected244 at risk EG0013 events3 affected118 at risk EG0028 events2 affected21 at risk EG003
Application Site Vesicles	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG000179 events43 affected244 at risk EG00121 events11 affected118 at risk EG0021 events1 affected21 at risk EG003
Application Site Papules	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG00063 events41 affected244 at risk EG00110 events9 affected118 at risk EG0022 events2 affected21 at risk EG003
Application Site Eczema	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG00066 events34 affected244 at risk EG00112 events10 affected118 at risk EG0021 events1 affected21 at risk EG003
Application Site Erosion	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG00044 events32 affected244 at risk EG0016 events5 affected118 at risk EG0020 events0 affected21 at risk EG003
Application Site Discoloration	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG00016 events15 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Food Allergy	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG00063 events33 affected244 at risk EG00120 events13 affected118 at risk EG0025 events5 affected21 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG00030 events24 affected244 at risk EG00122 events11 affected118 at risk EG0028 events5 affected21 at risk EG003
Seasonal Allergy	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG00050 events28 affected244 at risk EG0014 events3 affected118 at risk EG0025 events2 affected21 at risk EG003
Anaphylactic Reaction	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG00025 events19 affected244 at risk EG0012 events2 affected118 at risk EG0023 events3 affected21 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00087 events56 affected244 at risk EG00134 events21 affected118 at risk EG00210 events7 affected21 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00048 events22 affected244 at risk EG00121 events11 affected118 at risk EG0020 events0 affected21 at risk EG003
Teething	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00032 events12 affected244 at risk EG00112 events7 affected118 at risk EG0020 events0 affected21 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00091 events48 affected244 at risk EG00142 events24 affected118 at risk EG0024 events3 affected21 at risk EG003
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00066 events36 affected244 at risk EG00135 events23 affected118 at risk EG0022 events1 affected21 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00047 events27 affected244 at risk EG00116 events7 affected118 at risk EG0022 events2 affected21 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00028 events22 affected244 at risk EG00117 events10 affected118 at risk EG0027 events3 affected21 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00035 events22 affected244 at risk EG00130 events9 affected118 at risk EG0027 events3 affected21 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG00021 events15 affected244 at risk EG00114 events9 affected118 at risk EG0023 events2 affected21 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG000244 events85 affected244 at risk EG00196 events44 affected118 at risk EG00214 events4 affected21 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG000125 events59 affected244 at risk EG00167 events30 affected118 at risk EG00222 events7 affected21 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG00049 events36 affected244 at risk EG00127 events15 affected118 at risk EG0024 events2 affected21 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG00055 events37 affected244 at risk EG00124 events14 affected118 at risk EG0022 events2 affected21 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG00039 events23 affected244 at risk EG00113 events13 affected118 at risk EG0024 events3 affected21 at risk EG003
Dermatitis Diaper	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG00015 events9 affected244 at risk EG0017 events6 affected118 at risk EG0020 events0 affected21 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG000240 events103 affected244 at risk EG001129 events43 affected118 at risk EG00227 events13 affected21 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG000102 events53 affected244 at risk EG00135 events18 affected118 at risk EG00211 events2 affected21 at risk EG003
Viral Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00076 events47 affected244 at risk EG00125 events19 affected118 at risk EG0021 events1 affected21 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00041 events31 affected244 at risk EG00117 events13 affected118 at risk EG0024 events3 affected21 at risk EG003
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00046 events30 affected244 at risk EG00121 events13 affected118 at risk EG0027 events5 affected21 at risk EG003
Ear Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00042 events23 affected244 at risk EG00128 events15 affected118 at risk EG0021 events1 affected21 at risk EG003
Respiratory Tract Infection Viral	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00054 events29 affected244 at risk EG00121 events8 affected118 at risk EG0025 events2 affected21 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00024 events23 affected244 at risk EG0017 events3 affected118 at risk EG0020 events0 affected21 at risk EG003
Otitis Media	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00033 events21 affected244 at risk EG0018 events4 affected118 at risk EG0023 events3 affected21 at risk EG003
Croup Infectious	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00013 events12 affected244 at risk EG00115 events12 affected118 at risk EG0020 events0 affected21 at risk EG003
Influenza	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00014 events14 affected244 at risk EG0016 events5 affected118 at risk EG0022 events2 affected21 at risk EG003
Rhinitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00011 events10 affected244 at risk EG00112 events7 affected118 at risk EG0020 events0 affected21 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG00015 events14 affected244 at risk EG0011 events1 affected118 at risk EG0021 events1 affected21 at risk EG003
Pneumonia	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0006 events6 affected244 at risk EG0017 events6 affected118 at risk EG0022 events2 affected21 at risk EG003
Otitis Media Acute	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0001 events1 affected244 at risk EG0017 events6 affected118 at risk EG0021 events1 affected21 at risk EG003
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG00012 events10 affected244 at risk EG00118 events12 affected118 at risk EG0021 events1 affected21 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG00016 events11 affected244 at risk EG0014 events4 affected118 at risk EG0020 events0 affected21 at risk EG003
Eye Swelling	Eye disorders	MedDRA (20.1)	Non-systematic Assessment	EG00016 events12 affected244 at risk EG0014 events4 affected118 at risk EG0023 events2 affected21 at risk EG003
Application Site Rash	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Application Site Hemorrage	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Application Site Pain	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Application Site Discomfort	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0023 events1 affected21 at risk EG003
Application Site Dryness	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Influenza Like Illness	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0022 events2 affected21 at risk EG003
Irritability Postvaccinal	General disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Conjunctivitis Bacterial	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Pharyngitis Streptococcal	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0022 events2 affected21 at risk EG003
Sinusitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Bronchitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Bullous Impetigo	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0023 events1 affected21 at risk EG003
Coxsackie Viral Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Eye Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Gastrointestinal Viral Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Hand-Foot-And-Mouth Disease	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Herpangina	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Impetigo	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Localized Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Nail Bed Infection Bacterial	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Paronychia	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Perianal Streptococcal Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Skin Infection	Infections and infestations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Dermatitis Atopic	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Circumoral Oedema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Idiopathic Urticaria	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0023 events1 affected21 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Pruritis Generalized	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0023 events1 affected21 at risk EG003
Rash Generalized	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0022 events1 affected21 at risk EG003
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Urticaria Contact	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Allergic Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Bronchial Hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0023 events1 affected21 at risk EG003
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0022 events1 affected21 at risk EG003
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0023 events1 affected21 at risk EG003
Oral Pruritus	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Abdominal Discomfort	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Chapped Lips	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Lip Pruritus	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Lip Swelling	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Oral Pain	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0022 events1 affected21 at risk EG003
Allergy To Arthropod Sting	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Atopy	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Mite Allergy	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Mycotic Allergy	Immune system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Arthropod Sting	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Extra Dose Administered	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Hand Fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Head Injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Muscle Strain	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Conjunctivitis Allergic	Eye disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Eye Pruritus	Eye disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Erythema of Eyelid	Eye disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Ocular Hyperaemia	Eye disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Ear Pruritus	Ear and labyrinth disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Aggression	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Mood Altered	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Mood Swing	Psychiatric disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Eosinophil Count Increased	Investigations	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Growth Hormone Deficiency	Endocrine disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003
Febrile Convulsion	Nervous system disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0021 events1 affected21 at risk EG003
Hematoma	Vascular disorders	MedDRA (20.1)	Non-systematic Assessment	EG0000 events0 affected244 at risk EG0010 events0 affected118 at risk EG0020 events0 affected21 at risk EG003

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