A Study of Bermekimab (JNJ-77474462) in the Treatment of... | NCT04791319

ID	Type	Description	Link
2020-002587-31	EudraCT Number
77474462ADM2001	Other Identifier	Janssen Research & Development, LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Placebo	Placebo Comparator	Participants will receive subcutaneous (SC) placebo once a week (qw) through Week 15. At Week 16, participants will crossover to receive SC bermekimab Dose 2 qw through Week 31.	Drug: Placebo Drug: Bermekimab
Group 2: Bermekimab	Experimental	Participant will receive SC bermekimab Dose 1 qw from Week 0 through Week 31.	Drug: Bermekimab
Group 3: Bermekimab	Experimental	Participants will receive SC bermekimab Dose 2 qw from Week 0 through Week 15. At Week 16, participants who achieve an eczema area and severity index (EASI)-75 response (responders) will be rerandomized either to continue to receive bermekimab Dose 2 qw, or to receive bermekimab Dose 1 qw, through Week 31 and participants who do not achieve an EASI-75 response (non responders) will continue to receive bermekimab Dose 2 qw through Week 31.	Drug: Bermekimab
Group 4: Dupilumab	Active Comparator	Participants will receive a loading dose of SC dupilumab Dose 1 at Week 0, SC placebo every two week (q2w) from Week 1 through Week 15 and then dupilumab Dose 2 q2w from Week 2 through Week 14. At Week 16, participants who achieve EASI-75 response (dupilumab responders) will continue on dupilumab Dose 2 q2w through Week 30 and placebo q2w from Week 17 through Week 31. Participants who do not achieve an EASI-75 response (dupilumab non-responders) will receive placebo qw from Week 16 through Week 18 (washout period) and bermekimab Dose 2 qw from Week 19 through Week 31.

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo will be administered subcutaneously.	Group 1: Placebo Group 4: Dupilumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline) at Week 16	Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.	Week 16

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16	Percentage of participants achieving vIGA-AD at Week 16 were reported. It is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0, where 0=Clear: No inflammatory signs of AD; 1=almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2=mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3=moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher score indicated more severity of AD.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history
Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example [eg], due to important side effects or safety risks)
Be considered, in the opinion of the investigator, a suitable candidate for dupilumab (DUPIXENT) therapy according to their country's approved DUPIXENT product labeling
Have an eczema area and severity index (EASI) score greater than or equal (>=) to 16 at screening and at baseline
Have an investigator global assessment (IGA) score >=3 and involved body surface area (BSA) >=10 percent (%) at screening and baseline

Exclusion Criteria:

Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months before screening
Has or has had herpes zoster within the 2 months before screening
Has a history of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
California Allergy & Asthma Medical Group Inc.		Los Angeles	California	90025	United States
Wolverine Clinical Trials

ID	Title	Description
FG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) from Week 0 through Week 15.
FG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 2, 2021	Feb 1, 2023

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
BG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
BG002	Bermekimab 700 mg	Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to [>=] 75 percent [%] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
BG003	Dupilumab	Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.
BG004	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 Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline) at Week 16

Percentage of participants achieving EASI-75 at Week 16 were reported. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

The modified full analysis set (mFAS) included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
OG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
OG002	Bermekimab 700 mg	Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants who achieved an eczema area and severity index (EASI-75) response (greater than or equal to [>=] 75 percent [%] improvement from baseline) were considered as responders and were rerandomized in a 1:1 ratio either to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw or to receive bermekimab 350 mg SC injection qw through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.
OG003	Dupilumab	Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14. After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31. After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.

Units	Counts
Participants	OG00021 OG00124 OG00242 OG003

Title

Denominators

Categories

Title	Measurements
	OG0009.5 OG00116.7 OG00216.7 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		Chi-squared		0.489	Threshold for significance at 0.05 level.	MH weights	7.1			2-Sided	95	-12.1	26.2					Superiority
OG000 OG002		Chi-squared

Secondary

Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 16

Percentage of participants achieving vIGA-AD at Week 16 were reported. It is an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranging from 0, where 0=Clear: No inflammatory signs of AD; 1=almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2=mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3=moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present and 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher score indicated more severity of AD.

The mFAS included all participants who were randomized at Week 0 and received at least 1 dose of study intervention and had reached a visit by the time of the decision was made to terminate the study on 02 February 2022. Participants were excluded from the analysis after projected visit. Projected visit (weeks) = (decision date of study termination - first dose date +1) /7.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.

Secondary

Percentage of Participants With Improvement (Reduction From Baseline) in Eczema-Related Itch Numeric Rating Scale (NRS) of Score >=4 at Week 16 Among Participants With a Baseline Itch Value >=4

Percentage of participants with improvement (reduction from baseline) in eczema-related itch NRS of score >=4 at Week 16 among participants with a baseline itch value >=4 were reported. The eczema skin pain and Itch NRS is a 2-item patient-reported outcome that participants used to rate the severity of their eczema-related skin pain and eczema related itch daily. Participants were asked the following questions: Please rate the severity of your eczema-related skin pain at its worst in the past 24 hours; and please rate the severity of your eczema-related itch at its worst in the past 24 hours. Each item was on a 0 to 10 NRS ranging from 0 "none" to 10 "worst possible" and were scored separately. Higher score indicated more severity.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.

Secondary

Percentage of Participants Achieving EASI-90 (>= 90% Improvement in EASI From Baseline) at Week 16

Percentage of participants achieving EASI-90 at Week 16 were reported. EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) through Week 15. After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
OG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

The safety analysis set included all participants who had received at least 1 dose of study intervention.

Posted

Count of Participants

Participants

Up to Week 36

ID	Title	Description
OG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) from Week 0 through Week 15.
OG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31. Participants who received bermekimab 350 mg from Week 0 to Week 15 and continued to receive bermekimab 350 mg from Week 16 to Week 31 were combined in this arm.

Secondary

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any SAE with onset during the intervention period or that were a consequence of a pre-existing condition that has worsened since baseline was considered to be TESAEs. AEs are presented by individual dose received by participants during placebo-controlled period and active treatment period.

The safety analysis set included all participants who had received at least 1 dose of study intervention.

Posted

Count of Participants

Participants

Up to Week 36

ID	Title	Description
OG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) from Week 0 through Week 15.
OG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15.

Secondary

Serum Bermekimab Concentration Over Time

Serum bermekimab concentration over time were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.

The pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of bermekimab and had at least 1 valid blood sample drawn for PK analysis. Here, "n (number analyzed)" specifies number of participants who were analyzed at the specified timepoint and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.

Posted

Mean

Standard Deviation

micrograms per mililiters (mcg/mL)

Pre-dose at Week 0, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, and Week 36

ID	Title	Description
OG000	Placebo Then Bermekimab 700 mg	After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
OG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.

Secondary

Number of Participants With Anti-Bermekimab Antibodies

Number of participants with anti-bermekimab antibodies were reported. Data are presented by individual dose of investigational medicinal product received by participants during active treatment period as preplanned in protocol.

The immunogenicity analysis set included all participants who had received at least 1 dose of bermekimab and who had at least 1 sample obtained after their first dose of bermekimab for the detection of antibodies to bermekimab.

Posted

Count of Participants

Participants

Up to Week 36

ID	Title	Description
OG000	Placebo Then Bermekimab 700 mg	After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.
OG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15. After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.
OG002	Bermekimab 700 mg Then Bermekimab 700 mg (Non-responders)

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received two placebo subcutaneous (SC) injections once a week (qw) from Week 0 through Week 15.	33	0	33	15	33
EG001	Bermekimab 350 mg	Participants received a single bermekimab 350 milligrams (mg) SC injection qw from Week 0 through Week 15.	33	1	33	15	33
EG002	Bermekimab 700 mg	Participants received bermekimab 700 mg (2 doses of 350mg) SC injections qw from Week 0 through Week 15.	67	2	67	29	67
EG003	Dupilumab	Participants received a loading dose of dupilumab 600 mg (2 doses of 300 mg) SC injection at Week 0 followed by two placebo SC injections every two weeks (q2w) from Week 1 through Week 15 and a single dupilumab 300 mg SC injection q2w beginning at Week 2 through Week 14.	65	0	65	20	65
EG004	Placebo Then Bermekimab 700 mg	After completion of placebo-contorlled period, at Week 16 participants entered active treatment period and were crossed-over to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.	19	0	19	7	19
EG005	Bermekimab 350 mg Then Bermekimab 350 mg	After completion of placebo-controlled period, at Week 16 participants entered active treatment period and continued to receive a single bermekimab 350 mg SC injection qw through 31.	21	0	21	7	21
EG006	Bermekimab 700 mg Then Bermekimab 700 mg (Non-Responders)	After completion of placebo-controlled period, at Week 16 participants who did not achieved an eczema area and severity index (EASI-75) response (greater than or equal to [>=] 75 percent [%] improvement from baseline) were considered as non-responders and they continued bermekimab 700 mg SC injection qw through Week 31.	22	0	22	8	22
EG007	Bermekimab 700 mg Then Bermekimab 700 mg (Responders)	After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 700 mg (2 doses of 350 mg) SC injection qw through Week 31.	3	0	3	2	3
EG008	Bermekimab 700 mg Then Bermekimab 350 mg (Responders)	After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and were rerandomized to receive bermekimab 350 mg SC injection qw through Week 31.	5	0	5	2	5
EG009	Dupilumab Then Dupilumab 300 mg (Responders)	After completion of placebo-controlled period, at Week 16 participants who achieved an EASI-75 response were considered as responders and they continued to dupilumab 300 mg SC injection q2w from Week 16 through Week 30 and placebo SC injection q2w from Week 17 through Week 31.	27	0	27	9	27
EG010	Dupilumab Then Bermekimab 700 mg (Non-Responders)	After completion of placebo-controlled period, at Week 16 participants who did not achieved an EASI-75 response were considered as non-responders and they received placebo SC injection qw from Week 16 through Week 18 (that is, washout period), and bermekimab 700 mg SC injection qw from Week 19 through Week 31.	11	0	11	7	11

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Extrasystoles	Cardiac disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG0030 affected65 at risk EG0040 affected19 at risk EG0050 affected21 at risk EG0060 affected22 at risk EG0070 affected3 at risk EG0080 affected5 at risk EG0090 affected27 at risk EG0101 affected11 at risk
Dry Eye	Eye disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0011 affected33 at risk EG0021 affected67 at risk EG003
Chest Pain	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0021 affected67 at risk EG003
Fatigue	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected33 at risk EG0010 affected33 at risk EG0021 affected67 at risk EG003
Injection Site Erythema	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0012 affected33 at risk EG0025 affected67 at risk EG003
Injection Site Swelling	General disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0011 affected33 at risk EG0023 affected67 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0004 affected33 at risk EG0012 affected33 at risk EG0021 affected67 at risk EG003
Eczema Impetiginous	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Folliculitis	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0022 affected67 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Impetigo	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0021 affected67 at risk EG003
Lice Infestation	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected33 at risk EG0013 affected33 at risk EG0028 affected67 at risk EG003
Oral Herpes	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected33 at risk EG0010 affected33 at risk EG0021 affected67 at risk EG003
Pilonidal Cyst	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected33 at risk EG0013 affected33 at risk EG0024 affected67 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Vaccination Complication	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0011 affected33 at risk EG0020 affected67 at risk EG003
Blood Pressure Increased	Investigations	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0011 affected33 at risk EG0020 affected67 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0002 affected33 at risk EG0011 affected33 at risk EG0022 affected67 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0001 affected33 at risk EG0010 affected33 at risk EG0021 affected67 at risk EG003
Headache	Nervous system disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0025 affected67 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0011 affected33 at risk EG0020 affected67 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0012 affected33 at risk EG0020 affected67 at risk EG003
Dermatitis Atopic	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0004 affected33 at risk EG0013 affected33 at risk EG00211 affected67 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0020 affected67 at risk EG003

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Auricular Haematoma	Injury, poisoning and procedural complications	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0021 affected67 at risk EG0030 affected65 at risk EG004
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0010 affected33 at risk EG0021 affected67 at risk EG003
Dermatitis Atopic	Skin and subcutaneous tissue disorders	MedDRA Version 24.1	Non-systematic Assessment	EG0000 affected33 at risk EG0011 affected33 at risk EG0021 affected67 at risk EG003