Multiple Rising Dose Study of MK-6194 in Participants Wit... | NCT05450198

NCT05450198

ID	Type	Description	Link
MK-6194-008	Other Identifier	MSD
2022-001011-12	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Escalation Panel A	Experimental	Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).	Biological: MK-6194 Biological: Placebo
Dose Escalation Panel B	Experimental	Participants are randomized to medium dose MK-6194 or placebo administered q2w.	Biological: MK-6194 Biological: Placebo
Dose Escalation Panel C	Experimental	Participants are randomized to high dose MK-6194 or placebo administered q2w.	Biological: MK-6194 Biological: Placebo
Expansion Panel D	Experimental	Participants are randomized to medium dose MK-6194 or placebo administered q2w.	Biological: MK-6194 Biological: Placebo
Expansion Panel E	Experimental	Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.	Biological: MK-6194 Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MK-6194	Biological	MK-6194 administered subcutaneously (SC)	Dose Escalation Panel A Dose Escalation Panel B Dose Escalation Panel C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experience One or More Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.	Up to approximately 169 days
Number of Participants Who Discontinue Study Intervention Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study intervention due to an AE is presented.	Up to approximately 85 days

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194	Blood samples were collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.	Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
AUC From Days 29-43 (AUC29-43) of MK-6194

Eligibility Module

Eligibility Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Clinical diagnosis of atopic dermatitis for at least 6 months prior to the Screening visit.
Atopic dermatitis is of at least moderate severity.
History of inadequate response to a stable (≥1 month) regimen of medium to high potency topical corticosteroids or calcineurin inhibitors as treatment for atopic dermatitis within 6 months before the screening visit.
Body Mass Index (BMI) ≥18 and ≤38 kg/m2 at the screening visit.

Exclusion Criteria:

Concurrent significant skin disease other than atopic dermatitis (such as psoriasis) or a concurrent clinically significant disease.
Significant organ dysfunction that is unstable or inadequately treated within 6 months prior to Screening.
History of cancer (malignancy), with the exceptions: of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; other malignancies that have been successfully treated with appropriate follow up.
History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening.
History of organ or tissue allograft.
History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system (CNS) zoster.
Major surgery within 3 months prior to the screening visit or has a major surgery planned during the study.
Received a live or attenuated virus vaccine within 4 weeks prior to the Screening visit or intends to receive live or attenuated virus vaccination during the course of the study and for 12 weeks after the last dose of study drug.
Currently receiving any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Research Trials-Clinical Trials ( Site 0002)		North Little Rock	Arkansas	72117	United States

References Module

Label	URL
Merck Clinical Trials Information	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
FG001	MK-6194 Low Dose (Panel A)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 12, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Participants received low dose of MK-6194 administered SC Q2W for 7 doses.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
BG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
BG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.
BG003	MK-6194 High Dose (Panel F)	Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.
BG004	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, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00037.2± 11.0 BG00146.5± 11.3 BG00242.8± 16.8 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0005 BG0012 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194

Blood samples were collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.

The analysis population consisted of all participants who were randomized to MK-6194 and had data available. Samples were excluded if they were at the lower limit of quantification (BLQ) or unevaluable. Samples received thawed were unevaluable. For the Placebo arm, zero participants analyzed indicate data were not generated and no data were available. Panels were pre-specified in the protocol to be pooled at dose group level.

Posted

Geometric Least Squares Mean

95% Confidence Interval

day*ng/mL

Day 1 (Predose and 12 hours postdose), Day 8, and Day 15

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.
OG003	MK-6194 High Dose (Panel F)	Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.

Units	Counts
Participants	OG0000 OG0012 OG00215 OG003

Title

Denominators

Categories

Title	Measurements
	OG00132.3(13.9 to 75.1) OG00259.6(43.8 to 81.1)

Secondary

AUC From Days 29-43 (AUC29-43) of MK-6194

Blood samples were collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.

The analysis population consisted of all participants who were randomized to MK-6194 and had data available. Samples were excluded if they were at the BLQ or unevaluable. Samples received thawed were unevaluable. For the Placebo arm, zero participants analyzed indicate data were not generated and no data were available. Panels were pre-specified in the protocol to be pooled at dose group level.

Posted

Geometric Least Squares Mean

95% Confidence Interval

day*ng/mL

Day 29 (Predose and 12 hours postdose), Day 36, and Day 43

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.

Secondary

Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)

Blood samples were collected at pre-specified time points to determine the Cmax of MK-6194 in plasma.

Posted

Geometric Least Squares Mean

95% Confidence Interval

ng/mL

Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.

Secondary

Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)

Blood samples were collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.

The analysis population consisted of all participants who were randomized to MK-6194 and had data available. Samples received thawed were unevaluable. For the Placebo arm, zero participants analyzed indicate data were not generated and no data were available. Panels were pre-specified in the protocol to be pooled at dose group level.

Posted

Geometric Least Squares Mean

95% Confidence Interval

ng/mL

Predose on Days 15 and 29

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.
OG003

Secondary

Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)

Blood samples were collected at pre-specified time points to determine the Tmax of MK-6194 in plasma.

Posted

Geometric Least Squares Mean

95% Confidence Interval

day

Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.

Secondary

Geometric Mean Accumulation Ratio of AUC of MK-6194

Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of AUC of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.

Posted

Geometric Least Squares Mean

90% Confidence Interval

Ratio

Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.

Secondary

Geometric Mean Accumulation Ratio of Cmax of MK-6194

Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of Cmax of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.

Posted

Geometric Least Squares Mean

90% Confidence Interval

Ratio

Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.

Secondary

Fold Change From Baseline in Peak Regulatory T Cells (Tregs)

Blood samples were collected to determine the fold change from baseline (FCB) in peak Tregs. The peak Treg FCB was evaluated after the last dose of MK-6194 on Day 85 using natural-log transformed values with a linear model containing fixed effects.

The analysis population consisted of all participants who were randomized to MK-6194 and had data available. Panels were pre-specified in the protocol to be pooled at dose group level.

Posted

Geometric Least Squares Mean

95% Confidence Interval

Fold change from baseline

Baseline and Day 85

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose of (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.
OG003

Primary

Number of Participants Who Experience One or More Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.

The analysis population consisted of all participants who received ≥1 dose of study intervention. Panels were pre-specified in the protocol to be pooled at dose group level.

Posted

Count of Participants

Participants

Up to approximately 169 days

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.

Primary

Number of Participants Who Discontinue Study Intervention Due to an AE

The analysis population consisted of all participants who received ≥1 dose of study intervention. Panels were pre-specified in the protocol to be pooled at dose group level.

Posted

Count of Participants

Participants

Up to approximately 85 days

ID	Title	Description
OG000	Placebo	Participants received placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.
OG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.
OG002	MK-6194 High Dose (Panel B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.

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 placebo administered subcutaneously (SC) every 2 weeks (Q2W) in Panels A, B, C, D, E for 7 doses, or every 4 weeks (Q4W) in Panel F for 4 doses.	18	0	18	13	18
EG001	MK-6194 Low Dose (Panel A)	Participants received low dose of MK-6194 administered SC Q2W for 7 doses.	6	0	6	6	6
EG002	MK-6194 High Dose (Panels B-E)	Participants received high dose of MK-6194 administered SC Q2W for 7 doses. The dose was the same in Panels B-E and F.	36	2	36	30	36
EG003	MK-6194 High Dose (Panel F)	Participants received high dose of MK-6194 administered SC Q4W for 4 doses. The dose was the same in Panels B-E and F.	12	0	12	9	12
EG004	MK-6194 Total	Participants in Panels A through F.	54	2	54	45	54

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Inguinal hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0022 events1 affected36 at risk EG0030 events0 affected12 at risk EG0042 events1 affected54 at risk
Malaise	General disorders	MedDRA 27.0	Systematic Assessment		EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG0030 events0 affected12 at risk EG0041 events1 affected54 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0028 events7 affected36 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0022 events2 affected36 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected6 at risk EG0020 events0 affected36 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Chills	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Fatigue	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected6 at risk EG0022 events2 affected36 at risk EG003
Influenza like illness	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0022 events2 affected36 at risk EG003
Injection site discolouration	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0026 events2 affected36 at risk EG003
Injection site erythema	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG00119 events6 affected6 at risk EG002110 events25 affected36 at risk EG003
Injection site haematoma	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Injection site induration	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0016 events3 affected6 at risk EG00216 events8 affected36 at risk EG003
Injection site oedema	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Injection site pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0015 events3 affected6 at risk EG0027 events6 affected36 at risk EG003
Injection site pruritus	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected6 at risk EG00213 events3 affected36 at risk EG003
Injection site swelling	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG00216 events7 affected36 at risk EG003
Injection site urticaria	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Injection site warmth	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Malaise	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Oedema peripheral	General disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Pain	General disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Pyrexia	General disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Anal abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Cystitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Ear infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Localised infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected6 at risk EG0024 events3 affected36 at risk EG003
Ophthalmic herpes zoster	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Oral herpes	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Paronychia	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Rhinitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Skin bacterial infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Skin infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0024 events3 affected36 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Viral infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0021 events1 affected36 at risk EG003
Influenza A virus test positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Platelet count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
White blood cell count increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Hypovitaminosis	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0005 events4 affected18 at risk EG0011 events1 affected6 at risk EG0024 events4 affected36 at risk EG003
Sciatica	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Embedded device	Product Issues	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Initial insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0021 events1 affected36 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0022 events2 affected36 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0021 events1 affected36 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected6 at risk EG0022 events2 affected36 at risk EG003
Madarosis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected6 at risk EG0020 events0 affected36 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events2 affected6 at risk EG0020 events0 affected36 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0021 events1 affected36 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0020 events0 affected36 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected6 at risk EG0021 events1 affected36 at risk EG003

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

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

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