A Study of Lebrikizumab (LY3650150) in Combination With T... | NCT04760314

ID	Type	Description	Link
J2T-JE-KGAL	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Lebrikizumab 250 mg Every 4 weeks (Q4W)	Experimental	Participants received 500 mg of Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12, in combination with topical corticosteroid. Week 16 responders entered maintenance period and continued with the same treatment. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.	Drug: Lebrikizumab Drug: Topical Corticosteroid
Lebrikizumab 250 mg Every 2 weeks (Q2W)	Experimental	Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14, in combination with topical corticosteroid. Week 16 responders entered maintenance period and were randomly allocated to receive 250 mg lebrikizumab Q2W or 250 mg lebrikizumab Q4W, in a 1:1 ratio. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.	Drug: Lebrikizumab Drug: Topical Corticosteroid
Placebo	Placebo Comparator	Participants received two SC injections of Placebo as a loading dose at Baseline in combination with topical corticosteroid and Week 2 followed by a single injection Q2W from Week 4 until Week 14. Week 16 responders entered maintenance period and continued with the same treatment. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.	Drug: Placebo Drug: Topical Corticosteroid

Name	Type	Description	Arm Group Labels	Other Names
Lebrikizumab	Drug	Administered SC	Lebrikizumab 250 mg Every 2 weeks (Q2W) Lebrikizumab 250 mg Every 4 weeks (Q4W)

Measure	Description	Time Frame
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16	The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.	Baseline to Week 16
Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.	Week 16

Measure	Description	Time Frame
Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16	The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have chronic Atopic Dermatitis (AD) that has been present for ≥1 year before the screening.
Have moderate-to-severe AD, including all of the following:
- EASI score ≥16 at the baseline
- IGA score ≥3 (scale of 0 to 4) at the baseline
- AD involvement on ≥10% of Body Surface Area (BSA) at the baseline
Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:
- Inability to achieve good disease control, defined as mild disease or better (for example, IGA ≤2) after use of at least a medium-potency topical corticosteroids (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent TCS), whichever is shorter. Topical corticosteroids may be used with or without Topical calcineurin inhibitors (TCI) and/or topical Janus Kinase (JAK) inhibitors.
- Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and mycophenolate mofetil (MMF), will also be considered as surrogates for having inadequate response to topical therapy.
Body weight ≥40 kilogram (kg)

Exclusion Criteria:

Have a history of anaphylaxis
Have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for >24 hours at baseline.
Have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline.
Evidence of acute or chronic hepatitis or known liver cirrhosis.
Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at screening and a confirmed diagnosis of PCP.
Have a history of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments.
Have presence of significant uncontrolled neuropsychiatric disorder.
Have been exposed to a live vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Yanagihara dermatology clinic		Ainokawa, Ichikawa-shi	Chiba	272-0143	Japan
Kawashima Dermatology Clinic

PubMed Identifier	Type	Citation	Retractions
39442013	Derived	Katoh N, Tanaka A, Takahashi H, Shimizu R, Kataoka Y, Torisu-Itakura H, Morisaki Y, Yamamoto C, Igawa K. Long-term management of moderate-to-severe atopic dermatitis with lebrikizumab and concomitant topical corticosteroids: a 68-week randomized double-blind placebo-controlled phase III trial in Japan (ADhere-J). Br J Dermatol. 2025 Mar 18;192(4):597-610. doi: 10.1093/bjd/ljae394.

Label	URL
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis (ADhere-J)	View source

ID	Title	Description
FG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
FG001	Induction - Lebrikizumab 250mg Q4W

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 22, 2021	Jun 28, 2023

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 With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to Week 16

ID	Title	Description
OG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
OG001	Induction - Lebrikizumab 250 mg Q4W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.
OG002	Induction - Lebrikizumab 250 mg Q2W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.

Units	Counts
Participants	OG00082 OG00181 OG002123

Title

Denominators

Categories

Title	Measurements
	OG0006.1(0.9 to 11.3) OG00129.1(19.2 to 39.1) OG00233.4(25.0 to 41.8)

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		Cochran-Mantel-Haenszel		<0.001		Risk Difference (RD)	22.6			2-Sided	95	11.6	33.6					Superiority
OG000 OG002		Cochran-Mantel-Haenszel		<0.001

Primary

Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).

The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 16

ID	Title	Description
OG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
OG001	Induction - Lebrikizumab 250 mg Q4W

Secondary

Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).

Least Square (LS) Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.

Posted

Least Squares Mean

Standard Error

Percent change

Baseline to Week 16

ID	Title	Description
OG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
OG001	Induction - Lebrikizumab 250 mg Q4W

Secondary

Percentage of Participants Achieving EASI-90 at Week 16

The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 16

ID	Title	Description
OG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
OG001	Induction - Lebrikizumab 250 mg Q4W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.

Secondary

Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to Week 1

ID	Title	Description
OG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
OG001	Induction - Lebrikizumab 250 mg Q4W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.
OG002	Induction - Lebrikizumab 250 mg Q2W

Secondary

Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to Week 2

ID	Title	Description
OG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
OG001	Induction - Lebrikizumab 250 mg Q4W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.
OG002	Induction - Lebrikizumab 250 mg Q2W

Secondary

Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to Week 4

ID	Title	Description
OG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
OG001	Induction - Lebrikizumab 250 mg Q4W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.
OG002	Induction - Lebrikizumab 250 mg Q2W

Secondary

Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to Week 16

ID	Title	Description
OG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
OG001	Induction - Lebrikizumab 250 mg Q4W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.
OG002	Induction - Lebrikizumab 250 mg Q2W

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	82	2	82	52	82
EG001	Induction - Lebrikizumab 250mg Q4W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	81	0	81	49	81
EG002	Induction - Lebrikizumab 250mg Q2W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.	123	1	123	93	123
EG003	Maintenance Blinded Period - Lebrikizumab Q4W Responder/Lebrikizumab Q4W	Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Weeks 16 until Week 64.	38	1	38	31	38
EG004	Maintenance Blinded Period - Lebrikizumab Q2W Responder/ Lebrikizumab Q4W	Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Week 16 until Week 64.	33	0	33	25	33
EG005	Maintenance Blinded Period - Lebrikizumab Q2W Responder/Lebrikizumab Q2W	Maintenance Period (Week 16 - Week 68): Participants received 250 mg of Lebrikizumab administered SC Q2W from Week 16 until Week 66.	32	1	32	29	32
EG006	Maintenance Blinded Period - Placebo Responder/Placebo	Maintenance Secondary Population: Maintenance Period (Week 16 - Week 68): Participants received Placebo administered SC Q2W from Week 16 to Week 66.	11	0	11	10	11
EG007	Escape Arm Week 16 - Maintenance Open Label - Placebo Non Responder/Lebrikizumab 250 mg Q2W	Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received placebo in the Induction Period, loading dose was: Two 250 mg Lebrikizumab SC injection on Week 16 and two 250 mg Lebrikizumab SC injections on Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	71	1	71	63	71
EG008	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q4W Nonresponder/Lebrikizumab 250mg Q2W	Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q4W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	42	2	42	36	42
EG009	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q2W Nonresponder/Lebrikizumab 250mg Q2W	Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q2W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	55	1	55	49	55
EG010	Escape Arm Week 20 to 64 Maintenance Open Label Lebrikizumab 250 Q2W	Participants received 250 mg Lebrikizumab administered SC Q2W through Week 68 in an open-label fashion.	8	1	8	6	8

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaphylactic reaction	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG0031 events1 affected38 at risk EG0040 events0 affected33 at risk EG0050 events0 affected32 at risk EG0060 events0 affected11 at risk EG0070 events0 affected71 at risk EG0080 events0 affected42 at risk EG0090 events0 affected55 at risk EG0100 events0 affected8 at risk
Appendicitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Covid-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0010 events0 affected25 at risk EG0020 events0 affected41 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Tonsillectomy	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG0030 events0 affected38 at risk EG0040 events0 affected33 at risk EG0050 events0 affected32 at risk EG0060 events0 affected11 at risk EG0070 events0 affected71 at risk EG0080 events0 affected42 at risk EG0091 events1 affected55 at risk EG0100 events0 affected8 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
White blood cell disorder	Blood and lymphatic system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Otorrhoea	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Asthenopia	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Blepharitis	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events2 affected123 at risk EG003
Blepharitis allergic	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Cataract	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Central serous chorioretinopathy	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Chalazion	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events1 affected123 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Conjunctival hyperaemia	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected82 at risk EG00111 events10 affected81 at risk EG00223 events21 affected123 at risk EG003
Dry eye	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0011 events1 affected81 at risk EG0022 events2 affected123 at risk EG003
Eye opacity	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Eye paraesthesia	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Eye pruritus	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0023 events3 affected123 at risk EG003
Giant papillary conjunctivitis	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Glaucoma	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Keratitis	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Macular oedema	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Pingueculitis	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events1 affected123 at risk EG003
Punctate keratitis	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Retinal tear	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Acute abdomen	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events2 affected123 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0022 events2 affected123 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0013 events2 affected81 at risk EG0022 events2 affected123 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Administration site erythema	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Axillary pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Catheter site pruritus	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Chest pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Infusion site bruising	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Injection site erythema	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0023 events2 affected123 at risk EG003
Injection site haematoma	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Injection site pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Injection site paraesthesia	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Injection site pruritus	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0023 events2 affected123 at risk EG003
Injection site reaction	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG00211 events3 affected123 at risk EG003
Injection site swelling	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0022 events1 affected123 at risk EG003
Malaise	General disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0010 events0 affected81 at risk EG0025 events4 affected123 at risk EG003
Oedema peripheral	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Pyrexia	General disorders	MedDRA 25.1	Systematic Assessment	EG00015 events13 affected82 at risk EG00118 events15 affected81 at risk EG00232 events25 affected123 at risk EG003
Swelling	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Vaccination site pain	General disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected82 at risk EG0013 events3 affected81 at risk EG0024 events4 affected123 at risk EG003
Vaccination site reaction	General disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Food allergy	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Immunisation reaction	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events1 affected123 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Acne pustular	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Bartholinitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0010 events0 affected25 at risk EG0020 events0 affected41 at risk EG003
Body tinea	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Bronchitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Cellulitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0015 events5 affected81 at risk EG00213 events12 affected123 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0013 events2 affected81 at risk EG0020 events0 affected123 at risk EG003
Covid-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0012 events2 affected81 at risk EG0021 events1 affected123 at risk EG003
Cystitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dermatophytosis of nail	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Eczema herpeticum	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Erysipelas	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Folliculitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0008 events8 affected82 at risk EG0015 events5 affected81 at risk EG0027 events7 affected123 at risk EG003
Furuncle	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Gastroenteritis bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Gingivitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Herpes ophthalmic	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0011 events1 affected81 at risk EG0022 events1 affected123 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hordeolum	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Impetigo	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Infected dermal cyst	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Influenza	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Keratitis bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Malassezia infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Molluscum contagiosum	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0023 events1 affected123 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0015 events5 affected81 at risk EG0028 events7 affected123 at risk EG003
Omphalitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Ophthalmic herpes simplex	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Oral herpes	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events2 affected82 at risk EG0012 events2 affected81 at risk EG0026 events6 affected123 at risk EG003
Otitis externa	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0003 events3 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Paronychia	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Parotitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Pericoronitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events2 affected123 at risk EG003
Periodontitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Pilonidal disease	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Rhinitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Sinusitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0011 events1 affected81 at risk EG0022 events2 affected123 at risk EG003
Skin bacterial infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Skin candida	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Skin infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Tinea infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events2 affected123 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Urogenital infection bacterial	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Vestibulitis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected24 at risk EG0010 events0 affected25 at risk EG0020 events0 affected41 at risk EG003
Wound infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Bone fissure	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Dental restoration failure	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Heat illness	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Post vaccination syndrome	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Stab wound	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Blood uric acid increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Fibrin d dimer increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Fluoride increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Helicobacter test positive	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hormone level abnormal	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Liver function test increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Neutrophil count abnormal	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Platelet count increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
White blood cell count decreased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
White blood cell count increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events2 affected81 at risk EG0020 events0 affected123 at risk EG003
Metabolic disorder	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0023 events3 affected123 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events2 affected81 at risk EG0022 events2 affected123 at risk EG003
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events1 affected81 at risk EG0028 events5 affected123 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0024 events4 affected123 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Acrochordon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Oral fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0023 events3 affected123 at risk EG003
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Dyslalia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG00016 events9 affected82 at risk EG0014 events3 affected81 at risk EG0027 events4 affected123 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Menstrual headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0002 events1 affected24 at risk EG0010 events0 affected25 at risk EG0020 events0 affected41 at risk EG003
Migraine	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Parosmia	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Presyncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Somnolence	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Syncope	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0010 events0 affected25 at risk EG0020 events0 affected41 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Attention deficit hyperactivity disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dysphoria	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Mixed anxiety and depressive disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0010 events0 affected25 at risk EG0022 events2 affected41 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0011 events1 affected25 at risk EG0020 events0 affected41 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected24 at risk EG0010 events0 affected25 at risk EG0020 events0 affected41 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0010 events0 affected25 at risk EG0020 events0 affected41 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0023 events2 affected123 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events2 affected123 at risk EG003
Respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0023 events3 affected123 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Vocal cord inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected82 at risk EG0012 events2 affected81 at risk EG0024 events4 affected123 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Chloasma	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0011 events1 affected25 at risk EG0020 events0 affected41 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0023 events3 affected123 at risk EG003
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0012 events2 affected81 at risk EG0020 events0 affected123 at risk EG003
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Keratosis pilaris	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Milia	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0021 events1 affected123 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Needle track marks	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment	EG0002 events2 affected82 at risk EG0012 events2 affected81 at risk EG0020 events0 affected123 at risk EG003
Anal fistula repair	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0011 events1 affected81 at risk EG0020 events0 affected123 at risk EG003
Cataract operation	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dental care	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Dental implantation	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Intraocular lens implant	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Skin lesion removal	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0023 events1 affected123 at risk EG003
Skin operation	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0022 events2 affected123 at risk EG003
Tooth restoration	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Wisdom teeth removal	Surgical and medical procedures	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0021 events1 affected123 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003
Internal haemorrhage	Vascular disorders	MedDRA 25.1	Systematic Assessment	EG0000 events0 affected82 at risk EG0010 events0 affected81 at risk EG0020 events0 affected123 at risk EG003

ID	Term
D003876	Dermatitis, Atopic
D003872	Dermatitis
D004485	Eczema
D012871	Skin Diseases
D012873	Skin Diseases, Genetic

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

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description
BG000	Induction - Placebo	Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.
BG001	Induction - Lebrikizumab 250 mg Q4W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.
BG002	Induction - Lebrikizumab 250 mg Q2W	Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
BG003	Total	Total of all reporting groups