A Study of Ixekizumab (LY2439821) Compared to Guselkumab... | NCT03573323

ID	Type	Description	Link
I1F-MC-RHCR	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ixekizumab	Experimental	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	Drug: Ixekizumab
Guselkumab	Experimental	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	Drug: Guselkumab Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ixekizumab	Drug	Administered SC	Ixekizumab	LY2439821

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving PASI 75	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
Are a candidate for phototherapy and/or systemic therapy.
Have both an Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) score ≥12 at screening and at baseline.
Have ≥10% body surface area (BSA) involvement at screening and baseline.
If a male, agree to use a reliable method of birth control during the study.
If female, agree to use highly effective method of contraception.

Exclusion Criteria:

Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
Have a history of drug-induced psoriasis.
Had a clinically significant flare of psoriasis during the 12 weeks before baseline.
Use of tanning booths for at least 4 weeks before baseline.
Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept <28 days; infliximab, adalimumab, certolizumab pegol, or alefacept <60 days; golimumab <90 days; rituximab <12 months; secukinumab <5 months; or any other biologic agent (e.g., ustekinumab) <5 half lives.
Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.
Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have received treatment with ixekizumab.
Have previously failed to respond to an IL-17 antagonist, per investigator assessment.
Have had a live vaccination within 12 weeks of baseline.
Have a known allergy or hypersensitivity to any biologic therapy.
Have had any major surgery within 8 weeks of baseline.
Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.
Are women who are pregnant, or who are lactating (breast-feeding).

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
Total Skin and Beauty Dermatology Center PC		Birmingham	Alabama	35205	United States
University of Alabama at Birmingham

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38521874	Derived	Armstrong A, Gonzalez-Cantero A, Khattri S, Muzy G, Malatestinic WN, Lampropoulou A, Feely M, See SK, Mert C, Blauvelt A. Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies. Dermatol Ther (Heidelb). 2024 Apr;14(4):933-952. doi: 10.1007/s13555-024-01136-w. Epub 2024 Mar 23.
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IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 7, 2018	Jun 10, 2020

Arm/Group Information

ID	Title	Description
BG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
BG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
BG002	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

All randomized participants who received at least one dose of study drug and had baseline Age data.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00041.3(37.1 to 45.6) OG00124.9(21.1 to 28.6)

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														Superiority

Secondary

Percentage of Participants Achieving PASI 75

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Week 2

ID	Title	Description
OG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
OG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Secondary

Percentage of Participants Achieving PASI 90

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Week 4

ID	Title	Description
OG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
OG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Secondary

Percentage of Participants Achieving PASI 100

Posted

Number

95% Confidence Interval

percentage of participants

Week 4

ID	Title	Description
OG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
OG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Secondary

Percentage of Participants Achieving PASI 90

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
OG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Secondary

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)

The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.

Posted

Number

95% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
OG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Secondary

Percentage of Participants Achieving PASI 50

The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 50 were defined as having an improvement of at least 50% in the PASI scores compared to baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Week 1

ID	Title	Description
OG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
OG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Secondary

Percentage of Participants Achieving PASI 100

Posted

Number

95% Confidence Interval

percentage of participants

Week 8

ID	Title	Description
OG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
OG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Secondary

Percentage of Participants Achieving PASI 100

Posted

Number

95% Confidence Interval

percentage of participants

Week 24

ID	Title	Description
OG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
OG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	519	18	519	113	519
EG001	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	506	16	506	73	506
EG002	Ixekizumab Post-Treatment Follow Up	Participants who received ixekizumab in the blinded treatment periods entered the post treatment follow up period.	465	4	465	11	465
EG003	Guselkumab Post-Treatment Follow Up	Participants who received guselkumab in the blinded treatment periods entered the post treatment follow up period.	456	4	456	9	456

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG0030 events0 affected456 at risk
Angina unstable	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0012 events2 affected506 at risk EG0020 events0 affected465 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0010 events0 affected506 at risk EG0021 events1 affected465 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0021 events1 affected465 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0013 events2 affected506 at risk EG0020 events0 affected465 at risk EG003
Complicated appendicitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0010 events0 affected506 at risk EG0021 events1 affected465 at risk EG003
Infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0010 events0 affected506 at risk EG0021 events1 affected465 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0010 events0 affected506 at risk EG0021 events1 affected465 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Endometrial cancer stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected193 at risk EG0020 events0 affected164 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0010 events0 affected506 at risk EG0021 events1 affected465 at risk EG003
Rhabdomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Myxoedema coma	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Syncope	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Major depression	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected337 at risk EG0010 events0 affected313 at risk EG0020 events0 affected301 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected519 at risk EG0010 events0 affected506 at risk EG0020 events0 affected465 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003
Hypertensive urgency	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected519 at risk EG0011 events1 affected506 at risk EG0020 events0 affected465 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site reaction	General disorders	MedDRA 22.1	Systematic Assessment	EG00080 events49 affected519 at risk EG0019 events6 affected506 at risk EG0020 events0 affected465 at risk EG0032 events1 affected456 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00041 events34 affected519 at risk EG00129 events27 affected506 at risk EG0025 events5 affected465 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00044 events40 affected519 at risk EG00150 events41 affected506 at risk EG0026 events6 affected465 at risk EG003