A Study of LY3454738 in the Treatment of Adult Participan... | NCT05911841 | Trialant
NCT05911841
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
Dec 2, 2025Actual
Enrollment
234Actual
Phase
Phase 2
Conditions
Atopic Dermatitis
Interventions
LY3454738
Placebo
Countries
United States
Canada
China
Hungary
Japan
Mexico
Poland
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT05911841
Obsolete or Duplicate NCT IDs
NCT07020351
Organization Study
18569
Secondary IDs
ID
Type
Description
Link
J4E-MC-FR01
Other Identifier
Eli Lilly and Company
FR01 ISA
Other Identifier
Eli Lilly and Company
J4E-MC-IMMB Master Protocol
Other Identifier
Eli Lilly and Company
2022-502888-38-00
Other Identifier
EU Trial Number
Brief Title
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Official Title
A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52 Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The decision to terminate the study was due to efficacy/effectiveness reasons.
Expanded Access Info
No
Start Date
Jun 21, 2023Actual
Primary Completion Date
Oct 10, 2024Actual
Completion Date
Mar 14, 2025Actual
First Submitted Date
Jun 12, 2023
First Submission Date that Met QC Criteria
Jun 12, 2023
First Posted Date
Jun 22, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Oct 10, 2025
Results First Submitted that Met QC Criteria
Nov 17, 2025
Results First Posted Date
Dec 2, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 17, 2025
Last Update Posted Date
Dec 2, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).
Detailed Description
Not provided
Conditions Module
Conditions
Atopic Dermatitis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
234Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received placebo administered subcutaneously (SC) every two weeks (Q2W) from baseline to Week 14. Week 16 responders entered maintenance period and received placebo SC every four weeks (Q4W) until Week 40. Week 16 non-responders entered escape arm and received 800 milligrams (mg) of LY3454738 administered SC Q4W until Week 40.
Drug: LY3454738
Drug: Placebo
75 mg LY3454738
Experimental
Participants received 75 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and received 150 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
Drug: LY3454738
300 mg LY3454738
Experimental
Participants received 300 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and continued receiving 300 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
Drug: LY3454738
800 mg LY3454738
Experimental
Participants received 800 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and were re-randomized to either receive 800 mg of LY3454738 or placebo administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3454738
Drug
Administered SC
300 mg LY3454738
75 mg LY3454738
800 mg LY3454738
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Biologic and Small Molecule Naive Participants Achieving Eczema Area and Severity Index (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
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-50 (≥ 50% Reduction in EASI Score) at 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).
The EASI-50 responder is defined as a participant who achieves a ≥ 50% reduction from baseline in the EASI score.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Are candidates for systemic therapy.
ISA specific:
Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit:
EASI score greater than or equal to (≥)16
vIGA-AD score ≥3, and
≥10% of BSA involvement (per EASI BSA).
Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.
Exclusion Criteria:
ISA specific:
Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
Are currently being treated with topical or systemic therapy
Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
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
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Johnson Dermatology
Fort Smith
Arkansas
72916
United States
Arkansas Research Trials
References Module
Citations
Not provided
See Also Links
Label
URL
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Responders from 300 mg Q2W arm received 300 mg LY3454738 Q4W.
Responders from 75 mg Q2W arm received 150 mg LY3454738 Q4W.
Responders from placebo Q2W arm received placebo Q4W.
Escape Arm:
Participants who didn't achieve EASI-50 at Week 16 (induction non-responders) or who didn't achieve ≥25% improvement from baseline in EASI at Week 20, 24, 28, 32, or 36 (maintenance non-responders) were assigned to Escape Arm. These participants received LY3454738 800 mg Q4W through Week 40.
Recruitment Details
Induction Period (16 weeks):
Participants were randomly assigned to receive 75 mg or 300 mg or 800 mg of LY3454738 or placebo every 2 weeks (Q2W) subcutaneously (SC).
Maintenance Period (28 weeks):
At Week 16, participants who achieved a ≥50% improvement in EASI [EASI-50]) (responders) were reassigned as follows, continuing treatment through Week 40:
• Responders from the 800 mg Q2W group were re-randomized to receive either 800 mg LY3454738 every 4 weeks (Q4W) or placebo Q4W.
(continued)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
FG001
Induction - LY3454738 75 mg Q2W
Periods
Title
Milestones
Reasons Not Completed
Induction Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol: IMMB(b) Protocol
Sep 12, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Italy
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: LY3454738
Placebo
Drug
Administered SC
Placebo
Week 16
Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-90 (≥ 90% Reduction in EASI Score) at 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).
The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
Week 16
Percentage of Biologic and Small Molecule Naive Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75 at Week 16
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
Week 16
Percentage of Biologic and Small Molecule Naive Participants Achieving SCORAD-90 at Week 16
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
The SCORAD90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the SCORAD score.
Week 16
Percentage of Biologic and Small Molecule Naive Participants Achieving Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 at Week 16
vIGA-AD is a standardized clinical tool used to measure the severity of AD. It is a static 5-point scale ranging from 0 to 4, used to grade overall disease severity. Higher viGA-AD scores represent more severe disease. The scale is as below:
0-Clear: No inflammatory signs of atopic dermatitis (erythema, induration/papulation, lichenification, oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.
1-Almost Clear: Barely perceptible erythema, induration/papulation, and/or lichenification. No oozing/crusting.
2-Mild: Slight but definite erythema (pink), induration/papulation, and/or lichenification. No oozing/crusting.
3-Moderate: Clearly perceptible erythema (dull red), induration/papulation, and/or lichenification. Oozing and crusting may be present.
4-Severe: Marked erythema (deep or bright red), induration/papulation, and/or lichenification. Disease is widespread in extent. Oozing or crusting may be present.
Week 16
Percentage of Biologic and Small Molecule Naive Participants Achieving ≥4-point Improvement From Baseline in Itch Numeric Rating Scale (NRS) in the Subset of Biologic and Small Molecule Naive Participants With ≥4-point Itch NRS at Baseline
Percentage of biologic and small molecule naive participants achieving ≥4-point improvement from baseline in Itch NRS in the Subset of biologic and small molecule naive participants with ≥4-point Itch NRS at Baseline were reported.
The Itch 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."
Baseline, Week 16
Mean Percent Change From Baseline in EASI in Biologic and Small Molecule Naive Participants
Mean percent change from baseline in EASI in biologic and small molecule naive participants was reported.
Baseline, Week 16
Mean Percent Change From Baseline in SCORAD in Biologic and Small Molecule Naive Participants
Mean percent change from baseline in SCORAD in biologic and small molecule naive participants was reported.
Baseline, Week 16
Percentage of Biologic and Small Molecule Experienced Participants Achieving EASI-75 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
Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738 at Week 16
PK: Serum trough concentrations of LY3454738 were reported.
Day 113 post Day 1 Dose
North Little Rock
Arkansas
72217
United States
Dermatology Research Associates
Los Angeles
California
90045
United States
Encore Medical Research
Hollywood
Florida
33024
United States
Conquest Research
Winter Park
Florida
32789
United States
Allergy and Asthma Specialist
Owensboro
Kentucky
42301
United States
Revival Research Institute, LLC
Troy
Michigan
48084
United States
ActivMed Practices & Research, Inc.
Portsmouth
New Hampshire
03801
United States
Metropolitan Dermatology - Clark
Kenilworth
New Jersey
07033
United States
Oregon Dermatology and Research Center
Portland
Oregon
97210
United States
DermDox Centers for Dermatology
Camp Hill
Pennsylvania
17011
United States
Progressive Clinical Research
San Antonio
Texas
78213
United States
Center for Clinical Studies
Webster
Texas
77598
United States
Rejuvenation Dermatology
Calgary
Alberta
T2W 4X9
Canada
Rejuvenation Dermatology
Edmonton
Alberta
T5J 3S9
Canada
Wiseman Dermatology Research Inc.
Winnipeg
Manitoba
R3M 3Z4
Canada
CCA Medical Research
Ajax
Ontario
L1S 7K8
Canada
Hamilton Allergy
Hamilton
Ontario
L8S 1G5
Canada
Lynderm Research Inc.
Markham
Ontario
L3P 1X3
Canada
FACET Dermatology
Toronto
Ontario
M4E 1R7
Canada
Alpha Recherche Clinique
Québec
G2J 0C4
Canada
Xiangya Hospital Central South University
Changsha
Hunan
410008
China
Affiliated Hospital of Jiangsu University
Zhenjiang
Jiangsu
212000
China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
710061
China
Huashan Hospital, Fudan University
Shanghai
Shanghai Municipality
200040
China
Zhejiang Provincial People's Hospital
Hangzhou
Zhejiang
310014
China
Renmin Hospital of Wuhan University
Wuhan
430060
China
Allergo-Derm Bakos Kft
Szolnok
Jász-Nagykun-Szolnok
5000
Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár
Somogy County
7400
Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely
Vas County
9700
Hungary
Medmare Bt
Veszprém
Veszprém City
8200
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
4032
Hungary
Yasumoto Dermatology Clinic
Chikushino-shi
Fukuoka
818-0083
Japan
Takagi Dermatological Clinic
Obihiro-shi
Hokkaido
080-0013
Japan
Nomura Dermatology Clinic
Yokohama
Kanagawa
221-0825
Japan
Dermatology and Ophthalmology Kume Clinic
Sakai
Osaka
593-8324
Japan
Nihonbashi Sakura Clinic
Chuo-ku
Tokyo
103-0025
Japan
Tachikawa Dermatology Clinic
Tachikawa
Tokyo
190-0023
Japan
Centro de Atención en Enfermedades Inflamatorias CATEI
Guadalajara
Jalisco
44630
Mexico
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Ciudad de México
Mexico City
06100
Mexico
RM Pharma Specialists
Mexico City
Mexico City
03100
Mexico
Trials in Medicine
Mexico City
Mexico City
06700
Mexico
Eukarya PharmaSite
Monterrey
Nuevo León
64718
Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City
31207
Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City
68020
Mexico
Diamond Clinic
Krakow
Lesser Poland Voivodeship
31-559
Poland
MICS Centrum Medyczne Warszawa
Warsaw
Masovian Voivodeship
00-874
Poland
Specderm Poznanska
Bialystok
Podlaskie Voivodeship
15-375
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk
Pomeranian Voivodeship
80-546
Poland
"DERMED" Centrum Medyczne Sp. z o.o.
Lodz
Łódź Voivodeship
90-265
Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz
Łódź Voivodeship
90-436
Poland
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu
Incheon-gwangyeoksi [Incheon]
21431
South Korea
Korea University Ansan Hospital
Ansan-si
Kyǒnggi-do
15355
South Korea
Pusan National University Hospital
Busan
Pusan-Kwangyǒkshi
49241
South Korea
Chung-Ang University Hospital
Dongjak-gu
Seoul-teukbyeolsi [Seoul]
06973
South Korea
National Medical Center
Seoul
Seoul-teukbyeolsi [Seoul]
01812
South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul
Seoul-teukbyeolsi [Seoul]
07441
South Korea
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist
Kaohsiung
83301
Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City
New Taipei
236
Taiwan
Chung Shan Medical University Hospital
Taichung
Taichung
402
Taiwan
Tri-Service General Hospital
Taipei City
Taipei
114
Taiwan
National Taiwan University Hospital - Hsinchu branch
Hsinchu
300
Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City
235
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Taipei Veterans General Hospital
Taipei
11217
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan
333
Taiwan
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
FG002
Induction - LY3454738 300 mg Q2W
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
FG003
Induction - LY3454738 800 mg Q2W
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
FG004
Maintenance Period - Placebo Q2W to Placebo Q4W
Maintenance Period (Week 16 - Week 44): Participants received Placebo administered SC Q4W from Week 16 to Week 40.
FG005
Maintenance Period - LY3454738 75 mg Q2W to LY3454738 150 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 150 mg LY3454738 SC Q4W from Week 16 to Week 40.
FG006
Maintenance Period - LY3454738 300 mg Q2W to LY3454738 300 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 300 mg LY3454738 SC Q4W from Week 16 to Week 40.
FG007
Maintenance Period - LY3454738 800 mg Q2W to LY3454738 800 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 800 mg LY3454738 SC Q4W from Week 16 to Week 40.
FG008
Maintenance Period - LY3454738 800 mg Q2W to Placebo Q4W
Maintenance Period (Week 16 - Week 44): Participants received Placebo SC Q4W from Week 16 to Week 40.
FG009
Escape Period - LY3454738 800 mg Q4W
Participants received 800 mg LY3454738 administered SC Q4W through Week 44.
FG00065 subjectsStarted includes Biologic- and small-molecule-naive n = 35; Biologic- and/or small-molecule-experienced n = 30.
FG00131 subjectsStarted includes Biologic- and small-molecule-naive n = 30; Biologic- and/or small-molecule-experienced n = 1.
FG00245 subjectsStarted includes Biologic- and small-molecule-naive n = 29; Biologic- and/or small-molecule-experienced n = 16.
FG00393 subjectsStarted includes Biologic- and small-molecule-naive n = 60; Biologic- and/or small-molecule-experienced n = 33.
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Received At Least One Dose of Study Drug
FG00065 subjects
FG00131 subjects
FG00245 subjects
FG00393 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG00053 subjectsCompleted includes Responders n = 22; Non responders n = 31.
FG00126 subjectsCompleted includes Responders n = 13; Non responders n = 13.
FG00221 subjectsCompleted includes Responders n = 8; Non responders n = 13.
FG00376 subjectsCompleted includes Responders n = 39; Non responders n = 37.
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG00012 subjects
FG0015 subjects
FG00224 subjects
FG00317 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Study Terminated by Sponsor
FG0002 subjects
FG0010 subjects
FG00214 subjects
FG0036 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Withdrawal by Subject
FG0004 subjects
FG0013 subjects
FG0024 subjects
FG0036 subjects
FG004
Lack of Efficacy
FG0003 subjects
FG0010 subjects
FG0023 subjects
FG0033 subjects
FG004
Adverse Event
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Assigned Treatment by Mistake
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Maintenance Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm only during Induction Period.
FG0010 subjectsParticipants were assigned to this arm only during Induction Period.
FG0020 subjectsParticipants were assigned to this arm only during Induction Period.
FG0030 subjectsParticipants were assigned to this arm only during Induction Period.
FG00422 subjectsOnly those participants who were responders in the Induction Period at Week 16 entered the Maintenance Period.
FG00513 subjectsOnly those participants who were responders in the Induction Period at Week 16 entered the Maintenance Period.
FG0068 subjectsOnly those participants who were responders in the Induction Period at Week 16 entered the Maintenance Period.
FG00720 subjectsOnly those participants who were responders in the Induction Period at Week 16 entered the Maintenance Period.
FG00819 subjectsOnly those participants who were responders in the Induction Period at Week 16 entered the Maintenance Period.
FG0090 subjects
Received At Least One Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Enrolled to Escape Arm
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Escape Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjectsParticipants were assigned to this arm only during Maintenance Period.
FG0050 subjectsParticipants were assigned to this arm only during Maintenance Period.
FG0060 subjectsParticipants were assigned to this arm only during Maintenance Period.
FG0070 subjectsParticipants were assigned to this arm only during Maintenance Period.
FG0080 subjectsParticipants were assigned to this arm only during Maintenance Period.
FG009105 subjectsOnly those participants who were non-responders in the Induction Period at Week 16 and who did not achieve at least 25% improvement in EASI at Week 20, 24, 28, 32, or 36 entered the Escape Period.
Received At Least One Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
BG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
BG002
Induction - LY3454738 300 mg Q2W
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
BG003
Induction - LY3454738 800 mg Q2W
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00065
BG00131
BG00245
BG00393
BG004234
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038.0± 13.4
BG00137.3± 12.4
BG00236.1± 13.9
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00028
BG00113
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0007
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0004
BG0015
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
Title
Measurements
BG0005
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Biologic and Small Molecule Naive Participants Achieving Eczema Area and Severity Index (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 biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least 1 dose of study drug.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
OG002
Induction - LY3454738 300 mg Q2W
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
OG003
Induction - LY3454738 800 mg Q2W
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
Units
Counts
Participants
OG00035
OG00130
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG00014.3
OG00120.0
OG00217.2
OG003
Secondary
Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-50 (≥ 50% Reduction in EASI Score) at 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).
The EASI-50 responder is defined as a participant who achieves a ≥ 50% reduction from baseline in the EASI score.
All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
Secondary
Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-90 (≥ 90% Reduction in EASI Score) at 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).
The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
Secondary
Percentage of Biologic and Small Molecule Naive Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75 at Week 16
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
Secondary
Percentage of Biologic and Small Molecule Naive Participants Achieving SCORAD-90 at Week 16
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
The SCORAD90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the SCORAD score.
All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
Secondary
Percentage of Biologic and Small Molecule Naive Participants Achieving Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 at Week 16
vIGA-AD is a standardized clinical tool used to measure the severity of AD. It is a static 5-point scale ranging from 0 to 4, used to grade overall disease severity. Higher viGA-AD scores represent more severe disease. The scale is as below:
0-Clear: No inflammatory signs of atopic dermatitis (erythema, induration/papulation, lichenification, oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.
1-Almost Clear: Barely perceptible erythema, induration/papulation, and/or lichenification. No oozing/crusting.
2-Mild: Slight but definite erythema (pink), induration/papulation, and/or lichenification. No oozing/crusting.
3-Moderate: Clearly perceptible erythema (dull red), induration/papulation, and/or lichenification. Oozing and crusting may be present.
4-Severe: Marked erythema (deep or bright red), induration/papulation, and/or lichenification. Disease is widespread in extent. Oozing or crusting may be present.
All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Secondary
Percentage of Biologic and Small Molecule Naive Participants Achieving ≥4-point Improvement From Baseline in Itch Numeric Rating Scale (NRS) in the Subset of Biologic and Small Molecule Naive Participants With ≥4-point Itch NRS at Baseline
Percentage of biologic and small molecule naive participants achieving ≥4-point improvement from baseline in Itch NRS in the Subset of biologic and small molecule naive participants with ≥4-point Itch NRS at Baseline were reported.
The Itch 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 biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug in the subset of participants with ≥4-point Itch NRS at baseline.
Posted
Number
Percentage of participants
Baseline, Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
OG002
Induction - LY3454738 300 mg Q2W
Secondary
Mean Percent Change From Baseline in EASI in Biologic and Small Molecule Naive Participants
Mean percent change from baseline in EASI in biologic and small molecule naive participants was reported.
All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
OG002
Induction - LY3454738 300 mg Q2W
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
OG003
Induction - LY3454738 800 mg Q2W
Secondary
Mean Percent Change From Baseline in SCORAD in Biologic and Small Molecule Naive Participants
Mean percent change from baseline in SCORAD in biologic and small molecule naive participants was reported.
All biologic and small-molecule-naive participants who were randomly assigned to study intervention and took at least one dose of study drug.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
OG002
Induction - LY3454738 300 mg Q2W
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
OG003
Induction - LY3454738 800 mg Q2W
Secondary
Percentage of Biologic and Small Molecule Experienced Participants Achieving EASI-75 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 biologic and small-molecule-experienced participants who were randomly assigned to study intervention and took at least 1 dose of study drug.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
OG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
Secondary
Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738 at Week 16
PK: Serum trough concentrations of LY3454738 were reported.
All biologic and/or small molecule experienced or biologic-and-small-molecule naïve participants who were randomly assigned to study intervention and took at least 1 dose of LY3454738 and had evaluable PK data.
Posted
Mean
Standard Deviation
micrograms per milliliter (μg/mL)
Day 113 post Day 1 Dose
ID
Title
Description
OG000
LY3454738 75 mg
All participants who received 75 mg of LY3454738 given SC Q2W were included in this arm.
OG001
LY3454738 300 mg
All participants who received 300 mg of LY3454738 given SC Q2W were included in this arm.
OG002
LY3454738 800 mg
All participants who received 800 mg of LY3454738 given SC Q2W were included in this arm.
Units
Counts
Participants
Time Frame
Baseline Through Follow-up (Up To 52 Weeks)
Description
All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Induction - Placebo Q2W
Induction Period: (Baseline - Week 16): Participants received SC injections of Placebo Q2W from Baseline until Week 14.
0
65
3
65
35
65
EG001
Induction - LY3454738 75 mg Q2W
Induction Period (Baseline - Week 16): Participants received 75 mg of LY3454738 given SC Q2W from Baseline until Week 14.
0
31
1
31
19
31
EG002
Induction - LY3454738 300 mg Q2W
Induction Period (Baseline - Week 16): Participants received 300 mg of LY3454738 given SC Q2W from Baseline until Week 14.
0
45
1
45
20
45
EG003
Induction - LY3454738 800 mg Q2W
Induction Period (Baseline - Week 16): Participants received 800 mg of LY3454738 given SC Q2W from Baseline until Week 14.
0
93
1
93
52
93
EG004
Maintenance Period - Placebo Q2W to Placebo Q4W
Maintenance Period (Week 16 - Week 44): Participants received Placebo administered SC Q4W from Week 16 to Week 40.
0
22
1
22
13
22
EG005
Maintenance Period - LY3454738 75 mg Q2W to LY3454738 150 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 150 mg LY3454738 SC Q4W from Week 16 to Week 40.
0
13
1
13
7
13
EG006
Maintenance Period - LY3454738 300 mg Q2W to LY3454738 300 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 300 mg LY3454738 SC Q4W from Week 16 to Week 40.
0
8
0
8
4
8
EG007
Maintenance Period - LY3454738 800 mg Q2W to LY3454738 800 mg Q4W
Maintenance Period (Week 16 - Week 44): Participants received 800 mg LY3454738 SC Q4W from Week 16 to Week 40.
0
20
1
20
7
20
EG008
Maintenance Period - LY3454738 800 mg Q2W to Placebo Q4W
Maintenance Period (Week 16 - Week 44): Participants received Placebo SC Q4W from Week 16 to Week 40.
0
19
0
19
6
19
EG009
Escape Period - LY3454738 800 mg Q4W
Participants received 800 mg LY3454738 administered SC Q4W through Week 44.
0
105
0
39
105
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaphylactic shock
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected93 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected19 at risk
EG0090 events0 affected105 at risk
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Traumatic pain
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Device dislocation
Product Issues
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Hypotension
Vascular disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected93 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected19 at risk
EG0090 events0 affected105 at risk
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Middle ear inflammation
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 28.0
Systematic Assessment
EG0002 events1 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Dry eye
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Lens dislocation
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Anorectal polyp
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Administration site erythema
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Administration site pruritus
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Administration site swelling
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Asthenia
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Chills
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Condition aggravated
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Fatigue
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Hypothermia
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Influenza like illness
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Injection site bruising
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected45 at risk
EG003
Injection site erythema
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Injection site pruritus
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Injection site reaction
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected45 at risk
EG003
Oedema
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Oedema peripheral
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Pain
General disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Pyrexia
General disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Allergy to animal
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Atopy
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Food allergy
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Milk allergy
Immune system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Actinomycosis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Bacterial vulvovaginitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected21 at risk
EG003
Body tinea
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Covid-19
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Cystitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Fungal foot infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Furuncle
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Impetigo
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Influenza
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Joint abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0005 events5 affected65 at risk
EG0014 events4 affected31 at risk
EG0024 events3 affected45 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Paronychia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Puncture site infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Skin infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Staphylococcal impetigo
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0005 events4 affected65 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected21 at risk
EG003
Viral infection
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Barotitis media
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Eyelid scar
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Post procedural erythema
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0003 events3 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Blood glucose increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Blood pressure increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Heart rate increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Oesophagogastroscopy
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Protein urine present
Investigations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Weight decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected45 at risk
EG003
Weight increased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected45 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Pyogenic granuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected45 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)