A Study in Participants With Moderate to Severe Psoriasis... | NCT01646177 | Trialant
NCT01646177
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 28, 2020Actual
Enrollment
1,346Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Placebo
50 mg etanercept
80 mg ixekizumab
Countries
United States
Argentina
Bulgaria
Canada
Chile
Germany
Hungary
Mexico
Poland
Russia
Protocol Section
Identification Module
NCT ID
NCT01646177
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
13685
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBC
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)
Official Title
A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Acronym
UNCOVER-3
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Nov 1, 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 28, 2012Actual
Primary Completion Date
May 22, 2014Actual
Completion Date
Jul 22, 2019Actual
First Submitted Date
Jul 18, 2012
First Submission Date that Met QC Criteria
Jul 18, 2012
First Posted Date
Jul 20, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 20, 2016
Results First Submitted that Met QC Criteria
Aug 27, 2016
Results First Posted Date
Oct 21, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 29, 2014
Certification/Extension First Submitted that Passed QC Review
Sep 29, 2014
Certification/Extension First Posted Date
Oct 8, 2014Estimated
Last Update Submitted Date
Jul 17, 2020
Last Update Posted Date
Jul 28, 2020Actual
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
Not provided
Is FDA Regulated Device
Not provided
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
This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,346Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, participants are assigned to Dosing Regimen 2.
Drug: Placebo
50 mg etanercept
Active Comparator
Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2
Drug: 50 mg etanercept
80 mg ixekizumab Dosing Regimen 2
Experimental
Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 264.
Drug: 80 mg ixekizumab
80 mg ixekizumab Dosing Regimen 1
Experimental
Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is assigned to Dosing Regimen 2.
Drug: 80 mg ixekizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Administered SC
Placebo
50 mg etanercept
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)
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 (0,1) response was defined as a post-baseline sPGA score of 0 or 1.
Week 12
Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
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 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization
At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
Candidate for phototherapy and/or systemic therapy
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion Criteria:
Pustular, erythrodermic, and/or guttate forms of psoriasis
History of drug-induced psoriasis
Prior use of etanercept
Clinically significant flare of psoriasis during the 12 weeks prior to randomization
Concurrent or recent use of any biologic agent
Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
Serious disorder or illness other than plaque psoriasis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
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
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Egeberg A, Hawkes JE, Somani N, Burge R, See K, Gallo G, McKean-Matthews M, Gooderham M, Han G, Armstrong A. Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60. Dermatol Ther (Heidelb). 2024 Apr;14(4):1007-1018. doi: 10.1007/s13555-024-01147-7. Epub 2024 Apr 22.
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.
This study has 4 periods: Period 1 - Screening; Period 2 - Blinded Induction Dosing Period (Weeks 0 to 12); Period 3 - Long-Term Extension Period (Weeks 12 to 264); Period 4 - Post-Treatment Follow-Up Period (Minimum of 12 Weeks)
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo (PBO) for ixekizumab (Week 0) given as 2 subcutaneous (SC) injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
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.
Week 12
Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
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
Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Participants indicate their overall severity of itching from Psoriasis by circling the number that best describes the worst level of itching in the past 24 hours.
Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Baseline, Week 12
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI is a numeric, reproducible, objective tool used to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed psoriasis: 0 (none) to 4 (psoriasis in 4 quadrants of the nail) and fingernail matrix psoriasis (0 to 4) depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed and fingernail matrix psoriasis in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, and the sum of all the fingernails is the total NAPSI score (range, 0 to 80). LS Means in NAPSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Baseline, Week 12
Percent of Body Surface Area (BSA) Involvement of Psoriasis
Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb). LS Means in BSA were calculated using MMRM with baseline BSA as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Week 12
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
PSSI is a composite score ranging from 0 (best) to 72 (worst), derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. LS Means in PSSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Baseline, Week 12
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS Means in total QIDS-SR16 score were calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.
Baseline, Week 12
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)
The WPAI-PSO is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days. It has four domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 and ranged from 0 to 100. Higher scores indicate greater impairment in productivity. LS Means in each WPAI-PSO score were calculated using the ANCOVA model with treatment, pooled center and baseline WPAI-PSO score.
Baseline, Week 12
Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS Means in SF-36 score were calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.
Baseline, Week 12
Change From Baseline in Patient's Global Assessment of Disease Severity
The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Means in Patient's Global Assessment of Disease Severity score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Baseline, Week 12
Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement
Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 50 were defined as having an improvement of at least 50% in the PPASI scores compared to baseline.
Week 12
Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement
Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.
Week 12
Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement
Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.
Week 12
Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies
The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at any time post-baseline were summarized by treatment group. Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies were calculated as: number of participants with an evaluable baseline sample and ≥1 evaluable post-baseline sample/number of participants in the analysis population * 100.
Week 12
United States
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Bakersfield
California
93309
United States
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Bell Gardens
California
90201
United States
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Beverly Hills
California
90212
United States
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Irvine
California
92697
United States
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Los Angeles
California
90045
United States
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Oceanside
California
92056
United States
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San Diego
California
92123
United States
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Santa Monica
California
90404
United States
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Aurora
Colorado
80045
United States
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New Haven
Connecticut
06511
United States
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Edgewater
Florida
32132
United States
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Jacksonville
Florida
32216
United States
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Miami
Florida
33144
United States
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Ocala
Florida
34471
United States
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Ormond Beach
Florida
32174
United States
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Arlington Heights
Illinois
60005
United States
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Chicago
Illinois
60611
United States
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Skokie
Illinois
60077
United States
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Indianapolis
Indiana
46256
United States
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West Des Moines
Iowa
50265
United States
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Louisville
Kentucky
40217
United States
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Owensboro
Kentucky
42303
United States
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Boston
Massachusetts
02111
United States
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Ann Arbor
Michigan
48109
United States
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Omaha
Nebraska
68144
United States
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Henderson
Nevada
89074
United States
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Newington
New Hampshire
03801
United States
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East Windsor
New Jersey
08520
United States
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Albuquerque
New Mexico
87106
United States
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New York
New York
10075
United States
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Stony Brook
New York
11790
United States
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High Point
North Carolina
27262
United States
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Winston-Salem
North Carolina
27157
United States
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Portland
Oregon
97223
United States
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Hazleton
Pennsylvania
18201
United States
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Anderson
South Carolina
29621
United States
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Dallas
Texas
75246
United States
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San Antonio
Texas
78229
United States
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Salt Lake City
Utah
84132
United States
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West Jordan
Utah
84088
United States
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Buenos Aires
C1055AA0
Argentina
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Ciudad Autónoma de Buenosaire
C1199ABD
Argentina
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Plovdiv
4000
Bulgaria
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Sofia
1632
Bulgaria
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Varna
9010
Bulgaria
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Calgary
Alberta
T3A 2N1
Canada
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Vancouver
British Columbia
V5Z-3Y1
Canada
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Halifax
Nova Scotia
B3H0A2
Canada
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Brampton
Ontario
L6R 0W3
Canada
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Ottawa
Ontario
K2G 6E2
Canada
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Richmond Hill
Ontario
L4B 1A5
Canada
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Waterloo
Ontario
N2J 1C4
Canada
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Windsor
Ontario
N8W5L7
Canada
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Drummondville
Quebec
J2B 5L4
Canada
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Montreal
Quebec
H2K4L5
Canada
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Santiago
8420383
Chile
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Augsburg
86179
Germany
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Berlin
13125
Germany
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Bonn
53111
Germany
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Dresden
01069
Germany
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Erfurt
99084
Germany
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Ergolding
84038
Germany
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Frankfurt
60596
Germany
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Freiburg im Breisgau
79100
Germany
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Freising
85354
Germany
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Friedrichshafen
88045
Germany
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Gera
07548
Germany
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Hamburg
20253
Germany
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Hanau
63450
Germany
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Kiel
24148
Germany
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Leipzig
04103
Germany
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Mahlow
15831
Germany
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Mainz
55131
Germany
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Mannheim
68167
Germany
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Mönchengladbach
41236
Germany
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Münster
48159
Germany
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Northeim
37154
Germany
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Schwerin
19055
Germany
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Würzburg
97080
Germany
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Budapest
1036
Hungary
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Debrecen
4032
Hungary
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Kecskemét
6000
Hungary
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Makó
6900
Hungary
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Miskolc
3529
Hungary
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Orosháza
5900
Hungary
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Pécs
7632
Hungary
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Szeged
H-6720
Hungary
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Szolnok
H-5000
Hungary
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Szombathely
9700
Hungary
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Veszprém
8200
Hungary
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Monterrey
64460
Mexico
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Bialystok
15-017
Poland
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Krakow
30-510
Poland
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Warsaw
02-201
Poland
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Krasnodar
350020
Russia
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Moscow
127473
Russia
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Saint Petersburg
194356
Russia
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Saint Petersburg
195112
Russia
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Smolensk
214019
Russia
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Yaroslavl
150002
Russia
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.
Kirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.
Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
Blauvelt A, Lebwohl MG, Mabuchi T, Leung A, Garrelts A, Crane H, ElMaraghy H, Patel H, Ridenour T, See K, Gallo G, Paul C. Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021 Aug;85(2):360-368. doi: 10.1016/j.jaad.2020.11.022. Epub 2020 Nov 28.
Rich P, Goldblum O, Disch D, Lin CY, Merola JF, Elewski B. Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis. J Drugs Dermatol. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.
Yosipovitch G, Reich A, Steinhoff M, Beselin A, Kent T, Dossenbach M, Berggren L, Henneges C, Luger T. Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies. Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21.
Reich K, Jackson K, Ball S, Garces S, Kerr L, Chua L, Muram TM, Blauvelt A. Ixekizumab Pharmacokinetics, Anti-Drug Antibodies, and Efficacy through 60 Weeks of Treatment of Moderate to Severe Plaque Psoriasis. J Invest Dermatol. 2018 Oct;138(10):2168-2173. doi: 10.1016/j.jid.2018.04.019. Epub 2018 May 8.
Blauvelt A, Papp KA, Griffiths CEM, Puig L, Weisman J, Dutronc Y, Kerr LF, Ilo D, Mallbris L, Augustin M. Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). Am J Clin Dermatol. 2017 Apr;18(2):273-280. doi: 10.1007/s40257-016-0246-9.
van de Kerkhof P, Guenther L, Gottlieb AB, Sebastian M, Wu JJ, Foley P, Morita A, Goldblum O, Zhang L, Erickson J, Ball S, Rich P. Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis: results from the randomized, controlled and open-label phases of UNCOVER-3. J Eur Acad Dermatol Venereol. 2017 Mar;31(3):477-482. doi: 10.1111/jdv.14033. Epub 2016 Dec 2.
Armstrong AW, Lynde CW, McBride SR, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.
Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, Cameron GS, Erickson J, Zhang L, Secrest RJ, Ball S, Braun DK, Osuntokun OO, Heffernan MP, Nickoloff BJ, Papp K; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51. doi: 10.1016/S0140-6736(15)60125-8. Epub 2015 Jun 10.
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
FG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
FG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
FG004
PBO/IXE80Q4W
Participants who received placebo during the induction period and received 80 mg ixekizumab SC injection every four weeks (IXE80Q4W) in the Long-term extension period.
FG005
ETN/IXE80Q4W
Participants who received Etanercept during the induction period and received IXE80Q4W in the long-term extension period.
FG006
IXE80Q4W/IXE80Q4W
Participants who received 80 mg ixe Q4W during the induction period and received IXE80Q4W in the long-term extension period.
FG007
IXE80Q2W/IXE80Q4W
Participants who received 80 mg ixe Q2W (IXE80Q2W) during the induction period and received IXE80Q4W in the long-term extension period.
FG008
PBO Follow-Up Period
Participants who received PBO in the Induction Period and entered the Post-Treatment Follow-up Period.
FG009
ETN Follow-Up Period
Participants who received etanercept (ETN) in the Induction Period and entered the Post-Treatment Follow-up Period.
FG010
IXE80Q4W Follow-Up Period
Participants who received 80 mg ixe Q4W in the Induction Period and entered the Post-Treatment Follow-up Period.
FG011
IXE80Q2W Follow-Up Period
Participants who received 80 mg ixe Q2W in the Induction Period and entered the Post-Treatment Follow-up Period.
FG000193 subjects
FG001382 subjects
FG002386 subjects
FG003385 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Received at Least One Dose of Study Drug
FG000193 subjects
FG001382 subjects
FG002382 subjects
FG003384 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG000183 subjects
FG001369 subjects
FG002360 subjects
FG003363 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG00010 subjects
FG00113 subjects
FG00226 subjects
FG00322 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0014 subjects
FG0029 subjects
FG0038 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Protocol Violation
FG0001 subjects
FG0013 subjects
FG0028 subjects
FG0037 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0012 subjects
FG0024 subjects
FG0034 subjects
FG004
Physician Decision
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
Long-Term Extension Period (Week 12-264)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants completed prior period then proceeded to IXE80Q4W long-term extension period.
FG0010 subjectsParticipants completed prior period then proceeded to IXE80Q4W long-term extension period.
FG0020 subjectsParticipants completed prior period then proceeded to IXE80Q4W long-term extension period.
FG0030 subjectsParticipants completed prior period then proceeded to IXE80Q4W long-term extension period.
FG004183 subjectsParticipants completed prior period then proceeded to IXE80Q4W long-term extension period.
FG005369 subjectsParticipants completed prior period then proceeded to IXE80Q4W long-term extension period.
FG006360 subjectsParticipants completed prior period then proceeded to IXE80Q4W long-term extension period.
FG007362 subjectsParticipants completed prior period then proceeded to IXE80Q4W long-term extension period.
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 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
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow-Up Period (Minimum of 12 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjectsParticipants who completed or discontinued from study treatment and entered the follow-up period.
FG0050 subjectsParticipants who completed or discontinued from study treatment and entered the follow-up period.
FG0060 subjectsParticipants who completed or discontinued from study treatment and entered the follow-up period.
FG0070 subjectsParticipants who completed or discontinued from study treatment and entered the follow-up period.
FG008157 subjectsParticipants who completed or discontinued from study treatment and entered the follow-up period.
FG009309 subjectsParticipants who completed or discontinued from study treatment and entered the follow-up period.
FG010305 subjectsParticipants who completed or discontinued from study treatment and entered the follow-up period.
FG011313 subjectsParticipants who completed or discontinued from study treatment and entered the follow-up 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
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
BG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
BG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
BG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000193
BG001382
BG002386
BG003385
BG0041346
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00056
BG001113
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00025
BG00152
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0014
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Argentina
Title
Measurements
BG0002
BG0017
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
Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)
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 (0,1) response was defined as a post-baseline sPGA score of 0 or 1.
All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000193
OG001382
OG002386
OG003
Title
Denominators
Categories
Title
Measurements
OG00013
OG001159
OG002291
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
Primary
Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
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 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.
All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
Secondary
Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)
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.
All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
Secondary
Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
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.
All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
Secondary
Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
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.
All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
Secondary
Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Participants indicate their overall severity of itching from Psoriasis by circling the number that best describes the worst level of itching in the past 24 hours.
All randomized participants and had an Itch NRS score >=4 at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants and had at least one post-dose measurement of DLQI.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
Secondary
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI is a numeric, reproducible, objective tool used to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed psoriasis: 0 (none) to 4 (psoriasis in 4 quadrants of the nail) and fingernail matrix psoriasis (0 to 4) depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed and fingernail matrix psoriasis in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, and the sum of all the fingernails is the total NAPSI score (range, 0 to 80). LS Means in NAPSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants and had fingernail involvement at baseline and had at least one post-dose measurement of NAPSI.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Secondary
Percent of Body Surface Area (BSA) Involvement of Psoriasis
Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb). LS Means in BSA were calculated using MMRM with baseline BSA as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants and had at least one post-dose measurement of BSA.
Posted
Least Squares Mean
Standard Error
Percent
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Secondary
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
PSSI is a composite score ranging from 0 (best) to 72 (worst), derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. LS Means in PSSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants and had scalp psoriasis at baseline and had at least one post-dose measurement of PSSI.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Secondary
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS Means in total QIDS-SR16 score were calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.
All randomized participants and had at least one post-dose measurement of QIDS-SR16. Participants with missing QIDS-SR16 data were imputed by Last Observation Carried Forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
Secondary
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)
The WPAI-PSO is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days. It has four domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 and ranged from 0 to 100. Higher scores indicate greater impairment in productivity. LS Means in each WPAI-PSO score were calculated using the ANCOVA model with treatment, pooled center and baseline WPAI-PSO score.
All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of WPAI-PSO. Participants with missing WPAI-PSO data were imputed by Last Observation Carried Forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Secondary
Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS Means in SF-36 score were calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.
All randomized participants and had at least one post-dose measurement of SF-36. Participants with missing SF-36 data were imputed by Last Observation Carried Forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
Secondary
Change From Baseline in Patient's Global Assessment of Disease Severity
The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Means in Patient's Global Assessment of Disease Severity score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants and had at least one post-dose measurement of Patient's Global Assessment of Disease Severity.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
Secondary
Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement
Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 50 were defined as having an improvement of at least 50% in the PPASI scores compared to baseline.
All randomized participants and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Secondary
Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement
Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.
All randomized participants and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Secondary
Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement
Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.
All randomized participants and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Secondary
Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies
The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at any time post-baseline were summarized by treatment group. Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies were calculated as: number of participants with an evaluable baseline sample and ≥1 evaluable post-baseline sample/number of participants in the analysis population * 100.
All randomized participants who received at least one dose of study treatment and had evaluable data.
Posted
Count of Participants
Participants
No
Week 12
ID
Title
Description
OG000
Placebo
Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
OG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Time Frame
Up to 288 Weeks
Description
All randomized participants who received at least one dose of study drug. 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
Placebo
Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 (Q2W) until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).
5
193
40
193
EG001
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
8
382
90
382
EG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
6
382
115
382
EG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
9
384
123
384
EG004
PBO/IXE80Q4W Long-Term Extension
Participants who received placebo during the induction period and received 80 mg ixekizumab SC injection every four weeks (IXE80Q4W) in the Long-term extension period.
45
183
117
183
EG005
ETN/IXE80Q4W Long-Term Extension
Participants who received Etanercept during the induction period and received IXE80Q4W in the long-term extension period.
71
369
240
369
EG006
IXE80Q4W/IXE80Q4W Long-Term Extension
Participants who received 80 mg ixe Q4W during the induction period and received IXE80Q4W in the long-term extension period.
82
360
236
360
EG007
IXE80Q2W/IXE80Q4W Long-Term Extension
Participants who received 80 mg ixe Q2W (IXE80Q2W) during the induction period and received IXE80Q4W in the long-term extension period.
55
362
249
362
EG008
PBO Follow-Up Period
Participants who received PBO in the Induction Period and entered the Post-Treatment Follow-up Period.
5
157
9
157
EG009
ETN Follow-Up Period
Participants who received ETN in the Induction Period and entered the Post-Treatment Follow-up Period.
5
309
23
309
EG010
IXE80Q4W Follow-Up
Participants who received 80 mg ixe Q4W in the Induction Period and entered the Post-Treatment Follow-up Period.
2
305
14
305
EG011
IXE80Q2W Follow-Up
Participants who received 80 mg ixe Q2W in the Induction Period and entered the Post-Treatment Follow-up Period.
6
313
15
313
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG0030 events0 affected384 at risk
EG004
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Laryngocele
Congenital, familial and genetic disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cataract
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0011 events1 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diplopia
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Retinal vein thrombosis
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diverticulum oesophageal
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0021 events1 affected382 at risk
EG003
Pancreatitis necrotising
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Accidental death
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Chest discomfort
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Death
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hernia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Non-alcoholic steatohepatitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cellulitis staphylococcal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Chronic tonsillitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0011 events1 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Colonic abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Device related infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diabetic foot infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0021 events1 affected382 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gas gangrene
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gastroenteritis escherichia coli
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Orchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected137 at risk
EG0010 events0 affected269 at risk
EG0020 events0 affected254 at risk
EG003
Osteomyelitis acute
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pneumonia chlamydial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0021 events1 affected382 at risk
EG003
Pyonephrosis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Spinal cord abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Urinary tract infection pseudomonal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0021 events1 affected382 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Accident at work
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Avulsion fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Carotid artery restenosis
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Chemical burn of skin
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0011 events1 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Incision site haemorrhage
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0011 events1 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Post procedural bile leak
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Biopsy liver
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diabetic metabolic decompensation
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hyperinsulinaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Vitamin b12 deficiency
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Chondrocalcinosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Knee deformity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0011 events1 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Plica syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Rheumatic disorder
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Benign lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Benign neoplasm of thyroid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Bone cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Carcinoid tumour of the duodenum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cholesteatoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Ewing's sarcoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gallbladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hepatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0011 events1 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Non-hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Ovarian germ cell teratoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected137 at risk
EG0010 events0 affected269 at risk
EG0020 events0 affected254 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected137 at risk
EG0010 events0 affected269 at risk
EG0020 events0 affected254 at risk
EG003
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Rectal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Renal cell carcinoma stage ii
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Synovial sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Vulval cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Cerebral artery embolism
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0022 events1 affected382 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Haemorrhagic cerebral infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Miller fisher syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Reversible ischaemic neurological deficit
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Senile dementia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Polyhydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Acute stress disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Bipolar i disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Burnout syndrome
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0021 events1 affected382 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0012 events1 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Renal artery arteriosclerosis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Renal cyst haemorrhage
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected137 at risk
EG0010 events0 affected269 at risk
EG0020 events0 affected254 at risk
EG003
Breast disorder
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Genital haemorrhage
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected137 at risk
EG0010 events0 affected269 at risk
EG0021 events1 affected254 at risk
EG003
Uterine scar
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Lung consolidation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Nasal turbinate hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diabetic ulcer
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hypersensitivity vasculitis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Coronary artery bypass
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Fracture treatment
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Gastric bypass
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hernia repair
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hysterectomy
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Implantable cardiac monitor insertion
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Perineal operation
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected113 at risk
EG0020 events0 affected128 at risk
EG003
Air embolism
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Diabetic vascular disorder
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0010 events0 affected382 at risk
EG0020 events0 affected382 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected193 at risk
EG0016 events6 affected382 at risk
EG0027 events3 affected382 at risk
EG00312 events11 affected384 at risk
EG00412 events10 affected183 at risk
EG00529 events27 affected369 at risk
EG00618 events14 affected360 at risk
EG00732 events25 affected362 at risk
EG0080 events0 affected157 at risk
EG0090 events0 affected309 at risk
EG0100 events0 affected305 at risk
EG0110 events0 affected313 at risk
Injection site reaction
General disorders
MedDRA 22.0
Systematic Assessment
EG00021 events3 affected193 at risk
EG001207 events42 affected382 at risk
EG00299 events43 affected382 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0014 events4 affected382 at risk
EG0026 events6 affected382 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0012 events2 affected382 at risk
EG0022 events2 affected382 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0011 events1 affected382 at risk
EG0021 events1 affected382 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00012 events11 affected193 at risk
EG00122 events19 affected382 at risk
EG00229 events29 affected382 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0012 events2 affected382 at risk
EG0027 events7 affected382 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected193 at risk
EG0011 events1 affected382 at risk
EG0021 events1 affected382 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0005 events5 affected193 at risk
EG0018 events8 affected382 at risk
EG0028 events8 affected382 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0013 events3 affected382 at risk
EG0025 events5 affected382 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected113 at risk
EG0021 events1 affected128 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0005 events4 affected193 at risk
EG0017 events7 affected382 at risk
EG0029 events9 affected382 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected193 at risk
EG0013 events2 affected382 at risk
EG0028 events8 affected382 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG00010 events5 affected193 at risk
EG00115 events11 affected382 at risk
EG00223 events16 affected382 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected193 at risk
EG0014 events4 affected382 at risk
EG00210 events9 affected382 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected193 at risk
EG0012 events2 affected382 at risk
EG0028 events6 affected382 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected193 at risk
EG0014 events4 affected382 at risk
EG0029 events8 affected382 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected193 at risk
EG0010 events0 affected382 at risk
EG0026 events5 affected382 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected193 at risk
EG0019 events9 affected382 at risk
EG0023 events3 affected382 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ClinicalTrials.gov@lilly.com
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068800
Etanercept
C549079
ixekizumab
Ancestor Terms
ID
Term
D007141
Immunoglobulin Fc Fragments
D007128
Immunoglobulin Fragments
D010446
Peptide Fragments
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D007127
Immunoglobulin Constant Regions
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D012712
Serum Globulins
D005916
Globulins
D018124
Receptors, Tumor Necrosis Factor
D018121
Receptors, Cytokine
D011971
Receptors, Immunologic
D011956
Receptors, Cell Surface
D008565
Membrane Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG004
183 subjects
FG005369 subjects
FG006360 subjects
FG007362 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
135 subjects
FG005256 subjects
FG006244 subjects
FG007255 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
48 subjects
FG005113 subjects
FG006116 subjects
FG007107 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG00416 subjects
FG00534 subjects
FG00643 subjects
FG00730 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00411 subjects
FG00530 subjects
FG00629 subjects
FG00727 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0046 subjects
FG00517 subjects
FG00623 subjects
FG00718 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0046 subjects
FG00514 subjects
FG00610 subjects
FG00711 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0055 subjects
FG0065 subjects
FG0075 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0054 subjects
FG0060 subjects
FG0075 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
FG0061 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Clinical Relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0074 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Parent/Caregiver Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Missing Disposition Form
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG004
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008157 subjects
FG009309 subjects
FG010305 subjects
FG011313 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008126 subjects
FG009233 subjects
FG010225 subjects
FG011230 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00831 subjects
FG00976 subjects
FG01080 subjects
FG01183 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00813 subjects
FG00928 subjects
FG01034 subjects
FG01130 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0087 subjects
FG00921 subjects
FG01019 subjects
FG01119 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0098 subjects
FG0109 subjects
FG0119 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0099 subjects
FG0108 subjects
FG0119 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0096 subjects
FG0104 subjects
FG0117 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0092 subjects
FG0102 subjects
FG0113 subjects
Clinical Relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0113 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0111 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
Entry Criteria Not Met
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
0
BG0040
Between 18 and 65 years
BG000180
BG001349
BG002358
BG003351
BG0041238
>=65 years
BG00013
BG00133
BG00228
BG00334
BG004108
128
BG003131
BG004428
Male
BG000137
BG001269
BG002258
BG003254
BG004918
50
BG00357
BG004184
Not Hispanic or Latino
BG000133
BG001263
BG002269
BG003259
BG004924
Unknown or Not Reported
BG00035
BG00167
BG00267
BG00369
BG004238
4
BG0031
BG00410
Asian
BG0007
BG00111
BG00211
BG00312
BG00441
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0021
BG0034
BG0046
Black or African American
BG0008
BG00110
BG0029
BG0035
BG00432
White
BG000176
BG001351
BG002360
BG003361
BG0041248
More than one race
BG0001
BG0015
BG0021
BG0032
BG0049
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
6
BG0036
BG00421
Chile
Title
Measurements
BG00011
BG00121
BG00222
BG00322
BG00476
Mexico
Title
Measurements
BG0001
BG0012
BG0021
BG0031
BG0045
Bulgaria
Title
Measurements
BG0009
BG00112
BG00214
BG00313
BG00448
Germany
Title
Measurements
BG00045
BG00187
BG00290
BG00390
BG004312
Hungary
Title
Measurements
BG00018
BG00131
BG00231
BG00333
BG004113
Poland
Title
Measurements
BG0005
BG00110
BG00211
BG00313
BG00439
Russia
Title
Measurements
BG00011
BG00122
BG00220
BG00324
BG00477
Canada
Title
Measurements
BG00022
BG00144
BG00244
BG00342
BG004152
United States
Title
Measurements
BG00069
BG001146
BG002147
BG003141
BG004503
385
310
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000193
OG001382
OG002386
OG003385
Title
Denominators
Categories
Title
Measurements
OG00014
OG001204
OG002325
OG003336
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
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000193
OG001382
OG002386
OG003385
Title
Denominators
Categories
Title
Measurements
OG0000
OG00133
OG002139
OG003155
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
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000193
OG001382
OG002386
OG003385
Title
Denominators
Categories
Title
Measurements
OG0006
OG00198
OG002252
OG003262
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
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000193
OG001382
OG002386
OG003385
Title
Denominators
Categories
Title
Measurements
OG0000
OG00128
OG002135
OG003145
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
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000158
OG001312
OG002313
OG003320
Title
Denominators
Categories
Title
Measurements
OG00033
OG001200
OG002250
OG003264
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
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000191
OG001376
OG002375
OG003377
Title
Denominators
Categories
Title
Measurements
OG000-1.7± 0.32
OG001-8.0± 0.23
OG002-9.6± 0.23
OG003-10.2± 0.23
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
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000115
OG001233
OG002226
OG003228
Title
Denominators
Categories
Title
Measurements
OG0001.6362± 1.0991
OG001-6.4015± 0.7716
OG002-9.9793± 0.7838
OG003-10.4145± 0.7820
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
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000192
OG001378
OG002377
OG003380
Title
Denominators
Categories
Title
Measurements
OG000-0.7± 1.03
OG001-16.4± 0.73
OG002-23.2± 0.73
OG003-23.2± 0.73
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
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000175
OG001345
OG002344
OG003344
Title
Denominators
Categories
Title
Measurements
OG000-5.0± 0.53
OG001-15.9± 0.38
OG002-18.2± 0.38
OG003-18.8± 0.38
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
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
50 mg Etanercept
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000184
OG001379
OG002373
OG003373
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 0.20
OG001-0.5± 0.14
OG002-0.9± 0.14
OG003-1.3± 0.14
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
ANCOVA
0.473
2-Sided
Superiority or Other (legacy)
OG000
OG002
ANCOVA
0.015
2-Sided
Superiority or Other (legacy)
OG000
OG003
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.
Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000184
OG001376
OG002375
OG003373
Title
Denominators
Categories
Absenteeism Score
ParticipantsOG000120
ParticipantsOG001217
ParticipantsOG002230
ParticipantsOG003218
Title
Measurements
OG0000.0± 0.82
OG001-2.8± 0.62
OG002-2.0± 0.60
OG003
Activity Impairment Score
ParticipantsOG000184
ParticipantsOG001376
ParticipantsOG002375
ParticipantsOG003373
Presenteeism Score
ParticipantsOG000137
ParticipantsOG001243
ParticipantsOG002256
ParticipantsOG003242
Work Productively Loss Score
ParticipantsOG000120
ParticipantsOG001216
ParticipantsOG002228
ParticipantsOG003216
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
Includes analysis only from Absenteeism Score.
ANCOVA
0.006
2-Sided
Superiority or Other (legacy)
OG000
OG002
Includes analysis only from Absenteeism Score.
ANCOVA
0.045
2-Sided
Superiority or Other (legacy)
OG000
OG003
Includes analysis only from Absenteeism Score.
ANCOVA
0.012
2-Sided
Superiority or Other (legacy)
OG000
OG001
Includes analysis only from Activity Impairment Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Includes analysis only from Activity Impairment Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Includes analysis only from Activity Impairment Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG001
Includes analysis only from Presenteeism Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Includes analysis only from Presenteeism Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Includes analysis only from Presenteeism Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG001
Includes analysis only from Work Productively Loss Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Includes analysis only from Work Productively Loss Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Includes analysis only from Work Productively Loss Score.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG002
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000179
OG001365
OG002362
OG003357
Title
Denominators
Categories
PCS
Title
Measurements
OG000-0.1993± 0.5077
OG0013.1176± 0.3568
OG0024.1143± 0.3587
OG0033.9620± 0.3604
MCS
Title
Measurements
OG0001.1305± 0.5768
OG0012.6486± 0.4047
OG0023.7961± 0.4074
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Includes analysis only from PCS.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Includes analysis only from PCS.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Includes analysis only from PCS.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG001
Includes analysis only from MCS.
ANCOVA
0.031
2-Sided
Superiority or Other (legacy)
OG000
OG002
Includes analysis only from MCS.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Includes analysis only from MCS.
ANCOVA
<0.001
2-Sided
Superiority or Other (legacy)
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG000192
OG001377
OG002375
OG003376
Title
Denominators
Categories
Title
Measurements
OG000-0.5± 0.08
OG001-2.3± 0.06
OG002-3.1± 0.06
OG003-3.1± 0.06
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
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Mixed Models Analysis
<0.001
2-Sided
Superiority or Other (legacy)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG00054
OG00195
OG00287
OG00396
Title
Denominators
Categories
Title
Measurements
OG00026
OG00177
OG00275
OG00378
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
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG00054
OG00195
OG00287
OG00396
Title
Denominators
Categories
Title
Measurements
OG00019
OG00163
OG00269
OG00372
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
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
Units
Counts
Participants
OG00054
OG00195
OG00287
OG00396
Title
Denominators
Categories
Title
Measurements
OG00015
OG00157
OG00254
OG00361
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
2-Sided
Superiority or Other (legacy)
OG000
OG002
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG003
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
OG003
80 mg Ixekizumab Dosing Regimen 1 (Q2W)
A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.