A Phase 3 Study in Participants With Moderate to Severe P... | NCT01474512 | Trialant
NCT01474512
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Oct 3, 2019Actual
Enrollment
1,296Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
80 mg Ixekizumab Dosing Regimens 1, 2, and 3
Placebo
Countries
United States
Australia
Canada
Denmark
Germany
Hungary
Italy
Japan
Poland
Romania
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01474512
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12972
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHAZ
Other Identifier
Eli Lilly and Company
Brief Title
A Phase 3 Study in Participants With Moderate to Severe Psoriasis
Official Title
A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
Acronym
UNCOVER-1
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 18, 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
Nov 16, 2011Actual
Primary Completion Date
Jun 24, 2014Actual
Completion Date
Sep 20, 2018Actual
First Submitted Date
Nov 15, 2011
First Submission Date that Met QC Criteria
Nov 17, 2011
First Posted Date
Nov 18, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 20, 2016
Results First Submitted that Met QC Criteria
Apr 20, 2016
Results First Posted Date
May 27, 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
Sep 17, 2019
Last Update Posted Date
Oct 3, 2019Actual
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 LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.
Administered as two 80-mg subcutaneous (SC) injections at Week 0, then one 80-mg SC injection per Dosing Regimen 1 [every 2 weeks (Q2W)] up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 [every 4 weeks (Q4W)] or Dosing Regimen 3 [every 12 weeks Q12W)].
Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3
80 mg Ixekizumab Dosing Regimen 2 (Q4W)
Experimental
Administered as two 80-mg SC injections at Week 0, then one 80-mg SC injection per Dosing Regimen 2 (Q4W) up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 (Q4W) or Dosing Regimen 3 (Q12W).
Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3
80 mg Ixekizumab Dosing Regimen 3 (Q12W)
Experimental
Dosing Regimen 3 (Q12W) is not used until Week 12. At Week 12, participants who were re-randomized to this arm were administered one 80-mg SC injection Q12W.
Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3
Placebo
Placebo Comparator
Administered as 2 SC injections at Week 0, then 1 SC injection per Dosing Regimen 1 (Q2W) up to and including Week 10. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2 (Q4W).
Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Week 12
Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris 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 during the study
Women must agree to use 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
Clinically significant flare of psoriasis during the 12 weeks prior to randomization
Concurrent or recent use of any biologic agent
Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy 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 (IL)-17 antagonists, including LY2439821
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.
Participants received Ixekizumab (ixe) as responders (Resp, sPGA 0/1) in Induction (IND) re-randomized to receive ixe Q4W, Q12W or placebo (PBO) in Maintenance (MAIN) [Primary Population (Pop)]. In MAIN, non-responders (Non-Resp, sPGA >1) in IND received ixe Q4W, PBO Resp in IND received PBO (Secondary Pop). Ixe or PBO continued to end of study.
Recruitment Details
Induction Period (Week 0 to 12), Maintenance Period (Week 12 to 60); Long term Extension (Week 60 to 264) and Post treatment ( last treatment visit (week 264), or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo- Induction Period
Placebo was administered as 2 subcutaneous (SC) injections at week 0 then 1 PBO (SC) injection every 2 weeks (Q2W) up to Week 10.
Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline.
Week 12
Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
Week 60
Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Baseline, Week 12
Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score
DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point change from baseline is considered clinically relevant. Least squares (LS) mean change from baseline was calculated using mixed model repeated measures (MMRM).
Baseline, Week 12
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps 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 Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps 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, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM.
Baseline, Week 12
Percent of Body Surface Area (BSA) Involvement of Ps
BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM.
Week 12
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM.
Baseline, Week 12
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO)
WPAI-PSO is a participant administered, 6-item instrument used to assess the impact of Ps on the productivity impairment within the past 7 days. WPAI-PSO has 4 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 (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 with greater scores indicating greater impairment. LS mean change from baseline was calculated using analysis of covariance (ANCOVA).
Baseline, Week 12
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 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] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. LS mean change from baseline was calculated using ANCOVA.
Baseline, Week 12
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)
The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. 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 in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean change from baseline was calculated using ANCOVA.
Baseline, Week 12
Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)
The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). LS mean change from baseline calculated using MMRM.
Baseline, Week 12
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement
The Palmoplantar PASI is a composite score derived from the sum of scores for erythema, induration, and desquamation [scores range from 0 (none) to 4 (very severe) for each] multiplied by the score for the extent of palm and sole area involvement [scores range from 0 (0%) to 6 (90 to100%)], with a total scores range from 0 to 72. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 90%, or of 100%, respectively, in the PPASI scores compared to baseline.
Week 12
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
Weeks 12: Day 84 and Week 24: Day 168
Percentage of Participants With Anti-ixekizumab Antibodies
Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
Baseline through Week 12
United States
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Anaheim
California
92801
United States
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Bakersfield
California
93309
United States
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Fremont
California
94538
United States
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New Haven
Connecticut
06511
United States
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Jacksonville
Florida
32216
United States
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Miami
Florida
33175
United States
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Miramar
Florida
33027
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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Pinellas Park
Florida
33781
United States
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Tampa
Florida
33624
United States
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West Palm Beach
Florida
33409
United States
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Atlanta
Georgia
30327
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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Evansville
Indiana
47714
United States
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Indianapolis
Indiana
46256
United States
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South Bend
Indiana
46617
United States
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Owensboro
Kentucky
42303
United States
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Baton Rouge
Louisiana
70809
United States
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Troy
Michigan
48084
United States
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St Louis
Missouri
63117
United States
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New York
New York
10021
United States
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Rochester
New York
14623
United States
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The Bronx
New York
10467
United States
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Raleigh
North Carolina
27612
United States
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Cleveland
Ohio
44106
United States
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Portland
Oregon
97223
United States
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Johnston
Rhode Island
02919
United States
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Knoxville
Tennessee
37922
United States
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Salt Lake City
Utah
84132
United States
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Bellingham
Washington
98225
United States
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Seattle
Washington
98101
United States
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Kogarah
New South Wales
2217
Australia
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Benowa
Queensland
4217
Australia
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Woolloogabba
Queensland
4120
Australia
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Adelaide
South Australia
5000
Australia
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Carlton
Victoria
3053
Australia
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Parkville
Victoria
3050
Australia
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Fremantle
Western Australia
6160
Australia
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Surrey
British Columbia
V3R 6A7
Canada
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Winnipeg
Manitoba
R3C 1R4
Canada
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Moncton
New Brunswick
E1C8X3
Canada
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Halifax
Nova Scotia
B5H1Z4
Canada
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Ajax
Ontario
L1S7K8
Canada
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Barrie
Ontario
L4M6L2
Canada
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London
Ontario
N6A 3H7
Canada
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Newmarket
Ontario
L3Y6P5
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
N8W 1E6
Canada
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Montreal
Quebec
H3Z 2S6
Canada
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Aarhus
8000
Denmark
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Copenhagen
2400
Denmark
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Hellerup
2900
Denmark
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Berlin
13125
Germany
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Cologne
50937
Germany
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Darmstadt
64283
Germany
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Frankfurt
60596
Germany
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Hamburg
22143
Germany
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Hanau
63450
Germany
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Hanover
30449
Germany
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Kiel
24105
Germany
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Mahlow
39110
Germany
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Mainz
55131
Germany
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Münster
48149
Germany
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Quedlinburg
06484
Germany
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Wuppertal
42275
Germany
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Budapest
1036
Hungary
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Debrecen
4032
Hungary
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Miskolc
3529
Hungary
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Szeged
H-6720
Hungary
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Szolnok
H-5000
Hungary
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Szombathely
H-9700
Hungary
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Bergamo
24128
Italy
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Bologna
40100
Italy
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Padova
35128
Italy
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Pisa
56126
Italy
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Aichi
467-0001
Japan
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Fukuoka
814-0180
Japan
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Kochi
783-8505
Japan
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Kyoto
602-0841
Japan
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Shiga
520-2192
Japan
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Shizuoka
431-3125
Japan
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Tochigi
329- 0498
Japan
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Tokyo
169-0073
Japan
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Bialystok
15-017
Poland
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Elblag
82-300
Poland
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Krakow
30-510
Poland
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Lodz
90-265
Poland
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Lublin
20-081
Poland
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Szczecin
70-111
Poland
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Torun
87-100
Poland
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Warsaw
04-749
Poland
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Baia Mare
430193
Romania
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Bucharest
21155
Romania
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Craiova
200642
Romania
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Iași
700125
Romania
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Salford
Manchester
M6 8HD
United Kingdom
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Scunthorpe
North Lincolnshire
DN15 7BH
United Kingdom
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Dundee
Scotland
DD1 9SY
United Kingdom
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Nuneaton
Warwickshire
CV10 7BL
United Kingdom
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Lanarkshire
ML6 0JS
United Kingdom
Derived
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.
Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.
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.
160 milligrams (mg) ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
FG002
Ixe Q2W - Induction Period
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10.
FG003
Ixe/Placebo- Maintenance Period Primary Pop
Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
FG004
Ixe/Ixe Q12W - Maintenance Period Primary Pop
Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. Pbo injection was given in between doses Q4W to maintain blindness.
FG005
Ixe/Ixe Q4W - Maintenance Period Primary Pop
Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
FG006
Placebo Resp/Placebo - Maintenance Period Secondary Pop
Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
FG007
Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop
Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
FG008
Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop
Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
FG009
Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop
Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
FG010
Ixe Q4W - Maintenance Period Relapsed Population
Participants who relapsed during maintenance period prior to long term received, Ixe 80 mg as 1 SC injection Q4W for the remainder of the study to evaluate whether the response observed earlier could be regained on treatment with a higher dose.
FG011
Placebo Long-Term Extension (LTE)
Participants who received placebo at the start of the long-term extension period and remained on placebo. Participants who received placebo at the start of long-term extension period (Week 60) then switched to Ixe.
FG012
Ixe Long-Term Extension
Participants who received 80 mg ixe in all dosing regimens at the start of the long-term extension period from Week 60 to Week 264.
FG013
Total Ixe Long-Term Extension
Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in long-term extension (LTE) period.
FG014
Placebo Post-Treatment Follow-Up
Participants who received PBO prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
FG015
Ixe Q12W Post-Treatment Follow-Up
Participants who received 80 mg ixe 1 SC injection Q12W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
FG016
Ixe Q4W Post-Treatment Follow-Up
Participants who received 80 mg ixe Q4W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
FG017
Ixe Q2W Post-Treatment Follow-Up
Participants who received 80 mg ixe Q2W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
FG000431 subjects
FG001432 subjects
FG002433 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Received Study Drug
FG000431 subjects
FG001432 subjects
FG002433 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
COMPLETED
FG000407 subjects
FG001408 subjects
FG002415 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
FG00024 subjects
FG00124 subjects
FG00218 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG00110 subjects
FG00210 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lack of Efficacy
FG0007 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0016 subjects
FG0025 subjects
FG0030 subjects
FG004
Protocol Violation
FG0003 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Maintenance Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003226 subjects
FG004227 subjectsOne participant withdrew end of Induction but re-randomized and treated with maintenance dose ixe.
FG005229 subjects
FG00616 subjects
FG007391 subjects
FG00878 subjects
FG00962 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Received Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003226 subjects
FG004
Relapsed Population Received Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Relapsed Population Completers
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00324 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003202 subjects
FG004
Type
Comment
Reasons
Relapsed (sPGA ≥3)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Long-Term Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG01126 subjects9 participants did not start the long-term extension period.
FG0121054 subjectsParticipants received Ixe alone at the start of long-term extension.
FG0131075 subjectsParticipants received Ixe in all dosing regimens, including participants who switched PBO to Ixe.
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 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
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Post-Treatment Follow-Up
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG01418 subjectsIncludes participants who started the post treatment follow-up period.
FG01525 subjectsIncludes participants who started the post treatment follow-up period.
FG016700 subjectsIncludes participants who started the post treatment follow-up period.
FG017285 subjectsIncludes participants who started the post treatment follow-up period.
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 who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo administered as 2 SC injections Q2W up to Week 10.
BG001
Ixe Q4W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W.
BG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Week 10.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000431
BG001432
BG002433
BG0031296
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002
Static Physician Global Assessment (sPGA)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
Count of Participants
Participants
No
Title
Denominators
Categories
sPGA=3
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002
Psoriasis Area and Severity Index (PASI)
PASI combines body surface involvement in 4 regions (head, trunk, arms, and legs), percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for final PASI, calculated as: sum of severity parameters for each region*area score*weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Scores range from 0 (no Ps) to 72 (the most severe disease).
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000431
ParticipantsBG001
Itch Numeric Rating Scale (NRS)
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002
Dermatology-Specific Quality of Life Index (DLQI) Score
DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000431
ParticipantsBG001
Nail Psoriasis Severity Index (NAPSI)
The NAPSI is a numeric, reproducible, objective tool to evaluate the severity of fingernail bed Ps and fingernail matrix Ps. Each fingernail is given a score for fingernail bed Ps and fingernail matrix Ps, each with scores of 0 (none) to 4 (Ps in all 4 quadrants) depending on the features of each fingernail bed and fingernail matrix Ps.The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). The sum of all fingernails equals the total NAPSI score with a range from 0 to 80. Higher scores indicated more severe psoriasis.
ITT population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000283
ParticipantsBG001
Percent of Body Surface Area (BSA) involvement of Ps
BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).
Mean
Standard Deviation
percent of body surface
Title
Denominators
Categories
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002
Psoriasis Scalp Severity Index (PSSI)
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000393
ParticipantsBG001
Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)
QIDS-SR16 is a participant-administered, 16-item instrument to assess the existence and severity of depression symptoms. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy, sleep disturbance, change in appetite/weight, and psychomotor agitation/retardation) to give a total scores range from 0 to 27, higher scores indicate greater severity.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000430
ParticipantsBG001
Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)
WPAI-PSO is a self-administered, 6-item instrument used to assess the impact of Ps on productivity impairment within the past 7 days. WPAI-PSO has 4 domains: absenteeism, presenteeism (reduced productivity at work), an overall work impairment score and impairment in daily activities performed outside work. Four scores are derived as percentages: absenteeism, presenteeism (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage = each score * 100. Greater scores indicate greater impairment.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
Absenteeism
ParticipantsBG000281
ParticipantsBG001
Medical Outcomes Study 36-Item Short Form (SF36) Physical component (PCS) and Mental Component (MCS)
The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. 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 in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
PCS
ParticipantsBG000428
ParticipantsBG001
Patient's Global Assessment of Disease Severity (PatGA)
The PatGA is a single-item self-reported instrument asking the participant to rate severity of their psoriasis "today" by circling a number on a 0 to 5 numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000431
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Intent to Treat (ITT) Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Units
Counts
Participants
OG000431
OG001432
OG002433
Title
Denominators
Categories
Title
Measurements
OG0003.2
OG00176.4
OG00281.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
Primary
Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
ITT Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
Secondary
Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Secondary
Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
Secondary
Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
Maintenance Period Primary Population (MPPP): all randomized participants from Period 2 who achieved sPGA (0, 1), were re-randomized at Week 12 and who received at least 1 dose of study treatment Period 3. Participants did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.
Posted
Number
percentage of participants
Week 60
ID
Title
Description
OG000
Ixe/Placebo
Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
OG001
Ixe/Q12W
Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56 (Maintenance Period).
Secondary
Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had an Itch NRS score ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.
Posted
Number
percentage of participants
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Secondary
Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score
DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point change from baseline is considered clinically relevant. Least squares (LS) mean change from baseline was calculated using mixed model repeated measures (MMRM).
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had at least 1 post-baseline DLQI measurement.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
Secondary
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps 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 Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps 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, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
Secondary
Percent of Body Surface Area (BSA) Involvement of Ps
BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.
Posted
Least Squares Mean
Standard Error
percentage of body surface
Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Secondary
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Secondary
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO)
WPAI-PSO is a participant administered, 6-item instrument used to assess the impact of Ps on the productivity impairment within the past 7 days. WPAI-PSO has 4 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 (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 with greater scores indicating greater impairment. LS mean change from baseline was calculated using analysis of covariance (ANCOVA).
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
Secondary
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 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] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. LS mean change from baseline was calculated using ANCOVA.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
Secondary
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)
The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. 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 in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean change from baseline was calculated using ANCOVA.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
Secondary
Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)
The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). LS mean change from baseline calculated using MMRM.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Secondary
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement
The Palmoplantar PASI is a composite score derived from the sum of scores for erythema, induration, and desquamation [scores range from 0 (none) to 4 (very severe) for each] multiplied by the score for the extent of palm and sole area involvement [scores range from 0 (0%) to 6 (90 to100%)], with a total scores range from 0 to 72. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 90%, or of 100%, respectively, in the PPASI scores compared to baseline.
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps at baseline.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Secondary
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had Ctrough ss results at specified time points where the concentration met the definition of being a trough concentration.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms/milliliter (µg/mL)
Weeks 12: Day 84 and Week 24: Day 168
ID
Title
Description
OG000
Ixe Q2W - Induction Period
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W - Induction Period
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q4W - Maintenance Period
80 mg ixe administered as 1 SC injection Q4W from Week 12 up to Week 60
OG003
Ixe Q12W - Maintenance Period
80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Secondary
Percentage of Participants With Anti-ixekizumab Antibodies
Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
All randomized participants who received at least 1 dose of study drug and had evaluable data.
Posted
Number
percentage of participants
Baseline through Week 12
ID
Title
Description
OG000
Placebo
Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
OG001
Ixe Q4W
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Time Frame
Up to 276 Weeks
Description
All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were 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 - Induction Period
Placebo was administered as 2 subcutaneous (SC) injections at week 0 then 1 PBO (SC) injection every 2 weeks (Q2W) up to Week 10.
5
431
128
431
EG001
Ixe Q4W - Induction Period
160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W. Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
12
432
159
432
EG002
Ixe Q2W - Induction Period
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Weeks 2, 4, 6, 8 and 10.
7
433
170
433
EG003
Ixe/Placebo- Maintenance Period Primary Pop
Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
7
226
83
226
EG004
Ixe/Ixe Q12W - Maintenance Period Primary Pop
Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56. Pbo injection was given in between doses Q4W to maintain blindness.
11
227
122
227
EG005
Ixe/Ixe Q4W - Maintenance Period Primary Pop
Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
14
229
115
229
EG006
Placebo Resp/Placebo - Maintenance Period Secondary Pop
Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
0
16
8
16
EG007
Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop
Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
24
391
211
391
EG008
Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop
Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
8
78
55
78
EG009
Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop
Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
3
62
34
62
EG010
Ixe Q4W - Maintenance Period Relapse Pop
Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
11
348
114
348
EG011
Placebo Long-Term Extension
Participants who received placebo at the start of the long-term extension period and remained on placebo. Participants who received placebo at the start of long-term extension (Week 60) then switched to Ixe.
1
26
8
26
EG012
Ixe Long-Term Extension
Participants who received 80 mg ixe in all dosing regimen at the start of the long-term extension period from Week 60 to Week 264
134
1,054
414
1,054
EG013
Total Ixe Long-Term Extension
Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in LTE period.
134
1,075
414
1,075
EG014
Placebo Post-Treatment Follow-Up
Participants who received PBO prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
2
18
3
18
EG015
Ixe Q12W Post-Treatment Follow-Up
Participants who received 80 mg ixe Q12W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
0
25
2
25
EG016
Ixe Q4W Post Treatment Follow-Up
Participants who received 80 mg ixe Q4W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
13
700
33
700
EG017
Ixe Q2W Post-Treatment Follow-Up
Participants who received 80 mg ixe Q2W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
6
285
15
285
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG0030 events0 affected226 at risk
EG0040 events0 affected227 at risk
EG0050 events0 affected229 at risk
EG0060 events0 affected16 at risk
EG0070 events0 affected391 at risk
EG0080 events0 affected78 at risk
EG0090 events0 affected62 at risk
EG0100 events0 affected348 at risk
EG0110 events0 affected26 at risk
EG0123 events2 affected1,054 at risk
EG0133 events2 affected1,075 at risk
EG0140 events0 affected18 at risk
EG0150 events0 affected25 at risk
EG0160 events0 affected700 at risk
EG0170 events0 affected285 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Arteriospasm coronary
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Ventricular hypokinesia
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Congenital ectopic pancreas
Congenital, familial and genetic disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Congenital pyelocaliectasis
Congenital, familial and genetic disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Acute abdomen
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Chronic gastrointestinal bleeding
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0012 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pancreatitis relapsing
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Death
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Fatigue
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0024 events1 affected433 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Cellulitis pharyngeal
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cellulitis staphylococcal
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Chronic tonsillitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Clostridial sepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cystitis bacterial
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Device related infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Ear infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Endometritis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected128 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected142 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Gallbladder empyema
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Gastrointestinal bacterial infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Injection site cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Necrotising fasciitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Osteomyelitis chronic
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pilonidal cyst
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Staphylococcal osteomyelitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Tonsillitis bacterial
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Viral rash
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cardiac electrophysiologic study
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Catheterisation cardiac
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Endoscopic retrograde cholangiopancreatography
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Adrenal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Diffuse large b-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Hypopharyngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Laryngeal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected303 at risk
EG0010 events0 affected289 at risk
EG0020 events0 affected291 at risk
EG003
Pyogenic granuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Thyroid adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Intracranial aneurysm
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Meralgia paraesthetica
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Migraine
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Seizure
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Vascular encephalopathy
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected128 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected142 at risk
EG003
Hellp syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected128 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected142 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected128 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected142 at risk
EG003
Device dislocation
Product Issues
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Depression
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected128 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected142 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected128 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected142 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected128 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected142 at risk
EG003
Rectocele
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected128 at risk
EG0010 events0 affected143 at risk
EG0020 events0 affected142 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events1 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Drug reaction with eosinophilia and systemic symptoms
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pustular psoriasis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Bile duct stent insertion
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cholecystectomy
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Duodenal sphincterotomy
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Hernia hiatus repair
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Pancreaticoduodenectomy
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Tonsillectomy
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Ureteral stent insertion
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Varicose vein operation
Surgical and medical procedures
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Femoral artery aneurysm
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Shock
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Subclavian vein thrombosis
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0005 events4 affected431 at risk
EG00111 events10 affected432 at risk
EG00211 events9 affected433 at risk
EG0038 events8 affected226 at risk
EG0044 events4 affected227 at risk
EG0058 events8 affected229 at risk
EG0060 events0 affected16 at risk
EG00729 events22 affected391 at risk
EG0081 events1 affected78 at risk
EG0092 events2 affected62 at risk
EG0109 events8 affected348 at risk
EG0111 events1 affected26 at risk
EG01224 events21 affected1,054 at risk
EG01324 events21 affected1,075 at risk
EG0140 events0 affected18 at risk
EG0150 events0 affected25 at risk
EG0162 events2 affected700 at risk
EG0171 events1 affected285 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Injection site erythema
General disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG00124 events18 affected432 at risk
EG00240 events28 affected433 at risk
EG003
Injection site reaction
General disorders
MedDRA 21.1
Systematic Assessment
EG0005 events5 affected431 at risk
EG00147 events27 affected432 at risk
EG00277 events42 affected433 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected431 at risk
EG0012 events2 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Eye infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0014 events4 affected432 at risk
EG0022 events2 affected433 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG00045 events41 affected431 at risk
EG00146 events45 affected432 at risk
EG00257 events49 affected433 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0006 events6 affected431 at risk
EG0013 events3 affected432 at risk
EG0022 events2 affected433 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0004 events4 affected431 at risk
EG0016 events6 affected432 at risk
EG0025 events5 affected433 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected431 at risk
EG0010 events0 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG00017 events16 affected431 at risk
EG00120 events20 affected432 at risk
EG00227 events24 affected433 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0008 events8 affected431 at risk
EG0016 events6 affected432 at risk
EG0022 events2 affected433 at risk
EG003
Foreign body in eye
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Blood glucose increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG00011 events9 affected431 at risk
EG0014 events4 affected432 at risk
EG00212 events9 affected433 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0004 events4 affected431 at risk
EG0016 events6 affected432 at risk
EG0026 events4 affected433 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0022 events2 affected433 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0010 events0 affected432 at risk
EG0020 events0 affected433 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected431 at risk
EG0014 events4 affected432 at risk
EG0021 events1 affected433 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG00018 events15 affected431 at risk
EG00121 events16 affected432 at risk
EG00219 events18 affected433 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0023 events3 affected433 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0006 events6 affected431 at risk
EG0014 events4 affected432 at risk
EG0027 events7 affected433 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected431 at risk
EG0012 events2 affected432 at risk
EG0022 events2 affected433 at risk
EG003
Nail psoriasis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0007 events7 affected431 at risk
EG0014 events4 affected432 at risk
EG0023 events3 affected433 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG00012 events12 affected431 at risk
EG00110 events10 affected432 at risk
EG0026 events6 affected433 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected431 at risk
EG0014 events4 affected432 at risk
EG0024 events4 affected433 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG00016 events16 affected431 at risk
EG0012 events2 affected432 at risk
EG0024 events4 affected433 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected431 at risk
EG0011 events1 affected432 at risk
EG0024 events4 affected433 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
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
C549079
ixekizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
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0 subjects
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0 subjects
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FG0070 subjects
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FG0170 subjects
0 subjects
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FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
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FG0170 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
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FG0170 subjects
227 subjects
FG005229 subjects
FG00616 subjects
FG007391 subjects
FG00878 subjects
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FG0100 subjects
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FG0170 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG010348 subjects
FG0110 subjects
FG0120 subjects
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FG0140 subjects
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FG0160 subjects
FG0170 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG010321 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
108 subjects
FG005177 subjects
FG0066 subjects
FG007350 subjects
FG00862 subjects
FG00944 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
119 subjects
FG00552 subjects
FG00610 subjects
FG00741 subjects
FG00816 subjects
FG00918 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
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FG0150 subjects
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FG0170 subjects
186 subjects
FG004111 subjects
FG00539 subjects
FG0069 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG0042 subjects
FG0057 subjects
FG0060 subjects
FG00719 subjects
FG0081 subjects
FG0093 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
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FG0150 subjects
FG0160 subjects
FG0170 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
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FG0036 subjects
FG0042 subjects
FG0053 subjects
FG0061 subjects
FG0076 subjects
FG0083 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
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FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Clinical Relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00711 subjects
FG00811 subjects
FG00912 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
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FG0160 subjects
FG0170 subjects
Treated but Discontinued in Induction
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
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FG0160 subjects
FG0170 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG012836 subjects
FG013855 subjects
FG0140 subjects
FG0150 subjects
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FG0170 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG01126 subjects
FG012218 subjects
FG013220 subjects
FG0140 subjects
FG0150 subjects
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FG0170 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0113 subjects
FG01261 subjects
FG01361 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG01257 subjects
FG01358 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG01225 subjects
FG01325 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG01224 subjects
FG01325 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG01221 subjects
FG01321 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Clinical Relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0129 subjects
FG0139 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0129 subjects
FG0139 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0126 subjects
FG0136 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0125 subjects
FG0135 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Parent/Caregiver Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0131 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Switched From PBO to Ixe
FG0000 subjects
FG0010 subjects
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FG0030 subjects
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FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG01121 subjects
FG0120 subjects
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0 subjects
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FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
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FG01517 subjects
FG016544 subjects
FG017239 subjects
0 subjects
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FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
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FG01418 subjects
FG0158 subjects
FG016156 subjects
FG01746 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0148 subjects
FG0152 subjects
FG01658 subjects
FG01711 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0143 subjects
FG0152 subjects
FG01636 subjects
FG01717 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0143 subjects
FG0152 subjects
FG01631 subjects
FG0173 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG01612 subjects
FG0177 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0164 subjects
FG0175 subjects
Clinical Relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0166 subjects
FG0172 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0142 subjects
FG0152 subjects
FG0164 subjects
FG0170 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
FG0164 subjects
FG0170 subjects
Parent/Caregiver Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0161 subjects
FG0170 subjects
1296
Title
Measurements
BG00046.4± 13.40
BG00145.6± 12.95
BG00245.1± 12.40
BG00345.7± 12.93
433
ParticipantsBG0031296
Title
Measurements
Female
BG000128
BG001143
BG002142
BG003413
Male
BG000303
BG001289
BG002291
BG003883
433
ParticipantsBG0031296
Title
Measurements
BG00077
BG00169
BG00266
BG003212
Romania
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG0008
BG0013
BG0022
BG003
Hungary
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG00023
BG00117
BG00226
BG003
United States
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG000146
BG001156
BG002159
BG003
Japan
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG00013
BG00112
BG0028
BG003
Denmark
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG0004
BG0014
BG0028
BG003
Poland
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG00043
BG00141
BG00255
BG003
Italy
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG0003
BG0012
BG0021
BG003
United Kingdom
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG0007
BG0017
BG0027
BG003
Australia
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG00019
BG00115
BG0028
BG003
Germany
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG00088
BG001106
BG00293
BG003
433
ParticipantsBG0031296
Title
Measurements
BG000204
BG001197
BG002231
BG003632
sPGA=4, 5
ParticipantsBG000431
ParticipantsBG001432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG000227
BG001235
BG002202
BG003
432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG00020.32± 8.641
BG00120.03± 7.304
BG00220.09± 7.992
BG00320.15± 7.992
433
ParticipantsBG0031296
Title
Measurements
BG0007.0± 2.58
BG0017.0± 2.50
BG0027.2± 2.39
BG0037.1± 2.49
432
ParticipantsBG002433
ParticipantsBG0031296
Title
Measurements
BG00012.8± 7.11
BG00113.2± 7.02
BG00213.4± 7.02
BG00313.1± 7.05
281
ParticipantsBG002283
ParticipantsBG003847
Title
Measurements
BG00026.9± 20.492
BG00124.12± 18.243
BG00224.64± 18.916
BG00324.95± 19.238
433
ParticipantsBG0031296
Title
Measurements
BG00027.4± 17.77
BG00127.4± 16.20
BG00228.2± 17.83
BG00327.7± 17.27
413
ParticipantsBG002393
ParticipantsBG0031199
Title
Measurements
BG00021.8± 15.70
BG00119.9± 14.83
BG00221.1± 14.69
BG00320.9± 15.08
431
ParticipantsBG002431
ParticipantsBG0031292
Title
Measurements
BG0004.7± 4.34
BG0015.0± 4.34
BG0024.5± 4.09
BG0034.8± 4.26
287
ParticipantsBG002290
ParticipantsBG003858
Title
Measurements
BG0004.5± 17.07
BG0014.0± 16.26
BG0025.7± 19.41
BG0034.7± 17.63
Activity Impairment
ParticipantsBG000431
ParticipantsBG001429
ParticipantsBG002432
ParticipantsBG0031292
Title
Measurements
BG00031.3± 29.29
BG00134.7± 28.83
BG00234.2± 28.99
BG003
Presenteeism
ParticipantsBG000297
ParticipantsBG001301
ParticipantsBG002299
ParticipantsBG003897
Title
Measurements
BG00022.2± 25.85
BG00125.2± 27.22
BG00222.6± 26.46
BG003
Work Productively Loss
ParticipantsBG000279
ParticipantsBG001284
ParticipantsBG002288
ParticipantsBG003851
Title
Measurements
BG00024.6± 27.90
BG00127.0± 27.90
BG00224.9± 28.77
BG003
428
ParticipantsBG002432
ParticipantsBG0031288
Title
Measurements
BG00046.92± 9.769
BG00147.34± 9.169
BG00246.58± 9.146
BG00346.95± 9.363
MCS
ParticipantsBG000428
ParticipantsBG001428
ParticipantsBG002432
ParticipantsBG0031288
Title
Measurements
BG00048.77± 11.182
BG00147.46± 11.655
BG00247.94± 11.535
BG003
430
ParticipantsBG002430
ParticipantsBG0031291
Title
Measurements
BG0004.1± 0.95
BG0014.1± 0.88
BG0024.1± 0.94
BG0034.1± 0.92
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
2-Sided
Superiority or Other (legacy)
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Units
Counts
Participants
OG000431
OG001432
OG002433
Title
Denominators
Categories
Title
Measurements
OG0003.9
OG00182.6
OG00289.1
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
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000431
OG001432
OG002433
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG00134.5
OG00237.0
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
Fisher Exact
Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Fisher Exact
Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.
<0.001
2-Sided
Superiority or Other (legacy)
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Units
Counts
Participants
OG000431
OG001432
OG002433
Title
Denominators
Categories
PASI90
Title
Measurements
OG0000.5
OG00164.6
OG00270.9
PASI100
Title
Measurements
OG0000.0
OG00133.6
OG00235.3
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
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
P-value is for PASI90.
2-Sided
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
P-value is for PASI90.
2-Sided
Superiority or Other (legacy)
OG000
OG001
Fisher Exact
Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.
<0.001
P-value is for PASI100.
2-Sided
Superiority or Other (legacy)
OG000
OG002
Fisher Exact
Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.
<0.001
P-value is for PASI100.
2-Sided
Superiority or Other (legacy)
OG002
Ixe/Q4W
Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
Units
Counts
Participants
OG000226
OG001227
OG002229
Title
Denominators
Categories
Title
Measurements
OG0007.5
OG00137.4
OG00272.9
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
Regression, Logistic
Logistic Regression analysis included treatment and baseline weight category as factors.
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
Logistic Regression analysis included treatment and baseline weight category as factors.
<0.001
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000374
OG001379
OG002391
Title
Denominators
Categories
Title
Measurements
OG00015.5
OG00180.5
OG00285.9
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
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
2-Sided
Superiority or Other (legacy)
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Units
Counts
Participants
OG000421
OG001421
OG002427
Title
Denominators
Categories
Title
Measurements
OG000-1.0± 0.27
OG001-10.7± 0.27
OG002-11.1± 0.26
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
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Units
Counts
Participants
OG000280
OG001276
OG002279
Title
Denominators
Categories
Title
Measurements
OG0002.17± 0.672
OG001-7.19± 0.671
OG002-7.24± 0.657
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
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000426
OG001425
OG002428
Title
Denominators
Categories
Title
Measurements
OG0001.3± 0.67
OG001-21.4± 0.67
OG002-22.4± 0.66
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
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000393
OG001413
OG002393
Title
Denominators
Categories
Title
Measurements
OG000-1.8± 0.53
OG001-18.3± 0.52
OG002-19.2± 0.52
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
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Units
Counts
Participants
OG000420
OG001417
OG002427
Title
Denominators
Categories
Absenteeism
ParticipantsOG000253
ParticipantsOG001250
ParticipantsOG002255
Title
Measurements
OG0000.2± 0.88
OG001-3.5± 0.87
OG002-2.6± 0.84
Activity Impairment
ParticipantsOG000420
ParticipantsOG001417
ParticipantsOG002427
Title
Measurements
OG000
Presenteeism
ParticipantsOG000275
ParticipantsOG001273
ParticipantsOG002278
Title
Measurements
OG000
Work Productivity Loss
ParticipantsOG000250
ParticipantsOG001246
ParticipantsOG002252
Title
Measurements
OG000
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
P-value is for Absenteeism.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.
2-Sided
Superiority or Other (legacy)
OG000
OG002
ANCOVA
P-value is for absenteeism.
0.003
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
P-value is for activity impairment.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.
2-Sided
Superiority or Other (legacy)
OG000
OG002
ANCOVA
P-value is for activity impairment.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
P-value is for presenteeism.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.
2-Sided
Superiority or Other (legacy)
OG000
OG002
ANCOVA
P-value is for presenteeism.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
P-value is for work productively loss.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.
2-Sided
Superiority or Other (legacy)
OG000
OG002
ANCOVA
P-value is for work productively loss.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.
2-Sided
Superiority or Other (legacy)
OG002
Ixe Q2W
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Units
Counts
Participants
OG000421
OG001417
OG002423
Title
Denominators
Categories
Title
Measurements
OG000-0.1± 0.17
OG001-1.0± 0.17
OG002-1.3± 0.17
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
<0.001
LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.
2-Sided
Superiority or Other (legacy)
OG000
OG002
ANCOVA
<0.001
LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.
2-Sided
Superiority or Other (legacy)
160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
Units
Counts
Participants
OG000418
OG001415
OG002427
Title
Denominators
Categories
PCS
Title
Measurements
OG000-0.1747± 0.4012
OG0014.3081± 0.3990
OG0024.3159± 0.3878
MCS
Title
Measurements
OG0000.8729± 0.4638
OG0013.7386± 0.4633
OG0024.1293± 0.4480
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
P-value is for PCS.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.
2-Sided
Superiority or Other (legacy)
OG000
OG002
ANCOVA
P-value is for PCS.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
P-value is for MCS.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.
2-Sided
Superiority or Other (legacy)
OG000
OG002
ANCOVA
P-value is for MCS.
<0.001
The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000424
OG001425
OG002427
Title
Denominators
Categories
Title
Measurements
OG000-0.2± 0.06
OG001-3.1± 0.06
OG002-3.2± 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
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
OG000
OG002
Mixed Models Analysis
<0.001
LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000133
OG001131
OG002140
Title
Denominators
Categories
PPASI50
Title
Measurements
OG00035.3
OG00184.0
OG00282.9
PPASI75
Title
Measurements
OG00026.3
OG00174.8
OG00277.1
PPASI100
Title
Measurements
OG00020.3
OG00165.6
OG00270.0
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
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
P-value is for PPASI50.
2-Sided
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
P-value is for PPASI50.
2-Sided
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
P-value is for PPASI75
2-Sided
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
P-value is for PPASI75
2-Sided
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
P-value is for PPASI100
2-Sided
Superiority or Other (legacy)
OG000
OG002
Regression, Logistic
Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.
<0.001
P-value if for PPASI100.
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000192
OG001215
OG002223
OG00360
Title
Denominators
Categories
Week 12
Title
Measurements
OG0007.73± 79
OG0012.94± 89
OG002NA± NANo Induction Period results available.
OG003NA± NANo Induction Period results available.
Week 24
Title
Measurements
OG000NA± NANo Maintenance Period results available.
OG001NA± NANo Maintenance Period results available.