A Study to Evaluate the Efficacy and Safety of Mirikizuma... | NCT03482011 | Trialant
NCT03482011
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 25, 2020Actual
Enrollment
530Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Mirikizumab
Placebo
Countries
United States
Germany
Japan
Mexico
Poland
Puerto Rico
Russia
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT03482011
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16505
Secondary IDs
ID
Type
Description
Link
I6T-MC-AMAK
Other Identifier
Eli Lilly and Company
2017-003298-32
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Official Title
A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-1
Acronym
OASIS-1
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Feb 1, 2020
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
Apr 24, 2018Actual
Primary Completion Date
Mar 21, 2019Actual
Completion Date
Jan 16, 2020Actual
First Submitted Date
Mar 23, 2018
First Submission Date that Met QC Criteria
Mar 23, 2018
First Posted Date
Mar 29, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 31, 2020
Results First Submitted that Met QC Criteria
Aug 31, 2020
Results First Posted Date
Sep 25, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 6, 2020
Certification/Extension First Submitted that Passed QC Review
Mar 6, 2020
Certification/Extension First Posted Date
Mar 11, 2020Actual
Last Update Submitted Date
Aug 31, 2020
Last Update Posted Date
Sep 25, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Psoriasis
IL-23
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
530Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Mirikizumab
Experimental
Induction Period:
Participants received 250 milligrams (mg) mirikizumab administered subcutaneously (SC) every 4 weeks (Q4W).
Maintenance Period:
Participants received one of the four options below:
Placebo administered SC every 8 weeks (Q8W) for responders (≥PASI 90).
125 mg mirikizumab administered SC Q8W for responders (≥PASI 90).
250 mg mirikizumab administered SC Q8W for responders (≥PASI 90).
250 mg mirikizumab administered SC Q8W for non-responders (\
Drug: Mirikizumab
Placebo
Placebo Comparator
Induction Period: Participants received placebo administered SC Q4W.
Maintenance Period:
Participants received one of the two options below:
Placebo administered SC Q8W for responders (≥PASI 90).
250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48 for non-responders (< PASI 90).
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Mirikizumab
Drug
Administered SC
Mirikizumab
LY3074828
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was 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 16
Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 90)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria:
plaque psoriasis involving ≥10% BSA and absolute PASI score ≥12 in affected skin at screening and baseline
sPGA score of ≥3 at screening and baseline
Candidate for systemic therapy and/or phototherapy for psoriasis.
Exclusion Criteria:
Have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal laboratory values at screening, that in the opinion of the investigator, would potentially affect participant safety within the study or of interfering with the interpretation of data.
Breastfeeding or nursing women.
Have had serious, opportunistic, or chronic/recurring infection within 3 months prior to screening.
Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.
Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.
Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.
Have received topical psoriasis treatment within 14 days prior to baseline.
Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 12 weeks prior to baseline.
Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational.
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)
Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Week 16
Percentage of Participants Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Week 16
Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Week 16
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥1 at Baseline
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Week 16
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
The DLQI is a patient-reported, 10-question, 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 "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Week 16
Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Week 52
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
Week 16
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
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 score ranging from 0 (less severity) to 72 (more severity). LS Mean was calculated using MMRM model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
Week 16
Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 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 PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS Mean was calculated using MMRM model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
Week 16
Change From Baseline on the Short Form (SF)-36 Physical Component Summary (PCS)
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Baseline, Week 16
Change From Baseline on the SF-36 Mental Component Summary (MCS)
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Baseline, Week 16
Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline
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). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Baseline, Week 16
Change From Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Baseline, Week 16
Change From Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11
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. Whereas 0-5 indicates no symptoms. LS Mean was calculated using ANCOVA model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Baseline, Week 16
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)
The DLQI is a patient-reported, 10-question, 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 "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Week 16
Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16
Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab at Week 16.
Week 16: Day 113
Coral Gables
Florida
33134
United States
Renstar Medical Research
Ocala
Florida
34470
United States
Forward Clinical Trials, Inc
Tampa
Florida
33624
United States
Arlington Dermatology
Rolling Meadows
Illinois
60008
United States
The South Bend Clinic
South Bend
Indiana
46617
United States
Oregon Medical Research Center
Portland
Oregon
97223
United States
Dermatology and Skin Surgery Center
Exton
Pennsylvania
19341
United States
University of Utah MidValley Dematology
Murray
Utah
84107
United States
Multicare Health System
Tacoma
Washington
98405
United States
Gemeinschaftspraxis Mahlow
Mahlow
Brandenburg
15831
Germany
Universitätsklinikum Münster
Münster
North Rhine-Westphalia
48149
Germany
Praxis Gerlach
Dresden
Saxony
01097
Germany
Charité Universitätsmedizin Berlin
Berlin
10117
Germany
ISA GmbH
Berlin
10789
Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg
20246
Germany
Clinical Research Hamburg GmbH
Hamburg
22143
Germany
Toho University School of Medicine, Sakura Hospital
Sakura
Chiba
285-8741
Japan
Takagi Dermatological Clinic
Obihiro
Hokkaido
080-0013
Japan
Kanto Rosai Hospital
Kawasaki
Kanagawa
211-8510
Japan
Yokohama City University Hospital
Yokohama
Kanagawa
236-0004
Japan
Ryukyu University Hospital
Nakagami-gun
Okinawa
903-0215
Japan
Kume Clinic
Nishi-ku Sakai-shi
Osaka
593-8324
Japan
Shimane University Hospital
Izumo
Shimane
693-8501
Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji
Tokyo
193-0998
Japan
NTT Medical Center Tokyo
Shinagawa-KU
Tokyo
141-8625
Japan
Tokyo Medical University Hospital
Shinjuku-ku
Tokyo
160-0023
Japan
Seibo Hospital
Shinjuku-ku
Tokyo
161-8521
Japan
Shirasaki Clinic
Takaoka-shi
Toyama
9330871
Japan
Centro Medico del Angel S.C.
Mexicali
Estado de Baja California
21100
Mexico
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
Zapopan
Jalisco
45190
Mexico
Hospital de Jesus
Mexico City
Mexico City
06090
Mexico
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
Morella
Michoacán
58249
Mexico
B&B Investigaciones Medicas, SC
Mazatlán
Sinaloa
82140
Mexico
Kohler Milstein Research, S.A. de C.V.
Mérida
Yucatán
97070
Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal
3100
Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango
34000
Mexico
NZOZ ZDROWIE Osteo-Medic
Bialystok
15-351
Poland
"Dermed" Centrum Medyczne Sp. z o.o.
Lodz
90-265
Poland
Lubelskie Centrum Diagnostyczne
Świdnik
21-040
Poland
Centrum Medyczne AMED
Warsaw
01-518
Poland
DermMEDICA Sp. z o.o.
Wroclaw
51-318
Poland
Office of Dr. Alma M. Cruz
Carolina
PR
00985
Puerto Rico
GCM Medical Group PSC
San Juan
PR
00909
Puerto Rico
GBUZ Clinical dermatology and venereological dispensary
Krasnodar
350000
Russia
State scientific centre for dermatovenerology and cosmetolog
Moscow
107076
Russia
First Moscow State Medical University n.a. Sechenov
Moscow
119991
Russia
SPb SBHI Skin-venerologic dispensary #10
Saint Petersburg
194021
Russia
GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
Smolensk
214000
Russia
Tver State Medical University
Tver'
170100
Russia
Bucheon St. Mary's Hospital
Bucheon-si
Gyeonggi-do
14647
South Korea
Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
13620
South Korea
Bundang CHA General Hospital
Sungnam-si
Gyeonggi-do
13496
South Korea
Ajou University Hospital
Suwon
Gyeonggi-do
16499
South Korea
Kyung Hee University Hospital
Seoul
Korea
02447
South Korea
Korea University Guro Hospital
Seoul
Korea
08308
South Korea
Ulsan University Hospital
Ulsan
Korea
44033
South Korea
Chungnam National University Hospital
Daejeon
35015
South Korea
Chonnam National University Hospital
Gwangju
61469
South Korea
Severance Hospital Yonsei University Health System
Seoul
03722
South Korea
Hanyang University Medical Center
Seoul
04763
South Korea
Konkuk University Hospital
Seoul
05030
South Korea
National Taiwan University Hospital
Taipei
Zhongzheng District
100
Taiwan
National Taiwan University Hospital Hsin-Chu
Hsinchu
30059
Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City
83301
Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City
23561
Taiwan
Chung Shan Medical University Hospital
Taichung
40201
Taiwan
National Cheng Kung University Hospital
Tainan
70403
Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan Hsien
10508
Taiwan
FG002
Placebo Q4W to Placebo Q8W (Placebo Responder)
Maintenance Period: Participants received placebo administered SC every 8 weeks (Q8W). Responders had ≥PASI 90.
Participants had received placebo administered SC Q4W during induction period.
Follow-up Period: Participants did not receive drug during the follow-up period.
FG003
Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)
Maintenance Period: Participants received 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48. Non-responders had < PASI 90.
Participants had received placebo administered SC Q4W during induction period.
Follow-up Period: Participants did not receive drug during the follow-up period.
FG004
250 mg Miri Q4W Responders to Placebo Q8W
Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
Follow-up Period: Participants did not receive drug during the follow-up period.
FG005
250 mg Miri Q4W Responders to 125 mg Miri Q8W
Maintenance Period: Participants received 125 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
Follow-up Period: Participants did not receive drug during the follow-up period.
FG006
250 mg Miri Q4W Responder to 250 mg Miri Q8W
Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
Follow-up Period: Participants did not receive drug during the follow-up period.
Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Non-responders had < PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
Follow-up Period: Participants did not receive drug during the follow-up period.
FG000107 subjects
FG001423 subjects
FG0020 subjectsParticipants were assigned to this arm during maintenance period.
FG0030 subjectsParticipants were assigned to this arm during maintenance period.
FG0040 subjectsParticipants were assigned to this arm during maintenance period.
FG0050 subjectsParticipants were assigned to this arm during maintenance period.
FG0060 subjectsParticipants were assigned to this arm during maintenance period.
FG0070 subjectsParticipants were assigned to this arm during maintenance period.
Received at Least One Dose of Study Drug
FG000107 subjects
FG001422 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG000101 subjects
FG001412 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0006 subjects
FG00111 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lack of Efficacy
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Screen Failure
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Period (36 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm during induction period.
FG0010 subjectsParticipants were assigned to this arm during induction period.
FG0027 subjects
FG00394 subjects
FG00491 subjects
FG00590 subjects
FG00691 subjects
FG007140 subjects
Relapse
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Roll Over to I6T-MC-AMAH (NCT03556202)
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG00388 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG00390 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow-up Period (12 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm during induction period.
FG0010 subjectsParticipants were assigned to this arm during induction period.
FG0021 subjects
FG00310 subjects
FG0042 subjects
FG0054 subjects
FG0064 subjects
FG00721 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0035 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
BG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000107
BG001423
BG002530
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00045.7± 13.70
BG00146.4± 13.56
BG00246.3± 13.58
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00033
BG001124
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG00113
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00014
BG00150
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
South Korea
Title
Measurements
BG00011
BG00145
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was 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.
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Units
Counts
Participants
OG000107
OG001423
Title
Denominators
Categories
Title
Measurements
OG0006.5(1.9 to 11.2)
OG00169.3(64.9 to 73.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
Risk Difference (RD)
63.0
2-Sided
95
56.5
69.4
Superiority
Primary
Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 90)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 4
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Percentage of Participants Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100)
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Induction Period: All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Induction Period:All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Units
Counts
Participants
Secondary
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥1 at Baseline
PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Induction Period: All randomized participants who had PSS symptoms score ≥1 at baseline.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
The DLQI is a patient-reported, 10-question, 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 "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Induction Period: All randomized participants who had a baseline DLQI Total Score ≥5
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Secondary
Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. 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 PsO) to 72 (the most severe disease).
Maintenance Period: All re-randomized participants who were responders (≥PASI 90).
Posted
Number
95% Confidence Interval
Percentage of participants
Week 52
ID
Title
Description
OG000
250 mg Miri Q4W Responders to Placebo Q8W
Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
OG001
250 mg Miri Q4W Responders to 125 mg Miri Q8W
Secondary
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
Induction Period: All randomized participants who had palmoplantar involvement at baseline.
Posted
Least Squares Mean
Standard Error
score on a scale
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
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 score ranging from 0 (less severity) to 72 (more severity). LS Mean was calculated using MMRM model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
Induction Period: All randomized participants who had scalp Involvement at baseline.
Posted
Least Squares Mean
Standard Error
score on a scale
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 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 PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS Mean was calculated using MMRM model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
Induction Period: All randomized participants who had Nail Psoriasis involvement at baseline.
Posted
Least Squares Mean
Standard Error
score on a scale
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Change From Baseline on the Short Form (SF)-36 Physical Component Summary (PCS)
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Induction Period: All randomized participants who had a baseline and at least one post-baseline PCS value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Change From Baseline on the SF-36 Mental Component Summary (MCS)
SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Induction Period: All randomized participants who had a baseline and at least one post-baseline MCS value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline
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). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Induction Period: All randomized participants who had a baseline >= 2.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Units
Counts
Participants
Secondary
Change From Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Induction Period:All randomized participants who had a baseline and at least one post-baseline WPAI-PSO value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Change From Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11
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. Whereas 0-5 indicates no symptoms. LS Mean was calculated using ANCOVA model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
Induction Period: All participants who received at least one dose of study drug who had a baseline QIDS-SR16 total score >=11.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Secondary
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)
The DLQI is a patient-reported, 10-question, 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 "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
Induction Period: All randomized participants who had a baseline and at least one post-baseline DLQI value.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
OG001
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Secondary
Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16
Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab at Week 16.
Induction Period: All participants who received at least one dose of study drug who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter(micrograms/mL)
Week 16: Day 113
ID
Title
Description
OG000
250 mg Miri Q4W
Induction Period: Participants received 250 mg mirikizumab administered SC Q4W.
Units
Counts
Participants
OG000
Time Frame
Baseline Up To 64 Weeks
Description
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Q4W
Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90.
Participants had received placebo administered SC Q4W during induction period.
0
7
0
7
0
7
EG003
Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)
Maintenance Period: Participants received 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48. Non-responders had < PASI 90.
Participants had received placebo administered SC Q4W during induction period.
0
94
0
94
0
94
EG004
250 mg Miri Q4W Responders to Placebo Q8W
Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
0
91
3
91
49
91
EG005
250 mg Miri Q4W Responders to 125 mg Miri Q8W
Maintenance Period: Participants received 125 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
0
90
1
90
61
90
EG006
250 mg Miri Q4W Responder to 250 mg Miri Q8W
Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
0
91
3
91
55
91
EG007
250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)
Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Non-responders had < PASI 90.
Participants had received 250 mirikizumab administered SC Q4W during induction period.
0
140
0
140
0
140
EG008
Relapse
Participants that relapsed were in the following arms:
Placebo Q4W to Placebo Q8W (Placebo Responder).
250 mg Miri Q4W Responders to Placebo Q8W.
250 mg Miri Q4W Responders to 125 mg Miri Q8W.
250 mg Miri Q4W Responder to 250 mg Miri Q8W.
0
47
0
47
17
47
EG009
Placebo Q4W to Placebo Q8W (Responder) Follow-up Period
Follow-up Period: Participants did not receive drug during the follow-up period.
0
1
0
1
0
1
EG010
Placebo Q4W Discontinued During Induction-Follow-up Period
Follow-up Period: Participants did not receive drug during the follow-up period.
Participants discontinued (DC) before induction week 16 and counted as placebo non-responders.
0
4
0
4
0
4
EG011
Placebo Q4W to Placebo Non-Responder-Follow-up Period
Follow-up Period: Participants did not receive drug during the follow-up period.
0
6
0
6
0
6
EG012
250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period
Follow-up Period: Participants did not receive drug during the follow-up period.
0
2
0
2
0
2
EG013
250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period
Follow-up Period: Participants did not receive drug during the follow-up period.
0
4
0
4
0
4
EG014
250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period
Follow-up Period: Participants did not receive drug during the follow-up period.
0
4
0
4
0
4
EG015
250 Miri Q4W Discontinued During Induction-Follow-up
Follow-up Period: Participants did not receive drug during the follow-up period.
Participants discontinued (DC) before induction week 16 and counted as miri non-responders.
0
5
0
5
0
5
EG016
250 Miri Q4W to Miri Nonresponder-Follow-up Period
Follow-up Period: Participants did not receive drug during the follow-up period.
0
16
0
16
0
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected94 at risk
EG0042 events1 affected91 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected91 at risk
EG0070 events0 affected140 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected4 at risk
EG0140 events0 affected4 at risk
EG0150 events0 affected5 at risk
EG0160 events0 affected16 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Glomerulonephritis membranous
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Tonsillectomy
Surgical and medical procedures
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hilar lymphadenopathy
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected94 at risk
EG0040 events0 affected91 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected91 at risk
EG0070 events0 affected140 at risk
EG0080 events0 affected47 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected4 at risk
EG0140 events0 affected4 at risk
EG0150 events0 affected5 at risk
EG0160 events0 affected16 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Goitre
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Blepharitis
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cataract
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cataract subcapsular
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Visual impairment
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Defaecation disorder
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0019 events8 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gingival atrophy
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Fat necrosis
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0013 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hyperthermia
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Injection site erythema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Injection site induration
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Injection site pain
General disorders
MedDRA 22.1
Systematic Assessment
EG00020 events5 affected107 at risk
EG001109 events22 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Injection site pruritus
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0013 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Injection site reaction
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG00111 events5 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Injection site swelling
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Malaise
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Xerosis
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Acne pustular
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Body tinea
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Borrelia infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Enterocolitis bacterial
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected74 at risk
EG0011 events1 affected298 at risk
EG0020 events0 affected3 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Erythema migrans
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0015 events5 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0014 events4 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hepatitis a
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hepatitis e
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0013 events3 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG00014 events14 affected107 at risk
EG00161 events55 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0014 events4 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Otitis media
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Paronychia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Parotitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pelvic inflammatory disease
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected124 at risk
EG0020 events0 affected4 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected107 at risk
EG0017 events7 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0013 events3 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Salpingo-oophoritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected124 at risk
EG0020 events0 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Typhoid fever
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG00120 events16 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Urethritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG00110 events8 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0011 events1 affected124 at risk
EG0020 events0 affected4 at risk
EG003
Viral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0011 events1 affected124 at risk
EG0020 events0 affected4 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Post concussion syndrome
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0012 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected107 at risk
EG0013 events3 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Blood glucose increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Blood pressure increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Blood urea increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Fibrin d dimer increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Heart rate increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hepatitis b dna assay positive
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Liver function test increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Thyroxine free decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Very low density lipoprotein increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Weight decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Weight increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
White blood cell count increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Cardiometabolic syndrome
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0013 events3 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0013 events3 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected107 at risk
EG0013 events3 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0015 events5 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Overweight
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0015 events5 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0003 events3 affected107 at risk
EG00111 events10 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected107 at risk
EG0013 events3 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Enthesopathy
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0013 events3 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0012 events2 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Dysplastic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0011 events1 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected107 at risk
EG0010 events0 affected422 at risk
EG0020 events0 affected7 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)