A Study of Mirikizumab (LY3074828) in Participants With M... | NCT02899988 | Trialant
NCT02899988
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 18, 2020Actual
Enrollment
205Actual
Phase
Phase 2
Conditions
Plaque Psoriasis
Interventions
Mirikizumab
Placebo
Countries
United States
Canada
Germany
Japan
Poland
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT02899988
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16481
Secondary IDs
ID
Type
Description
Link
I6T-MC-AMAF
Other Identifier
Eli Lilly and Company
2016-001098-34
EudraCT Number
Brief Title
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis
Official Title
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 15, 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 14, 2016Actual
Primary Completion Date
Jun 19, 2017Actual
Completion Date
May 8, 2019Actual
First Submitted Date
Sep 9, 2016
First Submission Date that Met QC Criteria
Sep 9, 2016
First Posted Date
Sep 14, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
May 5, 2020
Results First Submitted that Met QC Criteria
Jun 5, 2020
Results First Posted Date
Jun 18, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 1, 2018
Certification/Extension First Submitted that Passed QC Review
Jun 1, 2018
Certification/Extension First Posted Date
Jun 7, 2018Actual
Last Update Submitted Date
Jun 5, 2020
Last Update Posted Date
Jun 18, 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)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Plaque Psoriasis
Keywords
IL-23
dermatology
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
205Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
30 mg Mirikizumab
Experimental
30 mg Mirikizumab administered subcutaneously (SC) every 8 weeks (Q8W).
Drug: Mirikizumab
100 mg Mirikizumab
Experimental
100 mg Mirikizumab administered SC Q8W.
Drug: Mirikizumab
300 mg Mirikizumab
Experimental
300 mg Mirikizumab administered SC Q8W.
Drug: Mirikizumab
Placebo
Placebo Comparator
Placebo administered SC Q8W.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Mirikizumab
Drug
Administered SC
100 mg Mirikizumab
30 mg Mirikizumab
300 mg Mirikizumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (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 With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
The 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 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% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline
sPGA score of ≥3 at screening and baseline
Candidate for biologic treatment for psoriasis.
Exclusion Criteria:
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
Breastfeeding or nursing (lactating) women.
Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.
Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to 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 8 weeks prior to baseline.
Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Renstar Medical Research
Ocala
Florida
34471
United States
Forward Clinical Trials, Inc
References Module
No data available
No data is available for this block.
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.
Induction: Participants received placebo subcutaneously (SC) every 8 weeks (Q8W) during Induction period.
FG001
Induction: 30 mg Mirikizumab Q8W
Induction: Participants received 30 milligram (mg) mirikizumab SC Q8W during Induction period.
Periods
Title
Milestones
Reasons Not Completed
Induction Period (16 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 21, 2018
May 4, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
LY3074828
Placebo
Drug
Administered SC
Placebo
Week 16
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
The 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 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 a Static Physician Global Assessment (sPGA) 0 and 0/1
The sPGA is the physician's determination of the participant's 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. Participants who did not meet the clinical response criteria or had missing data at Week 16 were considered non-responders for non-responder Imputation (NRI) analysis.
Week 16
Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score
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. The total score was calculated by summing the 8 individual items and ranged from 0 to 80, higher scores indicated greater symptom/sign severity. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region [United States/Outside United States (US/OUS)], previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = heterogeneous autoregressive.
Baseline, Week 16
Mean Change (Improvement) From Baseline on the Patient Global Assessment
The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
Baseline, Week 16
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score
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). Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
Baseline, Week 16
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, geographic region (US/OUS), and previous therapy (yes/no) as fixed factors and baseline value as covariate.
Baseline, Week 16
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Calgary
T2G 1B1
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Halifax
B3H1Z2
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Montreal
H2K4L5
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Peterborough
K9J 5K2
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Richmond Hill
L4B 1A5
Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Waterloo
N2J 1C4
Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Frankfurt am Main
60590
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamburg
20354
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mahlow
15831
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gifu
501-1194
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kurume
830-0011
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Morioka
020-8505
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nagoya
467-8602
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka
545-8586
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shinagawa-KU
141-8625
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shinjuku-ku
169-0073
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Takaoka-shi
9330871
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tsu
514-8507
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bialystok
15-017
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bialystok
15-351
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lodz
90-242
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lodz
90-265
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Świdnik
21-040
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw
01-518
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw
02-507
Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wroclaw
51-318
Poland
Grupo Dermatologico de Carolina
Carolina
00985
Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce
00716
Puerto Rico
FG002
Induction:100 mg Mirikizumab Q8W
Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.
FG003
Induction: 300 mg Mirikizumab Q8W
Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
FG004
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
Maintenance:
Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.
Participants who had greater than or equal to (≥) Psoriasis Area and Severity Index (PASI) 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
FG005
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
Maintenance:
Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
FG006
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
Maintenance:
Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
FG007
Maintenance: Placebo to 300 mg Mirikizumab Q8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.
Follow-up: Participants did not receive drug during the follow-up period.
FG008
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had less than (<) PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
Follow-up: Participants did not receive drug during the follow-up period.
FG009
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
Follow-up: participants did not receive drug during the follow-up period.
FG010
Maintenance: 300 mg Mirikizumab Q8W
Maintenance:
Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
FG00052 subjects
FG00151 subjects
FG00251 subjects
FG00351 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Received at Least One Dose of Study Drug
FG00052 subjects
FG00151 subjects
FG00251 subjects
FG00351 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG00050 subjects
FG00149 subjects
FG00251 subjects
FG00349 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Period (88 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsNo participants received placebo during maintenance period.
FG0010 subjectsNo participants received 30 mg mirikizumab Q8W in both induction and maintenance.
FG0020 subjectsNo participants received 100 mg mirikizumab Q8W in both induction and maintenance.
FG0030 subjects
FG00415 subjectsParticipants received 30 mg mirikizumab Q8W during induction period.
FG00530 subjectsParticipants received 100 mg mirikizumab Q8W during induction period.
FG00634 subjectsParticipants received 300 mg mirikizumab Q8W during induction period.
FG00750 subjectsParticipants received placebo during induction period.
FG00834 subjectsParticipants received 30 mg mirikizumab Q8W during induction arm.
FG00921 subjectsParticipants received 100 mg mirikizumab Q8W during induction arm.
FG01015 subjectsParticipants received 300 mg mirikizumab Q8W during induction arm.
Rescue Participants
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00310 subjectsIn PRN not regaining ≥ PASI 90 after 3 consecutive doses of drug or have \< PASI 50 after 1 dose.
Roll Over to AMAH (NCT03556202)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00313 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow-Up (16 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjectsNot all participants that completed maintenance period continued to follow-up period.
FG0054 subjectsNot all participants that completed maintenance period continued to follow-up period.
FG0063 subjectsNot all participants that completed maintenance period continued to follow-up period.
FG0073 subjectsNot all participants that completed maintenance period continued to follow-up period.
FG0086 subjectsNot all participants that completed maintenance period continued to follow-up period.
FG0092 subjectsNot all participants that completed maintenance period continued to follow-up period.
FG0100 subjectsNot all participants that completed maintenance period continued to follow-up period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
BG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
BG002
Induction: 100 mg Mirikizumab
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
BG003
Induction: 300 mg Mirikizumab
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00052
BG00151
BG00251
BG00351
BG004205
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
BG00046.0± 12.39
BG00149.2± 13.28
BG00246.0± 13.18
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00112
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0008
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
Title
Measurements
BG0004
BG0017
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (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).
All participants who received at least one dose of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
OG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
OG002
Induction: 100 mg Mirikizumab
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
OG003
Induction: 300 mg Mirikizumab
Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Units
Counts
Participants
OG00052
OG00151
OG00251
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG00129.4(16.9 to 41.9)
OG00258.8(45.3 to 72.3)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.009
Risk Difference (RD)
29.4
2-Sided
95
16.9
41.9
Superiority
OG000
OG002
Regression, Logistic
<0.001
Secondary
Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
The 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 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).
All participants who received at least one dose of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
OG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
OG002
Secondary
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
The 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 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).
All participants who received at least one dose of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
OG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
OG002
Secondary
Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1
The sPGA is the physician's determination of the participant's 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. Participants who did not meet the clinical response criteria or had missing data at Week 16 were considered non-responders for non-responder Imputation (NRI) analysis.
All participants who received at least one dose of drug.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
OG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
OG002
Induction: 100 mg Mirikizumab
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
Secondary
Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score
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. The total score was calculated by summing the 8 individual items and ranged from 0 to 80, higher scores indicated greater symptom/sign severity. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region [United States/Outside United States (US/OUS)], previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = heterogeneous autoregressive.
All participants who received at least one dose of study drug who had baseline and at least one post-baseline PSS observation.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
OG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
Secondary
Mean Change (Improvement) From Baseline on the Patient Global Assessment
The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
All participants who received at least one dose of study drug who had baseline and at least one post-baseline Patient Global Assessment observation.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
OG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
OG002
Induction: 100 mg Mirikizumab
Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.
Secondary
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score
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). Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
All participants who received at least one dose of study drug who had baseline and at least one post-baseline DLQI observation.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
OG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
Secondary
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, geographic region (US/OUS), and previous therapy (yes/no) as fixed factors and baseline value as covariate.
All participants who received at least one dose of study drug with a baseline value and at least 1 post-baseline value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Induction: Placebo
Induction: Placebo administered SC Q8W during Induction period.
OG001
Induction: 30 mg Mirikizumab
Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.
Secondary
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104
All participants who received at least one dose of study drug and had evaluable PK data.
Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
OG001
100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
OG002
300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.
Time Frame
Up To 120 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
Induction: Placebo
Induction: Participants received placebo SC Q8W during Induction period.
0
52
1
52
19
52
EG001
Induction: 30 mg Mirikizumab Q8W
Induction: Participants received 30 mg mirikizumab Q8W during Induction period.
0
51
1
51
24
51
EG002
Induction:100 mg Mirikizumab Q8W
Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.
0
51
0
51
19
51
EG003
Induction: 300 mg Mirikizumab Q8W
Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
0
51
1
51
19
51
EG004
Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
Maintenance:
Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period.
Participants who had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
0
15
1
15
13
15
EG005
Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
Maintenance:
Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
0
30
2
30
20
30
EG006
Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
Maintenance:
Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period.
Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.
0
34
1
34
23
34
EG007
Maintenance: Placebo to 300 mg Mirikizumab Q8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.
0
50
2
50
38
50
EG008
Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.
0
34
2
34
28
34
EG009
Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
Maintenance:
Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.
0
21
2
21
18
21
EG010
Maintenance: 300 mg Mirikizumab Q8W
Maintenance:
Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
0
15
3
15
13
15
EG011
300 mg Mirikizumab Q8W-Rescue
Participants received 300 mg Q8W mirikizumab during rescue.
0
10
1
10
9
10
EG012
30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up
Follow-up: Participants did not receive drug during the follow-up period.
0
2
0
2
0
2
EG013
100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up
Follow-up: Participants did not receive drug during the follow-up period.
0
4
0
4
1
4
EG014
300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up
Follow-up: Participants did not receive drug during the follow-up period.
0
3
0
3
0
3
EG015
Placebo to 300 mg Mirikizumab Q8W-Follow-up
Follow-up: Participants did not receive drug during the follow-up period.
0
3
0
3
0
3
EG016
30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
Follow-up: Participants did not receive drug during the follow-up period.
0
6
0
6
2
6
EG017
100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
Follow-up: Participants did not receive drug during the follow-up period.
0
2
0
2
1
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected15 at risk
EG0050 events0 affected30 at risk
EG0060 events0 affected34 at risk
EG0070 events0 affected50 at risk
EG0080 events0 affected34 at risk
EG0090 events0 affected21 at risk
EG0101 events1 affected15 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected4 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
Enlarged uvula
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Endocarditis bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Intraocular melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Nasal septal operation
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG0030 events0 affected51 at risk
EG0041 events1 affected15 at risk
EG0050 events0 affected30 at risk
EG0060 events0 affected34 at risk
EG0070 events0 affected50 at risk
EG0080 events0 affected34 at risk
EG0090 events0 affected21 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected10 at risk
EG0120 events0 affected2 at risk
EG0130 events0 affected4 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected6 at risk
EG0170 events0 affected2 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cataract
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected52 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Injection site pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected52 at risk
EG00115 events3 affected51 at risk
EG00214 events3 affected51 at risk
EG003
Injection site reaction
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hyperplastic cholecystopathy
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Body tinea
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected52 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Erythema migrans
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hepatitis a
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hepatitis e
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Localised infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0008 events7 affected52 at risk
EG0017 events5 affected51 at risk
EG0028 events6 affected51 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0013 events2 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected52 at risk
EG0016 events6 affected51 at risk
EG0023 events3 affected51 at risk
EG003
Urethritis chlamydial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected16 at risk
EG003
Wound infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Maternal exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected16 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Weight increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected52 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0012 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected52 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)