A Study to Evaluate the Efficacy and Safety of Bimekizuma... | NCT03598790 | Trialant
NCT03598790
Sponsor
UCB Biopharma SRL
Status
Completed
Last Update Posted
Apr 15, 2026Actual
Enrollment
1,353Actual
Phase
Phase 3
Conditions
Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Interventions
Bimekizumab
Countries
United States
Australia
Belgium
Canada
Germany
Hungary
Italy
Japan
Poland
Russia
South Korea
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03598790
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PS0014
Secondary IDs
ID
Type
Description
Link
2016-003427-30
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official Title
A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym
BE BRIGHT
Organization
UCB PharmaINDUSTRY
Status Module
Record Verification Date
Apr 2026
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 5, 2018Actual
Primary Completion Date
Nov 14, 2023Actual
Completion Date
Nov 14, 2023Actual
First Submitted Date
Jul 16, 2018
First Submission Date that Met QC Criteria
Jul 16, 2018
First Posted Date
Jul 26, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 8, 2024
Results First Submitted that Met QC Criteria
Nov 8, 2024
Results First Posted Date
Dec 6, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 2, 2026
Last Update Posted Date
Apr 15, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
UCB Biopharma SRLINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).
Detailed Description
The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.
Conditions Module
Conditions
Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Keywords
Bimekizumab
PSO
Psoriasis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,353Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Bimekizumab dose regimen 1
Experimental
Subjects are randomized to receive either dose regimen 1 (BKZ 1) or dose regimen 2 (BKZ 2) during the 144-week Treatment Period (open-label), those on BKZ 1 will switch to BKZ 2 at Week 24 or later (at the next scheduled clinic visit after Week 48)
Eligible subjects who completed the Treatment Period (open-label), and have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks.
Intervention Name: Bimekizumab
Drug: Bimekizumab
Bimekizumab dose regimen 2
Experimental
Subjects are randomized to receive BKZ 2 during the 144-week Treatment Period (open-label).
Eligible subjects who completed the Treatment Period (open-label), would continue OLE2 on BKZ 2.
Intervention Name: Bimekizumab
Drug: Bimekizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bimekizumab
Drug
Subjects will receive bimekizumab at pre-specified time-points.
Bimekizumab dose regimen 1
Bimekizumab dose regimen 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)
The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Secondary Outcomes
Measure
Description
Time Frame
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP
The number of SAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk is used.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Treatment Period (open-label)
Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria
Female subjects must be:
Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014
OLE2 Period (USA and Canada)
Completed the OLE Period without meeting any withdrawal criteria
Compliant with ongoing clinical study requirements
Female subject of childbearing potential must be willing to use highly effective method of contraception
Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
Signed a separate OLE2 Period ICF
Exclusion Criteria:
Treatment Period (open-label)
Subject has previously participated in this study
Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator
Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen
OLE2 Period (USA and Canada)
Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
Presence of active suicidal ideation or severe depression
Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Cohort A has Treatment Period (TP) (144 wks) followed by SFU Visit (20 wks after final dose). Cohort B has Screening Period (2 to 5 wks) and TP (144 wks) followed by SFU Visit (20 wks after final dose). After Protocol Amendment 3.3 (US) and 3.4 (Canada), 48-week OLE2 Period followed by SFU2 Visit (20 wks after final dose) was added in Cohort A.
Recruitment Details
The study started to enroll participants in September 2018 and concluded in November 2023. Participant flow refers to the Cohort A Safety Set, Cohort A OLE2 Period Set and Cohort B Safety Set. Participants who enrolled in PS0014 after completion of Phase 3 feeder studies were included in Cohort A. An additional Cohort B was added in Japan.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: BKZ 320 mg Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder studies (PS0008 [NCT03412747], PS0009 [NCT03370133], and PS0013 [NCT03410992]), participants were randomized to receive BKZ 320 milligrams (mg) subcutaneously (sc) every 8 weeks (Q8W) in this study during the 144-week (wk) Treatment Period. The BKZ 320 mg Q8W group consisted of all participants who received only Q8W during PS0014 study and did not switch dosing regimen at any time point.
Periods
Title
Milestones
Reasons Not Completed
Treatment Period (TP): Wk0-Wk144
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
Oct 12, 2021
Nov 8, 2024
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
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
UCB4940
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP
The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment were scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)
The PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)
PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum score is 0= no disease, maximum score is 72= maximal disease.
Week 144 compared to Baseline of PS0014 for Cohort B
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)
The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of clear [0] or almost clear [1] with at least two category improvement from Baseline at visit timepoint.
Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)
The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of 0 or 1 at Week 144.
Week 144 for Cohort B EP and GPP groups
Phoenix
Arizona
85032
United States
Ps0014 910
Bakersfield
California
93309
United States
Ps0014 927
Los Angeles
California
90033
United States
Ps0014 919
San Diego
California
92103
United States
Ps0014 955
San Diego
California
92123
United States
Ps0014 943
San Luis Obispo
California
93405
United States
Ps0014 967
Santa Monica
California
90404
United States
Ps0014 934
Washington D.C.
District of Columbia
20016
United States
Ps0014 909
Boynton Beach
Florida
33437
United States
Ps0014 912
Coral Gables
Florida
33134
United States
Ps0014 928
Fort Myers
Florida
33912
United States
Ps0014 906
Hollywood
Florida
33021
United States
Ps0014 907
Miami
Florida
33144
United States
Ps0014 903
Ocala
Florida
34470
United States
Ps0014 921
Ormond Beach
Florida
32174
United States
Ps0014 936
Tampa
Florida
33613
United States
Ps0014 941
Alpharetta
Georgia
30022
United States
Ps0014 954
Skokie
Illinois
60077
United States
Ps0014 911
Plainfield
Indiana
46168
United States
Ps0014 900
West Des Moines
Iowa
50265
United States
Ps0014 905
Overland Park
Kansas
66210
United States
Ps0014 962
Owensboro
Kentucky
42301
United States
Ps0014 922
Baton Rouge
Louisiana
70809
United States
Ps0014 944
New Orleans
Louisiana
70115
United States
Ps0014 940
Beverly
Massachusetts
01915
United States
Ps0014 925
Brighton
Massachusetts
02135
United States
Ps0014 917
Troy
Michigan
48084
United States
Ps0014 915
Clayton
Missouri
63105
United States
Ps0014 958
Omaha
Nebraska
68144
United States
Ps0014 901
Portsmouth
New Hampshire
03801
United States
Ps0014 908
East Windsor
New Jersey
08520
United States
Ps0014 956
Verona
New Jersey
07044
United States
Ps0014 947
Buffalo
New York
14221
United States
Ps0014 965
Kew Gardens
New York
11415
United States
Ps0014 913
New York
New York
10029-6501
United States
Ps0014 963
Rochester
New York
14623
United States
Ps0014 961
Rocky Mount
North Carolina
27804
United States
Ps0014 932
Oklahoma City
Oklahoma
73112
United States
Ps0014 920
Portland
Oregon
97210
United States
Ps0014 929
Portland
Oregon
97223
United States
Ps0014 937
Johnston
Rhode Island
02919
United States
Ps0014 945
Greer
South Carolina
29650
United States
Ps0014 931
Dallas
Texas
75231
United States
Ps0014 924
Houston
Texas
77004
United States
Ps0014 914
San Antonio
Texas
78213
United States
Ps0014 951
Webster
Texas
77598
United States
Ps0014 933
Murray
Utah
84107
United States
PS0014 7
Campbelltown
Australia
PS0014 3
Carlton
Australia
PS0014 8
East Melbourne
Australia
PS0014 4
Fremantle
Australia
Ps0014 10
Kogarah
Australia
PS0014 6
Kogarah
Australia
PS0014 5
Phillip
Australia
PS0014 2
Westmead
Australia
PS0014 9
Woolloongabba
Australia
Ps0014 50
Brussels
Belgium
Ps0014 51
Charleroi
Belgium
Ps0014 52
Liège
Belgium
Ps0014 658
Ajax
Canada
Ps0014 659
Calgary
Canada
Ps0014 672
Edmonton
Canada
Ps0014 673
Halifax
Canada
Ps0014 671
Hamilton
Canada
Ps0014 675
Markham
Canada
Ps0014 663
Mississauga
Canada
Ps0014 660
Montreal
Canada
Ps0014 668
North Bay
Canada
Ps0014 652
Oakville
Canada
Ps0014 667
Ottawa
Canada
Ps0014 661
Peterborough
Canada
Ps0014 665
Québec
Canada
Ps0014 651
Richmond Hill
Canada
Ps0014 650
Surrey
Canada
Ps0014 676
Surrey
Canada
Ps0014 653
Toronto
Canada
Ps0014 662
Toronto
Canada
Ps0014 664
Toronto
Canada
Ps0014 657
Waterloo
Canada
Ps0014 669
Windsor
Canada
Ps0014 670
Windsor
Canada
Ps0014 674
Winnipeg
Canada
Ps0014 207
Berlin
Germany
Ps0014 218
Bonn
Germany
Ps0014 209
Darmstadt
Germany
Ps0014 203
Dresden
Germany
Ps0014 214
Erlangen
Germany
Ps0014 208
Frankfurt
Germany
Ps0014 210
Friedrichshafen
Germany
Ps0014 202
Hamburg
Germany
Ps0014 211
Hamburg
Germany
Ps0014 220
Hamburg
Germany
Ps0014 212
Heidelberg
Germany
Ps0014 215
Lübeck
Germany
Ps0014 213
Mahlow
Germany
Ps0014 219
Münster
Germany
Ps0014 205
Osnabrück
Germany
Ps0014 217
Schweinfurt
Germany
Ps0014 200
Schwerin
Germany
Ps0014 204
Witten
Germany
Ps0014 252
Budapest
Hungary
Ps0014 254
Budapest
Hungary
Ps0014 255
Budapest
Hungary
Ps0014 261
Budapest
Hungary
Ps0014 256
Debrecen
Hungary
Ps0014 262
Encs
Hungary
Ps0014 251
Gyula
Hungary
Ps0014 253
Orosháza
Hungary
Ps0014 260
Szeged
Hungary
Ps0014 259
Szekszárd
Hungary
Ps0014 250
Szolnok
Hungary
Ps0014 258
Veszprém
Hungary
Ps0014 300
Roma
Italy
Ps0014 303
Roma
Italy
Ps0014 629
Asahikawa
Japan
Ps0014 605
Bunkyō City
Japan
Ps0014 607
Chiyoda-ku
Japan
Ps0014 610
Chūōku
Japan
Ps0014 601
Fukuoka
Japan
Ps0014 619
Gifu
Japan
Ps0014 620
Hamamatsu
Japan
Ps0014 608
Itabashi-ku
Japan
Ps0014 609
Kobe
Japan
Ps0014 600
Kurume
Japan
Ps0014 622
Matsumoto
Japan
Ps0014 604
Minatoku
Japan
Ps0014 623
Morioka
Japan
Ps0014 621
Nagoya
Japan
Ps0014 625
Nankoku
Japan
Ps0014 624
Obihiro
Japan
Ps0014 611
Osaka
Japan
Ps0014 614
Osaka
Japan
Ps0014 603
Sapporo
Japan
Ps0014 617
Sendai
Japan
Ps0014 613
Shimotsuke
Japan
Ps0014 602
Shinagawa-ku
Japan
Ps0014 612
Shinjuku-ku
Japan
Ps0014 618
Shinjuku-ku
Japan
Ps0014 626
Shinjuku-ku
Japan
Ps0014 628
Shinjuku-ku
Japan
Ps0014 606
Takaoka
Japan
Ps0014 615
Tokyo
Japan
Ps0014 627
Tokyo
Japan
Ps0014 616
Tsu
Japan
Ps0014 355
Bialystok
Poland
Ps0014 361
Bialystok
Poland
Ps0014 362
Bialystok
Poland
Ps0014 369
Bialystok
Poland
Ps0014 371
Bydgoszcz
Poland
Ps0014 352
Gdansk
Poland
Ps0014 358
Katowice
Poland
Ps0014 359
Katowice
Poland
Ps0014 366
Katowice
Poland
Ps0014 357
Kielce
Poland
Ps0014 363
Krakow
Poland
Ps0014 360
Lodz
Poland
Ps0014 372
Lodz
Poland
Ps0014 356
Lublin
Poland
Ps0014 364
Nowa Sól
Poland
Ps0014 374
Poznan
Poland
Ps0014 353
Szczecin
Poland
Ps0014 350
Warsaw
Poland
Ps0014 351
Warsaw
Poland
Ps0014 354
Warsaw
Poland
Ps0014 365
Wroclaw
Poland
Ps0014 367
Wroclaw
Poland
Ps0014 368
Wroclaw
Poland
Ps0014 370
Wroclaw
Poland
Ps0014 373
Wroclaw
Poland
Ps0014 400
Moscow
Russia
Ps0014 402
Moscow
Russia
Ps0014 403
Moscow
Russia
Ps0014 404
Saint Petersburg
Russia
Ps0014 405
Saint Petersburg
Russia
Ps0014 401
Saratov
Russia
Ps0014 406
Yaroslavl
Russia
Ps0014 701
Busan
South Korea
Ps0014 702
Gwangju
South Korea
Ps0014 705
Seongnam-si
South Korea
Ps0014 700
Seoul
South Korea
Ps0014 703
Seoul
South Korea
Ps0014 754
Taipei
Taiwan
Ps0014 755
Taipei
Taiwan
Ps0014 551
Dundee
United Kingdom
Ps0014 552
Liverpool
United Kingdom
Ps0014 550
Manchester
United Kingdom
Ps0014 554
Reading
United Kingdom
Ps0014 555
Salford
United Kingdom
Result
Thaci D, Vender R, de Rie MA, Conrad C, Pariser DM, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball AB. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. Br J Dermatol. 2023 Jan 23;188(1):22-31. doi: 10.1093/bjd/ljac021.
Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III trials. Br J Dermatol. 2024 Mar 15;190(4):477-485. doi: 10.1093/bjd/ljad429.
Lebwohl M, Merola JF, Strober B, Armstrong A, Yoshizaki A, Gisondi P, Szilagyi B, Peterson L, de Cuyper D, Cross N, Davies O, Gottlieb AB. Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials. J Am Acad Dermatol. 2024 Aug;91(2):281-289. doi: 10.1016/j.jaad.2024.03.041. Epub 2024 Apr 6.
Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22.
Okubo Y, Tada Y, Takahashi H, Abe M, Yamanaka K, Tilt N, Cross N, Deherder D, Matano M, Nakagawa H. Efficacy and Safety of Bimekizumab in Japanese Patients with Generalised Pustular Psoriasis and Erythrodermic Psoriasis: 3-Year Results from BE BRIGHT, a Multicentre, Open-Label, Phase 3 Study. Dermatol Ther (Heidelb). 2025 Oct;15(10):2947-2966. doi: 10.1007/s13555-025-01509-9. Epub 2025 Aug 11.
Armstrong A, Papp KA, Lebwohl M, Savage LJ, Yamanaka K, Vlase DE, Warham R, Lambert J, Lopez Pinto JM, Wixted K, Thaci D. Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT. Dermatol Ther (Heidelb). 2026 Jan;16(1):585-603. doi: 10.1007/s13555-025-01595-9. Epub 2025 Dec 8.
Krueger JG, Cutcutache I, Lebwohl M, Gudjonsson JE, Pinter A, Langley RG, Merola J, Tada Y, Skelton A, Rastrick J, Ferecsko AS, Page M, Davies O, Lopez Pinto JM, Warham R, Shaw S, Warren RB. Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability. J Allergy Clin Immunol. 2026 Apr;157(4):905-916. doi: 10.1016/j.jaci.2025.12.1013. Epub 2026 Jan 22.
Gisondi P, Elewski B, Pinter A, Yamaguchi Y, Gooderham M, Kavanagh S, Wixted K, Cross N, Szilagyi B, Merola JF. Bimekizumab efficacy in scalp, nail and palmoplantar psoriasis versus comparators and over 4 years. J Dermatolog Treat. 2026 Dec;37(1):2637344. doi: 10.1080/09546634.2026.2637344. Epub 2026 Mar 9.
Merola JF, Warren RB, Thaci D, Gordon KB, Nishida E, Strober B, Conrad C, Kavanagh S, Lopez Pinto JM, Hoepken B, Gisondi P. Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies. Am J Clin Dermatol. 2025 Nov;26(6):967-979. doi: 10.1007/s40257-025-00968-2. Epub 2025 Aug 31.
Blauvelt A, Langley RG, Lebwohl M, Strober B, Warren RB, Puig L, Morita A, Gordon KB, Fernandez-Penas P, Kavanagh S, Lopez Pinto JM, Lambert J, Hoepken B, Deherder D, Cross N, Thaci D. Bimekizumab durability of efficacy through 196 weeks and safety through 4 years in patients with moderate to severe plaque psoriasis: Results from the BE BRIGHT open-label extension trial. J Am Acad Dermatol. 2025 Sep;93(3):644-653. doi: 10.1016/j.jaad.2025.04.038. Epub 2025 Apr 24.
Kokolakis G, Warren RB, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Korber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Nunez Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023 Feb 22;188(3):330-340. doi: 10.1093/bjd/ljac089.
FG001
Cohort A: BKZ 320 mg Q4W/Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc every 4 weeks (Q4W) in this study during the 144-week Treatment Period. The participants switched to BKZ 320 mg Q8W as per protocol. The BKZ 320mg Q4W/Q8W group consisted of all participants who switched from Q4W to Q8W dosing at any of the scheduled switching time points during the study.
FG002
Cohort A: BKZ 320 mg Q4W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc Q4W in this study during the 144-week Treatment Period. The BKZ 320 mg Q4W group consisted of participants who discontinued prior to the planned change of dosing interval from BKZ 320 mg Q4W to BKZ 320 mg Q8W.
FG003
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
FG004
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score <3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
FG005
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
FG006
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
FG007
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
FG008
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
FG000384 subjects
FG001833 subjects
FG00270 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00645 subjects
FG00711 subjects
FG00810 subjects
COMPLETED
FG000326 subjects
FG001746 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00638 subjects
FG00710 subjects
FG0088 subjects
NOT COMPLETED
FG00058 subjects
FG00187 subjects
FG00270 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0067 subjects
FG0071 subjects
FG0082 subjects
Type
Comment
Reasons
Adverse Event
FG00024 subjects
FG00133 subjects
FG00224 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
FG0071 subjects
FG0082 subjects
Lack of Efficacy
FG0004 subjects
FG0017 subjects
FG0025 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0007 subjects
FG00111 subjects
FG00214 subjects
FG0030 subjects
FG004
Consent withdrawn by subject
FG00014 subjects
FG00126 subjects
FG00217 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Covid-19 Pandemic Circumstances
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Long IP pause; Investigator decided termination
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Withdrawn By Sponsor
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Patient Did Not Comply With Safety Precautions
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Covid-19 Pandemic Circumstances
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Sponsor's Decision
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Unplanned Elective Surgery
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-Compliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Site Closure; Subject did not want to transfer
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
COVID-19 restrictions; Subject unable to return
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Subject Withdraw Consent (Fear Of Another Ae)
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
The Subject Can't Visit the Hospital Anymore
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Completed treatment but missed Week 144 visit
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Non-Compliance-PI early terminated the subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
OLE2 Period: Wk 144/OLE2 BL- OLE2 Wk 48
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003226 subjects
FG00451 subjects
FG00541 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003216 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00310 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics refer to the Cohort A Safety Set (CA-SS) which consisted of all Cohort A study participants who received at least 1 dose of the investigational medicinal product (IMP) in this study and Cohort B Safety Set (CB-SS) which consisted of all Cohort B study participants in the Cohort B Enrolled Set (CB-ES) who received at least 1 dose of IMP in PS0014 study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: BKZ 320 mg Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder studies (PS0008 [NCT03412747], PS0009 [NCT03370133], and PS0013 [NCT03410992]), participants were randomized to receive BKZ 320 milligrams (mg) subcutaneously (sc) every 8 weeks (Q8W) in this study during the 144-week (wk) Treatment Period. The BKZ 320 mg Q8W group consisted of all participants who received only Q8W during PS0014 study and did not switch dosing regimen at any time point.
BG001
Cohort A: BKZ 320 mg Q4W/Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc every 4 weeks (Q4W) in this study during the 144-week Treatment Period. The participants switched to BKZ 320 mg Q8W as per protocol. The BKZ 320mg Q4W/Q8W group consisted of all participants who switched from Q4W to Q8W dosing at any of the scheduled switching time points during the study.
BG002
Cohort A: BKZ 320 mg Q4W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc Q4W in this study during the 144-week Treatment Period. The BKZ 320 mg Q4W group consisted of participants who discontinued prior to the planned change of dosing interval from BKZ 320 mg Q4W to BKZ 320 mg Q8W.
BG003
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
BG004
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
BG005
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000384
BG001833
BG00270
BG00345
BG00411
BG00510
BG0061353
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
BG00045.3± 13.7
BG00145.5± 13.2
BG00245.4± 13.4
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18 - <65 years
BG000349
BG001757
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000118
BG001221
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian/Alaskan Native
BG0001
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00020
BG00140
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)
The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. Cohort A OLE2 Period Set (CA-OL2S)-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
ID
Title
Description
OG000
Cohort A: BKZ 320 mg Q8W
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
OG001
Cohort A: BKZ 320 mg Q4W
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
OG002
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
OG003
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score <3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
OG004
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
Units
Counts
Participants
OG0001217
OG001903
OG002226
OG003
Title
Denominators
Categories
Title
Measurements
OG00097.83(91.73 to 104.22)
OG001179.68(166.62 to 193.49)
OG00279.02(65.97 to 93.89)
OG003
Secondary
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP
The number of SAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk is used.
CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. CA-OL2S-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
ID
Title
Description
OG000
Cohort A: BKZ 320 mg Q8W
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
OG001
Cohort A: BKZ 320 mg Q4W
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
Secondary
Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP
The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment were scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. CA-OL2S-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline.
Posted
Number
95% Confidence Interval
no. of new events per 100 subject-years
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
ID
Title
Description
OG000
Cohort A: BKZ 320 mg Q8W
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
OG001
Cohort A: BKZ 320 mg Q4W
Secondary
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)
The PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Cohort A FAS included all Cohort A enrolled study participants who received at least 1 dose of IMP and had a valid efficacy measurement for PASI at Baseline of the feeder study and at Baseline of this study. Cohort B Psoriasis FAS included study participants with chronic plaque PSO at Baseline. Study participants who had missing data at the Week 144 were treated as though they did not respond to the treatment using Non-responder imputation (NRI) method.
Posted
Number
percentage of participants
Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
ID
Title
Description
OG000
Cohort A: BKZ 320 mg Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder studies (PS0008 [NCT03412747], PS0009 [NCT03370133], and PS0013 [NCT03410992]), participants were randomized to receive BKZ 320 milligrams (mg) subcutaneously (sc) every 8 weeks (Q8W) in this study during the 144-week (wk) Treatment Period. The BKZ 320 mg Q8W group consisted of all participants who received only Q8W during PS0014 study and did not switch dosing regimen at any time point.
Secondary
Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)
PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum score is 0= no disease, maximum score is 72= maximal disease.
Cohort B GPP FAS included study participants with GPP at Baseline. Cohort B EP FAS included study participants with EP at Baseline. Only study participants with available data who had not discontinued study treatment at Week 144 were considered for the analysis.
Posted
Number
percentage of participants
Week 144 compared to Baseline of PS0014 for Cohort B
ID
Title
Description
OG000
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
OG001
Cohort B: GPP BKZ Total
Secondary
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)
The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of clear [0] or almost clear [1] with at least two category improvement from Baseline at visit timepoint.
Cohort A FAS included all Cohort A enrolled study participants who received at least 1 dose of IMP and had a valid efficacy measurement for PASI at Baseline of the feeder study and at Baseline of this study. Cohort B Psoriasis FAS included study participants with chronic plaque PSO at Baseline. Study participants who had missing data at the Week 144 were treated as though they did not respond to the treatment using NRI.
Posted
Number
percentage of participants
Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B
ID
Title
Description
OG000
Cohort A: BKZ 320 mg Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder studies (PS0008 [NCT03412747], PS0009 [NCT03370133], and PS0013 [NCT03410992]), participants were randomized to receive BKZ 320 milligrams (mg) subcutaneously (sc) every 8 weeks (Q8W) in this study during the 144-week (wk) Treatment Period. The BKZ 320 mg Q8W group consisted of all participants who received only Q8W during PS0014 study and did not switch dosing regimen at any time point.
Secondary
Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)
The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of 0 or 1 at Week 144.
Cohort B GPP FAS included study participants with GPP at Baseline. Cohort B EP FAS included study participants with EP at Baseline. Only study participants with available data who had not discontinued study treatment at Week 144 were considered for the analysis.
Posted
Number
percentage of participants
Week 144 for Cohort B EP and GPP groups
ID
Title
Description
OG000
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
OG001
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
Time Frame
From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
Description
TEAEs were defined as events that have a start date on or following the first administration of study treatment in PS0014 through the final administration of study treatment + 140 days (covering the 20-week SFU Period). Cohort A OLE2 Period Set (CA-OL2S) included all participants who received at least 1 dose of BKZ in the OLE2 Period. SS was used.
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
Cohort A: BKZ 320 mg Q8W
Participants who received BKZ 320 mg Q8W and who switched from Q4W to Q8W dosing at any of the scheduled time points during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group. All the adverse events occurred during the BKZ 320 mg Q8W treatment at any timepoint of the study were included in this arm.
9
1,217
124
1,217
771
1,217
EG001
Cohort A: BKZ 320 mg Q4W
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group. All the adverse events occurred during the BKZ 320 mg Q4W treatment at any timepoint of the study were included in this arm.
6
903
65
903
566
903
EG002
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
0
226
11
226
97
226
EG003
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score <3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
0
51
5
51
16
51
EG004
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
0
41
4
41
21
41
EG005
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
0
45
7
45
43
45
EG006
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
0
11
5
11
11
11
EG007
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
0
10
2
10
9
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG0030 events0 affected51 at risk
EG004
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Haemorrhagic diathesis
Blood and lymphatic system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Wolff-Parkinson-White syndrome
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hypertensive cardiomyopathy
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0012 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0004 events4 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0003 events3 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0023 events3 affected226 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0003 events3 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0013 events3 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Systolic dysfunction
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hyperparathyroidism primary
Endocrine disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cataract
Eye disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Retinal detachment
Eye disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Anal prolapse
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Oroantral fistula
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Death
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pain
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Stent-graft endoleak
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cholecystocholangitis
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0002 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Colonic abscess
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Bursitis infective
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Abscess limb
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0022 events2 affected226 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Staphylococcal abscess
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Erysipelas
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Streptococcal abscess
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00013 events13 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0003 events3 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Ketoacidosis
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Inclusion body myositis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0003 events2 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Kyphosis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Breast cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Colorectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Tongue neoplasm benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Lip and/or oral cavity cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Prostatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Prostate cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Metastatic bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cerebral artery embolism
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cerebrovascular disorder
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hemiplegic migraine
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Migraine
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Relapsing-remitting multiple sclerosis
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Intercostal neuralgia
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Spondylitic myelopathy
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pregnancy on oral contraceptive
Pregnancy, puerperium and perinatal conditions
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Bipolar I disorder
Psychiatric disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Drug dependence
Psychiatric disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Genital haemorrhage
Reproductive system and breast disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0004 events4 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Laryngeal ulceration
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pharyngeal ulceration
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Femoral artery embolism
Vascular disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Pulseless electrical activity
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Haemorrhoids thrombosed
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Hip arthroplasty
Surgical and medical procedures
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Gastrointestinal tract adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Erythrodermic psoriasis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pustular psoriasis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG0030 events0 affected51 at risk
EG0040 events0 affected41 at risk
EG0053 events2 affected45 at risk
EG0060 events0 affected11 at risk
EG0071 events1 affected10 at risk
Cardiac failure chronic
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cardiac hypertrophy
Cardiac disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA version 19.0
Non-systematic Assessment
EG0005 events5 affected1,217 at risk
EG0017 events7 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cataract
Eye disorders
MedDRA version 19.0
Non-systematic Assessment
EG00014 events12 affected1,217 at risk
EG0016 events6 affected903 at risk
EG0023 events2 affected226 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA version 19.0
Non-systematic Assessment
EG0008 events8 affected1,217 at risk
EG0015 events5 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Dry eye
Eye disorders
MedDRA version 19.0
Non-systematic Assessment
EG0004 events4 affected1,217 at risk
EG0015 events4 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG00027 events24 affected1,217 at risk
EG00120 events19 affected903 at risk
EG0022 events2 affected226 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG00015 events14 affected1,217 at risk
EG00117 events17 affected903 at risk
EG0022 events2 affected226 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG00014 events14 affected1,217 at risk
EG0017 events7 affected903 at risk
EG0023 events2 affected226 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG00012 events11 affected1,217 at risk
EG0015 events5 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG00013 events11 affected1,217 at risk
EG0014 events4 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0008 events8 affected1,217 at risk
EG0017 events5 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0006 events6 affected1,217 at risk
EG0014 events4 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0005 events5 affected1,217 at risk
EG0015 events5 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0004 events4 affected1,217 at risk
EG0013 events3 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0015 events5 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0003 events3 affected1,217 at risk
EG0013 events3 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0013 events3 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Coating in mouth
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Pyrexia
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG00030 events25 affected1,217 at risk
EG0019 events8 affected903 at risk
EG0023 events3 affected226 at risk
EG003
Peripheral swelling
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG0009 events8 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG0005 events5 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0024 events4 affected226 at risk
EG003
Malaise
General disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0013 events3 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG00010 events10 affected1,217 at risk
EG0014 events4 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG000223 events152 affected1,217 at risk
EG001230 events174 affected903 at risk
EG00215 events14 affected226 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG000238 events127 affected1,217 at risk
EG001234 events145 affected903 at risk
EG00218 events13 affected226 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG000187 events174 affected1,217 at risk
EG00118 events18 affected903 at risk
EG00235 events34 affected226 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG000127 events97 affected1,217 at risk
EG00185 events74 affected903 at risk
EG00214 events12 affected226 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00079 events58 affected1,217 at risk
EG00172 events49 affected903 at risk
EG0028 events6 affected226 at risk
EG003
Folliculitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00030 events24 affected1,217 at risk
EG00143 events35 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00028 events27 affected1,217 at risk
EG00122 events19 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00022 events20 affected1,217 at risk
EG00130 events25 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Otitis externa
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00019 events17 affected1,217 at risk
EG00115 events13 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Oral herpes
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00019 events15 affected1,217 at risk
EG00118 events16 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Angular cheilitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00015 events14 affected1,217 at risk
EG00118 events14 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00016 events16 affected1,217 at risk
EG00113 events12 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Influenza
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00013 events12 affected1,217 at risk
EG00111 events9 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00011 events10 affected1,217 at risk
EG0018 events7 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Cystitis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG00011 events9 affected1,217 at risk
EG0015 events4 affected903 at risk
EG0022 events2 affected226 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0003 events3 affected1,217 at risk
EG0015 events5 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Erysipelas
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0004 events3 affected1,217 at risk
EG0015 events4 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Paronychia
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0007 events5 affected1,217 at risk
EG0013 events2 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0005 events5 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0001 events1 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG00010 events10 affected1,217 at risk
EG0018 events8 affected903 at risk
EG0022 events2 affected226 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG00012 events9 affected1,217 at risk
EG0015 events5 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0007 events7 affected1,217 at risk
EG0016 events6 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0006 events5 affected1,217 at risk
EG0014 events4 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 19.0
Non-systematic Assessment
EG00023 events19 affected1,217 at risk
EG0016 events6 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA version 19.0
Non-systematic Assessment
EG00017 events15 affected1,217 at risk
EG0017 events7 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 19.0
Non-systematic Assessment
EG00014 events12 affected1,217 at risk
EG0016 events5 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 19.0
Non-systematic Assessment
EG0009 events9 affected1,217 at risk
EG0015 events5 affected903 at risk
EG0020 events0 affected226 at risk
EG003
White blood cell count decreased
Investigations
MedDRA version 19.0
Non-systematic Assessment
EG0003 events2 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG00014 events13 affected1,217 at risk
EG0018 events8 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG00011 events11 affected1,217 at risk
EG0019 events9 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG00012 events12 affected1,217 at risk
EG0016 events6 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG0007 events7 affected1,217 at risk
EG0014 events4 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA version 19.0
Non-systematic Assessment
EG0005 events5 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG00055 events48 affected1,217 at risk
EG00122 events19 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG00031 events28 affected1,217 at risk
EG00124 events23 affected903 at risk
EG0023 events3 affected226 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG00027 events26 affected1,217 at risk
EG0015 events5 affected903 at risk
EG0025 events5 affected226 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG00010 events9 affected1,217 at risk
EG00111 events9 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0007 events5 affected1,217 at risk
EG0018 events7 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0008 events7 affected1,217 at risk
EG0013 events3 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG00010 events7 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0012 events2 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0002 events2 affected1,217 at risk
EG0011 events1 affected903 at risk
EG0021 events1 affected226 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Non-systematic Assessment
EG0000 events0 affected1,217 at risk
EG0010 events0 affected903 at risk
EG0020 events0 affected226 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
OG006
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
OG007
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
51
OG00441
OG00545
OG00611
OG00710
77.11
(51.64 to 110.74)
OG00473.78(47.75 to 108.92)
OG005244.08(178.03 to 326.60)
OG006328.25(163.86 to 587.33)
OG007188.71(86.29 to 358.22)
OG002
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
OG003
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score <3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
OG004
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
OG005
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
OG006
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
OG007
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
Units
Counts
Participants
OG0001217
OG001903
OG002226
OG00351
OG00441
OG00545
OG00611
OG00710
Title
Denominators
Categories
Title
Measurements
OG0005.24(4.36 to 6.25)
OG0016.72(5.19 to 8.56)
OG0024.44(2.22 to 7.95)
OG0039.05(2.94 to 21.13)
OG0048.93(2.43 to 22.86)
OG0055.86(2.36 to 12.08)
OG00619.51(6.34 to 45.54)
OG0077.56(0.92 to 27.32)
Participants who received BKZ 320 mg Q4W during the 144-week Treatment Period. The participants who switched from BKZ 320 mg Q4W to Q8W during the study were included in both the BKZ 320 mg Q4W group and the BKZ 320 mg Q8W group.
OG002
Cohort A: Group A BKZ 320 mg Q8W
Participants who completed the Treatment Period (Week 0 to Week 144) were directly rolled over to the Open-Label Extension 2 (OLE2) Period. Participants continued receiving BKZ 320 mg sc Q8W for 40 additional weeks (from Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48).
OG003
Cohort A: Group B BKZ 320 mg Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the SFU or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants in OLE2 Period Group B with an IGA score <3 upon entry received BKZ 320 mg sc Q8W from the Week 144/OLE2 Period Baseline Visit to OLE2 Period Week 48.
OG004
Cohort A: Group B BKZ 320 mg Q4W/Q8W
Participants who had completed the Treatment Period Week 144 Visit and who were in the Safety Follow-Up (SFU) or had completed the SFU at the time of Protocol Amendment 3.3 and 3.4 implementation reinitiated BKZ treatment in the OLE2 Period after 4-week OLE2 Screening Period. Participants with an Investigator's Global Assessment (IGA) score greater than equal to (>=) 3 upon entry in the OLE2 Period received BKZ 320 mg sc Q4W for the first 16 weeks, and then switched to BKZ 320 mg Q8W until OLE2 Period Week 48.
OG005
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
OG006
Cohort B: EP BKZ Total
Participants with erythrodermic psoriasis (EP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
OG007
Cohort B: GPP BKZ Total
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
Units
Counts
Participants
OG0001217
OG001903
OG002226
OG00351
OG00441
OG00545
OG00611
OG00710
Title
Denominators
Categories
Title
Measurements
OG0002.11(1.57 to 2.76)
OG0012.59(1.69 to 3.80)
OG0020.79(0.10 to 2.86)
OG0031.77(0.04 to 9.86)
OG0044.37(0.53 to 15.79)
OG0052.42(0.50 to 7.08)
OG0063.27(0.08 to 18.19)
OG0077.68(0.93 to 27.74)
OG001
Cohort A: BKZ 320 mg Q4W/Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc every 4 weeks (Q4W) in this study during the 144-week Treatment Period. The participants switched to BKZ 320 mg Q8W as per protocol. The BKZ 320mg Q4W/Q8W group consisted of all participants who switched from Q4W to Q8W dosing at any of the scheduled switching time points during the study.
OG002
Cohort A: BKZ 320mg Q4W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc Q4W in this study during the 144-week Treatment Period. The BKZ 320 mg Q4W group consisted of participants who discontinued prior to the planned change of dosing interval from BKZ 320 mg Q4W to BKZ 320 mg Q8W.
OG003
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.
Units
Counts
Participants
OG000384
OG001832
OG00270
OG00345
Title
Denominators
Categories
Title
Measurements
OG00077.6
OG00180.2
OG0020
OG00373.3
Participants with generalized pustular psoriasis (GPP) in Cohort B received BKZ 320 mg sc Q4W until Week 16. Based on IGA response, participants received either BKZ 320 mg sc Q4W or BKZ 320 mg sc Q8W up to Week 144.
Units
Counts
Participants
OG00011
OG00110
Title
Denominators
Categories
Title
Measurements
OG00090.0
OG00185.7
OG001
Cohort A: BKZ 320 mg Q4W/Q8W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc every 4 weeks (Q4W) in this study during the 144-week Treatment Period. The participants switched to BKZ 320 mg Q8W as per protocol. The BKZ 320mg Q4W/Q8W group consisted of all participants who switched from Q4W to Q8W dosing at any of the scheduled switching time points during the study.
OG002
Cohort A: BKZ 320 mg Q4W
Based on the PASI90 response and the treatment/dose the participant was receiving in the feeder study, participants were randomized to receive BKZ 320 mg sc Q4W in this study during the 144-week Treatment Period. The BKZ 320 mg Q4W group consisted of participants who discontinued prior to the planned change of dosing interval from BKZ 320 mg Q4W to BKZ 320 mg Q8W.
OG003
Cohort B: PSO BKZ Total
Participants with chronic plaque psoriasis (PSO) in Cohort B received BKZ 320 mg sc Q4W until Week 16 and 320 mg Q8W thereafter through Week 40. At Week 48, Cohort B participants with chronic plaque PSO continued BKZ 320 mg Q8W up to Week 144. If the participant's dosing interval had changed to BKZ 320 mg Q4W under Protocol Amendment 1.2, the participant's dosing interval changed to BKZ 320 mg Q8W at the next scheduled clinic visit after implementation of Protocol Amendment 3.2.