A Study to Evaluate Further Therapeutic Strategies With G... | NCT03818035 | Trialant
NCT03818035
Sponsor
Janssen-Cilag International NV
Status
Completed
Last Update Posted
Jan 23, 2026Actual
Enrollment
880Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Guselkumab
Placebo Injection
Countries
France
Germany
Protocol Section
Identification Module
NCT ID
NCT03818035
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108514
Secondary IDs
ID
Type
Description
Link
2018-001238-16
EudraCT Number
CNTO1959PSO3012
Other Identifier
Janssen-Cilag International NV
2023-508424-34-00
Registry Identifier
EUCT number
Brief Title
A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis
Official Title
A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies With Guselkumab in Patients With Moderate-to-Severe Plaque-Type Psoriasis
Acronym
GUIDE
Organization
Janssen-Cilag International NVINDUSTRY
Status Module
Record Verification Date
Jan 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
Feb 8, 2019Actual
Primary Completion Date
Mar 7, 2022Actual
Completion Date
Jan 7, 2025Actual
First Submitted Date
Jan 11, 2019
First Submission Date that Met QC Criteria
Jan 23, 2019
First Posted Date
Jan 28, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Mar 6, 2023
Results First Submitted that Met QC Criteria
Apr 18, 2023
Results First Posted Date
May 10, 2023Actual
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
Jan 5, 2026
Last Update Posted Date
Jan 23, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen-Cilag International NVINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
880Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Guselkumab
Experimental
Participants in group 1 (Part 1) will receive 100 milligram (mg) guselkumab subcutaneously (SC) at Weeks 0, 4, 12 and 20.
Drug: Guselkumab
Part 2: Guselkumab q8w and Guselkumab q16w
Experimental
Eligible participants from Part 1 will continue to participate in Part 2. Participants (super responder [SRe]) with a Psoriasis Area and Severity Index (PASI) score = 0 at weeks 20 and 28 will be randomized to guselkumab 100 mg every 8 weeks (q8w) (group 2a) or guselkumab 100 mg q16w (group 2b), at weeks 28 to 60. Group 2b will receive placebo injection at weeks 28, 44 and 60 to keep the comparison double blind. Participants losing control of disease (PASI score >5) during study Part 2 (until week 60), will enter the re-treatment arm (group 2d) and receive guselkumab 100mg q8w (at re-treatment week 0), followed by administration at re-treatment-weeks 8 and 16.
Drug: Guselkumab
Part 2: Guselkumab q8w
Experimental
Participants (Non SRe) in group 2c with a PASI score greater than (>) 0 at week 20 and/or 28 will continue to receive guselkumab 100 mg q8w until week 60.
Drug: Guselkumab
Drug: Placebo Injection
Part 3: Guselkumab Withdrawal
Experimental
Participants from groups 2a and 2b with a PASI score <3 at week 68 will be included in Part 3 (group 3a and 3b) and be withdrawn from guselkumab. Study visits will be conducted every 12 weeks until week 220 (follow-up). Participants with fluctuating disease (PASI score greater than or equal to [>=] 3) at week 68 or PASI >5 (participants losing control of disease) at any visit during part 3 after week 68 will get an opportunity to enter the re-treatment-arm (group 3c) in which participants will receive three guselkumab injections of 100 mg q8w.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Guselkumab
Drug
Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68
Percentage of participants who achieved an absolute PASI <3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percent [%]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.
Week 68
Secondary Outcomes
Measure
Description
Time Frame
Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score
Time to improvement from baseline in PASI 75/90/100 response for participants with short disease duration (SDD) and longer disease duration (LDD) was reported. PASI was used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced numeric score ranging from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI responders were participants with >=75%, >=90%, 100% improvement in PASI respectively. For Part 2, data is reported only for those groups in which participants had PASI improvement post Week 28.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has a disease duration of plaque psoriasis of either less than or equal to (<=2) years or (greater than (>2) years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40 percentage (%) of participants must have a disease duration <=2 years
Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score >10 or affected body surface area (BSA) >10%) and additionally a Dermatology Life Quality Index (DLQI) score >10 at baseline (week 0)
Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination
Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
Exclusion Criteria:
Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab [MK3222], risankizumab [BI-655066])
Has received any systemic immunosuppressant (for example, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, fumaric acid esters), or anakinra within 4 weeks of the first administration of study drug.
Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline
Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug
Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug
Eyerich K, Asadullah K, Pinter A, Weisenseel P, Reich K, Paul C, Sabat R, Wolk K, Eyerich S, Lauffer F, Angsana J, Taut FJH, Kohler K, Chen Y, Sendecki J, Leung MWL, Wegner S, Personke Y, Gomez M, Kruger N, Tabori S, Schakel K. Noninferiority of 16-Week vs 8-Week Guselkumab Dosing in Super Responders for Maintaining Control of Psoriasis: The GUIDE Randomized Clinical Trial. JAMA Dermatol. 2024 Sep 1;160(9):953-963. doi: 10.1001/jamadermatol.2024.2463.
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
FG001
Periods
Title
Milestones
Reasons Not Completed
Part 1: Open-label (Week 0 to Week 8)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
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
Sep 26, 2024
Jan 5, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug: Guselkumab
Part 1: Guselkumab
Part 2: Guselkumab q8w
Part 2: Guselkumab q8w and Guselkumab q16w
Part 3: Guselkumab Withdrawal
TREMFYA
Placebo Injection
Drug
Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.
Part 2: Guselkumab q8w
Group 1: Week 0 up to Week 28; Group 2c: Week 28 up to Week 68
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
Percentage of participants with short (<=2 years) and longer (>2 years) disease duration who achieved an absolute PASI Score of 0, <=1 and less than (<) 3 was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
Group 1: Weeks 20 and 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Weeks 116, 164 and 220
Group 3a and Group 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Retain Disease Control (Absolute PASI Score < 3)
Percentage of participants who retain disease control (that is, absolute PASI score <3 from Week 68 through Week 220 for participants with short (<= 2 years) and longer (>2 years) disease duration was reported. Control of disease was defined as participants with a PASI score <3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease
From Week 68 up to Week 220
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75 responders were defined as participants with >= 75% improvement in PASI from baseline. PASI 90 responders were defined as participants with >= 90% improvement in PASI from baseline. PASI 100 responders were defined as participants with 100% improvement in PASI from baseline.
Group 1: Weeks 20, 28; Groups 2a, 2b, 2c: Week 68; Groups 3a, 3b: Weeks 116, 164 and 220
Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal
Time to loss of disease control (absolute PASI score >5) after treatment withdrawal beyond Week 68 up to Week 220 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
From Week 68 up to Week 220
Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28
Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
Weeks 12, 16, 20 and 28
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score
Change from baseline (Week 0) in DLQI score were reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b:Baseline (Week 0), Week 116, 164 and 220; Group 3c: Baseline (Re-Treatment [R] Week 0), Week R24
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
Percentage of participants who achieved a DLQI score 0/1 and <5 was reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Group 1: Week 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Week 116, 164 and 220; Group 3c: Week R24
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
Percent change from baseline in the psoriasis affected BSA (%) was reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA)
Group 1: Baseline (Week 0), Week 12, 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 52 and 68, Group 3a, 3b: Baseline (Week 0), Week 80, 104, 116, 140, 164, 188, 212 and 220
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Change from baseline in NAPPA-CLIN at Weeks 28, 68, 116 164, and 220 was reported. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement). A higher score indicated a worst involvement.
Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b: Baseline (Week 0), Week 116, 164, and 220
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68, 116, 164 and 220 was reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of >= 40 points in PSSD symptom score or sign score, and a >= 3-point change in individual PSSD item scale scores was defined as clinically meaningful change (response).
Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b: Baseline (Week 0), Week 116, 164, and 220
Groups 2a, 2b and 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score >= 1 at Week 28
Percentage of participants who achieved a PSSD sign score = 0 at Week 68 in participants with a PSSD sign score >= 1 at Week 28 was reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease.
Week 68
Groups 2a and 2b: Serum Trough Guselkumab Levels at Weeks 20, 28, 36 and 68
Serum trough guselkumab levels at Weeks 20, 28, 36 were analyzed. Serum samples were analyzed to determine trough concentrations of guselkumab using a validated specific, and sensitive method. Week 28 data are presented in Part 2 arms (Groups 2a and 2b) as these groups were established at Week 28, however pre-Week 28 trough concentrations are also reported under these groups to assess potential differences between Part 1 PK characteristics.
At Weeks 20, 28, 36, 68
Groups 2d and 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment
Percentage of participants who were re-treated due to loss of disease control (PASI >5) and regain control of disease (PASI <3) 24 weeks after start of re-treatment was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
Week R0 up to Week R24
Groups 1, 2a, 2b, 2c, 2d,3a, 3b, and 3c: Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Group 1: From Week 0 to Week 28; Group 2a,2b 2c: From Week 28 to Week 68; Group 3a, 3b: From Week 68 to Week 220; Group 2d, 3c: From Week R0 to Week R28
Groups 1, 2a, 2b, 2c, 2d, 3a,3b and 3c: Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant laboratory abnormalities was reported. Data of participants with at least one lab abnormality is reported. Abnormality criteria: Aspartate Aminotransferase (AST) >3, Alanine Aminotransferase (ALT).>5. For arm 3a and 3b, no drug was administered, hence no laboratory data was collected, per planned analysis.
Group 1: Week 20, Group 2a, 2b,2c: Week 68 and Group 2d and 3c: Week R28
Eyerich K, Weisenseel P, Pinter A, Schakel K, Asadullah K, Wegner S, Munoz-Elias EJ, Bartz H, Taut FJH, Reich K. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE). BMJ Open. 2021 Sep 13;11(9):e049822. doi: 10.1136/bmjopen-2021-049822.
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
FG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
FG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
FG004
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
Participants from Groups 2a and 2b who lost control of disease (PASI >=5) until Week 60 or were not eligible to enter withdrawal (PASI >=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8, and 16 from entering Group 2d.
FG005
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
FG006
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
FG007
Part 3 Group 3c: Re-Treatment Guselkumab 100mg
Super responders with loss of disease control at or any visit after Week 68 who entered the re-treatment (R) arm and received guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from re-treatment Week 0 until re-treatment Week 28 calculated from start of re-treatment due to loss disease control.
FG000880 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG000822 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00058 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0003 subjects
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FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG00010 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG00011 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0008 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event - Worsening of Psoriasis
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event - Other
FG00016 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-Compliance with Study Drug
FG0001 subjects
FG0010 subjects
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FG0030 subjects
FG004
Other
FG0007 subjects
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FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2: Double-blind (Week28 to Week68)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001148 subjectsOnly eligible participants from Part 1, were randomized into Part 2.
FG002150 subjectsOnly eligible participants from Part 1, were randomized into Part 2.
FG003525 subjectsAll participants not eligible for randomization from Part 1 continued in Group 2c.
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Treated
FG0000 subjects
FG001148 subjects
FG002149 subjects
FG003525 subjects
FG004
COMPLETED
FG0000 subjects
FG001137 subjects
FG002142 subjects
FG003496 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00111 subjects
FG0028 subjects
FG00329 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part3: Withdrawal (Week 68 to Week 220)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005136 subjects
FG006137 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Re-treatment (Week R0 Through Week R28)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0049 subjects
FG0050 subjects
FG0060 subjects
FG007227 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 Group 1: Guselkumab 100 mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
Denominators
Units
Counts
Participants
BG000880
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
Between 18 and 65 years
BG000817
>=65 years
BG000
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.5± 14.7
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000260
Male
BG000620
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0008
Black
Title
Measurements
BG000
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
FRANCE
Title
Measurements
BG00052
GERMANY
Title
Measurements
BG000
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
Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68
Percentage of participants who achieved an absolute PASI <3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated no involvement) to 6 (90 percent [%]-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.
For part 2, ITT analysis set included all randomized participants at week 28 or treated with at least one dose of study agent within study part 2 (study group 2c).
Posted
Number
90% Confidence Interval
Percentage of participants
Week 68
ID
Title
Description
OG000
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG001
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
Units
Counts
Participants
OG000148
OG001149
Title
Denominators
Categories
Title
Measurements
OG00092.6(88.0 to 95.8)
OG00191.9(87.3 to 95.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Wald Z-test
0.0013
Risk Difference (RD)
-0.6
2-Sided
90
-5.7
4.5
Non-Inferiority
One-sided two-group normal approximation Wald Z-test with Mantel-Haenszel stratum weights for 'disease duration' to test for non-inferiority of 100 mg q16w to 100 mg q8w with non-inferiority margin of 10%. Stratified analysis results were reported.
Secondary
Groups 1 and 2c: Time to Improvement From Baseline (Week 0) in PASI Score
Time to improvement from baseline in PASI 75/90/100 response for participants with short disease duration (SDD) and longer disease duration (LDD) was reported. PASI was used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced numeric score ranging from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI responders were participants with >=75%, >=90%, 100% improvement in PASI respectively. For Part 2, data is reported only for those groups in which participants had PASI improvement post Week 28.
ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set included all randomized participants at week 28 or treated with at least one dose of study agent within study part 2 (study group 2c).
Posted
Median
Inter-Quartile Range
Days
Group 1: Week 0 up to Week 28; Group 2c: Week 28 up to Week 68
ID
Title
Description
OG000
Part 1 Group 1: Participants With Disease Duration <= 2 Years
All participants enrolled with psoriasis of <=2 years disease duration (Short Disease Duration, SDD) received guselkumab 100 mg by SC injection at Week 0, Week 4, Week 12, and Week 20. Participants were followed from Week 0 until Week 28 or until early termination prior to Week 28.
Secondary
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 220
Percentage of participants with short (<=2 years) and longer (>2 years) disease duration who achieved an absolute PASI Score of 0, <=1 and less than (<) 3 was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set was used. Part 3, ITT set=all participants entering Part 3. N (overall number of participants analyzed)= number of participants evaluable for this outcome measure and 'n' (number analyzed)=number of participants analyzed at specified timepoints. n=0 signifies that timepoint was not applicable for that arm.
Posted
Number
Percentage of participants
Group 1: Weeks 20 and 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Weeks 116, 164 and 220
ID
Title
Description
OG000
Part 1 Group 1: Participants With Disease Duration <= 2 Years
All participants enrolled with psoriasis of <=2 years disease duration (Short Disease Duration, SDD) received guselkumab 100 mg by SC injection at Week 0, Week 4, Week 12, and Week 20. Participants were followed from Week 0 until Week 28 or until early termination prior to Week 28.
Secondary
Group 3a and Group 3b: Percentage of Participants With Short (<=2 Years) and Longer (>2 Years) Disease Duration Who Retain Disease Control (Absolute PASI Score < 3)
Percentage of participants who retain disease control (that is, absolute PASI score <3 from Week 68 through Week 220 for participants with short (<= 2 years) and longer (>2 years) disease duration was reported. Control of disease was defined as participants with a PASI score <3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease
For part 3, ITT analysis set included all participants entering study part 3 (either group 3a or 3b).
Posted
Number
95% Confidence Interval
Percentage of participants
From Week 68 up to Week 220
ID
Title
Description
OG000
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of <=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG001
Secondary
Groups 1, 2a, 2b, 2c, 3a and 3b: Percentage of Participants Who Achieved a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220
Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75 responders were defined as participants with >= 75% improvement in PASI from baseline. PASI 90 responders were defined as participants with >= 90% improvement in PASI from baseline. PASI 100 responders were defined as participants with 100% improvement in PASI from baseline.
For part 1 and 2, ITT analysis set was used. For part 3, ITT analysis set included all participants entering study part 3. n=0 signifies that specific timepoint was not applicable for that arm. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints
Posted
Number
Percentage of participants
Group 1: Weeks 20, 28; Groups 2a, 2b, 2c: Week 68; Groups 3a, 3b: Weeks 116, 164 and 220
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
Secondary
Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal
Time to loss of disease control (absolute PASI score >5) after treatment withdrawal beyond Week 68 up to Week 220 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
For part 3, ITT analysis set included all participants entering study part 3 (either group 3a or 3b).
Posted
Median
95% Confidence Interval
Days
From Week 68 up to Week 220
ID
Title
Description
OG000
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG001
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
Secondary
Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28
Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
ITT analysis set for part 1 included all participants treated with at least one dose of study agent.
Posted
Number
Percentage of participants
Weeks 12, 16, 20 and 28
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100 mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
Units
Counts
Participants
Secondary
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score
Change from baseline (Week 0) in DLQI score were reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
For part 1 and 2 ITT analysis set was used. For part 3, ITT analysis set included all participants entering study part 3. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm.
Posted
Mean
Standard Deviation
Score on scale
Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b:Baseline (Week 0), Week 116, 164 and 220; Group 3c: Baseline (Re-Treatment [R] Week 0), Week R24
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
OG001
Part 2 Group 2a: Guselkumab 100 mg Q8W
Secondary
Groups 1, 2a, 2b, 2c, 3a, 3b and 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5
Percentage of participants who achieved a DLQI score 0/1 and <5 was reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
For part 1, 2 and 3 ITT analysis set was used. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0 signifies that timepoint was not applicable for that arm.
Posted
Number
Percentage of participants
Group 1: Week 28; Groups 2a, 2b, 2c: Week 68; Groups 3a and 3b: Week 116, 164 and 220; Group 3c: Week R24
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
OG001
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
Secondary
Groups 1, 2a, 2b, 2c, 3a, and 3b: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA)
Percent change from baseline in the psoriasis affected BSA (%) was reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA)
For part 1, 2 and 3 ITT analysis set was used. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm..
Posted
Mean
Standard Deviation
Percent Change
Group 1: Baseline (Week 0), Week 12, 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 52 and 68, Group 3a, 3b: Baseline (Week 0), Week 80, 104, 116, 140, 164, 188, 212 and 220
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
OG001
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
Secondary
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220
Change from baseline in NAPPA-CLIN at Weeks 28, 68, 116 164, and 220 was reported. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement). A higher score indicated a worst involvement.
For part 1, 2 and 3 ITT analysis set was used. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm.
Posted
Mean
Standard Deviation
Score on scale
Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b: Baseline (Week 0), Week 116, 164, and 220
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
OG001
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
Secondary
Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220
Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68, 116, 164 and 220 was reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of >= 40 points in PSSD symptom score or sign score, and a >= 3-point change in individual PSSD item scale scores was defined as clinically meaningful change (response).
For part 1, 2 and 3 ITT analysis set was used. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. n=0, signifies that specified timepoint was not applicable for that arm.
Posted
Mean
Standard Deviation
Score on scale
Group 1: Baseline (Week 0), Week 28; Group 2a, 2b, 2c: Baseline (Week 0), Week 68; Group 3a and Group 3b: Baseline (Week 0), Week 116, 164, and 220
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
Secondary
Groups 2a, 2b and 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score >= 1 at Week 28
Percentage of participants who achieved a PSSD sign score = 0 at Week 68 in participants with a PSSD sign score >= 1 at Week 28 was reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease.
For part 2, ITT analysis set included all randomized participants at Week 28 or treated with at least one dose of study agent within study part 2 (study group 2c) and those who had PSSD sign score >=1 at Week 28.
Posted
Number
90% Confidence Interval
Percentage of participants
Week 68
ID
Title
Description
OG000
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG001
Secondary
Groups 2a and 2b: Serum Trough Guselkumab Levels at Weeks 20, 28, 36 and 68
Serum trough guselkumab levels at Weeks 20, 28, 36 were analyzed. Serum samples were analyzed to determine trough concentrations of guselkumab using a validated specific, and sensitive method. Week 28 data are presented in Part 2 arms (Groups 2a and 2b) as these groups were established at Week 28, however pre-Week 28 trough concentrations are also reported under these groups to assess potential differences between Part 1 PK characteristics.
For part 2, Pharmacokinetic (PK) Intent-to-treat analysis set included all randomized participants who had at least post baseline PK sample available. . Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.
Posted
Mean
Standard Deviation
micrograms/mL
At Weeks 20, 28, 36, 68
ID
Title
Description
OG000
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG001
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
Secondary
Groups 2d and 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment
Percentage of participants who were re-treated due to loss of disease control (PASI >5) and regain control of disease (PASI <3) 24 weeks after start of re-treatment was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.
Group 2d included the SRe participants who lost the disease control between Week 28 and 68, entered the re-treatment arm to receive guselkumab. Group 3c included SRe participants with fluctuating disease at Week 68 or loss of disease control at any other visit after Week 68, entered the re-treatment arm to receive guselkumab.
Posted
Number
Percentage of participants
Week R0 up to Week R24
ID
Title
Description
OG000
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
Participants from Groups 2a and 2b who lost control of disease (PASI >=5) until Week 60 or were not eligible to enter withdrawal (PASI >=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg at 0, 8, and 16weeks from entering Group 2d.
Secondary
Groups 1, 2a, 2b, 2c, 2d,3a, 3b, and 3c: Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set was used. For part 3, ITT analysis set included all participants entering study part 3. n=0, signifies that specified timepoint was not applicable for that arm. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.
Posted
Number
Percentage of participants
Group 1: From Week 0 to Week 28; Group 2a,2b 2c: From Week 28 to Week 68; Group 3a, 3b: From Week 68 to Week 220; Group 2d, 3c: From Week R0 to Week R28
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
Secondary
Groups 1, 2a, 2b, 2c, 2d, 3a,3b and 3c: Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant laboratory abnormalities was reported. Data of participants with at least one lab abnormality is reported. Abnormality criteria: Aspartate Aminotransferase (AST) >3, Alanine Aminotransferase (ALT).>5. For arm 3a and 3b, no drug was administered, hence no laboratory data was collected, per planned analysis.
ITT analysis set for part 1 included all participants treated with at least one dose of study agent. For part 2, ITT analysis set included all randomized participants at week 28 or treated with at least one dose of study agent within study part 2 (study group 2c). For part 3, ITT analysis set included all participants entering study part 3. 'n' (number analyzed)=number of participants analyzed at specified timepoints. n=0 signifies that timepoint was not applicable for that arm.
Posted
Count of Participants
Participants
Group 1: Week 20, Group 2a, 2b,2c: Week 68 and Group 2d and 3c: Week R28
ID
Title
Description
OG000
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
OG001
Part 2 Group 2a: Guselkumab 100 mg Q8W
Time Frame
Group 1: All-cause mortality: From screening (Week -4) to Week 28; serious and other AEs: Week0 to Week 28; Groups 2a,2b,2c (all-cause mortality and SAEs/other AEs): Week 28 to Week 68; Groups 3a, 3b (all-cause mortality and SAEs/other AEs): Week 68 to Week 220; Groups 2d, 3c (all-cause mortality and SAEs/other AEs): Week R0 to Week R28
Description
Same event may appear as AE and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another subject or 1 participants may have experienced both serious and non-serious event during study. Safety analysis population included all participants who were treated with at least one dose of study drug. All-cause mortality population included all randomized subject.
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
Part 1 Group 1: Guselkumab 100mg
Participants with moderate to severe plaque-type psoriasis received guselkumab 100 milligrams (mg) by subcutaneous (SC) injection at Weeks 0, 4, 12, and 20 in Part 1. Participants were followed from Week 0 through Week 28 or early termination prior to Week 28.
1
880
38
880
631
880
EG001
Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
0
148
7
148
101
148
EG002
Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
0
150
6
149
103
149
EG003
Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 till Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
1
525
33
525
367
525
EG004
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
Participants from Groups 2a and 2b who lost control of disease (PASI >=5) until Week 60 or were not eligible to enter withdrawal (PASI >=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg at 0, 8, and 16weeks from entering Group 2d.
0
9
0
9
6
9
EG005
Group 3a Guselkumab 100 mg Q8W
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg by SC injection every 8 weeks (Q8W) at Week 68. Participants were followed until Week 220.
0
136
3
136
75
136
EG006
Group 3b Guselkumab 100 mg Q16W
Super responders from Group 2b with PASI score <= 3 who were withdrawn from guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Week 68. Participants were followed until Week 220.
0
137
9
137
75
137
EG007
Group 3c Guselkumab 100 mg
Super responders with loss of disease control at or any visit after week 68 who entered the re-treatment arm and received guselkumab 100 mg by SC injection at re-treatment weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from Week 0 until Week 24 calculated from start of re-treatment due to loss disease control.
0
227
8
227
130
227
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Splenic Haematoma
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG0030 affected525 at risk
EG004
Acute Coronary Syndrome
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Arteriosclerosis Coronary Artery
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Cardiac Failure Chronic
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Colitis Ischaemic
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chest Pain
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cholecystitis Chronic
Hepatobiliary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Autoimmune Disorder
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Abscess of External Auditory Meatus
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Bacterial Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chronic Tonsillitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Erysipelas
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Infectious Mononucleosis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Peritonsillar Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Post Procedural Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Staphylococcal Bacteraemia
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Abdominal Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Bone Contusion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cartilage Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Clavicle Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ligament Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pelvic Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Traumatic Liver Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Benign Hepatic Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Colorectal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Craniopharyngioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Squamous Cell Carcinoma of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Transitional Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tumour Haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cerebellar Infarction
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nerve Compression
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pseudoradicular Syndrome
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Mental Disorder
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Suicidal Behaviour
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypersensitivity Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Decubitus Ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Extremity Necrosis
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypertensive Urgency
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG0031 affected525 at risk
EG004
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Spontaneous Haematoma
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Aortic Valve Incompetence
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Aortic Valve Sclerosis
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Aortic Valve Stenosis
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cardiac Perfusion Defect
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Cardiovascular Disorder
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Heart Valve Incompetence
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Left Ventricular Hypertrophy
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Mitral Valve Incompetence
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Supraventricular Extrasystoles
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Epidermal Naevus
Congenital, familial and genetic disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gilbert's Syndrome
Congenital, familial and genetic disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Keratosis Follicular
Congenital, familial and genetic disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Conductive Deafness
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ear Pruritus
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Excessive Cerumen Production
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Sudden Hearing Loss
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Androgen Deficiency
Endocrine disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Goitre
Endocrine disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hyperprolactinaemia
Endocrine disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blepharitis
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Borderline Glaucoma
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chalazion
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Conjunctival Irritation
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Conjunctivitis Allergic
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Dry Eye
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Eczema Eyelids
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Eye Irritation
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Eyelid Disorder
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Glaucoma
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Keratitis
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lacrimation Increased
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ocular Discomfort
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ocular Hyperaemia
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ocular Hypertension
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Optic Nerve Disorder
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Retinal Haemorrhage
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ulcerative Keratitis
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Vision Blurred
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Visual Impairment
Eye disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0013 affected148 at risk
EG0020 affected149 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Anal Fissure
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Colitis Ischaemic
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Dental Discomfort
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dental Necrosis
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00024 affected880 at risk
EG0015 affected148 at risk
EG0021 affected149 at risk
EG003
Diverticulum Intestinal
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Epigastric Discomfort
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Erosive Duodenitis
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Faeces Soft
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastric Disorder
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastrointestinal Disorder
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastrointestinal Pain
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastrointestinal Polyp Haemorrhage
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gingival Bleeding
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Gingival Cyst
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gingival Recession
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Haemorrhoids Thrombosed
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Mouth Cyst
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00014 affected880 at risk
EG0012 affected148 at risk
EG0021 affected149 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Paraesthesia Oral
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Periodontal Disease
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Poor Dental Condition
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tongue Discomfort
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0008 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Adverse Drug Reaction
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Application Site Erythema
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Asthenia
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chest Discomfort
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chest Pain
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Chills
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cyst
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Drug Ineffective
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fatigue
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00014 affected880 at risk
EG0011 affected148 at risk
EG0022 affected149 at risk
EG003
Foreign Body Reaction
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Impaired Healing
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Injection Site Erythema
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0008 affected880 at risk
EG0016 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Haematoma
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Injection Site Hypersensitivity
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Induration
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Oedema
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Pain
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Paraesthesia
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Reaction
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Scar
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Injection Site Swelling
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Localised Oedema
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pain
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Peripheral Swelling
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pyrexia
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0013 affected148 at risk
EG0021 affected149 at risk
EG003
Temperature Intolerance
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Vaccination Site Erythema
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Vaccination Site Pain
General disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Biliary Colic
Hepatobiliary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Hepatosplenomegaly
Hepatobiliary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Allergy to Arthropod Bite
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Allergy to Arthropod Sting
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Contrast Media Reaction
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Food Allergy
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Mite Allergy
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Abscess Jaw
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Abscess Limb
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Abscess Oral
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Acne Pustular
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Bacterial Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Bacterial Vaginosis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Balanitis Candida
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Body Tinea
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Borrelia Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Breast Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG00012 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Bronchitis Bacterial
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Candida Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cervicitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Chronic Sinusitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Coronavirus Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG00010 affected880 at risk
EG0014 affected148 at risk
EG0023 affected149 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0009 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Dermatitis Infected
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dermatophytosis of Nail
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Diabetic Foot Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Ear Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Eczema Infected
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Enteritis Infectious
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Epididymitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Erysipelas
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Erythema Migrans
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Folliculitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0007 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Fungal Foot Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fungal Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Furuncle
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastric Ulcer Helicobacter
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG00018 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Gastroenteritis Clostridial
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gastrointestinal Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG00012 affected880 at risk
EG0011 affected148 at risk
EG0022 affected149 at risk
EG003
Gastrointestinal Viral Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Genital Candidiasis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Genital Herpes
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Genital Infection Bacterial
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Genital Infection Fungal
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gingivitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Hantaviral Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Helicobacter Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Herpes Simplex
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Herpes Virus Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Hordeolum
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Infected Bite
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Infected Cyst
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Infected Dermal Cyst
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Infected Skin Ulcer
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Infectious Mononucleosis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Infective Glossitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0008 affected880 at risk
EG0015 affected148 at risk
EG0025 affected149 at risk
EG003
Joint Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Laryngitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Localised Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lyme Disease
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Malassezia Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Mastitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nail Bed Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Nasal Herpes
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG000214 affected880 at risk
EG00126 affected148 at risk
EG00223 affected149 at risk
EG003
Oesophageal Candidiasis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Oral Fungal Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0008 affected880 at risk
EG0012 affected148 at risk
EG0023 affected149 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Otitis Media
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Otitis Media Viral
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Paronychia
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Parotitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Pelvic Inflammatory Disease
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Periodontitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Peritonsillar Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Post Procedural Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Post-Acute Covid-19 Syndrome
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pulpitis Dental
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0011 affected148 at risk
EG0022 affected149 at risk
EG003
Pustule
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pyelitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG00013 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Root Canal Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Scarlet Fever
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0008 affected880 at risk
EG0013 affected148 at risk
EG0021 affected149 at risk
EG003
Skin Bacterial Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Candida
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Skin Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0022 affected149 at risk
EG003
Tinea Cruris
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Tinea Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tinea Manuum
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tinea Pedis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0014 affected148 at risk
EG0021 affected149 at risk
EG003
Tinea Versicolour
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG00012 affected880 at risk
EG0012 affected148 at risk
EG0023 affected149 at risk
EG003
Tonsillitis Bacterial
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG00022 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Urethritis Gonococcal
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0008 affected880 at risk
EG0011 affected148 at risk
EG0023 affected149 at risk
EG003
Urinary Tract Infection Bacterial
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Vaginal Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Viral Rash
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Viral Sinusitis
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Wound Infection
Infections and infestations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Arthropod Sting
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Bone Contusion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Burns Second Degree
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Burns Third Degree
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chemical Burn of Skin
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chillblains
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Clavicle Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0014 affected148 at risk
EG0024 affected149 at risk
EG003
Corneal Abrasion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Eye Contusion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Eye Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fibula Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Foreign Body in Eye
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fractured Coccyx
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Heat Stroke
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Human Bite
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Inappropriate Schedule of Product Administration
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG00011 affected880 at risk
EG0012 affected148 at risk
EG0024 affected149 at risk
EG003
Incision Site Erythema
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Incomplete Spinal Fusion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Joint Capsule Rupture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0011 affected148 at risk
EG0023 affected149 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Meniscus Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Muscle Rupture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Post Procedural Hypothyroidism
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Post Procedural Swelling
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Post-Traumatic Pain
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Procedural Dizziness
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0022 affected149 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tendon Injury
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tooth Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Traumatic Haematoma
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Urinary Retention Postoperative
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Vaccination Complication
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0024 affected149 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0007 affected880 at risk
EG0013 affected148 at risk
EG0022 affected149 at risk
EG003
Aortic Bruit
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Aspartate Aminotransferase Abnormal
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Basophil Count Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Bilirubin Conjugated Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Bilirubin Unconjugated Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Cholesterol Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Creatine Phosphokinase Abnormal
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG00020 affected880 at risk
EG0013 affected148 at risk
EG0026 affected149 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Glucose Decreased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Potassium Abnormal
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Potassium Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Triglycerides Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG00011 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Urea Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Uric Acid Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Body Temperature Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cardiac Murmur
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0009 affected880 at risk
EG0013 affected148 at risk
EG0021 affected149 at risk
EG003
Glycosylated Haemoglobin Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Haematocrit Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Heart Rate Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Hepatic Enzyme Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Lipase Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lipids Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Liver Function Test Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0023 affected149 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lymphocyte Morphology Abnormal
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Neutrophil Count Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Platelet Count Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Prostatic Specific Antigen Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Spermatozoa Abnormal
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Streptococcus Test Positive
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Transaminases Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tri-Iodothyronine Free Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Weight Decreased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Weight Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
White Blood Cell Count Increased
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
White Blood Cell Morphology Abnormal
Investigations
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fat Intolerance
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypovitaminosis
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Selenium Deficiency
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Vitamin B12 Deficiency
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Weight Fluctuation
Metabolism and nutrition disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00041 affected880 at risk
EG0014 affected148 at risk
EG0025 affected149 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00026 affected880 at risk
EG0016 affected148 at risk
EG0028 affected149 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Chondropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dactylitis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Enthesopathy
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Extremity Contracture
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0013 affected148 at risk
EG0020 affected149 at risk
EG003
Jaw Disorder
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Joint Stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Limb Discomfort
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Metatarsalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Muscle Tightness
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Musculoskeletal Discomfort
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nodal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0009 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0010 affected148 at risk
EG0023 affected149 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Plantar Fasciitis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Polymyalgia Rheumatica
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pseudarthrosis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Sacral Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tendon Disorder
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Trigger Finger
Musculoskeletal and connective tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Acanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Anogenital Warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Benign Hepatic Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Benign Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Benign Neoplasm of Adrenal Gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Benign Neoplasm of Eyelid
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dysplastic Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fibroadenoma of Breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0022 affected149 at risk
EG003
Fibrous Histiocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Melanocytic Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0012 affected148 at risk
EG0021 affected149 at risk
EG003
Osteoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Seborrhoeic Keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0023 affected149 at risk
EG003
Squamous Cell Carcinoma of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Transitional Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ageusia
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Anosmia
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cerebellar Stroke
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cervicobrachial Syndrome
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cognitive Disorder
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Cubital Tunnel Syndrome
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Disturbance in Attention
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Dizziness Postural
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Facial Paralysis
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Gliosis
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Head Discomfort
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00079 affected880 at risk
EG0018 affected148 at risk
EG0029 affected149 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Loss of Consciousness
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0012 affected148 at risk
EG0022 affected149 at risk
EG003
Migraine with Aura
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nerve Compression
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Neuritis
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Neuropathy Vitamin B6 Deficiency
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Orthostatic Intolerance
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Peripheral Nerve Lesion
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Post Herpetic Neuralgia
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Precerebral Arteriosclerosis
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pseudoradicular Syndrome
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Restless Legs Syndrome
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Sensory Disturbance
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Tension Headache
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Thoracic Outlet Syndrome
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Thoracic Radiculopathy
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0022 affected149 at risk
EG003
Device Physical Property Issue
Product Issues
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Attention Deficit Hyperactivity Disorder
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Burnout Syndrome
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Depressive Symptom
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Panic Attack
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Personality Disorder
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Post-Traumatic Stress Disorder
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Sleep Disorder
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Sleep Disorder Due to A General Medical Condition
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Stress
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Suicidal Behaviour
Psychiatric disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Urethral Stenosis
Renal and urinary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Haemorrhagic Ovarian Cyst
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Heavy Menstrual Bleeding
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Menopausal Symptoms
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Menstruation Irregular
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Polycystic Ovaries
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pruritus Genital
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Testicular Torsion
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Vulvovaginal Dryness
Reproductive system and breast disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Allergic Respiratory Symptom
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Allergic Sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0012 affected148 at risk
EG0020 affected149 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00011 affected880 at risk
EG0014 affected148 at risk
EG0022 affected149 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypersensitivity Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Increased Upper Airway Secretion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Larynx Irritation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nasal Discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nasal Pruritus
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nasal Septum Deviation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00012 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Painful Respiration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Sleep Apnoea Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Throat Irritation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Tonsillar Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Upper Airway Obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Actinic Keratosis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Chloasma
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dermal Cyst
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Dermatitis Psoriasiform
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Drug Eruption
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0012 affected148 at risk
EG0021 affected149 at risk
EG003
Dyshidrotic Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0008 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Eczema Asteatotic
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Eczema Nummular
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Erythema Nodosum
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Erythrodermic Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00011 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Koebner Phenomenon
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nail Dystrophy
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nail Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0004 affected880 at risk
EG0010 affected148 at risk
EG0023 affected149 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Perioral Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Pityriasis Rosea
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Polymorphic Light Eruption
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Prurigo
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0009 affected880 at risk
EG0012 affected148 at risk
EG0023 affected149 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00017 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Seborrhoeic Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0006 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Skin Burning Sensation
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Disorder
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Fissures
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Fragility
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Induration
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Maceration
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Mass
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Texture Abnormal
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Solar Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0021 affected149 at risk
EG003
Stasis Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Toxic Skin Eruption
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0005 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Urticaria Contact
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Urticaria Physical
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0020 affected149 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Stress at Work
Social circumstances
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Blood Pressure Fluctuation
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Extremity Necrosis
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Flushing
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Haematoma
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0002 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hot Flush
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0003 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG00048 affected880 at risk
EG0014 affected148 at risk
EG0025 affected149 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0011 affected148 at risk
EG0021 affected149 at risk
EG003
Hypertensive Urgency
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Peripheral Arterial Occlusive Disease
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Peripheral Venous Disease
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Thrombosis
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Varicose Vein
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
White Coat Hypertension
Vascular disorders
MedDRA Version 27.1
Non-systematic Assessment
EG0001 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Nail psoriasis
Nervous system disorders
MedDRA27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Headache
Nervous system disorders
MedDRA27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA27.1
Non-systematic Assessment
EG0000 affected880 at risk
EG0010 affected148 at risk
EG0020 affected149 at risk
EG003
There was an interruption of enrollment due to Corona Pandemic.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Participants Started Retreatment Phase Within Study Part 2 before Week 68
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Other
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0057 subjects
FG0066 subjects
FG0070 subjects
0 subjects
FG005129 subjects
FG006131 subjects
FG0070 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0065 subjects
FG0070 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0059 subjects
FG0063 subjects
FG0070 subjects
Other Adverse Events
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Non-compliance with study drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
Not Signed ICF
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0055 subjects
FG0064 subjects
FG0070 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Retreatment started
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005112 subjects
FG006115 subjects
FG0070 subjects
9 subjects
SRe participants with loss of disease control from Groups 2a and 2b, entered retreatment group 2d. Includes participants who were re-treated at Week 68.
FG0050 subjects
FG0060 subjects
FG007219 subjectsIncludes participants who were re-treated after Week 68.
0 subjects
FG0050 subjects
FG0060 subjects
FG0078 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Other Adverse Events
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
63
1
White
Title
Measurements
BG000859
More than one race
Title
Measurements
BG0002
Unknown or Not Reported
Title
Measurements
BG0003
Other
Title
Measurements
BG0007
828
OG001
Part 1 Group 1: Participants With Disease Duration > 2 Years
All participants enrolled with psoriasis of >2 years disease duration (Longer Disease Duration, LDD) received guselkumab 100 mg by SC injection at Week 0, Week 4, Week 12, and Week 20. Participants were followed from Week 0 until Week 28 or until early termination prior to Week 28.
OG002
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score > 0 at Week 20 and/or Week 28) with psoriasis of <=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Participants With Duration > 2 Years
Non Super responders (PASI score > 0 at Week 20 and/or Week 28) with psoriasis of >2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
Units
Counts
Participants
OG000357
OG001523
OG002178
OG003347
Title
Denominators
Categories
PASI 75
Title
Measurements
OG00084.0(81.0 to 89.0)
OG00184.0(81.0 to 90.0)
OG00284.0(83.0 to 112.0)
OG00384.0(83.0 to 105.0)
PASI 90
Title
Measurements
OG00089.0(84.0 to 134.0)
OG001106.0(84.0 to 140.0)
OG002112.0(84.0 to 153.0)
OG003
PASI 100
Title
Measurements
OG000141.0(105.0 to 210.0)
OG001200.0(113.0 to NA)NA signifies that upper limit of Inter-quartile range was not estimable due to insufficient number of participants with events.
OG002308.0(196.0 to 483.0)
OG003
OG001
Part 1 Group 1: Participants With Disease Duration > 2 Years
All participants enrolled with psoriasis of >2 years disease duration (Longer Disease Duration, LDD) received guselkumab 100 mg by SC injection at Week 0, Week 4, Week 12, and Week 20. Participants were followed from Week 0 until Week 28 or until early termination prior to Week 28.
OG002
Part 2 Group 2a: Participants With Disease Duration <= 2 Years
Super responders (PASI score = 0 at Week 20 and Week 28) with psoriasis of <=2 years disease duration (SDD) who completed study Part 1, randomized to guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2a: Participants With Disease Duration > 2 Years
Super responders (PASI score = 0 at Week 20 and Week 28) with psoriasis of >2 years disease duration (LDD) who completed study Part 1, randomized to guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 2 Group 2b: Participants With Disease Duration <= 2 Years
Super responders (PASI score = 0 at Week 20 and Week 28) with psoriasis of <=2 years disease duration (SDD) who completed study part 1, randomized to guselkumab 100 mg by SC injection every 16 weeks received at Week 36 and Week 52, received placebo at Week 28, Week 44 and Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG005
Part 2 Group 2b: Participants With Disease Duration > 2 Years
Super responders (PASI score = 0 at Week 20 and Week 28) with psoriasis of >2 years disease duration (LDD) who completed study part 1, randomized to guselkumab 100 mg by SC injection every 16 weeks received at Week 36 and Week 52, received placebo at Week 28, Week 44 and Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG006
Part 2 Group 2c: Participants With Disease Duration <= 2 Years
Non Super responders (PASI score > 0 at Week 20 and/or Week 28) with psoriasis of <=2 years disease duration (SDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG007
Part 2 Group 2c: Participants With Disease Duration > 2 Years
Non-Super responders (PASI score > 0 at Week 20 and/or Week 28) with psoriasis of >2 years disease duration (LDD) who completed study part 1, received guselkumab 100 mg by SC injection every 8 weeks starting at Week 28 until Week 60. Participants followed from Week 28 until Week 68 or early termination prior to Week 68.
OG008
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of <=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG009
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of >2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG010
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of <=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG011
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of >2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
Units
Counts
Participants
OG000357
OG001523
OG00275
OG00373
OG00476
OG00573
OG006178
OG007347
OG00867
OG00969
OG01071
OG01166
Title
Denominators
Categories
PASI = 0 (Week 20)
ParticipantsOG000357
ParticipantsOG001523
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00049.3
OG00132.7
PASI <=1 (Week 20)
ParticipantsOG000357
ParticipantsOG001523
ParticipantsOG0020
ParticipantsOG0030
PASI <3 (Week 20)
ParticipantsOG000357
ParticipantsOG001523
ParticipantsOG0020
ParticipantsOG0030
PASI = 0 ( Week 28)
ParticipantsOG000357
ParticipantsOG001523
ParticipantsOG0020
ParticipantsOG0030
PASI <=1 (Week 28)
ParticipantsOG000357
ParticipantsOG001523
ParticipantsOG0020
ParticipantsOG0030
PASI <3 (Week 28)
ParticipantsOG000357
ParticipantsOG001523
ParticipantsOG0020
ParticipantsOG0030
PASI = 0 (Week 68)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00275
ParticipantsOG00373
PASI <=1 (Week 68)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00275
ParticipantsOG00373
PASI <3 (Week 68)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00275
ParticipantsOG00373
PASI = 0 (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI <=1 (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI <3 (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI = 0 (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI <=1 (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI <3 (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI = 0 (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI <=1 (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI <3 (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of >2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG002
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of <=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG003
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of >2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
Units
Counts
Participants
OG00067
OG00169
OG00271
OG00366
Title
Denominators
Categories
Title
Measurements
OG0007.5(2.5 to 16.6)
OG0010.0(0.0 to 5.2)
OG0022.8(0.3 to 9.8)
OG0031.5(0.0 to 8.2)
OG001
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG005
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
Units
Counts
Participants
OG000880
OG001148
OG002149
OG003525
OG004136
OG005137
Title
Denominators
Categories
PASI 75 (Week 20)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00090.2
PASI 75 (Week 28)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 90 (Week 20)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 90 (Week 28)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 100 (Week 20)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 100 (Week 28)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 75 (Week 68)
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
PASI 90 (Week 68)
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
PASI 100 (Week 68)
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
PASI 75 (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 75 (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 75 (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 90 (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 90 (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 90 (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 100 (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 100 (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
PASI 100 (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Units
Counts
Participants
OG000136
OG001137
Title
Denominators
Categories
Title
Measurements
OG000245(203 to 286)
OG001189(166 to 251)
OG000880
Title
Denominators
Categories
Week 12
Title
Measurements
OG00017.8
Week 16
Title
Measurements
OG00029.0
Week 20
Title
Measurements
OG00039.4
Week 28
Title
Measurements
OG00044.4
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG005
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG006
Part 3 Group 3c: Re-Treatment Guselkumab 100mg
Super responders with loss of disease control at or any visit after Week 68 who entered the re-treatment (R) arm and received guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from re-treatment Week 0 until re-treatment Week 28 calculated from start of re-treatment due to loss disease control.
Units
Counts
Participants
OG000880
OG001148
OG002149
OG003525
OG004136
OG005137
OG006227
Title
Denominators
Categories
Week 28
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000-16.6± 6.2
Week 68
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
Week 116
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 164
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Week 220
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Re-Treatment till R24 weeks
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG005
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG006
Part 3 Group 3a: Participants With Disease Duration <=2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of <=2 years disease duration (SDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG007
Part 3 Group 3a: Participants With Disease Duration> 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of >2 years disease duration (LDD) from Group 2a who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG008
Part 3 Group 3b: Participants With Disease Duration <= 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of <=2 years disease duration (SDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG009
Part 3 Group 3b: Participants With Disease Duration > 2 Years
Super responders (PASI score < 3 at Week 68) with psoriasis of >2 years disease duration (LDD) from Group 2b who were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG010
Part 3 Group 3c: Re-Treatment Guselkumab 100mg
Super responders with loss of disease control at or any visit after Week 68 who entered the re-treatment (R) arm and received guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from re-treatment Week 0 until re-treatment Week 28 calculated from start of re-treatment due to loss disease control.
Units
Counts
Participants
OG000880
OG001148
OG002149
OG003525
OG004136
OG005137
OG00667
OG00769
OG00871
OG00966
OG010227
Title
Denominators
Categories
DLQI Score 0/1 (Week 28)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00060.9
DLQI Score<5 (Week 28)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DLQI Score 0/1 (Week 68)
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
DLQI Score<5 (Week 68)
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
DLQI Score 0/1 (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DLQI Score <5 (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DLQI Score 0/1 (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DLQI Score <5 (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DLQI Score 0/1 (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DLQI Score <5 (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DLQI Score 0/1 RT24
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DLQI Score <5 RT24
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG005
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
Units
Counts
Participants
OG000861
OG001141
OG002142
OG003492
OG004126
OG005107
Title
Denominators
Categories
At Week 12
ParticipantsOG000839
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000-19.3± 14.2
At Week 28
ParticipantsOG000861
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 52
ParticipantsOG0000
ParticipantsOG001141
ParticipantsOG002142
ParticipantsOG003492
At Week 68
ParticipantsOG0000
ParticipantsOG001136
ParticipantsOG002137
ParticipantsOG003492
At Week 80
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 104
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 116
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 140
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 164
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 188
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 212
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 220
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG005
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
Units
Counts
Participants
OG000406
OG00159
OG00260
OG003276
OG00410
OG00511
Title
Denominators
Categories
Hands (Week 28)
ParticipantsOG000406
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000-3.4± 3.2
Feet (Week 28)
ParticipantsOG000352
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Hands (Week 68)
ParticipantsOG0000
ParticipantsOG00159
ParticipantsOG00260
ParticipantsOG003276
Feet (Week 68)
ParticipantsOG0000
ParticipantsOG00146
ParticipantsOG00248
ParticipantsOG003250
Hands (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Feet (Week 116)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Hands (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Feet (Week 164)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Hands (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Feet (Week 220)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG005
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
Units
Counts
Participants
OG000863
OG001138
OG002140
OG003492
OG00441
OG00531
Title
Denominators
Categories
At Week 28 (Symptom)
ParticipantsOG000863
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000-57.2± 25.4
At Week 28 (Sign)
ParticipantsOG000863
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 68 (Symptom)
ParticipantsOG0000
ParticipantsOG001138
ParticipantsOG002140
ParticipantsOG003492
At Week 68 (Sign)
ParticipantsOG0000
ParticipantsOG001138
ParticipantsOG002140
ParticipantsOG003492
At Week 116 (Symptom)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 116 (Sign)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 164 (Symptom)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 164 (Sign)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 220 (Symptom)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
At Week 220 (Sign)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG002
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
Units
Counts
Participants
OG00086
OG00192
OG002453
Title
Denominators
Categories
Title
Measurements
OG00030.2(22.1 to 39.4)
OG00121.7(14.9 to 30.0)
OG00214.8(12.1 to 17.8)
Units
Counts
Participants
OG000147
OG001145
Title
Denominators
Categories
At Week 20
ParticipantsOG000147
ParticipantsOG001145
Title
Measurements
OG0001.61± 0.989
OG0011.60± 1.049
At Week 28
ParticipantsOG000144
ParticipantsOG001144
Title
Measurements
OG0001.58± 1.010
OG001
At Week 36
ParticipantsOG000143
ParticipantsOG001139
Title
Measurements
OG0001.68± 1.062
OG001
At Week 68
ParticipantsOG000133
ParticipantsOG001131
Title
Measurements
OG0001.56± 0.960
OG001
OG001
Part 3 Group 3c: Re-Treatment Guselkumab 100mg
Super responders with loss of disease control at or any visit after Week 68 who entered the re-treatment (R) arm and received guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from re-treatment Week 0 until re-treatment Week 28 calculated from start of re-treatment due to loss disease control.
Units
Counts
Participants
OG0009
OG001227
Title
Denominators
Categories
Title
Measurements
OG00088.8(29.2 to 100.0)
OG00198.2(95.5 to 99.5)
OG001
Part 2 Group 2a: Guselkumab 100 mg Q8W
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
Participants from Groups 2a and 2b who lost control of disease (PASI >=5) until Week 60 or were not eligible to enter withdrawal (PASI >=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg at 0, 8, and 16weeks from entering Group 2d.
OG005
Part 3 Group 3a: Withdrawal (Q8W)
Super responders from Group 2a with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG006
Part 3 Group 3b: Withdrawal (Q16W)
Super responders from Group 2b with PASI score <= 3 were withdrawn from guselkumab 100 mg at Week 68. Participants were followed until Week 220.
OG007
Part 3 Group 3c: Re-Treatment Guselkumab 100mg
Super responders with loss of disease control at or any visit after Week 68 who entered the re-treatment (R) arm and received guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from re-treatment Week 0 until re-treatment Week 28 calculated from start of re-treatment due to loss disease control.
Units
Counts
Participants
OG000880
OG001148
OG002149
OG003525
OG0049
OG005136
OG006137
OG007236
Title
Denominators
Categories
From Week 0 to Week 28
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00074.8
From Week 28 to Week 68
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
Week 68 to Week 220
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
From Week R0 to Week R28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Super responders (SRe) (Psoriasis Area and Severity Index [PASI] score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 8 weeks (Q8W) starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG002
Part 2 Group 2b: Guselkumab 100 mg Q16W
Super responders (PASI score = 0 at Week 20 and Week 28) who completed study Part 1, were randomized to receive guselkumab 100 mg by SC injection every 16 weeks (Q16W) at Weeks 36 and 52. To maintain the study blind, participants were administered placebo by SC injection at Weeks 28, 44 and 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG003
Part 2 Group 2c: Guselkumab 100 mg Q8W
Non-super responders (PASI score greater than [>] 0 at Week 20 and/or Week 28) who completed study Part 1 continued to receive guselkumab 100 mg by SC injection Q8W starting at Week 28 until Week 60. Participants were followed from Week 28 until Week 68 or early termination prior to Week 68.
OG004
Part 2 Group 2d: Re-Treatment Guselkumab 100mg
Participants from Groups 2a and 2b who lost control of disease (PASI >=5) until Week 60 or were not eligible to enter withdrawal (PASI >=3) at Week 68 were re-treated as Group 2d, receiving guselkumab 100 mg at 0, 8, and 16weeks from entering Group 2d.
OG005
Part 3 Group 3c: Re-Treatment Guselkumab 100mg
Super responders with loss of disease control at or any visit after Week 68 who entered the re-treatment (R) arm and received guselkumab 100 mg by SC injection at re-treatment Weeks 0, 8 and 16 calculated from the date of loss of disease control. Participants were followed from re-treatment Week 0 until re-treatment Week 28 calculated from start of re-treatment due to loss disease control.
Units
Counts
Participants
OG000880
OG001148
OG002149
OG003525
OG0049
OG005227
Title
Denominators
Categories
AST > 3 (Week 20)
ParticipantsOG000880
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0002
ALT > 5 (Week 20)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
AST > 3 (Week 68)
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
ALT > 5 (Week 68)
ParticipantsOG0000
ParticipantsOG001148
ParticipantsOG002149
ParticipantsOG003525
AST > 3 (Week R28)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ALT > 5 (Week R28)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
0 affected
9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0071 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0071 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0061 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
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EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0061 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
10 affected
525 at risk
EG0040 affected9 at risk
EG0054 affected136 at risk
EG0061 affected137 at risk
EG0074 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0071 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
5 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0061 affected137 at risk
EG0072 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0072 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
3 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0061 affected137 at risk
EG0070 affected227 at risk
3 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0071 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
2 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0061 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
11 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0071 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
3 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0071 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0061 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0061 affected137 at risk
EG0071 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
5 affected
525 at risk
EG0040 affected9 at risk
EG0053 affected136 at risk
EG0060 affected137 at risk
EG0074 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0061 affected137 at risk
EG0070 affected227 at risk
5 affected
525 at risk
EG0040 affected9 at risk
EG0055 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
8 affected
525 at risk
EG0040 affected9 at risk
EG00510 affected136 at risk
EG00612 affected137 at risk
EG0077 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0061 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
7 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0061 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0051 affected136 at risk
EG0061 affected137 at risk
EG0071 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
31 affected
525 at risk
EG0040 affected9 at risk
EG0053 affected136 at risk
EG0063 affected137 at risk
EG0077 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
1 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0040 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0042 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0041 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
0 affected
525 at risk
EG0041 affected9 at risk
EG0050 affected136 at risk
EG0060 affected137 at risk
EG0070 affected227 at risk
114.0
(84.0 to 196.0)
416.0
(198 to NA)
NA signifies that lower limit of Inter-quartile range was not estimable due to insufficient number of participants with events.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00067.8
OG00154.3
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00085.2
OG00182.4
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00051.8
OG00139.4
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00070.3
OG00159.5
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00086.8
OG00183.9
ParticipantsOG00476
ParticipantsOG00573
ParticipantsOG006178
ParticipantsOG007347
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00281.3
OG00380.8
OG00473.7
OG00564.4
OG00639.9
OG00737.2
ParticipantsOG00476
ParticipantsOG00573
ParticipantsOG006178
ParticipantsOG007347
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00286.7
OG00393.2
OG00481.6
OG00576.7
OG00673.6
OG00755.9
ParticipantsOG00476
ParticipantsOG00573
ParticipantsOG006178
ParticipantsOG007347
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG00290.7
OG00394.5
OG00493.4
OG00590.4
OG00688.8
OG00779.8
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG00814.9
OG0094.3
OG01012.7
OG0111.5
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG00825.4
OG0095.8
OG01018.3
OG0113.0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG00834.3
OG00911.6
OG01026.8
OG01110.6
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG00810.4
OG0091.4
OG0105.6
OG0110.0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG00813.4
OG0091.4
OG0107.0
OG0110.0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG00814.9
OG0092.9
OG01012.7
OG0113.0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG0089.0
OG0090
OG0105.6
OG0110
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG0089.0
OG0090
OG0105.6
OG0110
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00867
ParticipantsOG00969
ParticipantsOG01071
ParticipantsOG01166
Title
Measurements
OG00810.4
OG0090
OG0107.0
OG0111.5
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00090.7
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00073.6
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00076.0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00039.4
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00044.4
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00192.6
OG00294.0
OG00388.0
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00191.9
OG00285.9
OG00373.7
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00181.1
OG00269.1
OG00338.1
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG00427.9
OG00520.4
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG00410.3
OG0058.0
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG0045.1
OG0054.4
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG00418.4
OG00513.1
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG0047.4
OG0055.8
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG0045.1
OG0052.9
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG0049.6
OG0057.3
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG0045.9
OG0052.9
ParticipantsOG004136
ParticipantsOG005137
Title
Measurements
OG0044.4
OG0052.9
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG001-18.8± 5.6
OG002-17.0± 5.5
OG003-17.1± 5.8
Participants
OG004
136
ParticipantsOG005137
ParticipantsOG0060
Title
Measurements
OG004-16.5± 6.3
OG005-15.5± 6.4
Participants
OG004
136
ParticipantsOG005137
ParticipantsOG0060
Title
Measurements
OG004-18.1± 6.7
OG005-17.4± 7.8
Participants
OG004
136
ParticipantsOG005137
ParticipantsOG0060
Title
Measurements
OG004-20.9± 6.0
OG005-16.3± 6.5
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG006227
Title
Measurements
OG006-10.1± 6.8
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00078.4
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00183.1
OG00277.9
OG00361.9
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00189.2
OG00285.2
OG00378.9
ParticipantsOG004136
ParticipantsOG005137
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00415.4
OG00510.9
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00667
ParticipantsOG00769
ParticipantsOG00871
ParticipantsOG00966
ParticipantsOG0100
Title
Measurements
OG00634.3
OG00715.9
OG00826.8
OG0097.6
ParticipantsOG004136
ParticipantsOG005137
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0048.1
OG0055.8
ParticipantsOG004136
ParticipantsOG005137
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0048.1
OG0058.0
ParticipantsOG004136
ParticipantsOG005137
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0044.4
OG0052.9
ParticipantsOG004136
ParticipantsOG005137
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0045.1
OG0054.4
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG010227
Title
Measurements
OG01073.1
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG010227
Title
Measurements
OG01087.7
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000-23.8± 15.0
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG001-25.1± 15.1
OG002-24.3± 15.6
OG003-24.8± 14.6
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG001-24.8± 14.9
OG002-24.3± 15.8
OG003-25.0± 14.6
Participants
OG004
126
ParticipantsOG005107
Title
Measurements
OG004-23.8± 14.1
OG005-23.6± 15.6
Participants
OG004
54
ParticipantsOG00545
Title
Measurements
OG004-20.6± 15.1
OG005-22.5± 16.8
Participants
OG004
42
ParticipantsOG00531
Title
Measurements
OG004-22.4± 16.8
OG005-19.8± 13.0
Participants
OG004
18
ParticipantsOG00514
Title
Measurements
OG004-16.7± 8.5
OG005-19.6± 11.2
Participants
OG004
14
ParticipantsOG00512
Title
Measurements
OG004-18.2± 8.7
OG005-20.6± 11.2
Participants
OG004
11
ParticipantsOG0057
Title
Measurements
OG004-18.1± 8.2
OG005-20.4± 13.0
Participants
OG004
7
ParticipantsOG0056
Title
Measurements
OG004-18.3± 9.6
OG005-19.3± 13.9
Participants
OG004
7
ParticipantsOG0056
Title
Measurements
OG004-18.3± 9.6
OG00519.0± 13.6
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG000-3.1± 3.5
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001-4.0± 3.2
OG002-4.5± 3.5
OG003-4.0± 3.2
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG001-4.9± 3.5
OG002-4.6± 3.7
OG003-4.1± 3.6
Participants
OG004
10
ParticipantsOG00511
Title
Measurements
OG004-2.2± 4.3
OG005-2.2± 3.2
Participants
OG004
8
ParticipantsOG00510
Title
Measurements
OG004-3.4± 6.2
OG005-3.5± 3.9
Participants
OG004
2
ParticipantsOG0054
Title
Measurements
OG004-4.5± 3.5
OG005-3.0± 2.4
Participants
OG004
1
ParticipantsOG0055
Title
Measurements
OG004-8.0± NA'NA' signifies that SD could could not be calculated for a single participant.
OG005-3.6± 3.1
Participants
OG004
3
ParticipantsOG0053
Title
Measurements
OG004-4.3± 2.5
OG005-3.7± 2.5
Participants
OG004
1
ParticipantsOG0054
Title
Measurements
OG004-8.0± NA'NA' signifies that SD could could not be calculated for a single participant.