BENLYSTA® Special Drug Use Investigation | NCT03370263 | Trialant
NCT03370263
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
May 18, 2026Actual
Enrollment
1,514Actual
Phase
Not provided
Conditions
Systemic Lupus Erythematosus
Interventions
Benlysta
Countries
Japan
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03370263
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
207735
Secondary IDs
Not provided
Brief Title
BENLYSTA® Special Drug Use Investigation
Official Title
BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 15, 2018Actual
Primary Completion Date
Jul 31, 2025Actual
Completion Date
Jul 31, 2025Actual
First Submitted Date
Dec 6, 2017
First Submission Date that Met QC Criteria
Dec 6, 2017
First Posted Date
Dec 12, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 30, 2026
Results First Submitted that Met QC Criteria
Apr 24, 2026
Results First Posted Date
May 18, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 24, 2026
Last Update Posted Date
May 18, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta") in daily clinical practice. The aim of conducting this drug use investigation (DUI) in all subjects until data are accumulated from a certain number of subjects after Benlysta being marketed, data will be collected on safety and effectiveness of Benlysta in an early stage and thereby to take the necessary measures for proper use of Benlysta. Approximately 600 subjects will be enrolled in to this study. The observation period per subject will be 52 weeks from the start of Benlysta administration. BENLYSTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
Drug: Benlysta
Benlysta subcutaneous (SC)
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
Drug: Benlysta
Benlysta switched from IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV during the study.
Drug: Benlysta
Benlysta IV or SC (Initial route of administration unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Drug: Benlysta
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Benlysta
Drug
Benlysta was administered
Benlysta IV or SC (Initial route of administration unknown)
Benlysta intravenous (IV)
Benlysta subcutaneous (SC)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Drug Reactions (ADRs)
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
From the start of the study intervention (Day 1) up to maximum of 3 years
Number of Participants With Serious ADR of Events Defined as a Priority Study Matter
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Following serious ADRs were considered as priority study matter: 1. Serious hypersensitivity, 2. Serious infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, and opportunistic infection), 3. Reactivation of hepatitis B virus, 4. Progressive multifocal leukoencephalopathy, 5. Interstitial pneumonitis, 6. Malignant tumor, 7. Depression and events related to suicide/self-injury.
From the start of the study intervention (Day 1) up to maximum of 3 years
Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The study will include all subjects to whom Benlysta is administered. In addition, among subjects who start administration after launch, those to whom Benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well.
Exclusion Criteria:
N/A
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
The study will include all subjects to whom Benlysta is administered. In addition, among subjects who start administration after launch, those to whom Benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well.
Sampling Method
Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Hiroshima
730-0001
Japan
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
A total of 1514 participants were enrolled in the study.
Recruitment Details
This Special Drug Use Investigation was conducted under routine clinical practice in Japan as a non-interventional/observational study. No treatment arms were assigned by protocol; route of administration (intravenous [IV] or subcutaneous [SC]) was determined by treating physicians in real world care. Protocol confirms observational conduct in actual use conditions and does not define any randomized or assigned arms.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
FG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
FG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
FG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000543 subjects
FG001661 subjects
FG002308 subjects
FG0032 subjects
COMPLETED
FG000361 subjects
FG001462 subjects
FG002270 subjects
FG0031 subjects
NOT COMPLETED
FG000182 subjects
FG001199 subjects
FG00238 subjects
FG0031 subjects
Type
Comment
Reasons
Adverse Event
FG00051 subjects
FG00155 subjects
FG00211 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
BG001
Benlysta SC
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Adverse Drug Reactions (ADRs)
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
Safety Analysis Population included participants with locked case report forms (CRFs) and who do not correspond to criteria for exclusion from safety analysis set.
Posted
Count of Participants
Participants
From the start of the study intervention (Day 1) up to maximum of 3 years
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Adverse Events Module
Frequency Threshold
0
Time Frame
All-cause mortality, non-serious adverse events (SAEs) and SAEs were collected from the start of the study intervention (Day 1) up to maximum of 3 years
Description
All-cause mortality, non-SAEs and SAEs were collected for Safety Analysis Population (N=1514) included participants with locked CRFs and who do not correspond to criteria for exclusion from safety analysis set.
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
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Herpes zoster
Infections and infestations
MedDRA v27.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
More Info Module
Limitations and Caveats
Data have not been disclosed for the Lupus Impact Tracker (LIT) score outcome measures because the data cannot be reported externally at this time due to pending validation and copyright authorization by the copyright holder, although LIT assessments were collected at Baseline and Weeks 24 and 52. The data for pre-specified LIT outcome measures are anticipated to be disclosed by November 2027.
Change From Baseline in SELENA SLEDAI Score at Week 52
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Change From Baseline in Lupus Impact Tracker Score at Week 24
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Baseline (Day 0) and Week 24
Change From Baseline in Lupus Impact Tracker Score at Week 52
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Baseline (Day 0) and Week 52
Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in PGA Score at Week 52
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Percent Change From Baseline in Mean Daily Steroid Dose at Week 4
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 4
Percent Change From Baseline in Mean Daily Steroid Dose at Week 8
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 8
Percent Change From Baseline in Mean Daily Steroid Dose at Week 12
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 12
Percent Change From Baseline in Mean Daily Steroid Dose at Week 16
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 16
Percent Change From Baseline in Mean Daily Steroid Dose at Week 20
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 20
Percent Change From Baseline in Mean Daily Steroid Dose at Week 24
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 24
Percent Change From Baseline in Mean Daily Steroid Dose at Week 28
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 28
Percent Change From Baseline in Mean Daily Steroid Dose at Week 32
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 32
Percent Change From Baseline in Mean Daily Steroid Dose at Week 36
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 36
Percent Change From Baseline in Mean Daily Steroid Dose at Week 40
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 40
Percent Change From Baseline in Mean Daily Steroid Dose at Week 44
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 44
Percent Change From Baseline in Mean Daily Steroid Dose at Week 48
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 48
Percent Change From Baseline in Mean Daily Steroid Dose at Week 52
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 52
Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
At Week 24
Number of Participants Who Achieved LLDAS Response Criteria at Week 52
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
At Week 52
Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 24
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 52
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Change From Baseline in Urine Protein/Creatinine Ratio at Week 24
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in Urine Protein/Creatinine Ratio at Week 52
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
0 subjects
Withdrawal by Subject
FG00033 subjects
FG00139 subjects
FG0028 subjects
FG0030 subjects
Pregnancy
FG0005 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
Physician Decision
FG00016 subjects
FG00111 subjects
FG0024 subjects
FG0030 subjects
Lost to Follow-up
FG0009 subjects
FG00113 subjects
FG0023 subjects
FG0030 subjects
Lack of Efficacy
FG00067 subjects
FG00147 subjects
FG00210 subjects
FG0030 subjects
Death
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Other
FG0000 subjects
FG00129 subjects
FG0022 subjects
FG0031 subjects
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
BG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
BG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
BG004
Total
Total of all reporting groups
543
BG001661
BG002308
BG0032
BG0041514
Participants
Title
Denominators
Categories
ParticipantsBG000543
ParticipantsBG001661
ParticipantsBG002308
ParticipantsBG0032
ParticipantsBG0041514
Title
Measurements
13 to 85 years
BG000543
BG001661
BG002308
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000543
ParticipantsBG001661
ParticipantsBG002308
ParticipantsBG0032
ParticipantsBG0041514
Title
Measurements
Female
BG000470
BG001597
BG002287
BG003
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
Title
Measurements
BG0040
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000543
OG001661
OG002308
OG0032
Title
Denominators
Categories
Title
Measurements
OG000107
OG001110
OG00247
OG0030
Primary
Number of Participants With Serious ADR of Events Defined as a Priority Study Matter
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Following serious ADRs were considered as priority study matter: 1. Serious hypersensitivity, 2. Serious infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, and opportunistic infection), 3. Reactivation of hepatitis B virus, 4. Progressive multifocal leukoencephalopathy, 5. Interstitial pneumonitis, 6. Malignant tumor, 7. Depression and events related to suicide/self-injury.
Safety Analysis Population included participants with locked CRFs and who do not correspond to criteria for exclusion from safety analysis set.
Posted
Count of Participants
Participants
From the start of the study intervention (Day 1) up to maximum of 3 years
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000543
OG001661
OG002308
OG003
Title
Denominators
Categories
Serious Hypersensitivity
Title
Measurements
OG0003
OG0010
OG0020
OG003
Primary
Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population included participants in the safety analysis set and do not correspond to criteria for exclusion from the efficacy analysis set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Scores on a Scale
Baseline (Day 0) and Week 24
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000358
OG001450
OG002204
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.5± 4.8
OG001-2.8± 4.3
OG002-2.8± 4.3
OG003
Primary
Change From Baseline in SELENA SLEDAI Score at Week 52
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).
Posted
Mean
Standard Deviation
Scores on a Scale
Baseline (Day 0) and Week 52
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000304
OG001342
OG002172
OG003
Title
Denominators
Categories
Title
Measurements
OG000-3.1± 5.1
OG001-3.6± 5.3
OG002-3.2± 5.6
Primary
Change From Baseline in Lupus Impact Tracker Score at Week 24
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Not Posted
Nov 2027
Baseline (Day 0) and Week 24
Participants
Primary
Change From Baseline in Lupus Impact Tracker Score at Week 52
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Not Posted
Nov 2027
Baseline (Day 0) and Week 52
Participants
Primary
Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).
Posted
Mean
Standard Deviation
Scores on a Scale
Baseline (Day 0) and Week 24
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000288
OG001348
OG002174
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.44± 0.56
OG001-0.51± 0.55
OG002-0.44± 0.58
Primary
Change From Baseline in PGA Score at Week 52
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).
Posted
Mean
Standard Deviation
Scores on a Scale
Baseline (Day 0) and Week 52
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000223
OG001249
OG002138
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.64± 0.65
OG001-0.62± 0.63
OG002-0.53± 0.64
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 4
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 4
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000496
OG001615
OG002289
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.57± 37.30
OG001-1.61± 25.35
OG002-0.70± 3.56
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 8
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 8
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000477
OG001598
OG002289
OG003
Title
Denominators
Categories
Title
Measurements
OG000-3.46± 34.00
OG001-2.26± 26.21
OG002-1.15± 4.92
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 12
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 12
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000460
OG001583
OG002288
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.97± 42.70
OG001-2.81± 26.71
OG002-1.59± 7.05
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 16
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 16
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000441
OG001563
OG002288
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.59± 35.68
OG001-3.48± 27.19
OG002-0.70± 22.93
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 20
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 20
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000426
OG001552
OG002286
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.15± 36.90
OG001-3.90± 27.53
OG002-2.50± 6.95
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 24
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 24
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000410
OG001536
OG002281
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.36± 46.43
OG001-4.07± 27.94
OG002-2.61± 6.91
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 28
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 28
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000394
OG001492
OG002276
OG003
Title
Denominators
Categories
Title
Measurements
OG000-6.15± 39.51
OG001-4.24± 25.22
OG002-2.61± 7.70
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 32
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 32
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000382
OG001481
OG002275
OG003
Title
Denominators
Categories
Title
Measurements
OG000-6.59± 40.41
OG001-4.73± 29.43
OG002-2.67± 8.66
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 36
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 36
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000380
OG001476
OG002273
OG003
Title
Denominators
Categories
Title
Measurements
OG000-6.85± 40.58
OG001-5.01± 29.61
OG002-3.04± 8.01
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 40
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 40
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000372
OG001470
OG002267
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.61± 50.19
OG001-5.15± 29.83
OG002-3.17± 8.16
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 44
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 44
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000366
OG001464
OG002264
OG003
Title
Denominators
Categories
Title
Measurements
OG000-7.20± 41.60
OG001-5.40± 30.05
OG002-3.44± 7.96
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 48
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 48
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000361
OG001458
OG002264
OG003
Title
Denominators
Categories
Title
Measurements
OG000-7.43± 41.87
OG001-5.03± 22.21
OG002-3.63± 7.98
OG003
Primary
Percent Change From Baseline in Mean Daily Steroid Dose at Week 52
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 0) and Week 52
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000313
OG001437
OG002251
OG003
Title
Denominators
Categories
Title
Measurements
OG000-8.27± 45.01
OG001-3.98± 7.57
OG002-3.89± 7.80
OG003
Primary
Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).
Posted
Count of Participants
Participants
At Week 24
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000273
OG001328
OG002152
OG003
Title
Denominators
Categories
Title
Measurements
OG00048
OG00168
OG00234
Primary
Number of Participants Who Achieved LLDAS Response Criteria at Week 52
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).
Posted
Count of Participants
Participants
At Week 52
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000211
OG001239
OG002116
OG003
Title
Denominators
Categories
Title
Measurements
OG00036
OG00157
OG00237
Primary
Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
International Units per milliliter
Baseline (Day 0) and Week 24
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000355
OG001439
OG002216
OG003
Title
Denominators
Categories
Title
Measurements
OG00036.590± 72.145
OG00127.721± 53.206
OG00231.765± 62.527
OG003
Primary
Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Mean
Standard Deviation
International Units per milliliter
Baseline (Day 0) and Week 52
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000304
OG001355
OG002195
OG003
Title
Denominators
Categories
Title
Measurements
OG00030.984± 58.594
OG00126.890± 95.331
OG00228.346± 66.919
OG003
Primary
Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 24
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
Posted
Mean
Standard Deviation
Milligram per deciliter
Baseline (Day 0) and Week 24
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000377
OG001450
OG002228
OG003
Title
Denominators
Categories
C3
ParticipantsOG000377
ParticipantsOG001450
ParticipantsOG002228
ParticipantsOG003
Primary
Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 52
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
Posted
Mean
Standard Deviation
Milligram per deciliter
Baseline (Day 0) and Week 52
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000329
OG001357
OG002206
OG003
Title
Denominators
Categories
C3
ParticipantsOG000329
ParticipantsOG001357
ParticipantsOG002206
ParticipantsOG003
Primary
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).
Posted
Mean
Standard Deviation
Units per milliliter
Baseline (Day 0) and Week 24
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000304
OG001372
OG002173
OG003
Title
Denominators
Categories
Title
Measurements
OG00039.03± 15.20
OG00138.14± 13.19
OG00239.85± 14.57
Primary
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).
Posted
Mean
Standard Deviation
Units per milliliter
Baseline (Day 0) and Week 52
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000264
OG001300
OG002159
OG003
Title
Denominators
Categories
Title
Measurements
OG00039.60± 14.91
OG00138.55± 13.47
OG00239.73± 14.62
Primary
Change From Baseline in Urine Protein/Creatinine Ratio at Week 24
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).
Posted
Median
Inter-Quartile Range
Ratio
Baseline (Day 0) and Week 24
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000187
OG001210
OG002125
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.25200(0.07610 to 1.25000)
OG0010.17000(0.09000 to 0.48000)
OG0020.12000(0.06000 to 0.56000)
Primary
Change From Baseline in Urine Protein/Creatinine Ratio at Week 52
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.
Posted
Median
Inter-Quartile Range
Ratio
Baseline (Day 0) and Week 52
ID
Title
Description
OG000
Benlysta IV
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
OG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
OG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
OG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Units
Counts
Participants
OG000153
OG001170
OG002116
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.15000(0.07000 to 0.55000)
OG0010.15000(0.07800 to 0.50000)
OG0020.10000(0.06000 to 0.30630)
4
543
101
543
154
543
EG001
Benlysta SC
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
4
661
91
661
155
661
EG002
Benlysta Switched From IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV.
2
308
43
308
87
308
EG003
Benlysta IV or SC (Initial Route of Administration Unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0012 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Gastric adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Liver metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Oropharyngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Pancreatic cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Squamous cell carcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Breast cancer female
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Desmoid tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Lymphoproliferative disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Cholecystitis acute
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Ischaemic hepatitis
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Arrhythmia
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Cardiac arrest
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Cardiac failure
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Myocardial infarction
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Myocarditis
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Ventricular extrasystoles
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Lupus endocarditis
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Aortic dissection
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Deep vein thrombosis
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Lymphatic fistula
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Hypogammaglobulinaemia
Immune system disorders
MedDRA v27.0
Systematic Assessment
EG0003 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Autoimmune disorder
Immune system disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Haemophagocytic lymphohistiocytosis
Immune system disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Cataract
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Diplopia
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Ophthalmoplegia
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Retinal artery occlusion
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Retinal tear
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Cervical dysplasia
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Vertigo
Ear and labyrinth disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Hip arthroplasty
Surgical and medical procedures
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Cervical conisation
Surgical and medical procedures
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Abortion
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Device failure
Product Issues
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
EG00018 affected543 at risk
EG00116 affected661 at risk
EG0028 affected308 at risk
EG0030 affected2 at risk
Herpes zoster
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG00013 affected543 at risk
EG00110 affected661 at risk
EG0028 affected308 at risk
EG0030 affected2 at risk
Influenza
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0006 affected543 at risk
EG0019 affected661 at risk
EG0028 affected308 at risk
EG0030 affected2 at risk
Cystitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0006 affected543 at risk
EG0016 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Gastroenteritis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0003 affected543 at risk
EG0013 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Pharyngitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0006 affected543 at risk
EG0012 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Bronchitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0016 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Urinary tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0012 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Sinusitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0004 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Oral herpes
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0013 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Chronic sinusitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Vulvovaginal candidiasis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0010 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Enterocolitis viral
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Oral candidiasis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Periodontitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Acute sinusitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Herpes simplex
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Otitis media
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Viral infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Dermatitis infected
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Dermatophytosis of nail
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Fungal infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Hordeolum
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Molluscum contagiosum
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Mumps
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Parotitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Pyuria
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Rhinitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Skin infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Stitch abscess
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Tooth infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Coronavirus infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Tinea versicolor
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Laryngopharyngitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Bacterial cystitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Genital herpes simplex
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Pyrexia
General disorders
MedDRA v27.0
Systematic Assessment
EG00016 affected543 at risk
EG00118 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Malaise
General disorders
MedDRA v27.0
Systematic Assessment
EG0007 affected543 at risk
EG0017 affected661 at risk
EG0025 affected308 at risk
EG0030 affected2 at risk
Injection site pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0018 affected661 at risk
EG0028 affected308 at risk
EG0030 affected2 at risk
Condition aggravated
General disorders
MedDRA v27.0
Systematic Assessment
EG0005 affected543 at risk
EG0014 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Injection site erythema
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0014 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Injection site reaction
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0014 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Oedema peripheral
General disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Feeling abnormal
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Oedema
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Injection site swelling
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Asthenia
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Chest discomfort
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Chest pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Chills
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Fatigue
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Gait disturbance
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Injection site bruising
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Injection site haemorrhage
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Injection site induration
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Swelling face
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Physical deconditioning
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Injury associated with device
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0009 affected543 at risk
EG0019 affected661 at risk
EG0024 affected308 at risk
EG0030 affected2 at risk
Nausea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0004 affected543 at risk
EG0014 affected661 at risk
EG0024 affected308 at risk
EG0030 affected2 at risk
Constipation
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0012 affected661 at risk
EG0024 affected308 at risk
EG0030 affected2 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0012 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0012 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0012 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Stomatitis
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0014 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Vomiting
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0012 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Angular cheilitis
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Lupus enteritis
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Aphthous ulcer
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Eructation
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Gastritis
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Gingival swelling
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Salivary hypersecretion
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Toothache
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Faeces soft
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0016 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0003 affected543 at risk
EG0012 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0004 affected543 at risk
EG0012 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0012 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0014 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0004 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Purpura
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Alopecia areata
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Idiopathic urticaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Livedo reticularis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Miliaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Skin striae
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Koebner phenomenon
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Skin mass
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Chronic spontaneous urticaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG00020 affected543 at risk
EG00114 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0013 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0003 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Cough variant asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0010 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0013 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Vocal cord inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0012 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0004 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0013 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Loose body in joint
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Exposed bone in jaw
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Temporomandibular pain and dysfunction syndrome
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Headache
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0009 affected543 at risk
EG0019 affected661 at risk
EG0026 affected308 at risk
EG0030 affected2 at risk
Dizziness
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0013 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Hypoaesthesia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Post herpetic neuralgia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Migraine
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Neuralgia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Somnolence
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Tension headache
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Balance disorder
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Intercostal neuralgia
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
White blood cell count decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0005 affected543 at risk
EG0010 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Platelet count decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Blood immunoglobulin G decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Blood pressure increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Neutrophil count decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Complement factor decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Alanine aminotransferase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Aspartate aminotransferase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Blood calcium increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Blood folate decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Blood glucose decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Granulocyte count decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
White blood cell count increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Complement factor C3 decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Blood beta-D-glucan increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Protein urine present
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Hepatic enzyme increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Antinuclear antibody increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Hepatitis B DNA increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Double stranded DNA antibody positive
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Mycobacterium tuberculosis complex test positive
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Liver function test increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Proteinuria
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Hypertonic bladder
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Nocturia
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Urine abnormality
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Kidney enlargement
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Depression
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Insomnia
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0013 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Depressed mood
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Anxiety
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Depressive symptom
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Adjustment disorder with depressed mood
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Sleep disorder due to general medical condition, insomnia type
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Stress
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Mental disorder
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Psychiatric symptom
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0012 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0012 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0012 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Gout
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Copper deficiency
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Iron deficiency
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Obesity
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Zinc deficiency
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0003 affected543 at risk
EG0012 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0004 affected543 at risk
EG0014 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Lymphadenitis
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Foot fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0003 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Fall
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0023 affected308 at risk
EG0030 affected2 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Road traffic accident
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Wound
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Meniscus injury
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Avulsion fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Inflammatory pseudotumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0003 affected543 at risk
EG0011 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Liver disorder
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0014 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Hepatic steatosis
Hepatobiliary disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Palpitations
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Sinus tachycardia
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Hypertension
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Vascular pain
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Vasculitis
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Hot flush
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Venous thrombosis limb
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Seasonal allergy
Immune system disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Immune system disorders
Immune system disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0011 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Conjunctivitis allergic
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Corneal erosion
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Scintillating scotoma
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Visual acuity reduced
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Visual field defect
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Cervical dysplasia
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Premenstrual syndrome
Reproductive system and breast disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Vertigo
Ear and labyrinth disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0011 affected661 at risk
EG0022 affected308 at risk
EG0030 affected2 at risk
Ear discomfort
Ear and labyrinth disorders
MedDRA v27.0
Systematic Assessment
EG0001 affected543 at risk
EG0010 affected661 at risk
EG0020 affected308 at risk
EG0030 affected2 at risk
Silent thyroiditis
Endocrine disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected543 at risk
EG0010 affected661 at risk
EG0021 affected308 at risk
EG0030 affected2 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
2
BG0041514
1
BG0041355
Male
BG00073
BG00164
BG00221
BG0031
BG004159
2
0
Serious infections
Title
Measurements
OG00027
OG00124
OG0029
OG0030
Reactivation of hepatitis B virus
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Progressive Multifocal Leukoencephalopathy
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Interstitial Pneumonia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Malignant tumor
Title
Measurements
OG0004
OG0012
OG0023
OG0030
Depression and events related to suicide/self-injury
Title
Measurements
OG0001
OG0011
OG0021
OG0030
1
-4.0
± NA
Standard deviation could not be calculated for single participant.
0
0
0
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
1
0.00
± NA
As there was a single participant, mean value presented is the actual value. Standard deviation could not be calculated for single participant.
0
0
1
5.000
± NA
Standard deviation could not be calculated for single participant.
1
5.000
± NA
Standard deviation could not be calculated for single participant.
1
1
Title
Measurements
OG00082.57± 25.01
OG00182.08± 23.56
OG00283.79± 24.22
OG00396.00± NAStandard deviation could not be calculated for single participant.
C4
ParticipantsOG000364
ParticipantsOG001447
ParticipantsOG002213
ParticipantsOG0031
Title
Measurements
OG00018.26± 9.22
OG00116.88± 8.12
OG00217.15± 7.94
OG003
1
1
Title
Measurements
OG00085.45± 24.67
OG00185.05± 23.84
OG00285.16± 22.27
OG00397.00± NAStandard deviation could not be calculated for single participant.
C4
ParticipantsOG000309
ParticipantsOG001356
ParticipantsOG002196
ParticipantsOG0031
Title
Measurements
OG00018.71± 8.48
OG00117.34± 8.10
OG00217.38± 7.84
OG003
0
0
0
1
OG003
0.00000
(NA to NA)
As there was a single participant, median value presented is the actual value. Inter quartile range could not be calculated for single participant.
25.00
± NA
Standard deviation could not be calculated for single participant.
40.00
± NA
Standard deviation could not be calculated for single participant.