A Study of GSK3228836 in Participants With Chronic Hepati... | NCT04449029 | Trialant
NCT04449029
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
May 16, 2023Actual
Enrollment
457Actual
Phase
Phase 2
Conditions
Hepatitis B
Interventions
GSK3228836
Placebo
Nucleos(t)ide therapy
Countries
United States
Argentina
Bulgaria
Canada
China
France
Germany
Hong Kong
Italy
Japan
Malaysia
Philippines
Poland
Romania
Russia
Singapore
South Africa
South Korea
Spain
Taiwan
Thailand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04449029
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
209668
Secondary IDs
Not provided
Brief Title
A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
Official Title
Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)
Acronym
B-Clear
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Apr 2023
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
Jul 27, 2020Actual
Primary Completion Date
Mar 18, 2022Actual
Completion Date
Mar 18, 2022Actual
First Submitted Date
Jun 23, 2020
First Submission Date that Met QC Criteria
Jun 23, 2020
First Posted Date
Jun 26, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Mar 1, 2023
Results First Submitted that Met QC Criteria
Apr 21, 2023
Results First Posted Date
May 16, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 21, 2023
Last Update Posted Date
May 16, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) \
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis B
Keywords
Chronic Hepatitis B
GSK3228836
Hepatitis B virus surface antigen
Nucleos(t)ide therapy
Sustained virologic response
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
457Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: GSK3228836 300 mg + LD
Experimental
Eligible participants on stable nucleos(t)ide treatment will receive 300 milligrams (mg) GSK3228836 once weekly for 24 weeks along with loading dose (LD) of 300 mg GSK3228836 on Day 4 and Day 11.
Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.
Drug: GSK3228836
Drug: Placebo
Drug: Nucleos(t)ide therapy
Cohort 1: GSK3228836 300 mg + LD/ Placebo
Experimental
Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.
Drug: GSK3228836
Drug: Placebo
Drug: Nucleos(t)ide therapy
Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD
Experimental
Eligible participants on stable nucleos(t)ide treatment will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3228836
Drug
GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Achieving Sustained Virologic Response (SVR)
The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.
Up to Week 48
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Achieving HBsAg and HBV DNA<LLOQ
Participants achieving HBsAg and HBV DNA levels \
Up to Week 26
Number of Participants With Categorical Changes From Baseline in HBsAg Values
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age at the time of signing the informed consent.
Participants who have documented chronic HBV infection greater than equal to (>=6) months prior to screening and not currently on nucleos(t)ide analogue therapy population defined as participants who never received HBV treatment (treatment naive) or must have ended nucleos(t)ide therapy at least 6 months prior to the screening visit; OR Currently receiving stable nucleos(t)ide analogue therapy population defined as no changes to their nucleos(t)ide regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study.
Plasma or serum HBsAg concentration >100 international units per milliliter (IU/mL).
Plasma or serum HBV DNA concentration: Participants not currently on nucleos(t)ide analogue therapy, plasma or serum HBV DNA >2000 IU/mL; Participants who are receiving stable nucleos(t)ide analogue therapy must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.
ALT for treatment naive participants and for participants who are not currently receiving treatment: ALT <3 times ULN will be included initially if agreed by the independent data monitoring committee (IDMC) after review of safety data, the ALT inclusion criteria may be expanded to include participants with ALT <5 times ULN; ALT less than equal to (<=2) times ULN for participants who are receiving stable nucleos(t)ide analogue therapy.
Male and/or Female: A male participant is eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: Refrain from donating sperm AND be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or Must agree to use contraception/barrier as detailed below: Agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. A female participant is eligible to participate: If she is not pregnant or breastfeeding AND at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1 percent per year), preferably with low user dependency during the intervention period and for at least 90 days after the last dose of study treatment; A WOCBP must have both a confirmed menstrual period prior to the first dose of study intervention (additional evaluation [e.g., amenorrhea in athletes, birth control] should also be considered) and a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study treatment.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Capable of giving signed informed consent.
Exclusion Criteria:
Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate-severe liver disease other than chronic HBV, acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy) or physical examination.
Co-infection with Current or past history of Hepatitis C virus (HCV), Human immunodeficiency virus (HIV), Hepatitis D virus (HDV).
History of or suspected liver cirrhosis and/or evidence of cirrhosis as determined by both Aspartate aminotransferase (AST)-Platelet Index (APRI) >2 and FibroSure/FibroTest result >0.7. If only one parameter (APRI or FibroSure/FibroTest) result is positive, a discussion with the Medical Monitor is required before inclusion in study is permitted. Regardless of APRI of Fibrosure/FibroTest score, if the participant meets one of the following criteria, they will be excluded from the study: Liver biopsy (i.e., Metavir Score F4); Liver stiffness >12 kilopascals (kPa).
Diagnosed or suspected hepatocellular carcinoma as evidenced by the following: Alpha-fetoprotein concentration >=200 nanogram per milliliter (ng/mL); If the screening alpha fetoprotein concentration is >=50 ng/mL and <200 ng/mL, the absence of liver mass must be documented by imaging within 6 months before randomization.
History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
Anti-neutrophil cytoplasmic antibodies (ANCA) at screening by itself won't be an exclusion criterion, but if results are borderline positive or positive: myeloperoxidase-ANCA (MPO-ANCA) (Perinuclear antineutrophil cytoplasmic antibodies [pANCA]) and proteinase 3- ANCA (PR3-ANCA) (Cytoplasmic antineutrophil cytoplasmic antibodies [cANCA]) analysis will be conducted; A discussion with the Medical Monitor will be required to review participant's complete medical history to ensure no past history or current manifestations of a vasculitic/inflammatory/auto-immune condition before inclusion in study is permitted.
Low complement C3 (C3) at screening by itself won't be an exclusion criterion, but if it is present: A discussion with the Medical Monitor is required to review participant's complete medical history to ensure no past history or current manifestations of vasculitic/inflammatory/auto-immune conditions.
History of alcohol or drug abuse/dependence: Current alcohol use as judged by investigator to potentially interfere with participant compliance; History of or current drug abuse/dependence as judged by the investigator to potentially interfere with participant compliance. Refers to illicit drugs and substances with abuse potential. Medications that are used by the participant as directed, whether over-the-counter or through prescription, are acceptable and would not meet the exclusion criteria.
Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use.
Participants for whom immunosuppressive treatment is not advised, including therapeutic doses of steroids, will be excluded.
Currently taking, or took within 12 months of screening, any interferon-containing therapy.
Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors or anti-platelet agents like clopidogrel).
The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study treatment (whichever is longer) or 90 days (if half-life or duration is unknown).
Prior treatment with any oligonucleotide or small interfering ribonucleic acid (RNA) (Small interfering RNA [siRNA]) within 12 months prior to the first dosing day.
Fridericia's QT correction formula (QTcF) >=450 milliseconds (msec) (if single electrocardiogram [ECG] at screening shows QTcF>=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).
Laboratory results as follows: Serum albumin <3.5 grams per deciliter (g/dL), Glomerular filtration rate (GFR) <60 milliliter per minute per 1.73 square meter (mL/min /1.73 m^2) as calculated by the Chronic Kidney Disease Epidemiologic Collaboration (CKD-EPI) formula (for Japan, Japanese Society of Nephrology Chronic Kidney Disease Initiative [JSN-CKDI equation]), International normalized ratio (INR) >1.25. Platelet count <140 times 10^9 cells/L, Total bilirubin >1.25 times ULN. For participants with benign unconjugated hyperbilirubinemia with total bilirubin >1.25 times ULN, discussion for inclusion to the study is required with the Medical Monitor, Urine albumin to creatinine ratio (ACR) >=0.03 mg/mg (or >=30 mg/g). In the event of an ACR above this threshold, eligibility may be confirmed by a second measurement. In cases where participants have low urine albumin and low urine creatinine levels resulting in a urine ACR calculation >=0.03 mg/mg (or >=30 mg/g), the investigator should confirm that the participant does not have a history of diabetes, hypertension or other risk factors that may affect renal function and discuss with the Medical Monitor, or designee.
History of/sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
A total of 457 participants were enrolled in the study. These 457 participants were from 2 different set of populations (referred here after as on nucleos(t)ide [NA] and not on NA therapy). Participants from these subpopulations were randomized in a ratio of 3:3:3:1 into 4 treatment arms for each population (total of 8 arms).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
FG001
GSK3228836 for 12+12 WK (on NA Therapy)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 23, 2021
Mar 1, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants with CHB will be divided into two different cohorts; participants on stable nucleos(t)ide treatment and participants not currently on nucleos(t)ide therapy. For each cohort, participants will be randomized into one of the 4 different parallel arms to receive treatment.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Participants will be blinded to the study treatment.
Who Masked
Participant
Drug: GSK3228836
Drug: Placebo
Drug: Nucleos(t)ide therapy
Cohort 2: GSK3228836 300 mg + LD
Experimental
Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 24 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11.
Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.
Drug: GSK3228836
Drug: Placebo
Cohort 2: GSK3228836 300 mg + LD/ Placebo
Experimental
Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.
Drug: GSK3228836
Drug: Placebo
Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD
Experimental
Eligible participants not currently on nucleos(t)ide therapy will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.
Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of <0.5, greater than or equal to (>=) 0.5, >=1, >=1.5, and >=3 log10 international units per milliliter (IU/mL).
At Baseline and Week 24
Number of Participants With Categorical Changes From Baseline in HBV DNA Values
Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of <1, >=1, >=2, and >=3 log IU/mL.
At Baseline and Week 24
Number of Participants With Alanine Aminotransferase (ALT) Normalization
The ALT normalization (ALT≤ upper limit of normal [ULN]) over time in absence of rescue medication in participants with baseline ALT>ULN.
Participants who achieved ALT normalization were reported.
At Baseline and Week 24
Median Time to ALT Normalization
Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT>ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT >ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively.
Baseline and up to Week 48
Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb)
Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported.
Up to Week 48
Mean HBsAg and HBV DNA Level
Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points.
At Baseline, Week 12, and 24
Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level
Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).
At Baseline, Week 12, and 24
Mean Change From Baseline in HBsAg and HBV DNA Level
Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL).
At Baseline, Week 12, and 24
Mean Change From Baseline in HBeAg Level
Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).
At Baseline, Week 12, and 24
Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level
Blood samples were collected to assess anti-HBsAg level at indicated timepoints.
At Baseline, Week 36, and 48
Mean Change From Baseline in Anti-HBsAg Level
Blood samples were collected to assess anti-HBsAg level at indicated timepoints.
At Baseline, Week 12, and 24
Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836
Intensive pharmacokinetic (PK) sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h of GSK3228836.
Up to Week 24
Mean Maximum Observed Concentration (Cmax) of GSK3228836
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax of GSK3228836.
Up to Week 24
Median Time of Maximum Observed Concentration (Tmax) of GSK3228836
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax of GSK3228836.
Up to Week 24
Mean AUC0-24h of NA Therapies
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
Up to Week 24
Mean Ctau of NA Therapies
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Ctau. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
Up to Week 24
Mean Cmax of NA Therapies
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
Up to Week 24
Median Tmax of NA Therapies
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
Up to Week 24
Median Terminal Half-life (t1/2) of GSK3228836
Blood samples were collected from all participants for t1/2 analysis of GSK3228836. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.
Up to Week 48
Mean Ctau of GSK3228836
Blood samples were collected from all participants for Ctau analysis of GSK3228836 at indicated. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.
Up to Week 24
Miami
Florida
33125
United States
GSK Investigational Site
Miami
Florida
33136
United States
GSK Investigational Site
Decatur
Georgia
30033
United States
GSK Investigational Site
Boston
Massachusetts
02114
United States
GSK Investigational Site
New York
New York
10016
United States
GSK Investigational Site
Pittsburgh
Pennsylvania
15213
United States
GSK Investigational Site
Richmond
Virginia
23249
United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires
Buenos Aires
C1181ACH
Argentina
GSK Investigational Site
Buenos Aires
C1280AEB
Argentina
GSK Investigational Site
Sliven
8800
Bulgaria
GSK Investigational Site
Sofia
1431
Bulgaria
GSK Investigational Site
Sofia
1463
Bulgaria
GSK Investigational Site
Sofia
1527
Bulgaria
GSK Investigational Site
Calgary
Alberta
T2N 4Z6
Canada
GSK Investigational Site
Victoria
British Columbia
V8V 3M9
Canada
GSK Investigational Site
London
Ontario
N6A 2C2
Canada
GSK Investigational Site
Toronto
Ontario
M5G 2C4
Canada
GSK Investigational Site
Montreal
Quebec
H2L 4E9
Canada
GSK Investigational Site
Regina
Saskatchewan
S4P 0W5
Canada
GSK Investigational Site
Québec
G1V 4G2
Canada
GSK Investigational Site
Wuhan
Hubei
430030
China
GSK Investigational Site
Shenyang
Liaoning
110022
China
GSK Investigational Site
Chongqing
Sichuan
400042
China
GSK Investigational Site
Beijing
100015
China
GSK Investigational Site
Beijing
100034
China
GSK Investigational Site
Beijing
100050
China
GSK Investigational Site
Guangzhou
510000
China
GSK Investigational Site
Shanghai
200025
China
GSK Investigational Site
Clichy
92118
France
GSK Investigational Site
Créteil
94010
France
GSK Investigational Site
Limoges
87042
France
GSK Investigational Site
Lyon
69317
France
GSK Investigational Site
Nice
06202
France
GSK Investigational Site
Strasbourg
67200
France
GSK Investigational Site
Erlangen
Bavaria
91054
Germany
GSK Investigational Site
Frankfurt am Main
Hesse
60590
Germany
GSK Investigational Site
Frankfurt am Main
Hesse
60596
Germany
GSK Investigational Site
Berlin
10439
Germany
GSK Investigational Site
Hamburg
20146
Germany
GSK Investigational Site
Pokfulam
Hong Kong
GSK Investigational Site
Modena
Emilia-Romagna
41126
Italy
GSK Investigational Site
Milan
Lombardy
20122
Italy
GSK Investigational Site
Milan
Lombardy
20132
Italy
GSK Investigational Site
Milan
Lombardy
20157
Italy
GSK Investigational Site
Ehime
790-8524
Japan
GSK Investigational Site
Hiroshima
730-8619
Japan
GSK Investigational Site
Hiroshima
734-8551
Japan
GSK Investigational Site
Hokkaido
080-0024
Japan
GSK Investigational Site
Ishikawa
920-8650
Japan
GSK Investigational Site
Ishikawa
924-8588
Japan
GSK Investigational Site
Kagawa
760-8557
Japan
GSK Investigational Site
Kumamoto
860-8556
Japan
GSK Investigational Site
Kumamoto
862-8655
Japan
GSK Investigational Site
Miyagi
980-8574
Japan
GSK Investigational Site
Nagasaki
856-8562
Japan
GSK Investigational Site
Osaka
565-0871
Japan
GSK Investigational Site
Tokyo
113-8603
Japan
GSK Investigational Site
Tokyo
180-8610
Japan
GSK Investigational Site
Kuala Lumpur
59100
Malaysia
GSK Investigational Site
Makati City
1229
Philippines
GSK Investigational Site
Quezon City
1101
Philippines
GSK Investigational Site
Lublin
20-884
Poland
GSK Investigational Site
Mysłowice
41-400
Poland
GSK Investigational Site
Warsaw
00-332
Poland
GSK Investigational Site
Łańcut
37-100
Poland
GSK Investigational Site
Brasov
500283
Romania
GSK Investigational Site
Bucharest
030303
Romania
GSK Investigational Site
Cluj-Napoca
400139
Romania
GSK Investigational Site
Cluj-Napoca
400162
Romania
GSK Investigational Site
Craiova
200515
Romania
GSK Investigational Site
Galati
800179
Romania
GSK Investigational Site
Iași
700116
Romania
GSK Investigational Site
Timișoara
300310
Romania
GSK Investigational Site
Chelyabinsk
454052
Russia
GSK Investigational Site
Kaliningrad
236016
Russia
GSK Investigational Site
Krasnodar
350000
Russia
GSK Investigational Site
Moscow
121170
Russia
GSK Investigational Site
Moscow
125008
Russia
GSK Investigational Site
Novosibirsk
630005
Russia
GSK Investigational Site
Novosibirsk
630099
Russia
GSK Investigational Site
Saint Petersburg
190103
Russia
GSK Investigational Site
Saint Petersburg
191167
Russia
GSK Investigational Site
Samara
443063
Russia
GSK Investigational Site
Красноярск
660049
Russia
GSK Investigational Site
Singapore
119074
Singapore
GSK Investigational Site
Singapore
169608
Singapore
GSK Investigational Site
Singapore
529889
Singapore
GSK Investigational Site
Port Elizabeth
Eastern Cape
6001
South Africa
GSK Investigational Site
Ennerdale
Gauteng
1830
South Africa
GSK Investigational Site
Lenasia Johannesburg
Gauteng
1827
South Africa
GSK Investigational Site
Durban
KwaZulu-Natal
4052
South Africa
GSK Investigational Site
Kwaguqa Emalahleni
Mpumalanga
1039
South Africa
GSK Investigational Site
Vosloorus Ext 2
1475
South Africa
GSK Investigational Site
Busan
47392
South Korea
GSK Investigational Site
Busan
49241
South Korea
GSK Investigational Site
Daegu
41944
South Korea
GSK Investigational Site
Gyeonggi-do
15355
South Korea
GSK Investigational Site
Incheon
21565
South Korea
GSK Investigational Site
Seoul
03080
South Korea
GSK Investigational Site
Seoul
05505
South Korea
GSK Investigational Site
Seoul
06973
South Korea
GSK Investigational Site
Ulsan
44033
South Korea
GSK Investigational Site
Barcelona
08035
Spain
GSK Investigational Site
Barcelona
08036
Spain
GSK Investigational Site
Madrid
28029
Spain
GSK Investigational Site
Madrid
28031
Spain
GSK Investigational Site
Majadahonda (Madrid)
28222
Spain
GSK Investigational Site
Málaga
29010
Spain
GSK Investigational Site
Santander
39008
Spain
GSK Investigational Site
Seville
41013
Spain
GSK Investigational Site
Changhua
500
Taiwan
GSK Investigational Site
Taichung
40447
Taiwan
GSK Investigational Site
Bangkok
10330
Thailand
GSK Investigational Site
Bangkok
10400
Thailand
GSK Investigational Site
Chiang Mai
50200
Thailand
GSK Investigational Site
Phitsanulok
65000
Thailand
GSK Investigational Site
Songkhla
9110
Thailand
GSK Investigational Site
London
WC1E 6JB
United Kingdom
GSK Investigational Site
Newcastle upon Tyne
NE7 7DN
United Kingdom
GSK Investigational Site
Plymouth
PL6 8DH
United Kingdom
Derived
Joshi S, Freudenberg JM, Singh JM, Jordan WT, Felton L, Dixon S, Paff M, Theodore D, Walker J. Immunomodulation by bepirovirsen may induce killing of infected hepatocytes (B-Together study). Hepatol Int. 2026 Feb;20(1):46-58. doi: 10.1007/s12072-025-10917-0. Epub 2025 Oct 3.
Han K, Youssef AS, Magee M, Hood S, Tracey H, Kwoh J, Theodore D, Paff M, Nader A. Lack of Pharmacokinetic Drug-Drug Interactions Between Bepirovirsen and Nucleos(t)ide Analogs. Clin Pharmacol Drug Dev. 2025 Apr;14(4):281-291. doi: 10.1002/cpdd.1518. Epub 2025 Feb 14.
Cremer J, Elston R, Campbell FM, Kendrick S, Paff M, Quinn G, Theodore D. B-Clear Phase 2b Study Design: Establishing the Efficacy and Safety of Bepirovirsen in Patients with Chronic Hepatitis B Virus Infection. Adv Ther. 2023 Sep;40(9):4101-4110. doi: 10.1007/s12325-023-02531-z. Epub 2023 Jul 1.
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
FG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
FG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
FG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
FG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
FG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
FG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
FG00068 subjects
FG00168 subjects
FG00268 subjects
FG00323 subjects
FG00470 subjects
FG00568 subjects
FG00668 subjects
FG00724 subjects
COMPLETED
FG00065 subjects
FG00165 subjects
FG00266 subjects
FG00322 subjects
FG00464 subjects
FG00566 subjects
FG00663 subjects
FG00724 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG0046 subjects
FG0052 subjects
FG0065 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
BG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
BG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
BG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
BG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
BG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
BG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
BG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00068
BG00168
BG00268
BG00323
BG00470
BG00568
BG00668
BG00724
BG008457
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
YEARS
Title
Denominators
Categories
Title
Measurements
BG00049.0± 11.54
BG00146.1± 12.60
BG00247.4± 11.18
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00119
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Achieving Sustained Virologic Response (SVR)
The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.
The analysis was performed on the Intent to Treat (ITT) Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.
Posted
Count of Participants
Participants
Up to Week 48
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0016
OG0022
OG003
Secondary
Number of Participants Achieving HBsAg and HBV DNA<LLOQ
Participants achieving HBsAg and HBV DNA levels \
The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.
Posted
Count of Participants
Participants
Up to Week 26
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
Secondary
Number of Participants With Categorical Changes From Baseline in HBsAg Values
Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of <0.5, greater than or equal to (>=) 0.5, >=1, >=1.5, and >=3 log10 international units per milliliter (IU/mL).
The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. One participant from 12+12 weeks on NA therapy arm was randomized in error and is in ITT population but did not contribute any lab data so is not part of the analysis.
Posted
Count of Participants
Participants
At Baseline and Week 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
Secondary
Number of Participants With Categorical Changes From Baseline in HBV DNA Values
Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of <1, >=1, >=2, and >=3 log IU/mL.
The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.
Posted
Count of Participants
Participants
At Baseline and Week 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
Secondary
Number of Participants With Alanine Aminotransferase (ALT) Normalization
The ALT normalization (ALT≤ upper limit of normal [ULN]) over time in absence of rescue medication in participants with baseline ALT>ULN.
Participants who achieved ALT normalization were reported.
The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.
Posted
Count of Participants
Participants
At Baseline and Week 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
Secondary
Median Time to ALT Normalization
Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT>ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT >ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively.
The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. Only those participants with baseline ALT>ULN were analyzed.
Posted
Median
95% Confidence Interval
Weeks
Baseline and up to Week 48
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
Secondary
Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb)
Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported.
The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.
Posted
Count of Participants
Participants
Up to Week 48
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
Secondary
Mean HBsAg and HBV DNA Level
Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points.
The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.
Posted
Mean
Standard Deviation
Log10 (IU/mL)
At Baseline, Week 12, and 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
Secondary
Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level
Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).
The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.
Posted
Mean
Standard Deviation
Log10 unit per milliliter (U/mL)
At Baseline, Week 12, and 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
Secondary
Mean Change From Baseline in HBsAg and HBV DNA Level
Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL).
The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.
Posted
Mean
Standard Deviation
log IU/mL
At Baseline, Week 12, and 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
Secondary
Mean Change From Baseline in HBeAg Level
Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).
The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.
Posted
Mean
Standard Deviation
Log u/mL
At Baseline, Week 12, and 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
Secondary
Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level
Blood samples were collected to assess anti-HBsAg level at indicated timepoints.
The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data.
Posted
Mean
Standard Deviation
Log10 IU/mL
At Baseline, Week 36, and 48
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
Secondary
Mean Change From Baseline in Anti-HBsAg Level
Blood samples were collected to assess anti-HBsAg level at indicated timepoints.
The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data.
Posted
Mean
Standard Deviation
Log10 IU/mL
At Baseline, Week 12, and 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
Secondary
Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836
Intensive pharmacokinetic (PK) sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h of GSK3228836.
The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Mean
Standard Deviation
hour*micrograms per milliliter (h*ug/mL)
Up to Week 24
ID
Title
Description
OG000
GSK3228836 Dose Level 150mg
Represents Pharmacokinetic (PK) set of participants who received GSK3228836 at a dose level of 150 mg once a week.
OG001
GSK3228836 Dose Level 300mg
Represents Pharmacokinetic (PK) set of participants who received GSK3228836 at a dose level of 300 mg once a week.
Units
Counts
Participants
OG000
Secondary
Mean Maximum Observed Concentration (Cmax) of GSK3228836
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax of GSK3228836.
The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Mean
Standard Deviation
ug/mL
Up to Week 24
ID
Title
Description
OG000
GSK3228836 Dose Level 150mg
Represents PK set of participants who received GSK3228836 at a dose level of 150 mg once a week.
OG001
GSK3228836 Dose Level 300mg
Represents PK set of participants who received GSK3228836 at a dose level of 300 mg once a week.
Units
Counts
Participants
OG000
Secondary
Median Time of Maximum Observed Concentration (Tmax) of GSK3228836
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax of GSK3228836.
The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Median
Full Range
hour
Up to Week 24
ID
Title
Description
OG000
GSK3228836 Dose Level 150mg
Represents PK set of participants who received GSK3228836 at a dose level of 150 mg once a week.
OG001
GSK3228836 Dose Level 300mg
Represents PK set of participants who received GSK3228836 at a dose level of 300 mg once a week.
Units
Counts
Participants
OG000
Secondary
Mean AUC0-24h of NA Therapies
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Mean
Standard Deviation
h*nanograms per milliliter (h*ng/mL)
Up to Week 24
ID
Title
Description
OG000
Tenofovir Disoproxil Fumarate
Participants who received Tenofovir disoproxil fumarate 245 or 300 mg once daily.
OG001
Tenofovir Alafenamide
Participants who received Tenofovir alafenamide 25 mg once daily or every 2 days.
OG002
Entecavir
Participants who received Entecavir 0.5 mg once a daily.
Secondary
Mean Ctau of NA Therapies
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Ctau. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Mean
Standard Deviation
ng/mL
Up to Week 24
ID
Title
Description
OG000
Tenofovir Disoproxil Fumarate
Participants who received Tenofovir disoproxil fumarate 245 or 300 mg once daily.
OG001
Tenofovir Alafenamide
Participants who received Tenofovir alafenamide 25 mg once daily or every 2 days.
OG002
Entecavir
Participants who received Entecavir 0.5 mg once a daily.
Secondary
Mean Cmax of NA Therapies
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Mean
Standard Deviation
ng/mL
Up to Week 24
ID
Title
Description
OG000
Tenofovir Disoproxil Fumarate
Participants who received Tenofovir disoproxil fumarate 245 or 300 mg once daily.
OG001
Tenofovir Alafenamide
Participants who received Tenofovir alafenamide 25 mg once daily or every 2 days.
OG002
Entecavir
Participants who received Entecavir in 0.5 mg once daily.
Secondary
Median Tmax of NA Therapies
Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Median
Full Range
hour
Up to Week 24
ID
Title
Description
OG000
Tenofovir Disoproxil Fumarate
Participants who received Tenofovir disoproxil fumarate 245 or 300 mg once daily.
OG001
Tenofovir Alafenamide
Participants who received Tenofovir alafenamide 25 mg once daily or every 2 days.
OG002
Entecavir
Participants who received Entecavir 0.5 mg once a daily.
Secondary
Median Terminal Half-life (t1/2) of GSK3228836
Blood samples were collected from all participants for t1/2 analysis of GSK3228836. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.
The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Median
Full Range
Day
Up to Week 48
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
Secondary
Mean Ctau of GSK3228836
Blood samples were collected from all participants for Ctau analysis of GSK3228836 at indicated. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.
The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).
Posted
Mean
Standard Deviation
ng/mL
Up to Week 24
ID
Title
Description
OG000
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
Time Frame
All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks.
Description
The safety population included participants who received at least one dose of study treatment.
The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).
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
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
0
68
1
68
56
68
EG001
GSK3228836 for 12+12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
0
67
1
67
59
67
EG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
0
68
4
68
53
68
EG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
0
23
0
23
16
23
EG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
0
70
6
70
65
70
EG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
0
67
2
67
60
67
EG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
0
68
3
68
61
68
EG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
0
24
0
24
19
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG0030 events0 affected23 at risk
EG0041 events1 affected70 at risk
EG0050 events0 affected67 at risk
EG0060 events0 affected68 at risk
EG0070 events0 affected24 at risk
Haemorrhoids
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Chest pain
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Systemic inflammatory response syndrome
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
COVID-19 pneumonia
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatitis B
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Concussion
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Bile duct cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Cerebral infarction
Nervous system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Cryoglobulinaemia
Vascular disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hypotension
Vascular disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abnormal clotting factor
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG0030 events0 affected23 at risk
EG0040 events0 affected70 at risk
EG0050 events0 affected67 at risk
EG0061 events1 affected68 at risk
EG0070 events0 affected24 at risk
Anaemia
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0014 events3 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0013 events2 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Monocytosis
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0006 events4 affected68 at risk
EG0012 events2 affected67 at risk
EG0023 events1 affected68 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Angina pectoris
Cardiac disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Atrial fibrillation
Cardiac disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Palpitations
Cardiac disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Tachycardia
Cardiac disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Dyschromatosis
Congenital, familial and genetic disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Deafness
Ear and labyrinth disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
v24.1
Systematic Assessment
EG0002 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Ear pain
Ear and labyrinth disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vertigo
Ear and labyrinth disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hyperthyroidism
Endocrine disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hypothyroidism
Endocrine disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Asthenopia
Eye disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Blepharitis
Eye disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Dry eye
Eye disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Eye pain
Eye disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Keratitis
Eye disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Noninfective conjunctivitis
Eye disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Ocular hyperaemia
Eye disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Periorbital swelling
Eye disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events2 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Abdominal distension
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0003 events2 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Abdominal pain
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events1 affected68 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0024 events2 affected68 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Change of bowel habit
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Constipation
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0024 events4 affected68 at risk
EG003
Dental caries
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0002 events2 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Diarrhoea
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0006 events6 affected68 at risk
EG0012 events2 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Dry mouth
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Dyspepsia
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Faecaloma
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Flatulence
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Food poisoning
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Gastritis
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Gingival pain
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Gingival ulceration
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Haematochezia
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Nausea
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0023 events2 affected68 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Stomatitis
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events1 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Tooth disorder
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Toothache
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Vomiting
Gastrointestinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Asthenia
General disorders
v24.1
Systematic Assessment
EG0006 events5 affected68 at risk
EG0013 events1 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Chest discomfort
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Chest pain
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Chills
General disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0016 events4 affected67 at risk
EG0022 events1 affected68 at risk
EG003
Energy increased
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Fatigue
General disorders
v24.1
Systematic Assessment
EG0008 events5 affected68 at risk
EG0014 events4 affected67 at risk
EG00213 events7 affected68 at risk
EG003
Feeling abnormal
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hyperthermia
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Influenza like illness
General disorders
v24.1
Systematic Assessment
EG0002 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Injection site anaesthesia
General disorders
v24.1
Systematic Assessment
EG0002 events1 affected68 at risk
EG0018 events3 affected67 at risk
EG0024 events2 affected68 at risk
EG003
Injection site bruising
General disorders
v24.1
Systematic Assessment
EG00036 events7 affected68 at risk
EG00117 events11 affected67 at risk
EG00223 events7 affected68 at risk
EG003
Injection site discolouration
General disorders
v24.1
Systematic Assessment
EG00022 events8 affected68 at risk
EG00165 events9 affected67 at risk
EG00292 events14 affected68 at risk
EG003
Injection site discomfort
General disorders
v24.1
Systematic Assessment
EG00013 events2 affected68 at risk
EG00162 events9 affected67 at risk
EG00254 events9 affected68 at risk
EG003
Injection site erosion
General disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Injection site erythema
General disorders
v24.1
Systematic Assessment
EG000216 events36 affected68 at risk
EG001175 events37 affected67 at risk
EG002194 events34 affected68 at risk
EG003
Injection site haematoma
General disorders
v24.1
Systematic Assessment
EG0009 events5 affected68 at risk
EG00115 events3 affected67 at risk
EG0023 events1 affected68 at risk
EG003
Injection site haemorrhage
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Injection site hypoaesthesia
General disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Injection site induration
General disorders
v24.1
Systematic Assessment
EG00014 events3 affected68 at risk
EG0016 events3 affected67 at risk
EG00213 events4 affected68 at risk
EG003
Injection site nodule
General disorders
v24.1
Systematic Assessment
EG0003 events1 affected68 at risk
EG0012 events2 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Injection site pain
General disorders
v24.1
Systematic Assessment
EG00045 events11 affected68 at risk
EG00159 events15 affected67 at risk
EG002118 events21 affected68 at risk
EG003
Injection site pruritus
General disorders
v24.1
Systematic Assessment
EG00088 events14 affected68 at risk
EG00178 events17 affected67 at risk
EG002100 events15 affected68 at risk
EG003
Injection site swelling
General disorders
v24.1
Systematic Assessment
EG00045 events4 affected68 at risk
EG00112 events4 affected67 at risk
EG00270 events13 affected68 at risk
EG003
Injection site warmth
General disorders
v24.1
Systematic Assessment
EG0002 events1 affected68 at risk
EG00113 events5 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Malaise
General disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Nodule
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Non-cardiac chest pain
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0022 events1 affected68 at risk
EG003
Oedema peripheral
General disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Pain
General disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0014 events3 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Peripheral swelling
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Pyrexia
General disorders
v24.1
Systematic Assessment
EG00014 events10 affected68 at risk
EG0018 events6 affected67 at risk
EG00219 events10 affected68 at risk
EG003
Scar inflammation
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Sensation of foreign body
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Swelling
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vaccination site pain
General disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Food allergy
Immune system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Immunodeficiency
Immune system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Seasonal allergy
Immune system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Type III immune complex mediated reaction
Immune system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Bacterial infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Bacteriuria
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Bronchitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
COVID-19
Infections and infestations
v24.1
Systematic Assessment
EG0002 events2 affected68 at risk
EG0018 events8 affected67 at risk
EG0025 events5 affected68 at risk
EG003
Cellulitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Chronic hepatitis B
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Conjunctivitis
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Cystitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Diarrhoea infectious
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Epididymitis
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Folliculitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Fungal infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Fungal skin infection
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Furuncle
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Gastroenteritis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Genital herpes
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Gingivitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Helicobacter gastritis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatitis B
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Herpes dermatitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Herpes simplex
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Herpes virus infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Herpes zoster
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hordeolum
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0023 events2 affected68 at risk
EG003
Infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Influenza
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Injection site abscess
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Injection site cellulitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events2 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Nasopharyngitis
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected67 at risk
EG0025 events5 affected68 at risk
EG003
Oral herpes
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Oral infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Otitis externa
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Otitis media
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Otitis media acute
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Parotitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Periodontitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Pharyngitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Pustule
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Respiratory tract infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Respiratory tract infection viral
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Sinusitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Skin infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Subcutaneous abscess
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Suspected COVID-19
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Tonsillitis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Tooth abscess
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Tooth infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Upper respiratory tract infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Urethritis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Urinary tract infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Vaginal infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vaginitis gardnerella
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Viral infection
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Back injury
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Contusion
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Fall
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Injury
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Nail injury
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Post vaccination syndrome
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Tooth avulsion
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Tooth dislocation
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Tooth injury
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0002 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
v24.1
Systematic Assessment
EG0002 events2 affected68 at risk
EG0013 events2 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Alanine aminotransferase increased
Investigations
v24.1
Systematic Assessment
EG00013 events7 affected68 at risk
EG00110 events8 affected67 at risk
EG0026 events4 affected68 at risk
EG003
Albumin urine present
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Antineutrophil cytoplasmic antibody positive
Investigations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Antinuclear antibody positive
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Aspartate aminotransferase increased
Investigations
v24.1
Systematic Assessment
EG0003 events3 affected68 at risk
EG0011 events1 affected67 at risk
EG0023 events3 affected68 at risk
EG003
Autoantibody positive
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Bilirubin conjugated increased
Investigations
v24.1
Systematic Assessment
EG0002 events2 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Blood alkaline phosphatase increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Blood bilirubin increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Blood calcium decreased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Blood creatine increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Blood creatinine increased
Investigations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Blood potassium increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Blood pressure increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Body temperature increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0027 events1 affected68 at risk
EG003
C-reactive protein increased
Investigations
v24.1
Systematic Assessment
EG0002 events2 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Complement factor C3 decreased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Complement factor C4 decreased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Complement factor abnormal
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Complement factor increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Creatinine renal clearance decreased
Investigations
v24.1
Systematic Assessment
EG0004 events2 affected68 at risk
EG00121 events6 affected67 at risk
EG0022 events1 affected68 at risk
EG003
Creatinine urine increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Crystal urine present
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Eosinophil count increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Glomerular filtration rate decreased
Investigations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Hepatic enzyme increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hepatitis B DNA assay positive
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Immature granulocyte count increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
International normalised ratio increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Liver function test abnormal
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Mean cell volume decreased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Neutrophil count decreased
Investigations
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Platelet count decreased
Investigations
v24.1
Systematic Assessment
EG0006 events4 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Protein urine present
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Prothrombin time prolonged
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Red blood cells urine positive
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Total complement activity decreased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Transaminases increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Urinary sediment present
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Urine albumin/creatinine ratio
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Urine albumin/creatinine ratio increased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0023 events1 affected68 at risk
EG003
Urine analysis abnormal
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Urine leukocyte esterase positive
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
White blood cell count decreased
Investigations
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Cell death
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vitamin B complex deficiency
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0005 events3 affected68 at risk
EG0014 events3 affected67 at risk
EG0028 events6 affected68 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0005 events4 affected68 at risk
EG0015 events5 affected67 at risk
EG0028 events6 affected68 at risk
EG003
Bone swelling
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0002 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0005 events5 affected68 at risk
EG0016 events2 affected67 at risk
EG0024 events4 affected68 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events2 affected67 at risk
EG0024 events2 affected68 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Sacral pain
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Sjogren's syndrome
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Haemangioma of liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Neoplasm skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Ageusia
Nervous system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Dizziness
Nervous system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events2 affected67 at risk
EG0024 events3 affected68 at risk
EG003
Dysgeusia
Nervous system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Headache
Nervous system disorders
v24.1
Systematic Assessment
EG00010 events5 affected68 at risk
EG0018 events6 affected67 at risk
EG00215 events8 affected68 at risk
EG003
Hypoaesthesia
Nervous system disorders
v24.1
Systematic Assessment
EG0002 events2 affected68 at risk
EG0016 events2 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Lethargy
Nervous system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Migraine
Nervous system disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Paraesthesia
Nervous system disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Sciatica
Nervous system disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Somnolence
Nervous system disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Syncope
Nervous system disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Anxiety
Psychiatric disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Depressed mood
Psychiatric disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Depression
Psychiatric disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Insomnia
Psychiatric disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0012 events1 affected67 at risk
EG0022 events1 affected68 at risk
EG003
Irritability
Psychiatric disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Sleep disorder
Psychiatric disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Stress
Psychiatric disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Albuminuria
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Cylindruria
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Dysuria
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Glycosuria
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Haematuria
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Ketonuria
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Leukocyturia
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Nephrocalcinosis
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Nephropathy toxic
Renal and urinary disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Proteinuria
Renal and urinary disorders
v24.1
Systematic Assessment
EG0003 events1 affected68 at risk
EG0013 events2 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Renal cyst
Renal and urinary disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Urine abnormality
Renal and urinary disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Breast pain
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Cervical polyp
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Cervix haemorrhage uterine
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Genital haemorrhage
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Vulvovaginal inflammation
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vulvovaginal swelling
Reproductive system and breast disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events3 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Nasal pruritus
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0002 events2 affected68 at risk
EG0014 events3 affected67 at risk
EG0023 events2 affected68 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Reflux laryngitis
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0013 events2 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Asteatosis
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Drug reaction with eosinophilia and systemic symptoms
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0012 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0023 events2 affected68 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0011 events1 affected67 at risk
EG0023 events2 affected68 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0002 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Nail bed bleeding
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0011 events1 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0006 events3 affected68 at risk
EG0012 events2 affected67 at risk
EG0022 events1 affected68 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0008 events4 affected68 at risk
EG0017 events1 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0023 events2 affected68 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Skin hypertrophy
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Umbilical erythema
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0022 events2 affected68 at risk
EG003
Urticarial vasculitis
Skin and subcutaneous tissue disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Haematoma
Vascular disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Hot flush
Vascular disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Hypertension
Vascular disorders
v24.1
Systematic Assessment
EG0001 events1 affected68 at risk
EG0010 events0 affected67 at risk
EG0021 events1 affected68 at risk
EG003
Hypotension
Vascular disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Varicose vein
Vascular disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vascular pain
Vascular disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Vasculitis
Vascular disorders
v24.1
Systematic Assessment
EG0000 events0 affected68 at risk
EG0010 events0 affected67 at risk
EG0020 events0 affected68 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
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.
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
Title
Measurements
OG00016
OG0019
OG0028
OG0034
OG00417
OG00510
OG0066
OG0071
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
HBsAg< LLOQ, at baseline
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00268
ParticipantsOG00323
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00668
ParticipantsOG00724
Title
Measurements
OG0000
OG0010
OG0020
OG003
HBsAg decline <0.5 log10 IU/mL
ParticipantsOG00064
ParticipantsOG00163
ParticipantsOG00263
ParticipantsOG00322
HBsAg decline >=0.5 log10 IU/mL
ParticipantsOG00064
ParticipantsOG00163
ParticipantsOG00263
ParticipantsOG00322
HBsAg decline >=1 log10 IU/mL
ParticipantsOG00064
ParticipantsOG00163
ParticipantsOG00263
ParticipantsOG00322
HBsAg decline >=1.5 log10 IU/mL
ParticipantsOG00064
ParticipantsOG00163
ParticipantsOG00263
ParticipantsOG00322
HBsAg decline >=3 log10 IU/mL
ParticipantsOG00064
ParticipantsOG00163
ParticipantsOG00263
ParticipantsOG00322
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
HBV DNA < LLOQ, at Baseline
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00268
ParticipantsOG00323
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00668
ParticipantsOG00724
Title
Measurements
OG00066
OG00166
OG00266
OG003
HBV DNA decline <1 log10 IU/mL
ParticipantsOG00062
ParticipantsOG00160
ParticipantsOG00260
ParticipantsOG00320
HBV DNA decline >=1 log10 IU/mL
ParticipantsOG00062
ParticipantsOG00160
ParticipantsOG00260
ParticipantsOG00320
HBV DNA decline >=2 log10 IU/mL
ParticipantsOG00062
ParticipantsOG00160
ParticipantsOG00260
ParticipantsOG00320
HBV DNA decline >=3 log10 IU/mL
ParticipantsOG00062
ParticipantsOG00160
ParticipantsOG00260
ParticipantsOG00320
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
Participants with ALT > ULN, at Baseline
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00268
ParticipantsOG00323
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00668
ParticipantsOG00724
Title
Measurements
OG0006
OG0017
OG0026
OG003
Participants with ALT normalization, at Week 24
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0032
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG0006
OG0017
OG0026
OG0032
OG00420
OG00520
OG00621
OG0079
Title
Denominators
Categories
Title
Measurements
OG00016.6(1.1 to NA)Upper limit was Not estimable (NE) due to an insufficient number of participants with events.
OG0014.1(1.0 to 11.9)
OG0021(1.0 to 8.1)
OG0037(1.1 to NA)Upper limit was NE due to an insufficient number of participants.
OG00413.4(2.1 to NA)Upper limit was NE due to an insufficient number of participants with events
OG00515.1(4.3 to 18.1)
OG00610.7(5.1 to 21.1)
OG00718.1(1 to 32.1)
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
Title
Measurements
OG0003
OG0014
OG0025
OG0032
OG0046
OG0054
OG0066
OG0073
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
HBsAg, at Baseline
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00268
ParticipantsOG00323
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00668
ParticipantsOG00724
Title
Measurements
OG0003.29± 0.623
OG0013.26± 0.608
OG0023.33± 0.588
OG003
HBsAg, at Week 12
ParticipantsOG00065
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00322
HBsAg, at Week 24
ParticipantsOG00064
ParticipantsOG00163
ParticipantsOG00263
ParticipantsOG00322
HBV DNA, at Baseline
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00268
ParticipantsOG00323
HBV DNA, at Week 12
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00261
ParticipantsOG00322
HBV DNA, at Week 24
ParticipantsOG00062
ParticipantsOG00160
ParticipantsOG00260
ParticipantsOG00320
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00018
OG00120
OG00224
OG0037
OG00421
OG00516
OG00616
OG0077
Title
Denominators
Categories
HBeAg, at Baseline
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00224
ParticipantsOG0037
ParticipantsOG00421
ParticipantsOG00516
ParticipantsOG00616
ParticipantsOG0077
Title
Measurements
OG0000.49± 1.014
OG0010.12± 0.756
OG0020.36± 1.053
OG003
HBeAg, at Week 12
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00221
ParticipantsOG0037
HBeAg, at Week 24
ParticipantsOG00016
ParticipantsOG00118
ParticipantsOG00223
ParticipantsOG0037
OG002
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
HBsAg, at Baseline
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00268
ParticipantsOG00323
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00668
ParticipantsOG00724
Title
Measurements
OG0003.29± 0.623
OG0013.26± 0.608
OG0023.33± 0.588
OG003
HBsAg, at Week 12
ParticipantsOG00065
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00322
HBsAg, at Week 24
ParticipantsOG00064
ParticipantsOG00163
ParticipantsOG00263
ParticipantsOG00322
HBV DNA, at Baseline
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00268
ParticipantsOG00323
HBV DNA, at Week 12
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00261
ParticipantsOG00322
HBV DNA, at Week 24
ParticipantsOG00062
ParticipantsOG00160
ParticipantsOG00260
ParticipantsOG00320
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00018
OG00120
OG00224
OG0037
OG00421
OG00516
OG00616
OG0077
Title
Denominators
Categories
HBeAg, at Baseline
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00224
ParticipantsOG0037
ParticipantsOG00421
ParticipantsOG00516
ParticipantsOG00616
ParticipantsOG0077
Title
Measurements
OG0000.49± 1.014
OG0010.12± 0.756
OG0020.36± 1.053
OG003
HBeAg, at Week 12
ParticipantsOG00018
ParticipantsOG00119
ParticipantsOG00224
ParticipantsOG0037
HBeAg, at WeeK 24
ParticipantsOG00016
ParticipantsOG00118
ParticipantsOG00223
ParticipantsOG0037
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
At baseline
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00323
ParticipantsOG00469
ParticipantsOG00567
ParticipantsOG00667
ParticipantsOG00724
Title
Measurements
OG0000.67± 0.289
OG0010.65± 0.165
OG0020.64± 0.129
OG003
At Week 36
ParticipantsOG00065
ParticipantsOG00164
ParticipantsOG00265
ParticipantsOG00322
At Week 48
ParticipantsOG00065
ParticipantsOG00165
ParticipantsOG00266
ParticipantsOG00322
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG003
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
OG004
GSK3228836 for 24 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).
OG005
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
OG006
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.
OG007
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00168
OG00268
OG00323
OG00470
OG00568
OG00668
OG00724
Title
Denominators
Categories
At Baseline
ParticipantsOG00068
ParticipantsOG00167
ParticipantsOG00267
ParticipantsOG00323
ParticipantsOG00469
ParticipantsOG00567
ParticipantsOG00667
ParticipantsOG00724
Title
Measurements
OG0000.67± 0.289
OG0010.65± 0.165
OG0020.64± 0.129
OG003
At Week 12
ParticipantsOG00065
ParticipantsOG00164
ParticipantsOG00264
ParticipantsOG00322
At Week 24
ParticipantsOG00065
ParticipantsOG00165
ParticipantsOG00265
ParticipantsOG00322
12
OG00112
Title
Denominators
Categories
Title
Measurements
OG00055.214± 22.9901
OG001140.312± 37.3548
12
OG00112
Title
Denominators
Categories
Title
Measurements
OG0006.112± 2.8112
OG00114.956± 5.6592
12
OG00112
Title
Denominators
Categories
Title
Measurements
OG0003.008(2.00 to 4.02)
OG0013.017(2.00 to 5.00)
Units
Counts
Participants
OG0007
OG0015
OG00216
Title
Denominators
Categories
Title
Measurements
OG0002753.908± 661.3392
OG001308.167± 104.8297
OG00224.43± 6.761
Units
Counts
Participants
OG0007
OG0015
OG00216
Title
Denominators
Categories
Title
Measurements
OG00057.04± 17.0787
OG00110.31± 3.4802
OG0020.478± 0.1055
Units
Counts
Participants
OG0007
OG0015
OG00216
Title
Denominators
Categories
Title
Measurements
OG000318.857± 95.94
OG00119.36± 5.85
OG0026.526± 2.27
Units
Counts
Participants
OG0007
OG0015
OG00216
Title
Denominators
Categories
Title
Measurements
OG0001(0.52 to 1.47)
OG0011.417(0.93 to 1.55)
OG0020.983(0.48 to 2.02)
OG003
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.
Units
Counts
Participants
OG00068
OG00167
OG00270
OG00367
Title
Denominators
Categories
Title
Measurements
OG00028.897(7.52 to 191.98)
OG00124.918(8.84 to 216.43)
OG00227.846(10.19 to 149.74)
OG00338.205(6.87 to 161.83)
OG003
GSK3228836 for 12+12 WK (Not on NA Therapy)
All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.