A Trial To Evaluate The Efficacy And Safety Of Multiple C... | NCT04225715 | Trialant
NCT04225715
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Sep 19, 2025Actual
Enrollment
281Actual
Phase
Phase 2
Conditions
Hepatitis B, Chronic
Interventions
Nucleos(t)ide (NUC)
CpAM (RO7049389)
TLR7 (RO7020531)
siRNA (RO7445482)
PEG-IFN
PD-L1 LNA (RO7191863)
Countries
Bulgaria
Canada
Chile
China
France
Hong Kong
New Zealand
Romania
South Korea
Spain
Taiwan
Thailand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04225715
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
WV41073
Secondary IDs
ID
Type
Description
Link
2019-002086-35
EudraCT Number
Brief Title
A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
Official Title
A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
Acronym
Piranga
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Aug 2025
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 5, 2020Actual
Primary Completion Date
Jul 19, 2024Actual
Completion Date
Jul 19, 2024Actual
First Submitted Date
Jan 8, 2020
First Submission Date that Met QC Criteria
Jan 9, 2020
First Posted Date
Jan 13, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Jul 17, 2025
Results First Submitted that Met QC Criteria
Aug 29, 2025
Results First Posted Date
Sep 19, 2025Actual
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
Aug 29, 2025
Last Update Posted Date
Sep 19, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis B, Chronic
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
281Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Nucleos(t)ide (NUC) Control Arm
Active Comparator
Participants will continue their background NUC therapy for the 48-week treatment period. At the end of the treatment period, in line with current CHB treatment guidelines, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Participants will receive RO7049389 (600 mg once daily [QD]) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg once every other day [QOD]) will be administered during Weeks 1-12 and Weeks 25-36. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Drug: Nucleos(t)ide (NUC)
Drug: CpAM (RO7049389)
Drug: TLR7 (RO7020531)
Short Interfering Ribonucleic acid (siRNA; RO7445482) (Dose1) + NUC
Experimental
Participants will receive RO7445482 (Dose 1) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Drug: Nucleos(t)ide (NUC)
Drug: siRNA (RO7445482)
siRNA (RO7445482) (Dose 2) + NUC
Experimental
Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT)
HBsAg loss was defined as quantitative HBsAg <0.05 international units/milliliters (IU/mL). The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants *100. 95% confidence interval (CI) was calculated using the Clopper-Pearson method. Percentages have been rounded off.
Follow-up Week (FUW) 24
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HBsAg Loss
HBsAg loss was defined as quantitative HBsAg <0.05 IU/mL. The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants *100. 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off.
Combos 1 and 5: Weeks 24, 36, 48 and FUW 48; Combos 2, 3, 4, 6 and NUC Arm: Week 48 and FUW 48; Combo 7: Week 24; Combo 8: Week 36
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Body mass index between 18 and 32 kg/m2 inclusive.
Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for >=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for >=12 months, having received the same NUC therapy for >=3 months prior to screening.
HBV DNA below the lower LLOQ or < 20 IU/mL for > 6 months prior to screening and confirmed at screening.
Alanine transaminase (ALT) <=1.5 x upper limit of normal (ULN) for > 6 months prior to screening and confirmed at screening.
Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.
Exclusion Criteria:
Pregnant or lactating women.
Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV).
History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease.
History of or suspicion of Hepatocellular Carcinoma (HCC).
Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests.
Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study.
Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study.
History of alcohol abuse and/or drug abuse within one year of randomization.
History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment.
Currently taking, or have received within 3 months of Day 1, systemic corticosteroids.
Electrocardiogram (ECG) with clinically significant abnormalities.
Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Tokuda Hospital Sofia
Sofia
1407
Bulgaria
University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD
Hou J, Zhang W, Xie Q, Hua R, Tang H, Morano Amado LE, Yang SS, Peng CY, Su WW, Chuang WL, Kim DJ, Avihingsanon A, Kao JH, Leerapun A, Yuen MF, Asselah T, Liang X, Bo Q, Canducci F, Catanese MT, Chen E, Cheng C, Chughlay F, Das S, Glavini K, Guerreiro N, Huang Y, Kakrana P, Kazma R, Patil A, Pavlovic V, Surujbally B, Triyatni M, Upmanyu R, Wat C, Gane E; Piranga Study Group. Xalnesiran with or without an Immunomodulator in Chronic Hepatitis B. N Engl J Med. 2024 Dec 5;391(22):2098-2109. doi: 10.1056/NEJMoa2405485.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of a screening phase, followed by up to 48 weeks of treatment and up to 48 weeks of post-treatment follow-up. Multiple new combination therapies were compared against a common control. Combos 1, 5, 7 and 8 were prematurely terminated by the Sponsor.
Recruitment Details
A total of 281 participants with chronic hepatitis B (CHB) who had virologic suppression with Nucleos(t)ide (NUC) therapy took part in the study across 13 countries from 05 July 2020 to 19 July 2024.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. PEG-IFN will be administered at a dose of 180 μg once weekly (QW) for 48 weeks. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Drug: Nucleos(t)ide (NUC)
Drug: siRNA (RO7445482)
Drug: PEG-IFN
siRNA (RO7445482) + CpAM (RO7049389) + NUC
Experimental
Participants will receive RO7445482 (Dose 2) and RO7049389 (600 mg QD) in addition to their background NUC therapy for the 48-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Drug: Nucleos(t)ide (NUC)
Drug: CpAM (RO7049389)
Drug: siRNA (RO7445482)
siRNA (RO7445482) + TLR7 (RO7020531) + NUC
Experimental
Participants will receive RO7445482 (Dose 2) in addition to their background NUC therapy for the 48-week treatment period. RO7020531 (150 mg QOD) will be administered during Weeks 13-24 and Weeks 37-48 (i.e., 2 treatment cycles of 12 weeks' duration each and 42 doses of RO7020531 for each cycle). At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 13-24, in addition to their background NUC therapy for the 24-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Participants will receive RO7445482 (Dose 2) during Weeks 1-24 and RO7191863 (Dose 1) will be administered during Weeks 25-36, in addition to their background NUC therapy for the 36-week treatment period. At the end of the treatment period, participants will continue NUC treatment during the follow-up unless the NUC discontinuation criteria have been met.
Drug: Nucleos(t)ide (NUC)
Drug: siRNA (RO7445482)
Drug: PD-L1 LNA (RO7191863)
Nucleos(t)ide (NUC) Control Arm
Short Interfering Ribonucleic acid (siRNA; RO7445482) (Dose1) + NUC
Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as a quantitative HBsAg < 0.05 IU/mL and a positive anti-HBs antibody (defined as per assay reactive threshold anti-HBs ≥10 IU/L). 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off.
Combos 1 and 5: Weeks 24, 36, 48, FUW 24 and FUW 48; Combos 2, 3, 4, 6 and NUC Arm: Week 48, FUW 24 and FUW 48; Combo 7: Week 24 and FUW 24; Combo 8: Week 36 and FUW 24
Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants
HBeAg loss was defined as negative /non-reactive HBeAg level. Percentages have been rounded off.
Weeks 12, 24, 36, and 48; FUW 12, 24, 36, and 48
Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants
HBeAg seroconversion was defined as a negative /non-reactive HBeAg level and a positive anti-HBe antibody. Percentages have been rounded off.
Weeks 12, 24, 36, and 48; FUW 12, 24, 36, and 48
Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL
Chronic HBV infection is characterized by high levels of circulating HBV DNA. Therefore, HBV levels are indicative of virological response. At screening participants were on NUC therapy and had circulating HBV DNA levels below the assay LLOQ or below 20 IU/mL for at least 6 months. The emergence of a virological breakthrough (HBV DNA >100 IU/mL or >1 log increase from nadir) while on NUC therapy, or the emergence of a virological relapse (>2,000 IU/mL) in participants taken off NME combination and NUC therapy during follow-up, was monitored through the quantification of HBV DNA in plasma.
FUW 12, 24, 36, and 48
Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time
The serological markers of HBV infection include viral antigens (HBsAg & HBeAg) and antibody (anti-HBs). Changes in serological markers and efficacy biomarkers (HBV RNA) from baseline are reported. Change from baseline for HBV DNA was assessed in 'ON NUC' participants.
Combos 7 and 8: Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Week 1 (AUC1-0-168h) of PD-L1 LNA
The AUC was predicted and summarized by modelling & simulation via the population pharmacokinetics (PopPK) method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
Predose on Day 1 and up to 168 hours post dose (Week 1)
Combos 7 and 8: Maximum Plasma Concentration (Cmax) at Week 1 (Cmax1-0-168h) of PD-L1 LNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
Predose on Day 1 and up to 168 hours post dose (Week 1)
Combos 7 and 8: AUC Over the Dosing Interval at Week 12 (AUC12-0-168h) of PD-L1 LNA
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
Predose on Day 1 of Week 12 up to 168 hours post dose (Week 12)
Combos 7 and 8: Cmax at Week 12 (Cmax12-0-168h) of PD-L1 LNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
Predose on Day 1 of Week 12 up to 168 hours post dose (Week 12)
Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
Predose on Day 1 and 1-3 and 4-6 hours post dose each day, up to Day 28
Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
Predose on Day 1 and 1-3 and 4-6 hours post dose each day, up to Day 28
Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA
The AUC tau was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. Simulations for the dosing interval between Day 29 and Day 56 was done using population PK modeling informed by sparse PK samples collected on Days 1, 85, 169, 253, and 337 at predose, 1-3 hours, and 4-6 hours post dose.
From Day 29 up to Day 56
Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. Simulations for the dosing interval between Day 29 and Day 56 was done using population PK modeling informed by sparse PK samples collected on Days 1, 85, 169, 253, and 337 at predose, 1-3 hours, and 4-6 hours post dose.
From Day 29 up to Day 56
Combos 1 and 6: AUC of TLR7
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
Predose and 1-3 and 4-6 hours post-dose on Days 1, 3, 5 on Weeks 12 and 36
Combos 1 and 6: Cmax of TLR7
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
Predose and 1-3 and 4-6 hours post-dose on Days 1, 3, 5 on Weeks 12 and 36
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
From Day 1 up to end of 48 weeks of follow up (up to approximately 1.8 years)
Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies
Treatment-emergent anti drug antibody (ADA) was defined as participants who seroconverted or experienced a boost in preexisting ADA during the study. Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but develop an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples were greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
From Day 1 up to end of follow up (up to approximately 4 years)
Combos 7 and 8: Number of Participants With Anti-PD-L1 Antibodies
Treatment-emergent ADA was defined as participants who seroconverted or experienced a boost in preexisting ADA during the study. Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but develop an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples were greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
From Day 1 for Combo 7 and 8 up to end of follow up (Up to approximately 2 years)
Sofia
1431
Bulgaria
University of Calgary
Calgary
Alberta
T2N 2T9
Canada
Uni of Alberta Hospital
Edmonton
Alberta
T6G 2S2
Canada
Toronto Liver Centre
Toronto
Ontario
M6H 3M1
Canada
Hospital San Juan de Dios La Serena
La Serena
1700000
Chile
Beijing Friendship Hospital
Beijing
100050
China
The First Hospital of Jilin University
Changchun
130021
China
West China Hospital, Sichuan University
Chengdu
610041
China
Nanfang Hospital, Southern Medical University
Guangzhou
510515
China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai
200025
China
Huashan Hospital, Fudan University
Shanghai
200040
China
Hopital Beaujon
Clichy
92118
France
Queen Mary Hospital
Hong Kong
Hong Kong
Auckland Clinical Studies Limited
Auckland
1010
New Zealand
Middlemore Clinical Trials
Auckland
New Zealand
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca
400006
Romania
Chuncheon Sacred Heart Hospital
Gangwon-Do
200-704
South Korea
Asan Medical Center / Clinical Trial Center
Seoul
138-736
South Korea
SMG-SNU Boramae Medical Center
Seoul
156-707
South Korea
Seoul National University College of Medicine, Liver Research Institute
Seoul
South Korea
Hospital Alvaro Cunqueiro
Vigo
Pontevedra
36212
Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona
08035
Spain
Changhua Christian Hospital
Chang-hua
500
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
807
Taiwan
China Medical University Hospital
Taichung
40447
Taiwan
Taichung Veterans General Hospital
Taichung
40705
Taiwan
National Cheng Kung Univ Hosp
Tainan
00704
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
HIVNAT
Bangkok
10330
Thailand
Siriraj Hospital
Bangkok
10700
Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
50200
Thailand
King College Hospital NHS Foundation Trust
London
SE5 9RS
United Kingdom
Participants received core protein allosteric modulator (CpAM), 600 milligrams (mg) tablets, orally, once daily (QD) for 48 weeks and toll-like receptor 7 (TLR7) agonist, 150 mg, orally, once every other day (QOD) during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
FG002
Combo 2: siRNA (100 mg) + NUC
Participants received short interfering ribonucleic acid (siRNA), 100 mg, as a subcutaneous (SC) injection, every 4 weeks (Q4W) in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
FG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
FG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and pegylated interferon (PEG-IFN), 180 micrograms (µg), as a SC injection, every week (QW) in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
FG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
FG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
FG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and programmed death ligand-1 locked nucleic acid (PD-L1 LNA), 2 milligrams/kilograms (mg/kg), as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
FG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
FG00036 subjects
FG00138 subjects
FG00230 subjects
FG00330 subjects
FG00430 subjects
FG00519 subjects
FG00634 subjects
FG00733 subjects
FG00831 subjects
COMPLETED
FG00030 subjects
FG00137 subjects
FG00229 subjects
FG00330 subjects
FG00427 subjects
FG0059 subjects
FG00633 subjects
FG00715 subjects
FG00812 subjects
NOT COMPLETED
FG0006 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0043 subjects
FG00510 subjects
FG0061 subjects
FG00718 subjects
FG00819 subjects
Type
Comment
Reasons
Reason not Specified
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Arm Terminated By Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All participants population included all participants who were randomized to their treatment regimen.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG001
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG002
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00036
BG00138
BG00230
BG00330
BG00430
BG00519
BG00634
BG00733
BG00831
BG009281
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
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
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 24 Weeks Post-End of Treatment (EOT)
HBsAg loss was defined as quantitative HBsAg <0.05 international units/milliliters (IU/mL). The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants *100. 95% confidence interval (CI) was calculated using the Clopper-Pearson method. Percentages have been rounded off.
Modified Intent to Treat (mITT) population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis.
Posted
Number
95% Confidence Interval
percentage of participants
Follow-up Week (FUW) 24
ID
Title
Description
OG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG002
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00035
OG00135
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 10)
OG0010(0 to 0)
OG0026.7(0.8 to 22.1)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Difference in Response Rate
7.2
2-Sided
95
-2.1
16.4
95% CI for difference of two proportions was calculated using Cochran-Mantel-Haenszel (CMH) method.
Superiority
OG000
OG003
Secondary
Percentage of Participants With HBsAg Loss
HBsAg loss was defined as quantitative HBsAg <0.05 IU/mL. The percentage of participants with HBsAg loss was calculated as number of participants with HBsAg loss / total number of participants *100. 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off.
mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis. Number analyzed included participants with data available for analysis at that specified timepoint.
Posted
Number
95% Confidence Interval
percentage of participants
Combos 1 and 5: Weeks 24, 36, 48 and FUW 48; Combos 2, 3, 4, 6 and NUC Arm: Week 48 and FUW 48; Combo 7: Week 24; Combo 8: Week 36
ID
Title
Description
OG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Secondary
Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as a quantitative HBsAg < 0.05 IU/mL and a positive anti-HBs antibody (defined as per assay reactive threshold anti-HBs ≥10 IU/L). 95% CI was calculated using the Clopper-Pearson method. Percentages have been rounded off.
mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis. Number analyzed included participants with data available for analysis at that specified timepoint.
Posted
Number
95% Confidence Interval
percentage of participants
Combos 1 and 5: Weeks 24, 36, 48, FUW 24 and FUW 48; Combos 2, 3, 4, 6 and NUC Arm: Week 48, FUW 24 and FUW 48; Combo 7: Week 24 and FUW 24; Combo 8: Week 36 and FUW 24
ID
Title
Description
OG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Secondary
Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss in Baseline HBeAg-positive Participants
HBeAg loss was defined as negative /non-reactive HBeAg level. Percentages have been rounded off.
mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants from the mITT population who were positive for HBeAg at baseline. Number analyzed included participants with data available for analysis at that specified timepoint.
Posted
Number
percentage of participants
Weeks 12, 24, 36, and 48; FUW 12, 24, 36, and 48
ID
Title
Description
OG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG002
Combo 2: siRNA (100 mg) + NUC
Secondary
Percentage of Participants With HBeAg Seroconversion in Baseline HBeAg-positive Participants
HBeAg seroconversion was defined as a negative /non-reactive HBeAg level and a positive anti-HBe antibody. Percentages have been rounded off.
mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants from the mITT population who were positive for HBeAg at baseline. Number analyzed included participants with data available for analysis at that specified timepoint.
Posted
Number
percentage of participants
Weeks 12, 24, 36, and 48; FUW 12, 24, 36, and 48
ID
Title
Description
OG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG002
Secondary
Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantification (LLOQ), <200 IU/mL, and <2,000 IU/mL
Chronic HBV infection is characterized by high levels of circulating HBV DNA. Therefore, HBV levels are indicative of virological response. At screening participants were on NUC therapy and had circulating HBV DNA levels below the assay LLOQ or below 20 IU/mL for at least 6 months. The emergence of a virological breakthrough (HBV DNA >100 IU/mL or >1 log increase from nadir) while on NUC therapy, or the emergence of a virological relapse (>2,000 IU/mL) in participants taken off NME combination and NUC therapy during follow-up, was monitored through the quantification of HBV DNA in plasma.
mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis. Number analyzed included participants with data available for analysis at that specified timepoint. Different participants may have contributed data for each timepoint.
Posted
Count of Participants
Participants
FUW 12, 24, 36, and 48
ID
Title
Description
OG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 1: CpAM + TLR7 Agonist + NUC
Secondary
Change From Baseline in HBsAg, Anti-HBs, HBeAg, HBV Ribonucleic Acid (RNA) and HBV DNA Levels Over Time
The serological markers of HBV infection include viral antigens (HBsAg & HBeAg) and antibody (anti-HBs). Changes in serological markers and efficacy biomarkers (HBV RNA) from baseline are reported. Change from baseline for HBV DNA was assessed in 'ON NUC' participants.
mITT population included participants who were randomized and received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed included participants with data available for analysis. Number analyzed included participants with data available for analysis at that specified timepoint.
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Secondary
Combos 7 and 8: Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Week 1 (AUC1-0-168h) of PD-L1 LNA
The AUC was predicted and summarized by modelling & simulation via the population pharmacokinetics (PopPK) method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
PK population included participants who received at least one dose of the PD-L1 LNA and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
hours*nanomoles/liters (hr*nmol/L)
Predose on Day 1 and up to 168 hours post dose (Week 1)
ID
Title
Description
OG000
Combo 7 and 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 (Combo 7)/ Weeks 25-36 (Combo 8) in addition to their background NUC therapy for 24 weeks (Combo 7)/ 36 weeks (Combo 8). After Week 24/36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG000
Secondary
Combos 7 and 8: Maximum Plasma Concentration (Cmax) at Week 1 (Cmax1-0-168h) of PD-L1 LNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
PK population included participants who received at least one dose of the PD-L1 LNA and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
nanomoles/liters (nmol/L)
Predose on Day 1 and up to 168 hours post dose (Week 1)
ID
Title
Description
OG000
Combo 7 and 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 (Combo 7)/ Weeks 25-36 (Combo 8) in addition to their background NUC therapy for 24 weeks (Combo 7)/ 36 weeks (Combo 8). After Week 24/36 participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG000
Secondary
Combos 7 and 8: AUC Over the Dosing Interval at Week 12 (AUC12-0-168h) of PD-L1 LNA
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
PK population included participants who received at least one dose of the PD-L1 LNA and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
hr*nmol/L
Predose on Day 1 of Week 12 up to 168 hours post dose (Week 12)
ID
Title
Description
OG000
Combo 7 and 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 (Combo 7)/ Weeks 25-36 (Combo 8) in addition to their background NUC therapy for 24 weeks (Combo 7)/ 36 weeks (Combo 8). After Week 24/36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG000
Secondary
Combos 7 and 8: Cmax at Week 12 (Cmax12-0-168h) of PD-L1 LNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. As per planned analysis data was collected and reported in a pooled manner for Combos 7 and 8.
PK population included participants who received at least one dose of the PD-L1 LNA and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
nmol/L
Predose on Day 1 of Week 12 up to 168 hours post dose (Week 12)
ID
Title
Description
OG000
Combo 7 and 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 (Combo 7)/ Weeks 25-36 (Combo 8) in addition to their background NUC therapy for 24 weeks (Combo 7)/ 36 weeks (Combo 8). After Week 24/36 participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG000
Secondary
Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve (AUC) Over Days 1-28 of siRNA
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
PK population included participants who received at least one dose of the siRNA and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
hours*nanograms/millilitres (hr*ng/mL)
Predose on Day 1 and 1-3 and 4-6 hours post dose each day, up to Day 28
ID
Title
Description
OG000
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG002
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Secondary
Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 1-28 of siRNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
PK population included participants who received at least one dose of the siRNA and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
nanograms/millilitres (ng/mL)
Predose on Day 1 and 1-3 and 4-6 hours post dose each day, up to Day 28
ID
Title
Description
OG000
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG002
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Secondary
Combos 2, 3, 4, 6, 7 and 8: Area Under the Plasma Concentration Time Curve During the Dosing Interval (AUC Tau) Over Days 29-56 of siRNA
The AUC tau was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. Simulations for the dosing interval between Day 29 and Day 56 was done using population PK modeling informed by sparse PK samples collected on Days 1, 85, 169, 253, and 337 at predose, 1-3 hours, and 4-6 hours post dose.
PK population included participants who received at least one dose of the siRNA and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
hr*ng/mL
From Day 29 up to Day 56
ID
Title
Description
OG000
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG002
Combo 4: siRNA + PEG-IFN + NUC
Secondary
Combos 2, 3, 4, 6, 7 and 8: Cmax Over Days 29-56 of siRNA
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples. Simulations for the dosing interval between Day 29 and Day 56 was done using population PK modeling informed by sparse PK samples collected on Days 1, 85, 169, 253, and 337 at predose, 1-3 hours, and 4-6 hours post dose.
PK population included participants who received at least one dose of the siRNA and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
ng/mL
From Day 29 up to Day 56
ID
Title
Description
OG000
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG002
Combo 4: siRNA + PEG-IFN + NUC
Secondary
Combos 1 and 6: AUC of TLR7
The AUC was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
PK population included participants who received at least one dose of the TLR7 and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
ng*hr/mL
Predose and 1-3 and 4-6 hours post-dose on Days 1, 3, 5 on Weeks 12 and 36
ID
Title
Description
OG000
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Secondary
Combos 1 and 6: Cmax of TLR7
The Cmax was predicted and summarized by modelling & simulation via the PopPK method based on pre and post dose samples.
PK population included participants who received at least one dose of the TLR7 and had at least one evaluable post-baseline PK sample.
Posted
Mean
Standard Deviation
ng/mL
Predose and 1-3 and 4-6 hours post-dose on Days 1, 3, 5 on Weeks 12 and 36
ID
Title
Description
OG000
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Secondary
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Safety population included participants randomized to a treatment regimen who received at least one dose of any drug for their assigned treatment regimen, whether prematurely withdrawn from the study or not.
Posted
Count of Participants
Participants
From Day 1 up to end of 48 weeks of follow up (up to approximately 1.8 years)
ID
Title
Description
OG000
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Secondary
Combos 2, 3, 4, 5, 6, 7 and 8: Number of Participants With Anti-siRNA Antibodies
Treatment-emergent anti drug antibody (ADA) was defined as participants who seroconverted or experienced a boost in preexisting ADA during the study. Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but develop an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples were greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
Immunogenicity population included participants who had at least one pre-dose (baseline) or at least one post-dose assessment will be included and analyzed according to the treatment they actually received or were allocated to receive.
Posted
Count of Participants
Participants
From Day 1 up to end of follow up (up to approximately 4 years)
ID
Title
Description
OG000
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Secondary
Combos 7 and 8: Number of Participants With Anti-PD-L1 Antibodies
Treatment-emergent ADA was defined as participants who seroconverted or experienced a boost in preexisting ADA during the study. Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but develop an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples were greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
Immunogenicity population included participants who had at least one pre-dose (baseline) or at least one post-dose assessment will be included and analyzed according to the treatment they actually received or were allocated to receive.
Posted
Count of Participants
Participants
From Day 1 for Combo 7 and 8 up to end of follow up (Up to approximately 2 years)
ID
Title
Description
OG000
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG001
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Time Frame
From Day 1 up to end of 48 week follow up (up to approximately 1.8 years)
Description
Safety population included participants randomized to a treatment regimen who received at least one dose of any drug for their assigned treatment regimen, whether prematurely withdrawn from the study or not.
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
Combo 1: CpAM + TLR7 Agonist + NUC
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
0
38
3
38
33
38
EG001
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
0
30
3
30
27
30
EG002
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
0
30
4
30
29
30
EG003
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
0
30
2
30
29
30
EG004
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
0
19
0
19
18
19
EG005
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
0
34
2
34
33
34
EG006
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
0
33
0
33
23
33
EG007
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
0
31
0
31
25
31
EG008
NUC Control Arm
Participants continued their background NUC therapy for 48 weeks. Thereafter, in line with current CHB treatment guidelines, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
0
35
1
35
25
35
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diplopia
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG0031 events1 affected30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
Large intestine polyp
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Fascioliasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Vertebral osteophyte
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Benign hepatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Pancreatic neuroendocrine tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Panic reaction
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG0030 events0 affected30 at risk
EG0042 events2 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Monocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0012 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Sinus arrhythmia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0013 events2 affected30 at risk
EG0024 events3 affected30 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected30 at risk
EG0025 events2 affected30 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0012 events2 affected30 at risk
EG0022 events2 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0013 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 events2 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Chest discomfort
General disorders
MedDRA 27.0
Systematic Assessment
EG0003 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0005 events5 affected38 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG00062 events14 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Injection site reaction
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0012 events2 affected30 at risk
EG00216 events9 affected30 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0009 events6 affected38 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected30 at risk
EG003
Sensation of foreign body
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Thirst
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected38 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Hepatic mass
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected30 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0018 events7 affected30 at risk
EG0023 events3 affected30 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0006 events6 affected38 at risk
EG00110 events10 affected30 at risk
EG00217 events16 affected30 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0025 events4 affected30 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0013 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Hepatitis B reactivation
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0016 events6 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0005 events4 affected38 at risk
EG00124 events14 affected30 at risk
EG00216 events11 affected30 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG00010 events8 affected38 at risk
EG0015 events5 affected30 at risk
EG0026 events6 affected30 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Product dose omission issue
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0003 events2 affected38 at risk
EG00114 events13 affected30 at risk
EG00214 events14 affected30 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0005 events4 affected38 at risk
EG00122 events13 affected30 at risk
EG00221 events13 affected30 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0016 events5 affected30 at risk
EG0025 events5 affected30 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0004 events3 affected38 at risk
EG00111 events6 affected30 at risk
EG00217 events10 affected30 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0015 events1 affected30 at risk
EG0024 events3 affected30 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Cystatin C increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Electrocardiogram PR shortened
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Glutamate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected30 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0014 events3 affected30 at risk
EG0025 events3 affected30 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected38 at risk
EG0012 events1 affected30 at risk
EG0023 events1 affected30 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Protein urine present
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Thyroxine free decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0004 events4 affected38 at risk
EG0012 events1 affected30 at risk
EG0024 events1 affected30 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0013 events2 affected30 at risk
EG0022 events1 affected30 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG00110 events6 affected30 at risk
EG00215 events7 affected30 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0012 events1 affected30 at risk
EG0024 events1 affected30 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0019 events6 affected30 at risk
EG0029 events6 affected30 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected38 at risk
EG0013 events3 affected30 at risk
EG0024 events3 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected38 at risk
EG0012 events1 affected30 at risk
EG0023 events3 affected30 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0023 events2 affected30 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Haemangioma of liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected30 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0004 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG00024 events5 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Prostatic calcification
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected30 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0015 events4 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected38 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected30 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected38 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected30 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
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG004
Difference in Response Rate
24.3
2-Sided
95
9
39.5
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG006
Difference in Response Rate
12.3
2-Sided
95
1.3
23.3
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG007
Difference in Response Rate
0
2-Sided
95
0
0
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG008
Difference in Response Rate
6.7
2-Sided
95
-2.2
15.7
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG002
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00035
OG00136
OG00230
OG00330
OG00430
OG0054
OG00634
OG00733
OG00830
Title
Denominators
Categories
Week 24
ParticipantsOG0000
ParticipantsOG00136
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG00733
ParticipantsOG0080
Title
Measurements
OG0010(0 to 0)
OG0050(0 to 0)
OG0076.1(0.7 to 20.2)
Week 36
ParticipantsOG0000
ParticipantsOG00123
ParticipantsOG0020
ParticipantsOG0030
Week 48
ParticipantsOG00035
ParticipantsOG00120
ParticipantsOG00230
ParticipantsOG00330
FUW 48
ParticipantsOG00035
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00330
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG007
Combo 7: Week 24
6.2
6.2
2-Sided
95
-2
14.5
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG008
Combo 8: Week 36
Difference in Response Rate
13.4
2-Sided
95
1.2
25.6
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG002
Combo 2: Week 48
Difference in Response Rate
7.2
2-Sided
95
-2.1
16.4
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG003
Combo 3: Week 48
Difference in Response Rate
3.5
2-Sided
95
-3.1
10
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG004
Combo 4: Week 48
Difference in Response Rate
31.2
2-Sided
95
14.7
47.6
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG006
Combo 6: Week 48
Difference in Response Rate
18.4
2-Sided
95
5.4
31.4
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG002
Combo 2: FUW 48
Difference in Response Rate
8.1
2-Sided
95
-3.9
20.1
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG003
Combo 3: FUW 48
Difference in Response Rate
-2.7
2-Sided
95
-8.1
2.7
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG004
Combo 4: FUW 48
Difference in Response Rate
14.6
2-Sided
95
0.4
28.8
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG000
OG006
Combo 6: FUW 48
Difference in Response Rate
9.5
2-Sided
95
-2.5
21.5
95% CI for difference of two proportions was calculated using CMH method.
Superiority
OG002
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00035
OG00136
OG00230
OG00330
OG00430
OG0059
OG00634
OG00733
OG00830
Title
Denominators
Categories
Week 24
ParticipantsOG0000
ParticipantsOG00136
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0059
ParticipantsOG0060
ParticipantsOG00733
ParticipantsOG0080
Title
Measurements
OG0010(0 to 0)
OG0050(0 to 0)
OG0070(0 to 10.6)
Week 36
ParticipantsOG0000
ParticipantsOG00123
ParticipantsOG0020
ParticipantsOG0030
Week 48
ParticipantsOG00035
ParticipantsOG00120
ParticipantsOG00230
ParticipantsOG00330
FUW 24
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00230
ParticipantsOG00330
FUW 48
ParticipantsOG00035
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00330
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for the 24 weeks. After Week 24, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for the 36 weeks. After Week 36, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG0008
OG0018
OG0029
OG0038
OG00412
OG0057
OG00610
OG0079
OG0085
Title
Denominators
Categories
Week 12
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG00412
ParticipantsOG0057
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG0000
OG0010
OG00222.2
OG003
Week 24
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 36
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0034
Week 48
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0038
FUW 12
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0038
FUW 24
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
FUW 36
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
FUW 48
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG0038
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG0008
OG0018
OG0029
OG0038
OG00412
OG0057
OG00610
OG0079
OG0085
Title
Denominators
Categories
Week 12
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG0038
ParticipantsOG00412
ParticipantsOG0057
ParticipantsOG00610
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG0000
OG0010
OG00211.1
OG003
Week 24
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 36
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0034
Week 48
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0038
FUW 12
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0038
FUW 24
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
FUW 36
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
FUW 48
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG0038
Participants received CpAM, 600 mg tablets, orally, QD for 48 weeks and TLR7 agonist, 150 mg, orally, QOD during Weeks 1-12 and Weeks 25-36 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG002
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00035
OG00135
OG00230
OG00330
OG00430
OG0059
OG00634
OG00733
OG00830
Title
Denominators
Categories
FUW 12: OFF NUC (< LLOQ)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG00610
ParticipantsOG0073
ParticipantsOG0085
Title
Measurements
OG0000
OG0023
OG0034
OG004
FUW 12: OFF NUC (≥ LLOQ - < 200 IU/mL)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0036
FUW 12: OFF NUC (≥ 200 - < 2000 IU/mL)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0036
FUW 12: OFF NUC (≥ 2000 IU/mL)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0036
FUW 12: ON NUC (< LLOQ)
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG00219
ParticipantsOG00323
FUW 12: ON NUC (≥ LLOQ - < 200 IU/mL)
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG00219
ParticipantsOG00323
FUW 12: ON NUC (≥ 200 - < 2000 IU/mL)
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG00219
ParticipantsOG00323
FUW 12: ON NUC (≥ 2000 IU/mL)
ParticipantsOG00028
ParticipantsOG00132
ParticipantsOG00219
ParticipantsOG00323
FUW 24: OFF NUC (< LLOQ)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0035
FUW 24: OFF NUC (≥ LLOQ - < 200 IU/mL)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0035
FUW 24: OFF NUC (≥ 200 - < 2000 IU/mL)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0035
FUW 24: OFF NUC (≥ 2000 IU/mL)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0035
FUW 24: ON NUC (< LLOQ)
ParticipantsOG00027
ParticipantsOG00135
ParticipantsOG00224
ParticipantsOG00324
FUW 24: ON NUC (≥ LLOQ - < 200 IU/mL)
ParticipantsOG00027
ParticipantsOG00135
ParticipantsOG00224
ParticipantsOG00324
FUW 24: ON NUC (≥ 200 - < 2000 IU/mL)
ParticipantsOG00027
ParticipantsOG00135
ParticipantsOG00224
ParticipantsOG00324
FUW 24: ON NUC (≥ 2000 IU/mL)
ParticipantsOG00027
ParticipantsOG00135
ParticipantsOG00224
ParticipantsOG00324
FUW 36: OFF NUC (< LLOQ)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0035
FUW 36: OFF NUC (≥ LLOQ - < 200 IU/mL)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0035
FUW 36: OFF NUC (≥ 200 - < 2000 IU/mL)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0035
FUW 36: OFF NUC (≥ 2000 IU/mL)
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0035
FUW 36: ON NUC (< LLOQ)
ParticipantsOG00029
ParticipantsOG00131
ParticipantsOG00225
ParticipantsOG00325
FUW 36: ON NUC (≥ LLOQ - < 200 IU/mL)
ParticipantsOG00029
ParticipantsOG00131
ParticipantsOG00225
ParticipantsOG00325
FUW 36: ON NUC (≥ 200 - < 2000 IU/mL)
ParticipantsOG00029
ParticipantsOG00131
ParticipantsOG00225
ParticipantsOG00325
FUW 36: ON NUC (≥ 2000 IU/mL)
ParticipantsOG00029
ParticipantsOG00131
ParticipantsOG00225
ParticipantsOG00325
FUW 48: OFF NUC (< LLOQ)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
FUW 48: OFF NUC (≥ LLOQ - < 200 IU/mL)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
FUW 48: OFF NUC (≥ 200 - < 2000 IU/mL)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
FUW 48: OFF NUC (≥ 2000 IU/mL)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0037
FUW 48: ON NUC (< LLOQ)
ParticipantsOG00030
ParticipantsOG00128
ParticipantsOG00227
ParticipantsOG00323
FUW 48: ON NUC (≥ LLOQ - < 200 IU/mL)
ParticipantsOG00030
ParticipantsOG00128
ParticipantsOG00227
ParticipantsOG00323
FUW 48: ON NUC (≥ 200 - < 2000 IU/mL)
ParticipantsOG00030
ParticipantsOG00128
ParticipantsOG00227
ParticipantsOG00323
FUW 48: ON NUC (≥ 2000 IU/mL)
ParticipantsOG00030
ParticipantsOG00128
ParticipantsOG00227
ParticipantsOG00323
OG002
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
OG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during the follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00035
OG00136
OG00230
OG00330
OG00430
OG0059
OG00634
OG00733
OG00830
Title
Denominators
Categories
HBsAg: Week 24
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00228
ParticipantsOG00329
ParticipantsOG00428
ParticipantsOG0054
ParticipantsOG00618
ParticipantsOG00733
ParticipantsOG00830
Title
Measurements
OG000-0.08± 0.16
OG001-0.11± 0.26
OG002-1.49± 0.56
OG003
HBsAg: Week 36
ParticipantsOG00033
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00319
HBsAg: Week 48
ParticipantsOG00034
ParticipantsOG00120
ParticipantsOG00229
ParticipantsOG00330
HBsAg: FUW 24
ParticipantsOG00029
ParticipantsOG00135
ParticipantsOG00228
ParticipantsOG00330
HBsAg: FUW 48
ParticipantsOG00030
ParticipantsOG00128
ParticipantsOG00229
ParticipantsOG00330
Anti-HBs: Week 24
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00228
ParticipantsOG00329
Anti-HBs: Week 36
ParticipantsOG00034
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00319
Anti-HBs: Week 48
ParticipantsOG00034
ParticipantsOG00120
ParticipantsOG00229
ParticipantsOG00330
Anti-HBs: FUW 24
ParticipantsOG00029
ParticipantsOG00135
ParticipantsOG00228
ParticipantsOG00330
Anti-HBs: FUW 48
ParticipantsOG00030
ParticipantsOG00128
ParticipantsOG00229
ParticipantsOG00330
HBeAg: Week 24
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
HBeAg: Week 36
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0034
HBeAg: Week 48
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0038
HBeAg: FUW 24
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
HBeAg: FUW 48
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG0038
HBV RNA: Week 24
ParticipantsOG0009
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00314
HBV RNA: Week 36
ParticipantsOG0009
ParticipantsOG0016
ParticipantsOG0029
ParticipantsOG0039
HBV RNA: Week 48
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG00315
HBV RNA: FUW 24
ParticipantsOG0009
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00315
HBV RNA: FUW 48
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG00211
ParticipantsOG00315
HBV DNA: FUW 24
ParticipantsOG00027
ParticipantsOG00135
ParticipantsOG00224
ParticipantsOG00324
HBV DNA: FUW 48
ParticipantsOG00030
ParticipantsOG00128
ParticipantsOG0022
ParticipantsOG0037
63
Title
Denominators
Categories
Title
Measurements
OG0001047± 273
63
Title
Denominators
Categories
Title
Measurements
OG000163± 60.8
63
Title
Denominators
Categories
Title
Measurements
OG0001143± 286
63
Title
Denominators
Categories
Title
Measurements
OG000165± 60.9
OG003
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00334
OG00433
OG00531
Title
Denominators
Categories
Title
Measurements
OG0004670± 1112
OG00111098± 2499
OG00211073± 2272
OG0039831± 2215
OG0049780± 1942
OG0059110± 1418
OG003
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00334
OG00433
OG00531
Title
Denominators
Categories
Title
Measurements
OG000190± 116
OG001463± 203
OG002450± 168
OG003408± 168
OG004373± 149
OG005311± 97
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00334
OG00433
OG00531
Title
Denominators
Categories
Title
Measurements
OG0005401± 1245
OG00112591± 2659
OG00212623± 2428
OG00311207± 2371
OG00411216± 2068
OG00510513± 1511
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00334
OG00433
OG00531
Title
Denominators
Categories
Title
Measurements
OG000192± 116
OG001468± 204
OG002454± 169
OG003411± 169
OG004376± 150
OG005315± 98
Participants
OG00038
OG00134
Title
Denominators
Categories
Title
Measurements
OG0003139± 938.8
OG0012813± 75.33
Participants
OG00038
OG00134
Title
Denominators
Categories
Title
Measurements
OG0001548± 419.7
OG0011491± 334.8
OG002
Combo 2: siRNA (100 mg) + NUC
Participants received siRNA, 100 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 3: siRNA (200 mg) + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG007
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG008
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00035
OG00138
OG00230
OG00330
OG00430
OG00519
OG00634
OG00733
OG00831
Title
Denominators
Categories
Title
Measurements
OG00027
OG00134
OG00230
OG00329
OG00430
OG00518
OG00633
OG00726
OG00827
OG002
Combo 4: siRNA + PEG-IFN + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and PEG-IFN, 180 µg, as a SC injection, QW in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG003
Combo 5: siRNA + CpAM + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W and CpAM, 600 mg tablets, orally, QD in addition to their background NUC therapy for 48 weeks. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG004
Combo 6: siRNA + TLR7 Agonist + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W for 48 weeks and TLR7 agonist, 150 mg tablets, orally, QOD during Weeks 13-24 and Weeks 37-48 in addition to their background NUC therapy. After Week 48, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG005
Combo 7: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 13-24 in addition to their background NUC therapy for 24 weeks. After Week 24, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
OG006
Combo 8: siRNA + PD-L1 LNA + NUC
Participants received siRNA, 200 mg, as a SC injection, Q4W up to Week 24 and PD-L1 LNA, 2 mg/kg, as a SC injection, QW during Weeks 25-36 in addition to their background NUC therapy for 36 weeks. After Week 36, participants continued NUC treatment during follow-up unless the NUC discontinuation criteria were met.
Units
Counts
Participants
OG00030
OG00130
OG00230
OG00319
OG00434
OG00533
OG00631
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG00212
OG0031
OG0043
OG00510
OG00614
Units
Counts
Participants
OG00033
OG00131
Title
Denominators
Categories
Title
Measurements
OG00016
OG00115
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
3 events
3 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0061 events1 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0042 events2 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
5 events
5 affected
30 at risk
EG0042 events2 affected19 at risk
EG0052 events2 affected34 at risk
EG0062 events2 affected33 at risk
EG0072 events2 affected31 at risk
EG0080 events0 affected35 at risk
6 events
4 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0042 events2 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
6 events
4 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0062 events1 affected33 at risk
EG0074 events3 affected31 at risk
EG0080 events0 affected35 at risk
4 events
2 affected
30 at risk
EG0045 events4 affected19 at risk
EG0054 events4 affected34 at risk
EG0062 events1 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0053 events3 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0071 events1 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0042 events2 affected19 at risk
EG0052 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0054 events3 affected34 at risk
EG0062 events1 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
3 events
3 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0042 events2 affected19 at risk
EG0052 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0041 events1 affected19 at risk
EG0053 events1 affected34 at risk
EG0068 events2 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
1 events
1 affected
30 at risk
EG0041 events1 affected19 at risk
EG0052 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0071 events1 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0062 events1 affected33 at risk
EG0072 events2 affected31 at risk
EG0080 events0 affected35 at risk
12 events
7 affected
30 at risk
EG0041 events1 affected19 at risk
EG0053 events3 affected34 at risk
EG0068 events3 affected33 at risk
EG0073 events3 affected31 at risk
EG0080 events0 affected35 at risk
12 events
8 affected
30 at risk
EG0041 events1 affected19 at risk
EG00538 events16 affected34 at risk
EG0060 events0 affected33 at risk
EG0076 events4 affected31 at risk
EG0080 events0 affected35 at risk
39 events
15 affected
30 at risk
EG0044 events3 affected19 at risk
EG00510 events7 affected34 at risk
EG0069 events5 affected33 at risk
EG00737 events7 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0053 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
7 events
7 affected
30 at risk
EG0044 events4 affected19 at risk
EG00510 events7 affected34 at risk
EG0061 events1 affected33 at risk
EG0072 events2 affected31 at risk
EG0081 events1 affected35 at risk
1 events
1 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0052 events2 affected34 at risk
EG0061 events1 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
6 events
6 affected
30 at risk
EG0041 events1 affected19 at risk
EG0052 events2 affected34 at risk
EG0063 events3 affected33 at risk
EG0070 events0 affected31 at risk
EG0084 events4 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
17 events
17 affected
30 at risk
EG0043 events3 affected19 at risk
EG00518 events17 affected34 at risk
EG0063 events3 affected33 at risk
EG0074 events4 affected31 at risk
EG0088 events8 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0052 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG00510 events10 affected34 at risk
EG0064 events4 affected33 at risk
EG0077 events7 affected31 at risk
EG0083 events3 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0062 events2 affected33 at risk
EG0075 events4 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
16 events
13 affected
30 at risk
EG0046 events5 affected19 at risk
EG0056 events4 affected34 at risk
EG0061 events1 affected33 at risk
EG0074 events2 affected31 at risk
EG0084 events4 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0056 events4 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0072 events2 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0043 events3 affected19 at risk
EG0051 events1 affected34 at risk
EG0064 events4 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
23 events
19 affected
30 at risk
EG0047 events2 affected19 at risk
EG00533 events15 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG00813 events13 affected35 at risk
39 events
25 affected
30 at risk
EG00416 events10 affected19 at risk
EG00525 events15 affected34 at risk
EG0066 events6 affected33 at risk
EG0078 events6 affected31 at risk
EG0083 events3 affected35 at risk
14 events
6 affected
30 at risk
EG0041 events1 affected19 at risk
EG0056 events5 affected34 at risk
EG0063 events3 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
32 events
21 affected
30 at risk
EG0047 events7 affected19 at risk
EG00521 events11 affected34 at risk
EG0064 events4 affected33 at risk
EG0073 events2 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
7 events
5 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0072 events2 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
8 events
3 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
2 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0083 events2 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
9 events
7 affected
30 at risk
EG0041 events1 affected19 at risk
EG0051 events1 affected34 at risk
EG0062 events2 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
12 events
5 affected
30 at risk
EG0041 events1 affected19 at risk
EG0052 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
4 events
2 affected
30 at risk
EG0045 events3 affected19 at risk
EG0054 events2 affected34 at risk
EG0064 events4 affected33 at risk
EG0071 events1 affected31 at risk
EG0080 events0 affected35 at risk
5 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
24 events
12 affected
30 at risk
EG0040 events0 affected19 at risk
EG00511 events6 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
26 events
17 affected
30 at risk
EG0041 events1 affected19 at risk
EG0053 events3 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
12 events
8 affected
30 at risk
EG0042 events2 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
3 events
3 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0082 events2 affected35 at risk
14 events
8 affected
30 at risk
EG0040 events0 affected19 at risk
EG00511 events5 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
1 events
1 affected
30 at risk
EG0042 events2 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
3 events
3 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG00511 events4 affected34 at risk
EG0060 events0 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
1 events
1 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
3 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
5 events
3 affected
30 at risk
EG0041 events1 affected19 at risk
EG0053 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
1 events
1 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0053 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0073 events2 affected31 at risk
EG0081 events1 affected35 at risk
1 events
1 affected
30 at risk
EG0041 events1 affected19 at risk
EG0050 events0 affected34 at risk
EG0062 events2 affected33 at risk
EG0073 events3 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0043 events2 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0081 events1 affected35 at risk
4 events
3 affected
30 at risk
EG0041 events1 affected19 at risk
EG0054 events3 affected34 at risk
EG0060 events0 affected33 at risk
EG0072 events2 affected31 at risk
EG0080 events0 affected35 at risk
4 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0071 events1 affected31 at risk
EG0082 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG00512 events5 affected34 at risk
EG0061 events1 affected33 at risk
EG0071 events1 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0041 events1 affected19 at risk
EG0056 events3 affected34 at risk
EG0063 events2 affected33 at risk
EG0074 events3 affected31 at risk
EG0080 events0 affected35 at risk
2 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0052 events2 affected34 at risk
EG0061 events1 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0041 events1 affected19 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
3 events
3 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected33 at risk
EG0071 events1 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0052 events2 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
5 events
5 affected
30 at risk
EG0040 events0 affected19 at risk
EG0053 events3 affected34 at risk
EG0061 events1 affected33 at risk
EG0074 events4 affected31 at risk
EG0081 events1 affected35 at risk
6 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0071 events1 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0043 events3 affected19 at risk
EG0051 events1 affected34 at risk
EG0062 events2 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0063 events3 affected33 at risk
EG0071 events1 affected31 at risk
EG0081 events1 affected35 at risk
5 events
5 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
3 events
3 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected33 at risk
EG0072 events1 affected31 at risk
EG0080 events0 affected35 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected35 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected33 at risk
EG0072 events2 affected31 at risk
EG0080 events0 affected35 at risk
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00830
Title
Measurements
OG0010(0 to 0)
OG0050(0 to 0)
OG00813.3(3.8 to 30.7)
Participants
OG004
30
ParticipantsOG0054
ParticipantsOG00634
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0000(0 to 10)
OG0010(0 to 0)
OG0026.7(0.8 to 22.1)
OG0033.3(0.1 to 17.2)
OG00430(14.7 to 49.4)
OG0050(0 to 0)
OG00617.6(6.8 to 34.5)
Participants
OG004
30
ParticipantsOG0051
ParticipantsOG00634
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0002.9(0.1 to 14.9)
OG0010(0 to 0)
OG00210(2.1 to 26.5)
OG0030(0 to 11.6)
OG00416.7(5.6 to 34.7)
OG0050(0 to 0)
OG00611.8(3.3 to 27.5)
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG00830
Title
Measurements
OG0010(0 to 0)
OG0050(0 to 0)
OG0080(0 to 11.9)
Participants
OG004
30
ParticipantsOG0054
ParticipantsOG00634
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0000(0 to 10)
OG0010(0 to 0)
OG0023.3(0.1 to 17.2)
OG0030(0 to 11.6)
OG00423.3(9.9 to 42.3)
OG0050(0 to 0)
OG0060(0 to 10.3)
Participants
OG004
30
ParticipantsOG0059
ParticipantsOG00634
ParticipantsOG00733
ParticipantsOG00830
Title
Measurements
OG0000(0 to 10)
OG0010(0 to 0)
OG0023.3(0.1 to 17.2)
OG0030(0 to 11.6)
OG00420(7.7 to 38.6)
OG0050(0 to 0)
OG0063.1(0.1 to 16.2)
OG0070(0 to 10.9)
OG0080(0 to 11.6)
Participants
OG004
30
ParticipantsOG0051
ParticipantsOG00634
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0002.9(0.1 to 14.9)
OG0010(0 to 0)
OG0023.3(0.1 to 17.2)
OG0030(0 to 11.6)
OG00416.7(5.6 to 34.7)
OG0050(0 to 0)
OG0065.9(0.7 to 19.7)
50
OG00433.3
OG00528.6
OG00630
OG00711.1
OG00840
Participants
OG004
12
ParticipantsOG0052
ParticipantsOG0067
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG0000
OG0010
OG00237.5
OG00350
OG00441.7
OG00550
OG00628.6
OG00711.1
OG00840
Participants
OG004
9
ParticipantsOG0050
ParticipantsOG00610
ParticipantsOG0070
ParticipantsOG0085
Title
Measurements
OG00014.3
OG0010
OG00244.4
OG00325
OG00455.6
OG00650
OG00840
Participants
OG004
11
ParticipantsOG0052
ParticipantsOG00610
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG00012.5
OG00120
OG00244.4
OG00362.5
OG00454.5
OG00550
OG00650
Participants
OG004
11
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG00016.7
OG0010
OG00242.9
OG00362.5
OG00454.5
OG00533.3
OG00644.4
OG00711.1
OG00820
Participants
OG004
11
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG00014.3
OG0010
OG00212.5
OG00350
OG00436.4
OG00566.7
OG00644.4
OG00711.1
OG00860
Participants
OG004
11
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0076
ParticipantsOG0083
Title
Measurements
OG00012.5
OG0010
OG00212.5
OG00350
OG00427.3
OG00633.3
OG0070
OG00866.7
Participants
OG004
11
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0080
Title
Measurements
OG00014.3
OG00125
OG00233.3
OG00350
OG00427.3
OG00644.4
OG0070
0
OG0048.3
OG00514.3
OG0060
OG0070
OG0080
Participants
OG004
12
ParticipantsOG0052
ParticipantsOG0067
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG0000
OG0010
OG0020
OG00312.5
OG0048.3
OG0050
OG0060
OG0070
OG0080
Participants
OG004
9
ParticipantsOG0050
ParticipantsOG00610
ParticipantsOG0070
ParticipantsOG0085
Title
Measurements
OG0000
OG0010
OG00211.1
OG0030
OG00411.1
OG00610
OG0080
Participants
OG004
11
ParticipantsOG0052
ParticipantsOG00610
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0000
OG0010
OG00211.1
OG00312.5
OG00418.2
OG0050
OG00610
Participants
OG004
11
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG00016.7
OG0010
OG00214.3
OG00312.5
OG00418.2
OG0050
OG00611.1
OG0070
OG0080
Participants
OG004
11
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG00014.3
OG0010
OG0020
OG00325
OG0049.1
OG00533.3
OG00611.1
OG0070
OG0080
Participants
OG004
11
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0076
ParticipantsOG0083
Title
Measurements
OG00012.5
OG0010
OG0020
OG00325
OG0049.1
OG00611.1
OG0070
OG0080
Participants
OG004
11
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0080
Title
Measurements
OG00014.3
OG0010
OG00211.1
OG00337.5
OG0049.1
OG00633.3
OG0070
4
OG0067
OG0072
OG0084
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG00610
ParticipantsOG0073
ParticipantsOG0085
Title
Measurements
OG0001
OG0021
OG0031
OG0040
OG0062
OG0071
OG0081
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG00610
ParticipantsOG0073
ParticipantsOG0085
Title
Measurements
OG0000
OG0021
OG0031
OG0041
OG0061
OG0070
OG0080
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG00610
ParticipantsOG0073
ParticipantsOG0085
Title
Measurements
OG0000
OG0020
OG0030
OG0040
OG0060
OG0070
OG0080
ParticipantsOG00421
ParticipantsOG0058
ParticipantsOG00620
ParticipantsOG00730
ParticipantsOG00825
Title
Measurements
OG00028
OG00132
OG00219
OG00323
OG00421
OG0058
OG00620
OG00730
OG00824
ParticipantsOG00421
ParticipantsOG0058
ParticipantsOG00620
ParticipantsOG00730
ParticipantsOG00825
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00421
ParticipantsOG0058
ParticipantsOG00620
ParticipantsOG00730
ParticipantsOG00825
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
ParticipantsOG00421
ParticipantsOG0058
ParticipantsOG00620
ParticipantsOG00730
ParticipantsOG00825
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG0047
ParticipantsOG0050
ParticipantsOG00612
ParticipantsOG0078
ParticipantsOG0089
Title
Measurements
OG0000
OG0022
OG0033
OG0046
OG0065
OG0075
OG0086
ParticipantsOG0047
ParticipantsOG0050
ParticipantsOG00612
ParticipantsOG0078
ParticipantsOG0089
Title
Measurements
OG0001
OG0022
OG0030
OG0040
OG0065
OG0072
OG0081
ParticipantsOG0047
ParticipantsOG0050
ParticipantsOG00612
ParticipantsOG0078
ParticipantsOG0089
Title
Measurements
OG0000
OG0020
OG0032
OG0041
OG0062
OG0071
OG0081
ParticipantsOG0047
ParticipantsOG0050
ParticipantsOG00612
ParticipantsOG0078
ParticipantsOG0089
Title
Measurements
OG0001
OG0020
OG0030
OG0040
OG0060
OG0070
OG0081
ParticipantsOG00420
ParticipantsOG0059
ParticipantsOG00621
ParticipantsOG00724
ParticipantsOG00821
Title
Measurements
OG00027
OG00135
OG00222
OG00324
OG00420
OG0059
OG00621
OG00724
OG00821
ParticipantsOG00420
ParticipantsOG0059
ParticipantsOG00621
ParticipantsOG00724
ParticipantsOG00821
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00420
ParticipantsOG0059
ParticipantsOG00621
ParticipantsOG00724
ParticipantsOG00821
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00420
ParticipantsOG0059
ParticipantsOG00621
ParticipantsOG00724
ParticipantsOG00821
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG0000
OG0021
OG0033
OG0046
OG0061
OG0075
OG0083
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG0000
OG0021
OG0030
OG0040
OG0063
OG0070
OG0082
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG0001
OG0020
OG0032
OG0040
OG0065
OG0070
OG0080
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0086
Title
Measurements
OG0000
OG0021
OG0030
OG0040
OG0060
OG0070
OG0081
ParticipantsOG00421
ParticipantsOG0051
ParticipantsOG00624
ParticipantsOG00717
ParticipantsOG00813
Title
Measurements
OG00029
OG00131
OG00224
OG00325
OG00421
OG0051
OG00622
OG00716
OG00813
ParticipantsOG00421
ParticipantsOG0051
ParticipantsOG00624
ParticipantsOG00717
ParticipantsOG00813
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0062
OG0071
OG0080
ParticipantsOG00421
ParticipantsOG0051
ParticipantsOG00624
ParticipantsOG00717
ParticipantsOG00813
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00421
ParticipantsOG0051
ParticipantsOG00624
ParticipantsOG00717
ParticipantsOG00813
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG0020
OG0035
OG0043
OG0063
OG0074
OG0081
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG0021
OG0030
OG0043
OG0064
OG0071
OG0081
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG0021
OG0032
OG0040
OG0062
OG0070
OG0081
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG0020
OG0030
OG0040
OG0060
OG0070
OG0081
ParticipantsOG00421
ParticipantsOG0051
ParticipantsOG00623
ParticipantsOG00710
ParticipantsOG0088
Title
Measurements
OG00030
OG00128
OG00227
OG00323
OG00421
OG0051
OG00623
OG00710
OG0087
ParticipantsOG00421
ParticipantsOG0051
ParticipantsOG00623
ParticipantsOG00710
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
ParticipantsOG00421
ParticipantsOG0051
ParticipantsOG00623
ParticipantsOG00710
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
ParticipantsOG00421
ParticipantsOG0051
ParticipantsOG00623
ParticipantsOG00710
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
-1.78
± 0.59
OG004-1.89± 1.05
OG005-1.38± 0.41
OG006-1.74± 0.62
OG007-2.12± 0.73
OG008-1.8± 0.49
ParticipantsOG00422
ParticipantsOG0051
ParticipantsOG00634
ParticipantsOG0070
ParticipantsOG00830
Title
Measurements
OG000-0.08± 0.13
OG001-0.13± 0.23
OG002-1.52± 0.67
OG003-1.93± 0.47
OG004-2.14± 1.27
OG005-1.51± NASince only 1 participant was analyzed, standard deviation (SD) could not be calculated.
OG006-1.71± 0.69
OG008-2.08± 0.63
ParticipantsOG00428
ParticipantsOG0054
ParticipantsOG00634
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000-0.2± 0.52
OG001-0.09± 0.12
OG002-1.58± 0.63
OG003-1.93± 0.6
OG004-2.22± 1.16
OG005-1.3± 0.45
OG006-2.18± 0.86
ParticipantsOG00427
ParticipantsOG0059
ParticipantsOG00631
ParticipantsOG00732
ParticipantsOG00830
Title
Measurements
OG000-0.19± 0.35
OG001-0.18± 0.31
OG002-1.19± 0.76
OG003-1.71± 0.75
OG004-1.71± 1.24
OG005-1.5± 0.89
OG006-1.47± 0.81
OG007-1.3± 0.7
OG008-1.46± 0.74
ParticipantsOG00427
ParticipantsOG0051
ParticipantsOG00632
ParticipantsOG00715
ParticipantsOG00812
Title
Measurements
OG000-0.25± 0.43
OG001-0.25± 0.36
OG002-0.89± 0.76
OG003-1.2± 0.84
OG004-1.28± 1.12
OG005-2.02± NASince only 1 participant was analyzed, SD could not be calculated.
OG006-1.01± 0.8
OG007-0.91± 0.69
OG008-1.14± 0.83
ParticipantsOG00428
ParticipantsOG0054
ParticipantsOG00618
ParticipantsOG00733
ParticipantsOG00830
Title
Measurements
OG000-0.01± 0.04
OG001-0.01± 0.08
OG0020.06± 0.32
OG0030± 0
OG0040.03± 0.2
OG0050.06± 0.13
OG006-0.01± 0.04
OG0070.01± 0.12
OG008-0.03± 0.1
ParticipantsOG00422
ParticipantsOG0051
ParticipantsOG00634
ParticipantsOG0070
ParticipantsOG00830
Title
Measurements
OG000-0.01± 0.02
OG001-0.02± 0.09
OG0020.06± 0.34
OG0030± 0
OG0040.3± 0.69
OG0050± NASince only 1 participant was analyzed, SD could not be calculated.
OG006-0.07± 0.27
OG008-0.03± 0.11
ParticipantsOG00428
ParticipantsOG0054
ParticipantsOG00634
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG0000± 0.01
OG001-0.04± 0.11
OG0020.06± 0.35
OG0030± 0
OG0040.55± 0.96
OG0050.01± 0.02
OG006-0.05± 0.27
ParticipantsOG00427
ParticipantsOG0059
ParticipantsOG00631
ParticipantsOG00732
ParticipantsOG00825
Title
Measurements
OG000-0.02± 0.08
OG001-0.01± 0.06
OG0020.05± 0.31
OG0030.01± 0.05
OG0040.63± 1.04
OG0050.09± 0.2
OG006-0.02± 0.41
OG0070.01± 0.1
OG008-0.06± 0.2
ParticipantsOG00427
ParticipantsOG0051
ParticipantsOG00632
ParticipantsOG0079
ParticipantsOG0089
Title
Measurements
OG0000.04± 0.33
OG001-0.01± 0.04
OG0020.01± 0.28
OG0030.02± 0.12
OG0040.41± 0.93
OG0050± NASince only 1 participant was analyzed, SD could not be calculated.
OG0060.04± 0.49
OG0070.09± 0.26
OG0080.02± 0.07
Participants
OG004
12
ParticipantsOG0052
ParticipantsOG0067
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG000-0.08± 0.1
OG001-0.04± 0.13
OG002-0.39± 0.16
OG003-0.4± 0.21
OG004-0.37± 0.19
OG005-0.19± 0.32
OG006-0.53± 0.3
OG007-0.47± 0.32
OG008-0.46± 0.15
Participants
OG004
9
ParticipantsOG0050
ParticipantsOG00610
ParticipantsOG0070
ParticipantsOG0085
Title
Measurements
OG000-0.08± 0.14
OG001-0.05± 0.04
OG002-0.45± 0.2
OG003-0.53± 0.15
OG004-0.43± 0.2
OG006-0.65± 0.44
OG008-0.46± 0.26
Participants
OG004
11
ParticipantsOG0052
ParticipantsOG00610
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000-0.06± 0.15
OG001-0.06± 0.06
OG002-0.48± 0.18
OG003-0.48± 0.2
OG004-0.44± 0.19
OG005-0.28± 0.42
OG006-0.69± 0.44
Participants
OG004
11
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG0079
ParticipantsOG0085
Title
Measurements
OG000-0.19± 0.15
OG001-0.09± 0.12
OG002-0.02± 1.37
OG003-0.42± 0.22
OG004-0.33± 0.19
OG005-0.68± 0.73
OG006-0.56± 0.33
OG007-0.4± 0.37
OG008-0.51± 0.31
Participants
OG004
11
ParticipantsOG0050
ParticipantsOG0069
ParticipantsOG0075
ParticipantsOG0080
Title
Measurements
OG000-0.36± 0.31
OG001-0.22± 0.11
OG002-0.14± 1.06
OG003-0.38± 0.19
OG004-0.3± 0.16
OG006-0.5± 0.38
OG007-0.42± 0.47
ParticipantsOG00414
ParticipantsOG0052
ParticipantsOG00610
ParticipantsOG00733
ParticipantsOG0086
Title
Measurements
OG0000.09± 0.43
OG001-1.19± 1.19
OG002-0.7± 0.34
OG003-0.95± 0.6
OG004-1.43± 0.89
OG005-1.34± 0.65
OG006-0.92± 0.92
OG007-1.17± 1.26
OG008-0.81± 0.55
ParticipantsOG0049
ParticipantsOG0050
ParticipantsOG00615
ParticipantsOG0070
ParticipantsOG0086
Title
Measurements
OG0000.05± 0.3
OG001-1.66± 1.4
OG002-0.74± 0.41
OG003-0.73± 0.57
OG004-1.67± 0.9
OG006-0.76± 0.76
OG008-0.76± 0.56
ParticipantsOG00414
ParticipantsOG0052
ParticipantsOG00615
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000-0.04± 0.32
OG001-1.66± 1.4
OG002-0.8± 0.48
OG003-0.94± 0.6
OG004-1.43± 0.95
OG005-1.32± 0.68
OG006-0.9± 0.81
ParticipantsOG00414
ParticipantsOG0054
ParticipantsOG00613
ParticipantsOG00710
ParticipantsOG0086
Title
Measurements
OG000-0.25± 0.28
OG001-0.13± 0.12
OG002-0.68± 0.49
OG003-0.87± 0.59
OG004-0.64± 0.82
OG005-1.04± 0.63
OG006-0.51± 0.63
OG007-0.82± 0.75
OG008-0.81± 0.55
ParticipantsOG00414
ParticipantsOG0050
ParticipantsOG00614
ParticipantsOG0074
ParticipantsOG0082
Title
Measurements
OG000-0.43± 0.6
OG001-0.11± 0.19
OG002-0.6± 0.48
OG003-0.78± 0.55
OG004-0.85± 0.75
OG006-0.37± 0.52
OG007-0.98± 0.8
OG008-0.49± 0.57
ParticipantsOG00420
ParticipantsOG0059
ParticipantsOG00621
ParticipantsOG00724
ParticipantsOG00821
Title
Measurements
OG000NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG001NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG002NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG003NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG004NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG005NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG006NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG007NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG008NA± NAMean and SD were not estimable due to all of samples being below LLOQ.
ParticipantsOG0046
ParticipantsOG0051
ParticipantsOG0069
ParticipantsOG00710
ParticipantsOG0088
Title
Measurements
OG000NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG001NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG002NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG003NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG004NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG005NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG006NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG007NA± NAMean and SD were not estimable due to all of the samples being below LLOQ.
OG008NA± NAMean and SD were not estimable due to all of samples being below LLOQ.