An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56... | NCT03361956

ID	Type	Description	Link
2017-001110-29	EudraCT Number
56136379HPB2001	Other Identifier	Janssen Sciences Ireland UC

An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56... | NCT03361956 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A: Arm 1 (JNJ-56136379 or NA) (open label)	Experimental	Participants with hepatitis B virus (HBV) currently not being treated and receiving JNJ-56136379 tablet (at a lower dose) orally for 24 weeks, will stop further dosing with JNJ-56136379 and start treatment with nucleos(t)ide analog (NA) (entecavir [ETV] or tenofovir disoproxil fumarate [TDF]), and enter the 24 week post treatment follow-up phase.	Drug: JNJ-56136379 Drug: NA (ETV or TDF)
Part A: Arm 2 (Placebo+NA [ETV] or [TDF])	Placebo Comparator	Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks.	Drug: Placebo Drug: NA (ETV or TDF)
Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF])	Experimental	Participants with HBV currently not being treated will receive JNJ-56136379 along with NA (ETV or TDF) tablet orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks.	Drug: JNJ-56136379 Drug: NA (ETV or TDF)
Part A: Arm 4 (Placebo + NA [ETV or TDF])	Placebo Comparator	Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-56136379	Drug	Participants will receive JNJ-56136379 tablet orally.	Part A: Arm 1 (JNJ-56136379 or NA) (open label) Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF])

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24	Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline.	Baseline and Week 24
Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24	Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) <60 IU/mL. This outcome measure was planned to be analyzed for specified arms only.	Baseline and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment- Emergent Adverse Events (AEs)	An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs were AEs with onset during the treatment phase or that worsened since baseline.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m^2), extremes included
Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum hepatitis B surface antigen (HBsAg)-positive at screening and serum HBsAg- or hepatitis B virus (HBV) deoxyribonucleic acid (DNA)-positive at least 6 months prior to screening; Serum immunoglobulin M (IgM) anti- hepatitis B core-related (HBc) antibody negative at screening
In participants currently not being treated (Treatment Arms 1-2-3 and 6-7-8): Participants must not be receiving any CHB treatment at screening, that is, Have never received treatment with HBV antiviral medicines, including NAs or interferon (IFN) products, OR Have not been on treatment with HBV antiviral medicines, including nucleos(t)ide analog (NA)s or IFN products within 6 months prior to baseline (first intake of study drugs), and participants must be HBeAg-positive and have HBV DNA greater than or equal to (>=) 20,000 International Units Per Milliliter (IU/mL), OR be hepatitis B e antigen (HBeAg)-negative and have HBV DNA >=2,000 IU /mL at screening, and participants must have HBsAg greater than (>) 250 IU/mL at screening, and participants must have alanine aminotransferase (ALT) > upper limit of normal (ULN) and less than or equal to (<=) 5 * ULN at screening, determined in the central laboratory
In virologically suppressed participants (Treatment Arms 4-5 and 9-10): Participants must be virologically suppressed by current NA treatment (entecavir (ETV) or tenofovir disoproxil fumarate (TDF)) as defined by HBV DNA less than (<) 60 IU/mL at screening and at least 6 months prior to screening, and participants must be on the same NA treatment (ETV or TDF) and the same dose for >=12 months prior to screening, and participants must have HBsAg > 250 IU/mL at screening, and participants must have ALT <=2*ULN at screening
Participants must have: A liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening or at the time of screening, OR FibroScan liver stiffness measurement <8.0 kilopascal (kPa) within 6 months prior to screening or at the time of screening

Exclusion Criteria:

Main Study:

Participants who test positive for anti-hepatitis B surface (HBs) antibodies
Participants with current hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), hepatitis D virus (HDV) infection (confirmed by HDV antibody), hepatitis E virus infection (confirmed by hepatitis E antibody IgM), or human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening; participants with a history of or current HCV infection (confirmed by HCV antibody). Evidence of other active infection (bacterial, viral, fungal, including acute tuberculosis) deemed clinically relevant by the investigator that would interfere with study conduct or its interpretation will also lead to exclusion
Participants with any evidence of hepatic decompensation at any time point prior to or at the time of screening: Direct bilirubin >1.2* ULN, or International normalized ratio (INR) >1.5* ULN, or Serum albumin < lower limit of normal (LLN), or documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy
Participants with a history of cardiac arrhythmia (example, extrasystoli, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant 12 lead electrocardiograms (ECGs) abnormalities), moderate to severe valvular disease, or uncontrolled hypertension at screening
Participants with contraindications to the use of ETV or TDF per local prescribing information

Substudy:

Presence of coagulopathy or hemoglobinopathy (including sickle cell disease, thalassemia)
Use of any anti-coagulant, anti-platelet, or non-steroidal anti-inflammatory drug medications from 10 days before until 5 days after each liver biopsy
Presence of ascites, focal liver lesions, and other findings that would be contraindications for liver biopsies

Contacts/Locations Module

Name	Affiliation	Role
Janssen Sciences Ireland UC Clinical Trial	Janssen Sciences Ireland UC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The Office of Franco Felizarta, MD		Bakersfield	California	93301	United States
Orlando Immunology Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37385475	Derived	Verbinnen T, Talloen W, Janssen HLA, Zoulim F, Shukla U, Vandenbossche JJ, Biermer M, De Meyer S, Lenz O. Viral sequence analysis of chronic hepatitis B patients treated with the capsid assembly modulator JNJ-56136379 in the JADE phase 2a study. Antiviral Res. 2023 Aug;216:105660. doi: 10.1016/j.antiviral.2023.105660. Epub 2023 Jun 28.
36697207

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] less than (<) 60 International units per milliliter [IU/mL]) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received placebo matching to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 2, 2019	Sep 2, 2022

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG0040 subjects
Other		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects FG004
Withdrawal by Subject		FG0002 subjects FG0012 subjects FG0022 subjects FG0030 subjects FG004
Disease Relapse		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects FG004
Physician Decision		FG0000 subjects FG0012 subjects FG0020 subjects FG0031 subjects FG004
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] less than (<) 60 International units per milliliter [IU/mL]) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received placebo matching to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
BG001	Part A: JNJ-56136379 75 mg (Open Label)	Currently not treated participants received JNJ-56136379 75 mg (3*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75 mg from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
BG002	Part A: JNJ-56136379 75 mg + NA	Virologically suppressed or currently not treated participants received JNJ-56136379 75 mg (3*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
BG003	Part B: JNJ-56136379 250 mg (Open-label)	Currently not treated participants received JNJ-56136379 250 mg (2100 mg and 225 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
BG004	Part B: JNJ-56136379 250 mg + NA	Virologically suppressed or currently not treated participants received JNJ-56136379 250 mg (2100 mg and 225 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00041.6± 9.53 BG00139.2± 12.06 BG00240.3± 11.12 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG0019 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

BELGIUM

Title	Measurements
	BG0003 BG0012 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

Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24

Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline.

Intent-to-Treat Population (ITT) consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n'(number analyzed) represents number of participants evaluable for the specified categories.

Posted

Mean

Standard Deviation

log10 IU per milliliter (log10 IU/mL)

Baseline and Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
OG001	Part A: JNJ-56136379 75 mg (Open Label)	Currently not treated participants received 3*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75 mg from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
OG002	Part A: JNJ-56136379 75 mg + NA	Currently not treated participants received 3*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.
OG003	Part B: JNJ-56136379 250 mg (Open Label)	Currently not treated participants received 2100 mg and 225 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.
OG004	Part B: JNJ-56136379 250 mg + NA	Currently not treated participants received 2100 mg and 225 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Units	Counts
Participants	OG00021 OG00121 OG00233 OG003

Title	Denominators	Categories
HBeAg Positive	ParticipantsOG0008 ParticipantsOG0018 ParticipantsOG00212 ParticipantsOG003

Primary

Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24

Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) <60 IU/mL. This outcome measure was planned to be analyzed for specified arms only.

ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline and Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Number of Participants With Treatment- Emergent Adverse Events (AEs)

An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs were AEs with onset during the treatment phase or that worsened since baseline.

The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.

Posted

Count of Participants

Participants

Up to Week 48

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Number of Participants With Serious Adverse Events (SAEs)

A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.

Posted

Count of Participants

Participants

Up to Week 80

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests

Number of participants with clinically significant changes in vital signs, physical examinations, ECG, and clinical laboratory tests (including hematology, blood biochemistry, blood coagulation, and urinalysis) were reported.

The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.

Posted

Count of Participants

Participants

Up to Week 80

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time

Change from baseline in HBsAg levels in currently not treated population based on HBeAg status was reported.

Posted

Mean

Standard Deviation

log10 IU/mL

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time

Change from baseline in HBsAg levels in virologically suppressed population based on HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only.

Posted

Mean

Standard Deviation

log10 IU/mL

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population

Percentage of participants with HBsAg levels <1,000 or <100 IU/mL in currently not treated population based on their HBeAg status were reported.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population

Percentage of participants with HBsAg levels <1,000 or <100 IU/mL in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population

Percentage of participants with >0.5 log10 IU/mL or >1 log10 IU/mL reduction in HBsAg from baseline in currently not treated population based on their HBeAg status were reported.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population

Percentage of participants with >0.5 log10 IU/mL or >1 log10 IU/mL reduction in HBsAg from baseline in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population

Change from baseline in HBV DNA levels in currently not treated population based on their HBeAg status was reported.

ITT population consisted of all participants who are randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants would be shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline up to Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Change From Baseline in HBV DNA Levels in Virologically Suppressed Population

Change from baseline in HBV DNA levels in virologically supressed population based on their HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline up to Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population

Percentage of participants with undetectable HBV DNA levels in currently not treated population based on their HBeAg status was evaluated.

ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure 'n' (number analyzed) represents number of participants evaluable for the specified categories.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population

Percentage of participants with undetectable HBV DNA levels in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml)) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Change From Baseline in HBeAg Levels in Currently Not Treated Population

Change from baseline in HBeAg levels in HBeAg positive currently not treated population was reported.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline up to Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Change From Baseline in HBeAg Levels in Virologically Suppressed Population

Change from baseline in HBeAg levels in HBeAg positive virologically suppressed population was reported. This outcome measure was planned to be analyzed for specified arms only.

Posted

Mean

Standard Deviation

log10 IU/mL

Baseline up to Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population

Percentage of participants with >0.5 log10 IU/mL and >1 log10 IU/mL reduction in HBeAg from baseline in HBeAg positive currently not treated population was reported.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population

Percentage of participants with >0.5 log10 IU/mL and >1 log10 IU/mL reduction in HBeAg from baseline in HBeAg positive virologically suppressed population was reported. This outcome measure was planned to be analyzed for specified arms only.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population

Percentage of participants with HBsAg seroclearance in currently not treated population based on their HBeAg status were reported. Seroclearance at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at Week 24/48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed at specified timepoints only.

ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.

Posted

Number

Percentage of participants

Weeks 24 and 48

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population

Percentage of participants with HBsAg seroclearance in virologically suppressed population based on their HBeAg status were reported. Seroclearance at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at Week 24/48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed for specified arms and specific timepoints only .

ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.

Posted

Number

Percentage of participants

Weeks 24 and 48

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population

Percentage of participants with HBsAg seroconversion in currently not treated population based on their HBeAg status were reported. Seroconversion at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at week 24/48 of the treatment and an appearance of Anti-HBs. This outcome measure was planned to be analyzed for specified timepoints only.

Posted

Number

Percentage of participants

Weeks 24 and 48

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population

Percentage of participants with HBsAg seroconversion in virologically suppressed population based on their HBeAg status were reported. Seroconversion at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at week 24/48 of the treatment and an appearance of Anti-HBs. This outcome measure was planned to be analyzed for specified arms and specified timepoints only.

Posted

Number

Percentage of participants

Weeks 24 and 48

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population

Percentage of participants with normalized ALT levels in currently not treated population, whose ALT levels were above upper limit of normal at baseline based on their HBeAg status were reported.

The safety population included all participants who received at least one dose of the study agent with ALT values higher than upper limit of normal (ULN) at baseline if time point is available; all safety endpoints were analyzed by the treatment arm as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population

Percentage of participants with normalized ALT levels in virologically suppressed population, whose ALT levels were above upper limit of normal at baseline based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only.

The safety population included all participants who received at least one dose of the study agent with ALT values higher than ULN at baseline if time point is available; all safety endpoints were analyzed by the treatment arm as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.

Posted

Number

Percentage of participants

Weeks 24, 48 and Follow-up Week 24

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With Virological Breakthrough in Currently Not Treated Population

Percentage of participants with virological breakthrough in currently not treated population based on their HBeAg status was reported. Virological breakthrough defined as confirmed on treatment HBV DNA increase by >1 log10 from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay.

ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.

Posted

Number

Percentage of participants

Weeks 24 and 48

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population

Percentage of participants with virological breakthrough in virologically suppressed population based on their HBeAg status was reported. Virological breakthrough defined as confirmed on treatment HBV DNA increase by >1 log10 from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay. This outcome measure was planned to be analyzed for specified arms only.

Posted

Number

Percentage of participants

Weeks 24 and 48

ID	Title	Description
OG000	Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.

Secondary

Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population

Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 in currently not treated population was determined. As planned, plasma concentration of ETV co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.

The pharmacokinetic (PK) analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.

Posted

Mean

Standard Deviation

nanograms per milliliter (ng/mL)

Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4

ID	Title	Description
OG000	Part A: Placebo (Matching JNJ-56136379 75 mg) + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg]) plus 1 tablet of NA (0.5 mg ETV) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (ETV) for additional 24 weeks.

Secondary

Plasma Concentrations of ETV in Virologically Suppressed Population

Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 in virologically suppressed population was determined. As planned, plasma concentration of ETV co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.

The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.

Posted

Mean

Standard Deviation

ng/mL

Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4

ID	Title	Description
OG000	Part A: Placebo (Matching JNJ-56136379 75 mg) + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg]) plus 1 tablet of NA (0.5 mg ETV) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (ETV) for additional 24 weeks.

Secondary

Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population

Plasma concentrations of TDF administered as monotherapy or co-administered with JNJ-56136379 was determined. As planned, plasma concentration of TDF co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling.

Posted

Mean

Standard Deviation

nanograms per milliliter (ng/mL)

Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4

ID	Title	Description
OG000	Part A: Placebo (Matching JNJ-56136379 75 mg) + Nucleos(t)Ide Analog (NA)	Currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg]) plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.

Secondary

Plasma Concentrations of TDF in Virologically Suppressed Population

Posted

Mean

Standard Deviation

ng/mL

Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4

ID	Title	Description
OG000	Part A: Placebo (Matching JNJ-56136379 75 mg) + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) participants received matching placebo to JNJ-56136379 (75 milligrams [mg]) plus 1 tablet of NA (300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (TDF) for additional 24 weeks.

Secondary

Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population

Plasma concentrations of JNJ-56136379 in currently not treated population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. As planned, the plasma concentration of JNJ-56136379 when co-administered with NA was determined separately for each NA treatment (ETV and TDF). Samples were analyzed using POP PK modeling.

Posted

Mean

Standard Deviation

ng/mL

Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4

ID	Title	Description
OG000	Part A: JNJ-56136379 75 mg (Open Label)	Currently not treated participants received 3*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75 mg from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and receive treatment with only NA (either ETV or TDF) for additional 24 weeks.
OG001

Secondary

Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population

Plasma concentrations of JNJ-56136379 in virologically suppressed population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. As planned, the plasma concentration of JNJ-56136379 when co-administered with NA was determined separately for each NA treatment (ETV and TDF). Samples were analyzed using POP PK modeling.

Posted

Mean

Standard Deviation

ng/mL

Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4

ID	Title	Description
OG000	Part A: JNJ-56136379 75 mg + NA (ETV)	Virologically suppressed participants received 3*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (ETV) for additional 24 weeks.
OG001

Secondary

Number of Participants With Treatment-Associated Mutations

Number of participants with treatment-associated mutations were reported. Viral genome sequence analysis was performed to evaluate emergence of mutations associated with JNJ-56136379 considering 15 HBV core protein positions of interest. This outcome measure was planned to be analyzed for specified arms only.

Posted

Count of Participants

Participants

From Week 0 to Week 24, From Week 25 to Week 48, Up to Follow-up Week 24

ID	Title	Description
OG000	Part A: JNJ-56136379 75 mg (Open Label)	Currently not treated participants received 3*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75 mg from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Initial Treatment Phase: Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA)	Virologically suppressed (who were on entecavir [ETV] or tenofovir disoproxil fumarate [TDF] for at least 12 months prior to screening and had hepatitis B virus [HBV] deoxyribonucleic acid [DNA] <60 IU/ml) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams [mg] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	43	1	43	9	43
EG001	Initial Treatment Phase: Part A: JNJ-56136379 75 mg (Open Label)	Currently not treated participants received 3*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	28	1	28	18	28
EG002	Initial Treatment Phase: Part A: JNJ-56136379 75 mg + NA	Virologically suppressed or currently not treated participants received 3*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	66	0	66	19	66
EG003	Initial Treatment Phase: Part B: JNJ-56136379 250 mg (Open-label)	Currently not treated participants received 2100 mg and 225 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	32	0	32	12	32
EG004	Initial Treatment Phase: Part B: JNJ-56136379 250 mg + NA	Virologically suppressed or currently not treated participants received 2100 mg and 225 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	63	1	63	11	63
EG005	Treatment Extension Phase: Parts A and B: Pooled Placebo + NA	Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	33	0	33	25	33
EG006	Treatment Extension Phase: Part A: JNJ-56136379 75 mg (Open Label)	Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75mg from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	3	0	3	2	3
EG007	Treatment Extension Phase: Part A: JNJ-56136379 75 mg + NA	Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	43	4	43	38	43
EG008	Treatment Extension Phase: Part B: JNJ-56136379 250 mg (Open-label)	Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks.	20	0	20	15	20
EG009	Treatment Extension Phase: Part B: JNJ-56136379 250 mg + NA	Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks.	48	3	48	42	48

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG0030 affected32 at risk EG004
Cardiac Failure Acute	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Myocarditis	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Appendicitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Toxic Shock Syndrome Streptococcal	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Post-Traumatic Neck Syndrome	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Muscle Necrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Ovarian Haemorrhage	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG0030 affected32 at risk EG0040 affected63 at risk EG0050 affected33 at risk EG0060 affected3 at risk EG0070 affected43 at risk EG0081 affected20 at risk EG0091 affected48 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Neutrophilia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Atrioventricular Block First Degree	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Atrioventricular Block Second Degree	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Bundle Branch Block Right	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Defect Conduction Intraventricular	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Palpitations	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Ear Congestion	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Motion Sickness	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Tympanic Membrane Perforation	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Goitre	Endocrine disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Cataract	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Conjunctivitis Allergic	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dry Eye	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Swelling of Eyelid	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Xerophthalmia	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Abdominal Discomfort	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Abdominal Tenderness	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Chronic Gastritis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0020 affected66 at risk EG003
Dental Caries	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0021 affected66 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Duodenal Ulcer	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0022 affected66 at risk EG003
Epigastric Discomfort	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Faeces Hard	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Gingival Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hiatus Hernia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hypoaesthesia Oral	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Mouth Ulceration	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0021 affected66 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Periodontal Disease	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Tongue Disorder	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Tooth Impacted	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Asthenia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Chest Discomfort	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Cyst	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Fatigue	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0024 affected66 at risk EG003
Influenza Like Illness	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0022 affected66 at risk EG003
Malaise	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Non-Cardiac Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Pyrexia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Thirst	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Gallbladder Polyp	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hepatic Cyst	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hepatic Pain	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0021 affected66 at risk EG003
Hepatic Steatosis	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Ocular Icterus	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Seasonal Allergy	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Alveolar Osteitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Appendicitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Asymptomatic Bacteriuria	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Bronchitis Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Cystitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Ear Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Folliculitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Furuncle	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Gingivitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Helicobacter Gastritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hepatitis B	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Herpes Virus Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Influenza	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Laryngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Laryngitis Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Localised Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected43 at risk EG0011 affected28 at risk EG0023 affected66 at risk EG003
Periodontitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Pharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Pharyngitis Streptococcal	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Pulpitis Dental	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Rhinitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Suspected Covid-19	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Tooth Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Tuberculosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0012 affected28 at risk EG0023 affected66 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0020 affected66 at risk EG003
Vaginal Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Viral Pharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Viral Tracheitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Vulvitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Corneal Abrasion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Eye Contusion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Gingival Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Muscle Strain	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Skin Laceration	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Amylase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0020 affected66 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Blood Bilirubin Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Blood Calcium Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Blood Cholesterol Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Blood Creatine Phosphokinase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Blood Glucose Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Blood Magnesium Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Blood Potassium Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Blood Triglycerides	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Blood Triglycerides Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Electrocardiogram QT Prolonged	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Electrocardiogram T Wave Inversion	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Glomerular Filtration Rate Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Hepatic Enzyme Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hepatitis B Dna Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Lipase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Protein Urine Present	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Sars-Cov-2 Test Positive	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Ultrasound Liver Abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Urinary Sediment Present	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Urine Analysis Abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Urine Leukocyte Esterase Positive	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Weight Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Abnormal Loss of Weight	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Glucose Tolerance Impaired	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Impaired Fasting Glucose	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Iron Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Joint Noise	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Trigger Finger	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Cerebral Ischaemia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Disturbance in Attention	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Epilepsy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Headache	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0013 affected28 at risk EG0025 affected66 at risk EG003
Memory Impairment	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Neuromuscular Pain	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Parkinson's Disease	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Poor Quality Sleep	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Sciatica	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Somnolence	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0022 affected66 at risk EG003
Syncope	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Aggression	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Anxiety	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Attention Deficit Hyperactivity Disorder	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Depression	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dysphoria	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0021 affected66 at risk EG003
Irritability	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Suicidal Ideation	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Urinary Incontinence	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Urinary Tract Discomfort	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Adenomyosis	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Cervical Polyp	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Menstruation Irregular	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Vaginal Discharge	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dry Throat	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Nasal Polyps	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0012 affected28 at risk EG0020 affected66 at risk EG003
Respiratory Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Upper Respiratory Tract Inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Alopecia Areata	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0022 affected66 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Lichen Planus	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0012 affected28 at risk EG0020 affected66 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected43 at risk EG0010 affected28 at risk EG0021 affected66 at risk EG003
Skin Discolouration	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0011 affected28 at risk EG0020 affected66 at risk EG003
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Abortion Induced	Surgical and medical procedures	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Dental Implantation	Surgical and medical procedures	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Haematoma	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003
Hypertensive Crisis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected43 at risk EG0010 affected28 at risk EG0020 affected66 at risk EG003

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

Title

Denominators

Categories

HBeAg Positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG0000.008± 0.1224 OG001-0.063± 0.2272 OG0020.105± 0.1809

HBeAg Negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Title

Denominators

Categories

Vital Signs

Title	Measurements
	OG0000 OG0010 OG0020 OG0030 OG0040

Physical Examinations

Title	Measurements
	OG0000 OG0010 OG0020 OG003

ECG

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Clinical Laboratory Tests: Hematology

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Clinical Laboratory Tests: Blood biochemistry

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Clinical Laboratory Tests: Blood coagulation

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Clinical Laboratory Tests: Urinalysis

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

Week 24: HBeAg Positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00411

Title	Measurements
	OG000-0.251± 0.3144 OG001-0.096± 0.3567 OG002-0.142± 0.3443 OG003

Week 24: HBeAg Negative

- ParticipantsOG00013
- ParticipantsOG00113
- ParticipantsOG00221
- ParticipantsOG00316

Week 48: HBeAg Positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Follow-up Week 24: HBeAg Positive

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG00313

Follow-up Week 24: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG00113
- ParticipantsOG00216
- ParticipantsOG00314

Title

Denominators

Categories

Week 24: HBeAg Positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG0000.008± 0.1224 OG001-0.063± 0.2272 OG0020.105± 0.1809

Week 24: HBeAg Negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 48: HBeAg Positive

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: HBeAg Negative

- ParticipantsOG00013
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Follow-up Week 24: HBeAg Positive

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: HBeAg Negative

- ParticipantsOG00015
- ParticipantsOG00123
- ParticipantsOG00214

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: HBsAg<100 IU/mL: HBeAg positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00411

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Week 24: HBsAg<1000 IU/mL: HBeAg positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314

Week 24: HBsAg<100 IU/mL: HBeAg negative

- ParticipantsOG00013
- ParticipantsOG00113
- ParticipantsOG00221
- ParticipantsOG00316

Week 24: HBsAg<1000 IU/mL: HBeAg negative

- ParticipantsOG00013
- ParticipantsOG00113
- ParticipantsOG00221
- ParticipantsOG00316

Week 48: HBsAg<100 IU/mL: HBeAg positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: HBsAg<1000 IU/mL: HBeAg positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: HBsAg<100 IU/mL: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Week 48: HBsAg<1000 IU/mL: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Positive

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG003

Follow-up Week 24:HBsAg<1000 IU/mL: HBeAg positive

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG003

Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG00113
- ParticipantsOG00216
- ParticipantsOG003

Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG00113
- ParticipantsOG00216
- ParticipantsOG003

Title

Denominators

Categories

Week 24: HBsAg<100 IU/mL: HBeAg positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG0000 OG0010 OG0020

Week 24: HBsAg<1000 IU/mL: HBeAg positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG000

Week 24: HBsAg<100 IU/mL: HBeAg negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 24: HBsAg<1000 IU/mL: HBeAg negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 48: HBsAg<100 IU/mL: HBeAg positive

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: HBsAg<1000 IU/mL: HBeAg positive

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: HBsAg<100 IU/mL: HBeAg Negative

- ParticipantsOG00013
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Week 48: HBsAg<1000 IU/mL: HBeAg Negative

- ParticipantsOG00013
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Follow-up Week 24: HBsAg<100 IU/mL: HBeAg positive

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg positive

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: HBsAg<100 IU/mL: HBeAg negative

- ParticipantsOG00015
- ParticipantsOG00123
- ParticipantsOG00214

Title	Measurements
	OG000

Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg negative

- ParticipantsOG00015
- ParticipantsOG00123
- ParticipantsOG00214

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: >0.5 log10 IU/mL: HBeAg Positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00411

Title	Measurements
	OG00012.5 OG00112.5 OG0028.3 OG003

Week 24: >1 log10IU/mL: HBeAg Positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314

Week 24: >0.5 log10 IU/mL: HBeAg Negative

- ParticipantsOG00013
- ParticipantsOG00113
- ParticipantsOG00221
- ParticipantsOG00316

Week 24: >1 log10 IU/mL: Negative

- ParticipantsOG00013
- ParticipantsOG00113
- ParticipantsOG00221
- ParticipantsOG00316

Week 48: >0.5 log10 IU/mL: HBeAg Positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: >1 log10 IU/mL: HBeAg Positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: >0.5 log10 IU/mL: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Week 48: >1 log10 IU/mL: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG003

Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG003

Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG00113
- ParticipantsOG00216
- ParticipantsOG003

Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG00113
- ParticipantsOG00216
- ParticipantsOG003

Title

Denominators

Categories

Week 24: >0.5 log10 IU/mL: HBeAg Positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG0000 OG0010 OG0020

Week 24: >1 log10 IU/mL: HBeAg Positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG000

Week 24: >0.5 log10 IU/mL: HBeAg Negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 24: >1 log10 IU/mL: HBeAg Negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 48: >0.5 log10 IU/mL: HBeAg Positive

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: >1 log10 IU/mL: HBeAg Positive

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: >0.5 log10 IU/mL: HBeAg Negative

- ParticipantsOG00013
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Week 48: >1 log10 IU/mL: HBeAg Negative

- ParticipantsOG00013
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative

- ParticipantsOG00015
- ParticipantsOG00123
- ParticipantsOG00214

Title	Measurements
	OG000

Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative

- ParticipantsOG00015
- ParticipantsOG00123
- ParticipantsOG00214

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: HbeAg Positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00411

Title	Measurements
	OG000-5.211± 1.1986 OG001-3.284± 2.1148 OG002-5.531± 0.7915 OG003

Week 24:HbeAg Negative

- ParticipantsOG00013
- ParticipantsOG00114
- ParticipantsOG00221
- ParticipantsOG00316

Week 48: HbeAg Positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: HbeAg Negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Follow-up Week 24: HbeAg Positive

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG00313

Follow-up Week 24: HbeAg Negative

- ParticipantsOG00011
- ParticipantsOG00113
- ParticipantsOG00216
- ParticipantsOG00314

Title

Denominators

Categories

Week 24: HbeAg Positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG000-0.051± 0.1142 OG0010.000± 0.3374 OG0020.021± 0.2665

Week 24: HbeAg Negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 48: HbeAg Positive

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: HbeAg Negative

- ParticipantsOG00013
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Follow-up Week 24: HbeAg Positive

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: HbeAg Negative

- ParticipantsOG00015
- ParticipantsOG00123
- ParticipantsOG00214

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: HBeAg Positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00411

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Week 24: HBeAg Negative

- ParticipantsOG00013
- ParticipantsOG00114
- ParticipantsOG00221
- ParticipantsOG00316

Week 48: HBeAg Positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Follow-up Week 24: HBeAg Positive

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG00313

Follow-up Week 24: HBeAg Negative

- ParticipantsOG00011
- ParticipantsOG00113
- ParticipantsOG00216
- ParticipantsOG00314

Title

Denominators

Categories

Week 24: HBeAg positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG00040.0 OG00122.2 OG00240.0

Week 24: HBeAg negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 48: HBeAg positive

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: HBeAg negative

- ParticipantsOG00013
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Follow-up Week 24: HBeAg positive

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: HBeAg negative

- ParticipantsOG00015
- ParticipantsOG00123
- ParticipantsOG00214

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00411

Title	Measurements
	OG000-0.811± 0.7953 OG001-0.456± 0.2908 OG002-0.487± 2974 OG003

Week 48

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Follow-up Week 24

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG00313

Title

Denominators

Categories

Week 24

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG000-0.313± 0.5281 OG001-0.315± 0.4681 OG002-0.162± 0.2037

Week 48

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: >0.5 log10 IU/mL

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00411

Title	Measurements
	OG00062.5 OG00150 OG00241.7 OG003

Week 24: >1 log10 IU/mL

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314

Week 48: >0.5 log10 IU/mL

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: >1 log10 IU/mL

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Follow-up Week 24: >0.5 log10 IU/mL

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG00313

Follow-up Week 24: >1 log10 IU/mL

- ParticipantsOG0007
- ParticipantsOG00110
- ParticipantsOG00212
- ParticipantsOG00313

Title

Denominators

Categories

Week 24: >0.5 log10 IU/mL

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG00020 OG00133.3 OG00210

Week 24: >1 log10 IU/mL

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG000

Week 48: >0.5 log10 IU/mL

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: >1 log10 IU/mL

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: >0.5 log10 IU/mL

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Follow-up Week 24: >1 log10 IU/mL

- ParticipantsOG0004
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: HbeAg Positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00410

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Week 24: HbeAg Negative

- ParticipantsOG00013
- ParticipantsOG00112
- ParticipantsOG00221
- ParticipantsOG00315

Week 48: HbeAg Positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: HbeAg Negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Title

Denominators

Categories

Week 24: HbeAg Positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG0000 OG0010 OG0020

Week 24: HbeAg Negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 48: HbeAg Positive

- ParticipantsOG0005
- ParticipantsOG0019
- ParticipantsOG0029

Title	Measurements
	OG000

Week 48: HbeAg Negative

- ParticipantsOG00013
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: HbeAg Positive

- ParticipantsOG0008
- ParticipantsOG0018
- ParticipantsOG00211
- ParticipantsOG00313
- ParticipantsOG00410

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Week 24: HbeAg negative

- ParticipantsOG00013
- ParticipantsOG00112
- ParticipantsOG00221
- ParticipantsOG00315

Week 48: HbeAg Positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: HbeAg negative

- ParticipantsOG00011
- ParticipantsOG0010
- ParticipantsOG0029
- ParticipantsOG00313

Title

Denominators

Categories

Week 24: HbeAg Positive

- ParticipantsOG0006
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG0000.0 OG0010.0 OG0020.0

Week 24: HbeAg negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00219

Title	Measurements
	OG000

Week 48: HbeAg Positive

- ParticipantsOG0009
- ParticipantsOG0015
- ParticipantsOG0028

Title	Measurements
	OG000

Week 48: HbeAg negative

- ParticipantsOG00010
- ParticipantsOG00121
- ParticipantsOG00215

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: HBeAg positive

- ParticipantsOG0008
- ParticipantsOG0015
- ParticipantsOG00211
- ParticipantsOG00314
- ParticipantsOG0049

Title	Measurements
	OG00062.5 OG00160.0 OG00254.5 OG003

Week 24: HBeAg negative

- ParticipantsOG0009
- ParticipantsOG00112
- ParticipantsOG00216
- ParticipantsOG00311

Week 48: HBeAg positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0035

Week 48: HBeAg negative

- ParticipantsOG0008
- ParticipantsOG0010
- ParticipantsOG0026
- ParticipantsOG0039

Follow-up Week 24: HBeAg positive

- ParticipantsOG0007
- ParticipantsOG0017
- ParticipantsOG00211
- ParticipantsOG00313

Follow-up Week 24: HBeAg negative

- ParticipantsOG0008
- ParticipantsOG00112
- ParticipantsOG00212
- ParticipantsOG00311

Title

Denominators

Categories

Week 24: HBeAg Positive

- ParticipantsOG0000
- ParticipantsOG0011
- ParticipantsOG0023

Title	Measurements
	OG001100.0 OG00233.3

Week 24: HBeAg Negative

- ParticipantsOG0002
- ParticipantsOG0013
- ParticipantsOG0022

Title	Measurements
	OG000

Week 48: HBeAg positive

- ParticipantsOG0000
- ParticipantsOG0011
- ParticipantsOG0023

Title	Measurements
	OG001

Week 48: HBeAg negative

- ParticipantsOG0002
- ParticipantsOG0012
- ParticipantsOG0022

Title	Measurements
	OG000

Follow-up Week 24: HBeAg Positive

- ParticipantsOG0000
- ParticipantsOG0011
- ParticipantsOG0023

Title	Measurements
	OG001

Follow-up Week 24: HBeAg negative

- ParticipantsOG0002
- ParticipantsOG0013
- ParticipantsOG0021

Title	Measurements
	OG000

Title

Denominators

Categories

Week 24: HbeAg Positive

- ParticipantsOG0008
- ParticipantsOG00112
- ParticipantsOG00212
- ParticipantsOG00314
- ParticipantsOG00413

Title	Measurements
	OG0000 OG00116.7 OG0020 OG003

Week 24: HbeAg Negative

- ParticipantsOG00014
- ParticipantsOG00116
- ParticipantsOG00221
- ParticipantsOG00318

Week 48: HbeAg Positive

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0036

Week 48: HbeAg Negative

- ParticipantsOG00012
- ParticipantsOG0013
- ParticipantsOG00210
- ParticipantsOG00314

Title

Denominators

Categories

Week 24: HbeAg Positive

- ParticipantsOG0006
- ParticipantsOG0019
- ParticipantsOG00210

Title	Measurements
	OG0000 OG0010 OG0020

Week 24: HbeAg Negative

- ParticipantsOG00015
- ParticipantsOG00124
- ParticipantsOG00220

Title	Measurements
	OG000

Week 48: HbeAg Positive

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG00210

Title	Measurements
	OG000

Week 48: HbeAg Negative

- ParticipantsOG00014
- ParticipantsOG00123
- ParticipantsOG00217

Title	Measurements
	OG000

Title

Denominators

Categories

Day 1: 0 hours

- ParticipantsOG0000
- ParticipantsOG0010
- ParticipantsOG0022
- ParticipantsOG0034

Title	Measurements
	OG002NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG003NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.

Day 1: 2 hours

- ParticipantsOG0001
- ParticipantsOG0012
- ParticipantsOG0024
- ParticipantsOG0033

Week 1: 0 hours

- ParticipantsOG0001
- ParticipantsOG0013
- ParticipantsOG0025
- ParticipantsOG0036

Week 2: 0 hours

- ParticipantsOG0001
- ParticipantsOG0012
- ParticipantsOG0025
- ParticipantsOG0037

Week 4: 0 hours

- ParticipantsOG0001
- ParticipantsOG0012
- ParticipantsOG0025
- ParticipantsOG0037

Week 8: 0 hours

- ParticipantsOG0001
- ParticipantsOG0012
- ParticipantsOG0025
- ParticipantsOG0036

Week 12: 0 hours

- ParticipantsOG0001
- ParticipantsOG0012
- ParticipantsOG0026
- ParticipantsOG0036

Week 20: 0 hours

- ParticipantsOG0001
- ParticipantsOG0011
- ParticipantsOG0025
- ParticipantsOG0037

Week 24: 0 hours

- ParticipantsOG0001
- ParticipantsOG0011
- ParticipantsOG0024
- ParticipantsOG0036

Week 28: 0 hours

- ParticipantsOG0001
- ParticipantsOG0011
- ParticipantsOG0021
- ParticipantsOG0034

Week 32: 0 hours

- ParticipantsOG0001
- ParticipantsOG0010
- ParticipantsOG0021
- ParticipantsOG0034

Week 36: 0 hours

- ParticipantsOG0001
- ParticipantsOG0010
- ParticipantsOG0021
- ParticipantsOG0034

Week 44: 0 hours

- ParticipantsOG0001
- ParticipantsOG0010
- ParticipantsOG0021
- ParticipantsOG0033

Week 48: 0 hours

- ParticipantsOG0001
- ParticipantsOG0010
- ParticipantsOG0023
- ParticipantsOG0034

Follow-up: Week 2

- ParticipantsOG0001
- ParticipantsOG0011
- ParticipantsOG0025
- ParticipantsOG0035

Follow-up: Week 4

- ParticipantsOG0001
- ParticipantsOG0011
- ParticipantsOG0025
- ParticipantsOG0036

Title

Denominators

Categories

Day 1: 0 hours

- ParticipantsOG0001
- ParticipantsOG0010
- ParticipantsOG0027
- ParticipantsOG0030

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0020.683± 0.414

Day 1: 2 hours

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG0026
- ParticipantsOG0033

Week 1: 0 hours

- ParticipantsOG0004
- ParticipantsOG0011
- ParticipantsOG00214
- ParticipantsOG0034

Week 2: 0 hours

- ParticipantsOG0003
- ParticipantsOG0011
- ParticipantsOG00214
- ParticipantsOG0034

Week 4: 0 hours

- ParticipantsOG0003
- ParticipantsOG0011
- ParticipantsOG00210
- ParticipantsOG0034

Week 8: 0 hours

- ParticipantsOG0002
- ParticipantsOG0011
- ParticipantsOG00211
- ParticipantsOG0034

Week 12: 0 hours

- ParticipantsOG0003
- ParticipantsOG0011
- ParticipantsOG00211
- ParticipantsOG0034

Week 20: 0 hours

- ParticipantsOG0002
- ParticipantsOG0011
- ParticipantsOG00210
- ParticipantsOG0034

Week 24: 0 hours

- ParticipantsOG0002
- ParticipantsOG0011
- ParticipantsOG00212
- ParticipantsOG0034

Week 28: 0 hours

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG00211
- ParticipantsOG0034

Week 32: 0 hours

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG00211
- ParticipantsOG0034

Week 36: 0 hours

- ParticipantsOG0003
- ParticipantsOG0010
- ParticipantsOG00211
- ParticipantsOG0034

Week 44: 0 hours

- ParticipantsOG0002
- ParticipantsOG0010
- ParticipantsOG00211
- ParticipantsOG0034

Week 48: 0 hours

- ParticipantsOG0003
- ParticipantsOG0010
- ParticipantsOG00211
- ParticipantsOG0035

Follow-up: Week 2

- ParticipantsOG0002
- ParticipantsOG0012
- ParticipantsOG00211
- ParticipantsOG0036

Follow-up: Week 4

- ParticipantsOG0003
- ParticipantsOG0012
- ParticipantsOG00210
- ParticipantsOG0036

Title

Denominators

Categories

Day 1: 0 hours

- ParticipantsOG0002
- ParticipantsOG0011
- ParticipantsOG0024
- ParticipantsOG0034

Title

Measurements

OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size.
OG002NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG003

Day 1: 2 hours

- ParticipantsOG0009
- ParticipantsOG0017
- ParticipantsOG00222
- ParticipantsOG00325

Week 1: 0 hours

- ParticipantsOG0009
- ParticipantsOG0018
- ParticipantsOG00224
- ParticipantsOG00324

Week 2: 0 hours

- ParticipantsOG0009
- ParticipantsOG0018
- ParticipantsOG00222
- ParticipantsOG00324

Week 4: 0 hours

- ParticipantsOG0009
- ParticipantsOG0017
- ParticipantsOG00222
- ParticipantsOG00324

Week 8: 0 hours

- ParticipantsOG0009
- ParticipantsOG0017
- ParticipantsOG00223
- ParticipantsOG00323

Week 12: 0 hours

- ParticipantsOG0009
- ParticipantsOG0017
- ParticipantsOG00224
- ParticipantsOG00323

Week 20: 0 hours

- ParticipantsOG0009
- ParticipantsOG0017
- ParticipantsOG00224
- ParticipantsOG00323

Week 24: 0 hours

- ParticipantsOG0009
- ParticipantsOG0017
- ParticipantsOG00223
- ParticipantsOG00323

Week 28: 0 hours

- ParticipantsOG0006
- ParticipantsOG0015
- ParticipantsOG0029
- ParticipantsOG00317

Week 32: 0 hours

- ParticipantsOG0006
- ParticipantsOG0015
- ParticipantsOG0028
- ParticipantsOG00316

Week 36: 0 hours

- ParticipantsOG0005
- ParticipantsOG0015
- ParticipantsOG0029
- ParticipantsOG00316

Week 44: 0 hours

- ParticipantsOG0006
- ParticipantsOG0015
- ParticipantsOG0028
- ParticipantsOG00316

Week 48: 0 hours

- ParticipantsOG0006
- ParticipantsOG0014
- ParticipantsOG0028
- ParticipantsOG00315

Follow-up: Week 2

- ParticipantsOG0008
- ParticipantsOG0017
- ParticipantsOG00221
- ParticipantsOG00319

Follow-up: Week 4

- ParticipantsOG0009
- ParticipantsOG0017
- ParticipantsOG00222
- ParticipantsOG00321

Title

Denominators

Categories

Day 1: 0 hours

- ParticipantsOG0002
- ParticipantsOG0012
- ParticipantsOG0023
- ParticipantsOG0034

Title

Measurements

OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG00268.9± 10.1
OG003

Day 1: 2 hours

- ParticipantsOG0003
- ParticipantsOG0018
- ParticipantsOG00218
- ParticipantsOG00316

Week 1: 0 hours

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG00218
- ParticipantsOG00318

Week 2: 0 hours

- ParticipantsOG0005
- ParticipantsOG0018
- ParticipantsOG00218
- ParticipantsOG00319

Week 4: 0 hours

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG00218
- ParticipantsOG00318

Week 8: 0 hours

- ParticipantsOG0004
- ParticipantsOG0017
- ParticipantsOG00218
- ParticipantsOG00319

Week 12: 0 hours

- ParticipantsOG0004
- ParticipantsOG0017
- ParticipantsOG00218
- ParticipantsOG00318

Week 20: 0 hours

- ParticipantsOG0004
- ParticipantsOG0017
- ParticipantsOG00215
- ParticipantsOG00318

Week 24: 0 hours

- ParticipantsOG0005
- ParticipantsOG0017
- ParticipantsOG00215
- ParticipantsOG00316

Week 28: 0 hours

- ParticipantsOG0004
- ParticipantsOG0016
- ParticipantsOG00214
- ParticipantsOG00316

Week 32: 0 hours

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG00213
- ParticipantsOG00314

Week 36: 0 hours

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG00214
- ParticipantsOG00314

Week 44: 0 hours

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG00213
- ParticipantsOG00311

Week 48: 0 hours

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG00213
- ParticipantsOG00310

Follow-up: Week 2

- ParticipantsOG0004
- ParticipantsOG0016
- ParticipantsOG00212
- ParticipantsOG00310

Follow-up: Week 4

- ParticipantsOG0005
- ParticipantsOG0017
- ParticipantsOG00214
- ParticipantsOG0039

Title

Denominators

Categories

Day 1: 0 hour

- ParticipantsOG0006
- ParticipantsOG0014
- ParticipantsOG0022
- ParticipantsOG0034
- ParticipantsOG0043
- ParticipantsOG0054

Title

Measurements

OG000NA± NAHere "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.
OG001NA± NAHere "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.
OG002NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG003

Day 1: 2 hour

- ParticipantsOG00024
- ParticipantsOG00127
- ParticipantsOG0028
- ParticipantsOG00322

Week 1: 0 hours

- ParticipantsOG00027
- ParticipantsOG00130
- ParticipantsOG0028
- ParticipantsOG00324

Week 2: 0 hours

- ParticipantsOG00026
- ParticipantsOG00131
- ParticipantsOG0028
- ParticipantsOG00323

Week 4: 0 hours

- ParticipantsOG00027
- ParticipantsOG00131
- ParticipantsOG0028
- ParticipantsOG00323

Week 8: 0 hours

- ParticipantsOG00026
- ParticipantsOG00131
- ParticipantsOG0028
- ParticipantsOG00324

Week 12: 0 hours

- ParticipantsOG00026
- ParticipantsOG00129
- ParticipantsOG0028
- ParticipantsOG00324

Week 20: 0 hours

- ParticipantsOG00022
- ParticipantsOG00130
- ParticipantsOG0028
- ParticipantsOG00324

Week 24: 0 hours

- ParticipantsOG0008
- ParticipantsOG00121
- ParticipantsOG0023
- ParticipantsOG00314

Week 28: 0 hours

- ParticipantsOG0003
- ParticipantsOG00120
- ParticipantsOG0023
- ParticipantsOG0039

Week 32: 0 hours

- ParticipantsOG0000
- ParticipantsOG00120
- ParticipantsOG0023
- ParticipantsOG0038

Week 36: 0 hours

- ParticipantsOG0000
- ParticipantsOG00119
- ParticipantsOG0023
- ParticipantsOG0039

Week 44: 0 hours

- ParticipantsOG0000
- ParticipantsOG0019
- ParticipantsOG0023
- ParticipantsOG0038

Week 48: 0 hours

- ParticipantsOG0000
- ParticipantsOG00132
- ParticipantsOG0020
- ParticipantsOG0032

Follow-up: Week 2

- ParticipantsOG00021
- ParticipantsOG00128
- ParticipantsOG0028
- ParticipantsOG00321

Follow-up: Week 4

- ParticipantsOG00022
- ParticipantsOG00129
- ParticipantsOG0028
- ParticipantsOG00322

Title

Denominators

Categories

Day 1: 0 hour

- ParticipantsOG0006
- ParticipantsOG0012
- ParticipantsOG0020
- ParticipantsOG0034

Title

Measurements

OG000NA± NAHere "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.
OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG003NA± NAHere "NA" indicates that mean and standard deviation was not calculated due to below qualification limit (BQL) that is \<10.0 ng/mL.

Day 1: 2 hour

- ParticipantsOG00013
- ParticipantsOG00116
- ParticipantsOG0027
- ParticipantsOG00317

Week 1: 0 hours

- ParticipantsOG00015
- ParticipantsOG00116
- ParticipantsOG0028
- ParticipantsOG00318

Week 2: 0 hours

- ParticipantsOG00015
- ParticipantsOG00117
- ParticipantsOG0028
- ParticipantsOG00319

Week 4: 0 hours

- ParticipantsOG00015
- ParticipantsOG00116
- ParticipantsOG0028
- ParticipantsOG00319

Week 8: 0 hours

- ParticipantsOG00015
- ParticipantsOG00117
- ParticipantsOG0028
- ParticipantsOG00319

Week 12: 0 hours

- ParticipantsOG00014
- ParticipantsOG00116
- ParticipantsOG0028
- ParticipantsOG00318

Week 20: 0 hours

- ParticipantsOG00015
- ParticipantsOG00117
- ParticipantsOG0028
- ParticipantsOG00318

Week 24: 0 hours

- ParticipantsOG00014
- ParticipantsOG00117
- ParticipantsOG0028
- ParticipantsOG00316

Week 28: 0 hours

- ParticipantsOG00015
- ParticipantsOG00116
- ParticipantsOG0028
- ParticipantsOG00316

Week 32: 0 hours

- ParticipantsOG00015
- ParticipantsOG00114
- ParticipantsOG0028
- ParticipantsOG00314

Week 36: 0 hours

- ParticipantsOG00015
- ParticipantsOG00115
- ParticipantsOG0028
- ParticipantsOG00314

Week 44: 0 hours

- ParticipantsOG00015
- ParticipantsOG00114
- ParticipantsOG0028
- ParticipantsOG00312

Week 48: 0 hours

- ParticipantsOG0005
- ParticipantsOG0012
- ParticipantsOG0022
- ParticipantsOG0036

Follow-up: Week 2

- ParticipantsOG00014
- ParticipantsOG00113
- ParticipantsOG0028
- ParticipantsOG00314

Follow-up: Week 4

- ParticipantsOG00015
- ParticipantsOG00114
- ParticipantsOG0028
- ParticipantsOG00315

Title

Denominators

Categories

Emergence of mutations during 24 weeks (Week 0 to Week 24)

Title	Measurements
	OG0008 OG0010 OG0024 OG0030

Emergence of mutations between 25 and 48 weeks (Week 25 to Week 48)

Title	Measurements
	OG0002 OG0010 OG0020 OG003

Emergence of mutations on NA treatment (Up to Follow-up Week 24)

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0021.39± 0.709 OG0031.18± 0.197

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.321± 0.0961 OG0030.289± 0.0351

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.285± 0.166 OG0030.377± 0.0531

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.417± 0.143 OG0030.414± 0.0742

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.353± 0.226 OG0030.466± 0.0913

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.467± 0.188 OG0030.479± 0.0650

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0020.441± 0.147 OG0030.481± 0.0625

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0020.395± 0.309 OG0030.385± 0.0415

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG002NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0030.527± 0.0302

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG002NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0030.462± 0.0410

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG002NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0030.442± 0.0517

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG002NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0030.438± 0.0352

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0020.542± 0.311 OG0030.307± 0.176

Title	Measurements
	OG000NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0020.354± 0.260 OG0030.309± 0.161

Title	Measurements
	OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0021.86± 0.639 OG0031.89± 0.429

Title	Measurements
	OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0020.496± 0.179 OG0030.493± 0.0816

Title	Measurements
	OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0020.617± 0.408 OG0030.537± 0.109

Title	Measurements
	OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG001NA± NAHere "NA" indicates that mean and standard deviation was not estimable due to small sample size. OG0020.491± 0.144 OG0030.576± 0.121

Title	Measurements
	OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.446± 0.148 OG0030.519± 0.153

Title	Measurements
	OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.467± 0.201 OG0030.489± 0.144

Title	Measurements
	OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.525± 0.177 OG0030.517± 0.121

Title

Measurements

OG000NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG0020.635± 0.449
OG0030.433± 0.117

Title	Measurements
	OG0001.00± 1.13 OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG0020.445± 0.164 OG0030.725± 0.598

Title	Measurements
	OG00111797± 2482 OG003NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point. OG00411220± 2464 OG00510740± 2400

Title

Measurements

OG0003918± 1259
OG001NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG002NA± NAHere "NA" indicates that actual sampling time deviated too much from nominal scheduled sampling time. Therefore, data could not be estimated and analyzed at specific time point.
OG00315080± 8060

ID	Term
D008672	Metals, Alkali
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light
D008670	Metals