A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Partici... | NCT04535544

NCT04535544

ID	Type	Description
2020-001249-37	EudraCT Number
73763989HPB2004	Other Identifier	Janssen Research & Development, LLC
2023-506763-33-00	Registry Identifier	EUCT number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate Active Treatment arm: JNJ-73763989 + NA	Experimental	Participants will receive JNJ-73763989 subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir [ETV], tenofovir disoproxil, or tenofovir alafenamide [TAF]) once daily for 144 Weeks in Part 1 and for at least 96 weeks in Part 2.	Drug: JNJ-73763989 Drug: Entecavir (ETV) monohydrate Drug: Tenofovir disoproxil Drug: Tenofovir alafenamide (TAF)
Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NA	Placebo Comparator	Participants will receive matching placebo to JNJ-73763989 SC injection Q4W along with NA (ETV, tenofovir disoproxil, or TAF) once daily for 52 Weeks followed by JNJ-73763989 SC injection Q4W along with NA once daily for 96 weeks in Part 1 and for at least 48 weeks in Part 2.	Drug: JNJ-73763989 Drug: Placebo Drug: Entecavir (ETV) monohydrate Drug: Tenofovir disoproxil Drug: Tenofovir alafenamide (TAF)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-73763989	Drug	JNJ-73763989 will be administered as a SC injection.	Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NA Immediate Active Treatment arm: JNJ-73763989 + NA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)	Percentage of participants with HDV RNA greater than or equal to (>=) 2 log10 International Units Per Milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. Target not detected (TND) was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.	At Week 48
Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach)	Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \	At Week 48

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening
For Part 1: hepatitis D RNA (HDV RNA) greater than or equal to (>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values >= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (<=) 10000 IU/mL at screening or HDV RNA values at screening are <= 100000 IU/mL
Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN)
Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of >= 140000 per deciliter (dL) for enrollment into Part-2

Exclusion Criteria:

Evidence of infection with hepatitis A, C, or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
Evidence of liver disease of non-HBV/HDV etiology
Signs of hepatocellular carcinoma (HCC)
Significant laboratory abnormalities as defined in the protocol at screening
Participants with a history of malignancy within 5 years before screening
Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
History of or current clinically significant skin disease or drug rash
Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients or excipients of the placebo content
Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information
Participants who have taken any therapies disallowed per protocol
Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
Male participants who plan to father a child while enrolled
Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Redwood City	California	94063	United States
Harvard Medical School Massachusetts General Hospital

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA)	In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 27, 2024	Oct 15, 2024

Arm/Group Information

ID	Title	Description
BG000	Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA)	In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
BG001	Part 1: Placebo + NA	In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
BG002	Part 2: JNJ-73763989 + NA	In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
BG003	Part 2: Placebo + NA	In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.
BG004	Total	Total of all reporting groups

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

Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)

Percentage of participants with HDV RNA greater than or equal to (>=) 2 log10 International Units Per Milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. Target not detected (TND) was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.

Intent-to-Treat analysis set (ITT) included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.

Posted

Number

Percentage of Participants

At Week 48

ID	Title	Description
OG000	Part 1: JNJ-73763989 + Nucleos(t)Ide Analog (NA)	In the double-blind phase, participants received JNJ-73763989 100 milligrams (mg) subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil 245 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.
OG001	Part 1: Placebo + NA	In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to Week 148). After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.

Units	Counts
Participants	OG00017 OG0015

Title

Denominators

Categories

Title	Measurements
	OG00023.5 OG0010.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Stratum-adjusted Mantel-Haenszel (MH) test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).	Mantel-Haenszel		0.011		Difference of percentage	23.7			2-Sided	95	3.52	43.96					Superiority

Primary

Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach)

Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \

ITT analysis set included all participants who were randomly assigned to an intervention arm and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomly assigned to.

Posted

Number

Percentage of Participants

At Week 48

ID	Title	Description
OG000	Part 2: JNJ-73763989 + NA	In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks. After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to Week 144). After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DB: Part 1: JNJ-73763989 + NA	In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.	17	2	17	17	17
EG001	DB: Part 1: Placebo + NA	In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.	5	0	5	3	5
EG002	DB: Part 2: JNJ-73763989 + NA	In the double-blind phase, participants received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.	24	3	24	20	24
EG003	DB: Part 2: Placebo + NA	In the double-blind phase, participants received placebo matching to JNJ-73763989 SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 52 weeks.	6	0	6	5	6
EG004	OL: Part 1: JNJ-73763989 + NA	After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to study Week 144).	5	0	5	4	5
EG005	OL: Part 1: Placebo + NA	After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to study Week 148).	4	1	4	4	4
EG006	OL: Part 2: JNJ-73763989 + NA	After completion of double-blind phase, participants entered open-label phase and continued to receive JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 92 weeks (up to study Week 144).	14	0	14	2	14
EG007	OL: Part 2: Placebo + NA	After completion of double-blind phase, participants entered open-label phase and received JNJ-73763989 100 mg SC injection Q4W along with NA (ETV 0.5 mg, tenofovir disoproxil 245 mg, or TAF 25 mg) tablet orally once daily for 96 weeks (up to study Week 148).	5	0	5	2	5
EG008	FU: Part 1: JNJ-73763989 + NA	After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.	16	1	16	11	16
EG009	FU: Part 1: Placebo + NA	After completion of open-label phase, participants entered 48-week follow-up phase during which JNJ-73633989 treatment was stopped and NA treatment alone was continued.	3	0	3	3	3
EG010	FU: Part 2: JNJ-73763989 + NA	After completion of open-label phase, participants entered 48-week follow-up phase and stopped JNJ-73633989 treatment and continued NA treatment alone.	6	0	6	4	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary Artery Disease	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG0030 affected6 at risk EG0040 affected5 at risk EG0051 affected4 at risk EG0060 affected14 at risk EG0070 affected5 at risk EG0080 affected16 at risk EG0090 affected3 at risk EG0100 affected6 at risk
Keratitis	Eye disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Appendicitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Transaminases Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Intermenstrual Bleeding	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG0030 affected6 at risk EG0040 affected5 at risk EG0050 affected4 at risk EG0060 affected14 at risk EG0070 affected5 at risk EG0080 affected16 at risk EG0090 affected3 at risk EG0100 affected6 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Coronary Artery Disease	Cardiac disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Motion Sickness	Ear and labyrinth disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Conjunctivitis Allergic	Eye disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Keratitis	Eye disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Vision Blurred	Eye disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Abdominal Discomfort	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Epigastric Discomfort	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Frequent Bowel Movements	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0003 affected17 at risk EG0010 affected5 at risk EG0022 affected24 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Varices Oesophageal	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Asthenia	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0023 affected24 at risk EG003
Fatigue	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0004 affected17 at risk EG0010 affected5 at risk EG0022 affected24 at risk EG003
Feeling Hot	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Injection Site Discolouration	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Injection Site Erythema	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Injection Site Pain	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Non-Cardiac Chest Pain	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Oedema Peripheral	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Pyrexia	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Vessel Puncture Site Swelling	General disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Autoimmune Hepatitis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Gallbladder Polyp	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Hepatic Fibrosis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Hepatic Steatosis	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Seasonal Allergy	Immune system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Acarodermatitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Bacteriuria	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Covid-19	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Furuncle	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Gingivitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Helicobacter Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Influenza	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0023 affected24 at risk EG003
Localised Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Oral Herpes	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Pharyngitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Rhinitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Sinusitis	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Tooth Abscess	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected5 at risk EG0020 affected24 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0022 affected24 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected5 at risk EG0021 affected24 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Face Injury	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Hand Fracture	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Limb Crushing Injury	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Muscle Rupture	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Post Procedural Complication	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Procedural Nausea	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Thermal Burn	Injury, poisoning and procedural complications	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0009 affected17 at risk EG0010 affected5 at risk EG0027 affected24 at risk EG003
Amylase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected5 at risk EG0020 affected24 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0007 affected17 at risk EG0010 affected5 at risk EG0024 affected24 at risk EG003
Beta 2 Microglobulin Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Bilirubin Conjugated Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Blood Bilirubin Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Blood Creatine Phosphokinase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Gamma-Glutamyltransferase Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Human Chorionic Gonadotropin Positive	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Liver Function Test Abnormal	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Transaminases Increased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Weight Decreased	Investigations	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Increased Appetite	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Iron Deficiency	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0022 affected24 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0022 affected24 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Spinal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Haemangioma of Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Hepatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Burning Sensation	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Headache	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0004 affected17 at risk EG0010 affected5 at risk EG0022 affected24 at risk EG003
Intercostal Neuralgia	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Lethargy	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Memory Impairment	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Presyncope	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Trigeminal Neuralgia	Nervous system disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Anxiety	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Depressed Mood	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Renal Colic	Renal and urinary disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Heavy Menstrual Bleeding	Reproductive system and breast disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Alopecia Areata	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Cellulite	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Pigmentation Disorder	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0022 affected24 at risk EG003
Skin Discolouration	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003
Umbilical Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0020 affected24 at risk EG003
Hypertension	Vascular disorders	MedDRA Version 26.0	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected5 at risk EG0021 affected24 at risk EG003

ID	Term
D003699	Hepatitis D
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D007239	Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
C413685	entecavir
D000068698	Tenofovir
C442442	tenofovir alafenamide