A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Comb... | NCT00922207

NCT00922207

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: Adefovir Drug: peginterferon alfa-2a [Pegasys]
2	Experimental	Drug: Entecavir Drug: peginterferon alfa-2a [Pegasys]
3	Placebo Comparator	Drug: Placebo Drug: peginterferon alfa-2a [Pegasys]

Name	Type	Description	Arm Group Labels	Other Names
Adefovir	Drug	From week -4 to week 2	1
Entecavir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment	HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).	Week 100

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.	Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Changhua Christian Hospital; Internal Medicine		Changhua		500	Taiwan
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

References Module

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No data is available for this block.

IPD Sharing Statement Module

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No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir (Hepsera) 10 milligrams (mg) tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peginterferon alfa-2a (peg-IFN-alfa-2a; Pegasys) 180 micrograms (µg) subcutaneous (SC) injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Intent-to-treat (ITT) analysis population included all randomized participants who received at least one dose of study medication.

Arm/Group Information

ID	Title	Description
BG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
BG001	Peg-IFN-Alfa-2a + Entecavir	Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
BG002	Peg-IFN-Alfa-2a + Placebo	Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00091 BG00195 BG00294 BG003280

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
	OG00027.4(17.8 to 36.9) OG00129.5(20.0 to 39.1) OG00236.3(26.4 to 46.1)

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		Cochran-Mantel-Haenszel		0.6853		Odds Ratio (OR)	0.90			2-Sided	95	0.46	1.75					Superiority or Other
OG000 OG002		Cochran-Mantel-Haenszel		0.1977

Secondary

Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.

ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Posted

Mean

Standard Deviation

copies/mL

Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

ID	Title	Description
OG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG001	Peg-IFN-Alfa-2a + Entecavir	Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG002	Peg-IFN-Alfa-2a + Placebo

Secondary

Percentage of Participants Who Were HBeAg Negative

ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

ID	Title	Description
OG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG001	Peg-IFN-Alfa-2a + Entecavir	Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG002	Peg-IFN-Alfa-2a + Placebo	Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.

Secondary

Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive

ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Posted

Number

percentage of participants

Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

ID	Title	Description
OG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG001	Peg-IFN-Alfa-2a + Entecavir	Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG002	Peg-IFN-Alfa-2a + Placebo	Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.

Secondary

Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels

The normal range for ALT is 10 to 40 international units per liter (IU/L).

ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Posted

Number

percentage of participants

Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100

ID	Title	Description
OG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG001	Peg-IFN-Alfa-2a + Entecavir	Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG002	Peg-IFN-Alfa-2a + Placebo

Secondary

Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Posted

Mean

Standard Deviation

International Units/milliliter (IU/mL)

Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

ID	Title	Description
OG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG001	Peg-IFN-Alfa-2a + Entecavir	Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG002	Peg-IFN-Alfa-2a + Placebo	Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.

Secondary

Percentage of Participants With Combined Response

Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).

ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Posted

Number

percentage of participants

Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

ID	Title	Description
OG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG001	Peg-IFN-Alfa-2a + Entecavir	Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
OG002	Peg-IFN-Alfa-2a + Placebo

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Peg-IFN-Alfa-2a + Adefovir	Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.	7	91	85	91
EG001	Peg-IFN-Alfa-2a + Entecavir	Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.	12	94	83	94
EG002	Peg-IFN-Alfa-2a + Placebo	Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.	7	93	89	93

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyperthyroidism	Endocrine disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected94 at risk EG0020 affected93 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0021 affected93 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected94 at risk EG0020 affected93 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Hepatitis B	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected94 at risk EG0020 affected93 at risk
Liver abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected94 at risk EG0021 affected93 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected94 at risk EG0021 affected93 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 affected91 at risk EG0014 affected94 at risk EG0021 affected93 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected94 at risk EG0021 affected93 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected94 at risk EG0020 affected93 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk
Blighted ovum	Pregnancy, puerperium and perinatal conditions	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected94 at risk EG0021 affected93 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected94 at risk EG0020 affected93 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0010 affected94 at risk EG0021 affected93 at risk
Upper gastrointestinal heamorrhage	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected94 at risk EG0020 affected93 at risk
Appendicitis perforated	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected94 at risk EG0020 affected93 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chills	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0006 affected91 at risk EG0010 affected94 at risk EG0024 affected93 at risk
Fatigue	General disorders	MedDRA 17.1	Non-systematic Assessment	EG00013 affected91 at risk EG00112 affected94 at risk EG00215 affected93 at risk
Influenza like illnes	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 affected91 at risk EG0015 affected94 at risk EG0023 affected93 at risk
Injection site pain	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0004 affected91 at risk EG0015 affected94 at risk EG0024 affected93 at risk
Malaise	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 affected91 at risk EG0013 affected94 at risk EG0025 affected93 at risk
Pyrexia	General disorders	MedDRA 17.1	Non-systematic Assessment	EG00020 affected91 at risk EG00119 affected94 at risk EG00221 affected93 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 affected91 at risk EG0012 affected94 at risk EG0021 affected93 at risk
Influenza	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0004 affected91 at risk EG0018 affected94 at risk EG0022 affected93 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0008 affected91 at risk EG0017 affected94 at risk EG00210 affected93 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0006 affected91 at risk EG00111 affected94 at risk EG00214 affected93 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG00014 affected91 at risk EG00117 affected94 at risk EG00218 affected93 at risk
Weight decreased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0005 affected91 at risk EG0019 affected94 at risk EG0023 affected93 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0008 affected91 at risk EG0017 affected94 at risk EG00210 affected93 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0007 affected91 at risk EG0016 affected94 at risk EG0024 affected93 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG00017 affected91 at risk EG00113 affected94 at risk EG00218 affected93 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0008 affected91 at risk EG00114 affected94 at risk EG0028 affected93 at risk
Headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG00021 affected91 at risk EG00117 affected94 at risk EG00220 affected93 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0006 affected91 at risk EG0014 affected94 at risk EG00211 affected93 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0006 affected91 at risk EG0018 affected94 at risk EG0028 affected93 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 affected91 at risk EG0013 affected94 at risk EG0026 affected93 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0007 affected91 at risk EG0019 affected94 at risk EG0024 affected93 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 affected91 at risk EG0011 affected94 at risk EG0024 affected93 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0006 affected91 at risk EG0015 affected94 at risk EG0026 affected93 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00014 affected91 at risk EG0019 affected94 at risk EG00213 affected93 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 affected91 at risk EG0010 affected94 at risk EG0028 affected93 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0004 affected91 at risk EG0016 affected94 at risk EG0023 affected93 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0007 affected91 at risk EG00110 affected94 at risk EG0028 affected93 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0006 affected91 at risk EG0019 affected94 at risk EG0027 affected93 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0004 affected91 at risk EG0012 affected94 at risk EG0025 affected93 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG00023 affected91 at risk EG00127 affected94 at risk EG00225 affected93 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0007 affected91 at risk EG0011 affected94 at risk EG0025 affected93 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG00011 affected91 at risk EG00114 affected94 at risk EG00215 affected93 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG00010 affected91 at risk EG00110 affected94 at risk EG0027 affected93 at risk

ID	Term
D019694	Hepatitis B, Chronic

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
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
C053001	adefovir
C413685	entecavir
C100416	peginterferon alfa-2a

Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.