A Rollover Study of BI 201335 in Combination With Pegylat... | NCT01330316

NCT01330316

ID	Type	Description	Link
2011-000141-20	EudraCT Number	EudraCT

Status Module

Label	Type	Description	Intervention Names
BI 201335 for 24 weeks	Experimental	BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks	Drug: BI 201335 Drug: PegIFN/RBV

Name	Type	Description	Arm Group Labels	Other Names
BI 201335	Drug	BI 201335 for 24 weeks	BI 201335 for 24 weeks
PegIFN/RBV

Measure	Description	Time Frame
Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL	The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.	12 weeks post treatment, up to 60 weeks

Measure	Description	Time Frame
Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)	Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.	24 weeks post treatment, up to 72 weeks
Early Treatment Success (ETS)

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Chronic hepatitis C infection of GT-1 in patients who failed prior treatment with PegIFN and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.

Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [EOT]).
Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
Female patients:
- with documented hysterectomy,
- who have had both ovaries removed,
- with documented tubal ligation,
- who are post-menopausal with last menstrual period at least 12 months prior to screening, or
- of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of RBV in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of RBV.
Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap.

or

Male patients:
- who are documented to be sterile, or
- who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
Signed informed consent form prior to trial participation.

Exclusion criteria:

Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criteria.
HIV co-infection
Hepatitis B virus (HBV) infection based on presence of HBs-Ag
Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patients ability to participate in this study
Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened.
Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to enrolment and throughout the treatment phase of this trial.
Known hypersensitivity to any ingredient of the study drugs.
Alpha fetoprotein value > 100 ng/mL at screening; if > 20 ng/mL and = 100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2).

Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1220.48.0004 Boehringer Ingelheim Investigational Site		Birmingham	Alabama		United States
1220.48.0091 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
26572686	Derived	Foster GR, Ferenci P, Asselah T, Mantry P, Dufour JF, Bourliere M, Forton D, Maevskaya M, Wright D, Yoshida EM, Garcia-Samaniego J, Oliveira C, Wright M, Warner N, Sha N, Quinson AM, Stern JO. Open-label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1-infected patients who failed placebo plus peginterferon and ribavirin. J Viral Hepat. 2016 Mar;23(3):227-31. doi: 10.1111/jvh.12485. Epub 2015 Nov 17.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Relapse	Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients. At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV. ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8. Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL

The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG00043 OG00175

Title

Denominators

Categories

Title	Measurements
	OG00095.3(89.1 to 100) OG00154.7(43.4 to 65.9)

Secondary

Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)

Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

24 weeks post treatment, up to 72 weeks

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Early Treatment Success (ETS)

ETS, defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.

FAS

Posted

Number

percentage of participants

week 4 and week 8

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)

This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.

FAS

Posted

Number

participants

Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.

This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.

FAS

Posted

Number

participants

48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)

This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.

FAS

Posted

Number

participants

Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.

This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.

FAS

Posted

Number

participants

Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Occurrence of Adverse Events (Overall and by DAIDS Grade)

This outcome measure will be presented as the percentage of subjects with any adverse event (AE).

Percentages are calculated using total number of subjects per treatment cohort as the denominator.

The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment.

FAS

Posted

Number

percentage of participants

from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants

Secondary

Occurrence of Adverse Events Leading to Treatment Discontinuation

This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.

FAS

Posted

Number

percentage of participants

from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Occurrence of Serious Adverse Events (SAEs)

This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.

FAS

Posted

Number

percentage of participants

from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Occurrence of Drug-related AEs as Assessed by the Investigator

This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.

FAS

Posted

Number

percentage of participants

from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants	OG000

Secondary

Laboratory Test Abnormalities by DAIDS Grades

This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.

FAS

Posted

Number

percentage of participants

baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants

Secondary

Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]

This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.

In this outcome measure Haemoglobin is presented.

FAS

Posted

Mean

Standard Deviation

gram (g)/decilitre (dL)

baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants

Secondary

Changes From Baseline in Laboratory Test Values Over Time [ALT]

In this outcome measure ALT is presented.

FAS

Posted

Mean

Standard Deviation

Units (U)/Litre (L)

baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants

Secondary

Changes From Baseline in Laboratory Test Values Over Time [AST]

In this outcome measure AST is presented.

FAS

Posted

Mean

Standard Deviation

U/L

baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants

Secondary

Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]

In this outcome measure Bilirubin total is presented.

FAS

Posted

Mean

Standard Deviation

milligram (mg)/dL

baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)

ID	Title	Description
OG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
OG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ascites	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk
Diarrhoea	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	17.0	Systematic Assessment	EG0001 affected43 at risk EG0010 affected75 at risk
Hepatic failure	Hepatobiliary disorders	17.0	Systematic Assessment	EG0001 affected43 at risk EG0010 affected75 at risk
Gastroenteritis	Infections and infestations	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk
Oral fungal infection	Infections and infestations	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk
Pneumonia	Infections and infestations	17.0	Systematic Assessment	EG0001 affected43 at risk EG0010 affected75 at risk
Decreased appetite	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk
Dehydration	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk
Presyncope	Nervous system disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.0	Systematic Assessment	EG0000 affected43 at risk EG0011 affected75 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0009 affected43 at risk EG00120 affected75 at risk
Neutropenia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0002 affected43 at risk EG0017 affected75 at risk
Thrombocytopenia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0001 affected43 at risk EG0015 affected75 at risk
Dry eye	Eye disorders	17.0	Systematic Assessment	EG0001 affected43 at risk EG0014 affected75 at risk
Abdominal discomfort	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0014 affected75 at risk
Abdominal pain	Gastrointestinal disorders	17.0	Systematic Assessment	EG0006 affected43 at risk EG0013 affected75 at risk
Abdominal pain upper	Gastrointestinal disorders	17.0	Systematic Assessment	EG0002 affected43 at risk EG0018 affected75 at risk
Diarrhoea	Gastrointestinal disorders	17.0	Systematic Assessment	EG00014 affected43 at risk EG00121 affected75 at risk
Dry mouth	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0014 affected75 at risk
Dyspepsia	Gastrointestinal disorders	17.0	Systematic Assessment	EG0002 affected43 at risk EG0015 affected75 at risk
Nausea	Gastrointestinal disorders	17.0	Systematic Assessment	EG00022 affected43 at risk EG00134 affected75 at risk
Stomatitis	Gastrointestinal disorders	17.0	Systematic Assessment	EG0003 affected43 at risk EG0012 affected75 at risk
Vomiting	Gastrointestinal disorders	17.0	Systematic Assessment	EG00011 affected43 at risk EG00115 affected75 at risk
Asthenia	General disorders	17.0	Systematic Assessment	EG0007 affected43 at risk EG00113 affected75 at risk
Chills	General disorders	17.0	Systematic Assessment	EG0003 affected43 at risk EG0012 affected75 at risk
Fatigue	General disorders	17.0	Systematic Assessment	EG00014 affected43 at risk EG00111 affected75 at risk
Influenza like illness	General disorders	17.0	Systematic Assessment	EG0005 affected43 at risk EG0014 affected75 at risk
Malaise	General disorders	17.0	Systematic Assessment	EG0001 affected43 at risk EG0016 affected75 at risk
Pyrexia	General disorders	17.0	Systematic Assessment	EG0004 affected43 at risk EG0018 affected75 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	17.0	Systematic Assessment	EG00012 affected43 at risk EG0016 affected75 at risk
Jaundice	Hepatobiliary disorders	17.0	Systematic Assessment	EG0005 affected43 at risk EG00110 affected75 at risk
Urinary tract infection	Infections and infestations	17.0	Systematic Assessment	EG0003 affected43 at risk EG0011 affected75 at risk
Haemoglobin decreased	Investigations	17.0	Systematic Assessment	EG0003 affected43 at risk EG0011 affected75 at risk
Weight decreased	Investigations	17.0	Systematic Assessment	EG0003 affected43 at risk EG0013 affected75 at risk
Decreased appetite	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0003 affected43 at risk EG00116 affected75 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0002 affected43 at risk EG0014 affected75 at risk
Back pain	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0000 affected43 at risk EG0014 affected75 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0002 affected43 at risk EG0014 affected75 at risk
Myalgia	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0003 affected43 at risk EG0019 affected75 at risk
Dizziness	Nervous system disorders	17.0	Systematic Assessment	EG0003 affected43 at risk EG0015 affected75 at risk
Dysgeusia	Nervous system disorders	17.0	Systematic Assessment	EG0002 affected43 at risk EG0014 affected75 at risk
Headache	Nervous system disorders	17.0	Systematic Assessment	EG00010 affected43 at risk EG00115 affected75 at risk
Depression	Psychiatric disorders	17.0	Systematic Assessment	EG0003 affected43 at risk EG0014 affected75 at risk
Insomnia	Psychiatric disorders	17.0	Systematic Assessment	EG0005 affected43 at risk EG00114 affected75 at risk
Irritability	Psychiatric disorders	17.0	Systematic Assessment	EG0002 affected43 at risk EG0016 affected75 at risk
Cough	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG0005 affected43 at risk EG00111 affected75 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG0004 affected43 at risk EG0013 affected75 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG0002 affected43 at risk EG0014 affected75 at risk
Alopecia	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0004 affected43 at risk EG0016 affected75 at risk
Dry skin	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0004 affected43 at risk EG0018 affected75 at risk
Eczema	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0001 affected43 at risk EG0015 affected75 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0003 affected43 at risk EG0011 affected75 at risk
Pruritus	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG00013 affected43 at risk EG00123 affected75 at risk
Rash	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG00012 affected43 at risk EG00121 affected75 at risk
Hypertension	Vascular disorders	17.0	Systematic Assessment	EG0003 affected43 at risk EG0011 affected75 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Title	Description
BG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
BG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Relapse	FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.			1	43	38	43
EG001	Non-relapse	FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.			6	75	68	75