Efficacy and Safety of BI 201335 (Faldaprevir) in Combina... | NCT01297270

ID	Type	Description	Link
2010-021716-42	EudraCT Number	EudraCT

Label	Type	Description	Intervention Names
PegIFN/RBV	Active Comparator	48 weeks	Drug: PegIFN/RBV
BI 201335 for 24 weeks	Experimental	BI 201 335 QD dosing in combination with IFN/RBV	Drug: PegIFN/RBV Drug: BI201335
BI201335 for 12 weeks	Experimental	BI 201335 QD doing in combination with PEFG IFN/RBV	Drug: BI201335 Drug: PegIFN/RBV
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BI201335	Drug	QD BI 201335	BI201335 for 12 weeks
PegIFN/RBV

Measure	Description	Time Frame
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)	Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV 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 Virologic Response 24 Weeks Post-treatment (SVR24)	Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration. Hepatitis C virus Ribonucleic acid (HCV RNA)	24 weeks post treatment, up to 72 weeks

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
2. liver biopsy consistent with chronic HCV infection.
HCV genotype 1 infection confirmed by genotypic testing at screening.
Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
HCV RNA = 1,000 IU/mL at screening
Documentation of a liver biopsy within 3 years or fibroscan within 6 months of the screening visit.

Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not exclude patients from a trial.
Age 18 to 70 years
Female patients:

(c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) 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 ribavirin 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 ribavirin.

Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device.

Male patients:
1. who are documented to be sterile, or
2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) 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.
Signed informed consent form prior to trial participation

Exclusion criteria:

HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
Evidence of acute or chronic liver disease due to causes other than chronic HCV infection.
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 patient¿s ability to participate in this study.
Usage of any investigational drugs within 28 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 28 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 screening and throughout the treatment phase.
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).
Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following:
1. International normalized ratio (INR) of =1.7
2. Serum Albumin =3.5 g/dL
3. Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome).
Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1220.47.0004 Boehringer Ingelheim Investigational Site		Birmingham	Alabama		United States
1220.47.0045 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
27049487	Derived	Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourliere M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Bocher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naive HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.

ID	Title	Description
FG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
FG001

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 Virologic Response 12 Weeks Post Treatment (SVR12)

Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

95% Confidence Interval

percentage of participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV	Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.

Units	Counts
Participants	OG000262 OG001263 OG002132

Title

Denominators

Categories

Title	Measurements
	OG00067.9(62.3 to 73.6) OG00164.3(58.5 to 70.1) OG00247.0(38.5 to 55.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Cochran-Mantel-Haenszel		<0.0001		Mean Difference (Final Values)	20.7			2-Sided	95	10.7	30.6			Estimate adjusted for genotype and race using Koch's method, with continuity correction	No	Superiority or Other
OG001 OG002		Cochran-Mantel-Haenszel

Secondary

Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.

Hepatitis C virus Ribonucleic acid (HCV RNA)

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication and had SVR data at week 24.

Posted

Number

95% Confidence Interval

percentage of participants

24 weeks post treatment, up to 72 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Secondary

Early Treatment Success (ETS)

Percentage of participants with early treatment success (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.

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

percentage of participants

Week 4 and week 8

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV	Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.

Secondary

ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES

The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Secondary

ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO

The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Secondary

ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES

The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Secondary

ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO

The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Secondary

AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Secondary

AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO

The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Secondary

AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES

The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Secondary

AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO

The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline

Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
OG002	Placebo and PegIFN/RBV

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MEDDRA 17.0	Systematic Assessment	EG0002 affected262 at risk EG0010 affected263 at risk EG0021 affected132 at risk
Neutropenia	Blood and lymphatic system disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Pancytopenia	Blood and lymphatic system disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Acute myocardial infarction	Cardiac disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Angina pectoris	Cardiac disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Epidermolysis	Congenital, familial and genetic disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Optic ischaemic neuropathy	Eye disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0010 affected263 at risk EG0021 affected132 at risk
Ascites	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Diarrhoea	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0012 affected263 at risk EG0020 affected132 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Large intestine perforation	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Nausea	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0012 affected263 at risk EG0020 affected132 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Pancreatitis	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Umbilical hernia	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Vomiting	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0013 affected263 at risk EG0020 affected132 at risk
Malaise	General disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Bile duct stone	Hepatobiliary disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0010 affected263 at risk EG0021 affected132 at risk
Cholecystitis	Hepatobiliary disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Hepatic failure	Hepatobiliary disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0012 affected263 at risk EG0020 affected132 at risk
Hypersensitivity	Immune system disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Cellulitis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Diverticulitis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Infective chondritis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Pneumonia	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Sepsis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Subcutaneous abscess	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0021 affected132 at risk
Vulval abscess	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Accidental overdose	Injury, poisoning and procedural complications	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Contusion	Injury, poisoning and procedural complications	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Fibula fracture	Injury, poisoning and procedural complications	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Jaw fracture	Injury, poisoning and procedural complications	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Laceration	Injury, poisoning and procedural complications	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0010 affected263 at risk EG0021 affected132 at risk
Ligament sprain	Injury, poisoning and procedural complications	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Tibia fracture	Injury, poisoning and procedural complications	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Dehydration	Metabolism and nutrition disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Hypokalaemia	Metabolism and nutrition disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Hyponatraemia	Metabolism and nutrition disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Back pain	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Cerebral ischaemia	Nervous system disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0012 affected263 at risk EG0020 affected132 at risk
Bipolar disorder	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Depression	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0022 affected132 at risk
Drug dependence	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Mental status changes	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0010 affected263 at risk EG0021 affected132 at risk
Personality disorder	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Suicidal ideation	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0021 affected132 at risk
Suicide attempt	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Renal failure acute	Renal and urinary disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0011 affected263 at risk EG0020 affected132 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk
Rash	Skin and subcutaneous tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0000 affected262 at risk EG0012 affected263 at risk EG0020 affected132 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0001 affected262 at risk EG0010 affected263 at risk EG0020 affected132 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MEDDRA 17.0	Systematic Assessment	EG00059 affected262 at risk EG00155 affected263 at risk EG00227 affected132 at risk
Neutropenia	Blood and lymphatic system disorders	MEDDRA 17.0	Systematic Assessment	EG00035 affected262 at risk EG00124 affected263 at risk EG00214 affected132 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MEDDRA 17.0	Systematic Assessment	EG00013 affected262 at risk EG00114 affected263 at risk EG00211 affected132 at risk
Ocular icterus	Eye disorders	MEDDRA 17.0	Systematic Assessment	EG0003 affected262 at risk EG00114 affected263 at risk EG0021 affected132 at risk
Abdominal pain	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG00020 affected262 at risk EG00123 affected263 at risk EG00210 affected132 at risk
Abdominal pain upper	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG00015 affected262 at risk EG0018 affected263 at risk EG0029 affected132 at risk
Constipation	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG00022 affected262 at risk EG00114 affected263 at risk EG0027 affected132 at risk
Diarrhoea	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG00071 affected262 at risk EG00189 affected263 at risk EG00223 affected132 at risk
Dry mouth	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG00015 affected262 at risk EG00116 affected263 at risk EG0026 affected132 at risk
Dyspepsia	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG00026 affected262 at risk EG00117 affected263 at risk EG0023 affected132 at risk
Nausea	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG00099 affected262 at risk EG001150 affected263 at risk EG00252 affected132 at risk
Vomiting	Gastrointestinal disorders	MEDDRA 17.0	Systematic Assessment	EG00040 affected262 at risk EG00170 affected263 at risk EG00211 affected132 at risk
Asthenia	General disorders	MEDDRA 17.0	Systematic Assessment	EG00010 affected262 at risk EG00119 affected263 at risk EG0026 affected132 at risk
Chills	General disorders	MEDDRA 17.0	Systematic Assessment	EG00040 affected262 at risk EG00138 affected263 at risk EG00225 affected132 at risk
Fatigue	General disorders	MEDDRA 17.0	Systematic Assessment	EG000113 affected262 at risk EG001133 affected263 at risk EG00270 affected132 at risk
Influenza like illness	General disorders	MEDDRA 17.0	Systematic Assessment	EG00025 affected262 at risk EG00114 affected263 at risk EG00215 affected132 at risk
Injection site erythema	General disorders	MEDDRA 17.0	Systematic Assessment	EG00013 affected262 at risk EG00113 affected263 at risk EG00211 affected132 at risk
Injection site reaction	General disorders	MEDDRA 17.0	Systematic Assessment	EG00026 affected262 at risk EG00113 affected263 at risk EG0024 affected132 at risk
Pain	General disorders	MEDDRA 17.0	Systematic Assessment	EG00015 affected262 at risk EG00122 affected263 at risk EG0029 affected132 at risk
Pyrexia	General disorders	MEDDRA 17.0	Systematic Assessment	EG00038 affected262 at risk EG00141 affected263 at risk EG00220 affected132 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MEDDRA 17.0	Systematic Assessment	EG0008 affected262 at risk EG00125 affected263 at risk EG0020 affected132 at risk
Jaundice	Hepatobiliary disorders	MEDDRA 17.0	Systematic Assessment	EG0006 affected262 at risk EG00124 affected263 at risk EG0020 affected132 at risk
Bronchitis	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG0005 affected262 at risk EG00114 affected263 at risk EG0022 affected132 at risk
Upper respiratory tract infection	Infections and infestations	MEDDRA 17.0	Systematic Assessment	EG00018 affected262 at risk EG00119 affected263 at risk EG0029 affected132 at risk
Weight decreased	Investigations	MEDDRA 17.0	Systematic Assessment	EG00015 affected262 at risk EG00120 affected263 at risk EG00210 affected132 at risk
Decreased appetite	Metabolism and nutrition disorders	MEDDRA 17.0	Systematic Assessment	EG00054 affected262 at risk EG00163 affected263 at risk EG00226 affected132 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG00036 affected262 at risk EG00136 affected263 at risk EG00222 affected132 at risk
Back pain	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG00015 affected262 at risk EG00116 affected263 at risk EG00211 affected132 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0002 affected262 at risk EG0018 affected263 at risk EG0027 affected132 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG00047 affected262 at risk EG00153 affected263 at risk EG00237 affected132 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MEDDRA 17.0	Systematic Assessment	EG00011 affected262 at risk EG00112 affected263 at risk EG0028 affected132 at risk
Disturbance in attention	Nervous system disorders	MEDDRA 17.0	Systematic Assessment	EG0009 affected262 at risk EG00114 affected263 at risk EG0028 affected132 at risk
Dizziness	Nervous system disorders	MEDDRA 17.0	Systematic Assessment	EG00041 affected262 at risk EG00139 affected263 at risk EG00225 affected132 at risk
Dysgeusia	Nervous system disorders	MEDDRA 17.0	Systematic Assessment	EG00016 affected262 at risk EG00115 affected263 at risk EG0023 affected132 at risk
Headache	Nervous system disorders	MEDDRA 17.0	Systematic Assessment	EG00084 affected262 at risk EG00181 affected263 at risk EG00245 affected132 at risk
Hypoaesthesia	Nervous system disorders	MEDDRA 17.0	Systematic Assessment	EG0008 affected262 at risk EG0015 affected263 at risk EG0027 affected132 at risk
Anxiety	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG00015 affected262 at risk EG00125 affected263 at risk EG00214 affected132 at risk
Depression	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG00032 affected262 at risk EG00136 affected263 at risk EG00211 affected132 at risk
Insomnia	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG00071 affected262 at risk EG00166 affected263 at risk EG00238 affected132 at risk
Irritability	Psychiatric disorders	MEDDRA 17.0	Systematic Assessment	EG00035 affected262 at risk EG00132 affected263 at risk EG00227 affected132 at risk
Chromaturia	Renal and urinary disorders	MEDDRA 17.0	Systematic Assessment	EG0005 affected262 at risk EG00120 affected263 at risk EG0020 affected132 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MEDDRA 17.0	Systematic Assessment	EG00046 affected262 at risk EG00143 affected263 at risk EG00221 affected132 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MEDDRA 17.0	Systematic Assessment	EG00031 affected262 at risk EG00122 affected263 at risk EG00220 affected132 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MEDDRA 17.0	Systematic Assessment	EG00012 affected262 at risk EG00117 affected263 at risk EG0029 affected132 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MEDDRA 17.0	Systematic Assessment	EG0006 affected262 at risk EG0017 affected263 at risk EG0027 affected132 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MEDDRA 17.0	Systematic Assessment	EG00015 affected262 at risk EG00113 affected263 at risk EG0028 affected132 at risk
Alopecia	Skin and subcutaneous tissue disorders	MEDDRA 17.0	Systematic Assessment	EG00045 affected262 at risk EG00151 affected263 at risk EG00222 affected132 at risk
Dry skin	Skin and subcutaneous tissue disorders	MEDDRA 17.0	Systematic Assessment	EG00030 affected262 at risk EG00137 affected263 at risk EG00215 affected132 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0004 affected262 at risk EG0014 affected263 at risk EG0028 affected132 at risk
Pruritus	Skin and subcutaneous tissue disorders	MEDDRA 17.0	Systematic Assessment	EG00070 affected262 at risk EG00194 affected263 at risk EG00237 affected132 at risk
Rash	Skin and subcutaneous tissue disorders	MEDDRA 17.0	Systematic Assessment	EG00093 affected262 at risk EG001105 affected263 at risk EG00241 affected132 at risk
Rash macular	Skin and subcutaneous tissue disorders	MEDDRA 17.0	Systematic Assessment	EG0005 affected262 at risk EG00114 affected263 at risk EG0022 affected132 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	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
BG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
BG002	Placebo and PegIFN/RBV	Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Faldaprevir 120mg and PegIFN/RBV	Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	21	262	255	262
EG001	Faldaprevir 240mg and PegIFN/RBV	Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.	26	263	258	263
EG002	Placebo and PegIFN/RBV	Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.	8	132	130	132