Safety and Efficacy Study in Subjects With Chronic HCV an... | NCT01741545

ID	Type	Description	Link
2012-003463-22	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)	Experimental	Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks	Biological: Pegylated-Interferon-lambda Drug: Ribavirin Drug: Daclatasvir
Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)	Experimental	Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks	Biological: Pegylated-Interferon-lambda Drug: Ribavirin Drug: Daclatasvir

Name	Type	Description	Arm Group Labels	Other Names
Pegylated-Interferon-lambda	Biological		Cohort A: Genotype-2,-3 (Lambda/RBV/DCV) Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)

Measure	Description	Time Frame
Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12	SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.	Follow-up Week 12

Measure	Description	Time Frame
Percentage of Participants With Rapid Virologic Response (RVR)	RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.	Treatment Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR)

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Boswell Clinic		Palo Alto	California	94304	United States
Rush University Medical Center

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort A	Participants with hepatitis C virus (HCV) genotype (GT)-2 or GT-3 infection (Cohort A) were treated with peginterferon lambda-1a (pegIFNλ-1a referred to as Lambda)/Ribavirin (RBV)/Daclatasvir (DCV). Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
BG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12

SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.

The analysis was performed in modified intent to treat (mITT) population defined as participants meeting the response criteria over all treated participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Follow-up Week 12

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Units	Counts
Participants	OG00012 OG00139

Title

Denominators

Categories

Title	Measurements
	OG00091.7(61.5 to 99.8) OG00189.7(75.8 to 97.1)

Secondary

Percentage of Participants With Rapid Virologic Response (RVR)

RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.

mITT population.

Posted

Number

95% Confidence Interval

Percentage of participants

Treatment Week 4

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Secondary

Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.

mITT population.

Posted

Number

95% Confidence Interval

Percentage of participants

Treatment Week 12

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Secondary

Percentage of Participants With End of the Treatment Response (EOTR)

EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.

mITT population.

Posted

Number

95% Confidence Interval

Percentage of participants

End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Secondary

Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)

SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.

mITT population.

Posted

Number

95% Confidence Interval

Percentage of participants

Follow-up Week 24

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Secondary

Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment

Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) <10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) <750 mm^3, and/or thrombocytopenia: platelets <50,000 mm^3.

mITT population.

Posted

Number

95% Confidence Interval

Percentage of participants

After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Secondary

Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment

Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.

mITT population.

Posted

Number

95% Confidence Interval

Percentage of participants

After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Secondary

Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death

AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.

All treated participants.

Posted

Number

Percentage of participants

From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B

Secondary

Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities

Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): >2.0*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : >5*ULN; Aspartate aminotransferase (AST): >5*ULN; Prothrombin Time (PT): >1.50*ULN; Bilirubin (Total): >2.5*ULN; Triglycerides (fasting): >750 mg/dL.

All treated participants.

Posted

Count of Participants

Participants

After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

ID	Title	Description
OG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
OG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort A	Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).	0	12	0	12	10	12
EG001	Cohort B	Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing <75 kg = 1000 mg and participants weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).	0	39	4	39	36	39

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haematoma	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events3 affected39 at risk
Haemorrhage	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG00112 events12 affected39 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected12 at risk EG0019 events9 affected39 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0015 events5 affected39 at risk
Influenza like illness	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Insomnia	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected12 at risk EG00113 events13 affected39 at risk
Sleep disorder	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0015 events5 affected39 at risk
Affect lability	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Anger	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Anxiety	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Irritability	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0012 events2 affected39 at risk
Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Initial insomnia	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Blood bilirubin increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0012 events2 affected39 at risk
Weight decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events2 affected39 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected39 at risk
Lipase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected39 at risk
Blood bicarbonate decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events3 affected39 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0017 events7 affected39 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events3 affected39 at risk
Disturbance in attention	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0018 events8 affected39 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0016 events6 affected39 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events3 affected39 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0013 events3 affected39 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0012 events2 affected39 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Chromaturia	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0014 events4 affected39 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0017 events7 affected39 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0014 events4 affected39 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0011 events1 affected39 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0014 events4 affected39 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0012 events2 affected39 at risk
Hypothyroidism	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected39 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected12 at risk EG0015 events5 affected39 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	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hepatitis acute	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected39 at risk
Jaundice	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected39 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected39 at risk
Arthritis bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected39 at risk

ID	Term
C000600496	peginterferon lambda-1a
D012254	Ribavirin
C549273	daclatasvir