Safety and Efficacy of Daclatasvir (BMS-790052) Plus Stan... | NCT00874770

ID	Type	Description	Link
EUDRACT# 2009-010149-29

Label	Type	Description	Intervention Names
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)	Experimental	Active Comparator	Drug: Daclatasvir Drug: Peginterferon alpha-2a Drug: ribavirin
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)	Experimental	Active Comparator	Drug: Daclatasvir Drug: Peginterferon alpha-2a Drug: ribavirin
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)	Experimental	Active Comparator	Drug: Daclatasvir Drug: Peginterferon alpha-2a Drug: ribavirin
Placebo, Peginterferon alpha-2a, ribavirin (D)	Active Comparator		Drug: Placebo Drug: Peginterferon alpha-2a Drug: ribavirin

Name	Type	Description	Arm Group Labels	Other Names
Daclatasvir	Drug	Tablets, oral, 3 mg, Daily, 48 weeks	Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)

Measure	Description	Time Frame
Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12	eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.	A Weeks 4 and 12

Measure	Description	Time Frame
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4	RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.	At Week 4
Percentage of Participants With Early Virologic Response (EVR) at Week 12

Measure	Description	Time Frame
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase	An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.

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

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Liver & Digestive Specialists (Alds)		Montgomery	Alabama	36116	United States
University Of Colorado Denver & Hospital

PubMed Identifier	Type	Citation	Retractions
22714001	Derived	Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hezode C, Lim JK, Bronowicki JP, Abrams GA, Brau N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

ID	Title	Description
FG000	Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).

ID	Title	Description
BG000	Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin	Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
BG001	Daclatasvir 10-mg+pegIFNα-2a+Ribavirin	Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
BG002	Daclatasvir 60-mg+pegIFNα-2a+Ribavirin	Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
BG003	Placebo+pegIFNα-2a+Ribavirin	Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG00112 BG00212 BG00312 BG00448

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

Other Pre-specified

Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase

An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.

All participants who received at least 1 dose of study drug.

Posted

Number

participants

SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug

ID	Title	Description
OG000	Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG001	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin	Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG002	Daclatasvir 60 mg + pegIFNα-2a + Ribavirin	Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG003	Placebo + pegIFNα-2a + Ribavirin	Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).

Units	Counts
Participants	OG00012 OG00112 OG00212 OG003

Title

Denominators

Categories

SAEs

Title	Measurements
	OG0001 OG0011 OG0021 OG003

Other Pre-specified

Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period

All participants who received at least 1 dose of study drug. n=evaluable patients

Posted

Number

participants

From Day 31 up to Week 24 of post treatment follow-up

ID	Title	Description
OG000	Daclatasvir 3 mg + pegIFNα-2a + Rribavirin	Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG001	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin

Primary

Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12

eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.

All participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

A Weeks 4 and 12

ID	Title	Description
OG000	Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG001	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin	Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG002	Daclatasvir 60 mg + pegIFNα-2a + Ribavirin	Participants received 60 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).

Secondary

Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.

All participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

At Week 4

ID	Title	Description
OG000	Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG001	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin	Participants received 10-mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG002	Daclatasvir 60 mg + pegIFNα-2a + Ribavirin	Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).

Secondary

Percentage of Participants With Early Virologic Response (EVR) at Week 12

EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.

All participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

At Week 12

ID	Title	Description
OG000	Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG001	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin	Participants received 10 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG002	Daclatasvir 60 mg + pegIFNα-2a + Ribavirin

Secondary

Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12

cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12

All participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

At Week 12

ID	Title	Description
OG000	Daclatasvir 3 mg + pegIFNα-2a + Riibavirin	Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG001	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin	Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG002	Daclatasvir 60 mg + pegIFNα-2a + Ribavirin	Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).

Other Pre-specified

Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results

Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.

All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point

Posted

Number

participants

From screening up to Week 12 (treatment period)

ID	Title	Description
OG000	Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
OG001	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG0031 affected12 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected12 at risk EG0021 affected12 at risk EG003
Blood pressure fluctuation	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0013 affected12 at risk EG0024 affected12 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected12 at risk EG0021 affected12 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Ear infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Genital herpes	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Weight decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0003 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Carbuncle	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Cubital tunnel syndrome	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected12 at risk EG0020 affected12 at risk EG003
Flushing	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Food aversion	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Hallucination, auditory	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Injection site reaction	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Oral herpes	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Tremor	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Vision blurred	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Dizziness	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected12 at risk EG0022 affected12 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected12 at risk EG0023 affected12 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0012 affected12 at risk EG0020 affected12 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Injection site erythema	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Irritability	General disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected12 at risk EG0016 affected12 at risk EG0023 affected12 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Presyncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected12 at risk EG0013 affected12 at risk EG0024 affected12 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Skin atrophy	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Syncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected12 at risk EG0024 affected12 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Asthenia	General disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected12 at risk EG0011 affected12 at risk EG0025 affected12 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Dry eye	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Hordeolum	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Injection site pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Liver function test abnormal	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Burning sensation	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0022 affected12 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0022 affected12 at risk EG003
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG0006 affected12 at risk EG0017 affected12 at risk EG0026 affected12 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Gingival disorder	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Influenza like illness	General disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected12 at risk EG0016 affected12 at risk EG0022 affected12 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0022 affected12 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected12 at risk EG0013 affected12 at risk EG0022 affected12 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected12 at risk EG0020 affected12 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected12 at risk EG0014 affected12 at risk EG0022 affected12 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Tooth infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Agitation	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Body tinea	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Depression	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0013 affected12 at risk EG0022 affected12 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0009 affected12 at risk EG0017 affected12 at risk EG0023 affected12 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Injection site irritation	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected12 at risk EG0014 affected12 at risk EG0025 affected12 at risk EG003
Malaise	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Poor quality sleep	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Tongue ulceration	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Xeroderma	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected12 at risk EG0011 affected12 at risk EG0023 affected12 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0013 affected12 at risk EG0022 affected12 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Chills	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected12 at risk EG0012 affected12 at risk EG0022 affected12 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Influenza	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Injection site pruritus	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Mood swings	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected12 at risk EG0013 affected12 at risk EG0022 affected12 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected12 at risk EG0021 affected12 at risk EG003
Pallor	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0013 affected12 at risk EG0023 affected12 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Weight increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Ageusia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected12 at risk EG0013 affected12 at risk EG0026 affected12 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0013 affected12 at risk EG0021 affected12 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Gingival hypertrophy	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected12 at risk EG0021 affected12 at risk EG003
Lip injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0022 affected12 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected12 at risk EG0015 affected12 at risk EG0024 affected12 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected12 at risk EG0010 affected12 at risk EG0022 affected12 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0022 affected12 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Wound infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003

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

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Daclatasvir 3 mg + pegIFNα-2a + Ribavirin	Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).	1	12	12	12
EG001	Daclatasvir 10 mg + pegIFNα-2a + Ribavirin	Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).	1	12	12	12
EG002	Daclatasvir 60 mg + pegIFNα-2a + Ribavirin	Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).	1	12	12	12
EG003	Placebo + pegIFNα-2a + Ribavirin	Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).	0	12	12	12

ID	Term
C549273	daclatasvir
C100416	peginterferon alfa-2a
D012254	Ribavirin