Study of the Anti-HCV Drug (BMS-790052) Combined With Peg... | NCT01170962

NCT01170962

ID	Type	Description	Link
2010-019378-34	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin	Experimental	(prior null responders)	Drug: BMS-790052 Drug: peginterferon alfa-2a Drug: ribavirin
Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin	Experimental	(prior null responders)	Drug: BMS-790052 Drug: peginterferon alfa-2a Drug: ribavirin
Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin	Experimental	(prior partial responders)	Drug: BMS-790052 Drug: peginterferon alfa-2a Drug: ribavirin
Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin	Experimental	(prior partial responders)	Drug: BMS-790052 Drug: peginterferon alfa-2a Drug: ribavirin
Arm 5: Placebo plus peginterferon alfa-2a and ribavirin	Experimental	(prior partial responders only)	Drug: Placebo Drug: peginterferon alfa-2a

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-790052	Drug	Film coated tablet, Oral, 20 mg, once daily, 24 weeks	Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Extended Rapid Virologic Response (eRVR)	eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.	Week 4, Week 12
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)	SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA \	Follow-up Week 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment	AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.	From first dose to last dose plus 7 days, up to 49 weeks
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period	AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.	From day 8 post last dose of treatment up-to Week 72

Measure	Description	Time Frame
Percentage of Participants With Rapid Virologic Response (RVR)	RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \	Week 4

Eligibility Module

Contacts/Locations Module

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
Scripps Clinic

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Daclatasvir (20 mg): Prior Null and Partial Responders	Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Daclastavir (20mg): Prior Null and Partial Responders	Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
BG001	Daclastavir (60mg): Prior Null and Partial Responders	Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
BG002	Placebo: Prior Partial Responders	Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

Title	Measurements
	OG00018.0(13.8 to 22.3) OG00119.7(15.3 to 24.1) OG00225.7(19.0 to 32.4) OG003

Primary

Percentage of Participants With 24-week Sustained Virologic Response (SVR24)

SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA \

All treated participants who received at least 1 dose of study therapy.

Posted

Number

80% Confidence Interval

percentage of participants

Follow-up Week 24

ID	Title	Description
OG000	Daclatasvir (20 mg): Prior Null Responders	Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
OG001	Daclatasvir (60 mg): Prior Null Responders

Primary

Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

Safety population included all treated participants.

Posted

Number

participants

From first dose to last dose plus 7 days, up to 49 weeks

ID	Title	Description
OG000	Daclatasvir (20 mg): Prior Null and Partial Responders	Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.

Secondary

Percentage of Participants With Rapid Virologic Response (RVR)

RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \

All treated participants who received at least 1 dose of study therapy.

Posted

Number

80% Confidence Interval

percentage of participants

Week 4

ID	Title	Description
OG000	Daclatasvir (20 mg): Prior Null Responders	Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
OG001	Daclatasvir (60 mg): Prior Null Responders

Secondary

Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \

All treated participants who received at least 1 dose of study therapy.

Posted

Number

80% Confidence Interval

percentage of participants

Week 12

ID	Title	Description
OG000	Daclatasvir (20 mg): Prior Null Responders	Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
OG001	Daclatasvir (60 mg): Prior Null Responders

Secondary

Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)

SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA \

All treated participants who received at least 1 dose of study therapy.

Posted

Number

80% Confidence Interval

percentage of participants

Follow-up Week 12

ID	Title	Description
OG000	Daclatasvir (20 mg): Prior Null Responders	Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
OG001	Daclatasvir (60 mg): Prior Null Responders

Secondary

Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures

Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.

All treated participants who received at least 1 dose of study therapy.

Posted

Number

participants

Baseline to follow-up Week 48

ID	Title	Description
OG000	Daclatasvir (20 mg): Prior Null Responders	Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
OG001	Daclatasvir (60 mg): Prior Null Responders

Secondary

Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures

Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.

All treated participants who received at least 1 dose of study therapy.

Posted

Number

participants

Baseline to follow-up Week 48

ID	Title	Description
OG000	Daclatasvir (20 mg): Prior Null Responders	Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
OG001	Daclatasvir (60 mg): Prior Null Responders

Primary

Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period

AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

Safety population included all treated participants.

Posted

Number

participants

From day 8 post last dose of treatment up-to Week 72

ID	Title	Description
OG000	Daclatasvir (20 mg): Prior Null and Partial Responders	Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Daclatasvir (20 mg): Prior Null and Partial Responders	Participant (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.	14	203	190	203
EG001	Daclatasvir (60 mg): Prior Null and Partial Responders	Participant (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.	11	199	195	199
EG002	Placebo: Prior Partial Responders	Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.	3	17	15	17

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Angina unstable	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Bladder perforation	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Cat scratch disease	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Lacunar infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Lung infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Streptococcus test positive	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Anaemia haemolytic autoimmune	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Influenza like illness	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Retinal exudates	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Retinal haemorrhage	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Postoperative wound infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Substance abuse	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0020 affected17 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0020 affected17 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG00043 affected203 at risk EG00128 affected199 at risk EG0024 affected17 at risk
Anxiety	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG00013 affected203 at risk EG00116 affected199 at risk EG0021 affected17 at risk
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG00055 affected203 at risk EG00138 affected199 at risk EG0021 affected17 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00035 affected203 at risk EG00147 affected199 at risk EG0023 affected17 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00038 affected203 at risk EG00136 affected199 at risk EG0024 affected17 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected203 at risk EG00110 affected199 at risk EG0021 affected17 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00015 affected203 at risk EG0017 affected199 at risk EG0023 affected17 at risk
Gingival abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Memory impairment	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0008 affected203 at risk EG0015 affected199 at risk EG0021 affected17 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0007 affected203 at risk EG00110 affected199 at risk EG0021 affected17 at risk
Photophobia	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 affected203 at risk EG0017 affected199 at risk EG0021 affected17 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00038 affected203 at risk EG00138 affected199 at risk EG0021 affected17 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected203 at risk EG0012 affected199 at risk EG0021 affected17 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0009 affected203 at risk EG00110 affected199 at risk EG0022 affected17 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00019 affected203 at risk EG00116 affected199 at risk EG0022 affected17 at risk
Amnesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected203 at risk EG0013 affected199 at risk EG0021 affected17 at risk
Blepharitis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00022 affected203 at risk EG00111 affected199 at risk EG0020 affected17 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected203 at risk EG0012 affected199 at risk EG0021 affected17 at risk
Injection site erythema	General disorders	MedDRA 15.1	Systematic Assessment	EG00015 affected203 at risk EG00114 affected199 at risk EG0020 affected17 at risk
Injection site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0013 affected199 at risk EG0021 affected17 at risk
Pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0009 affected203 at risk EG0019 affected199 at risk EG0021 affected17 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Rhinitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0013 affected199 at risk EG0021 affected17 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00013 affected203 at risk EG00114 affected199 at risk EG0022 affected17 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00028 affected203 at risk EG00131 affected199 at risk EG0022 affected17 at risk
Blood bilirubin increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00039 affected203 at risk EG00165 affected199 at risk EG0024 affected17 at risk
Feeling abnormal	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00040 affected203 at risk EG00133 affected199 at risk EG0024 affected17 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00055 affected203 at risk EG00145 affected199 at risk EG0023 affected17 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG00031 affected203 at risk EG00131 affected199 at risk EG0024 affected17 at risk
Palpitations	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected203 at risk EG0012 affected199 at risk EG0021 affected17 at risk
Pharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 affected203 at risk EG0012 affected199 at risk EG0021 affected17 at risk
Sleep disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG00012 affected203 at risk EG00112 affected199 at risk EG0020 affected17 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00019 affected203 at risk EG00112 affected199 at risk EG0023 affected17 at risk
Alanine aminotransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Disturbance in attention	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected203 at risk EG00110 affected199 at risk EG0022 affected17 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00013 affected203 at risk EG0016 affected199 at risk EG0021 affected17 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00046 affected203 at risk EG00139 affected199 at risk EG0024 affected17 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Emotional disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0006 affected203 at risk EG0014 affected199 at risk EG0021 affected17 at risk
Insomnia	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG00053 affected203 at risk EG00153 affected199 at risk EG0025 affected17 at risk
Oedema peripheral	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected203 at risk EG0015 affected199 at risk EG0022 affected17 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0009 affected203 at risk EG0015 affected199 at risk EG0021 affected17 at risk
Affect lability	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected203 at risk EG0012 affected199 at risk EG0021 affected17 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00036 affected203 at risk EG00142 affected199 at risk EG0021 affected17 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00011 affected203 at risk EG0014 affected199 at risk EG0020 affected17 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00011 affected203 at risk EG0015 affected199 at risk EG0021 affected17 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0009 affected203 at risk EG00114 affected199 at risk EG0022 affected17 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0005 affected203 at risk EG0014 affected199 at risk EG0022 affected17 at risk
Weight decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG00013 affected203 at risk EG0016 affected199 at risk EG0022 affected17 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected203 at risk EG0013 affected199 at risk EG0021 affected17 at risk
Chills	General disorders	MedDRA 15.1	Systematic Assessment	EG00016 affected203 at risk EG00127 affected199 at risk EG0024 affected17 at risk
Depressed mood	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Depression	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG00025 affected203 at risk EG00123 affected199 at risk EG0023 affected17 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00026 affected203 at risk EG00132 affected199 at risk EG0025 affected17 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00011 affected203 at risk EG00110 affected199 at risk EG0020 affected17 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0008 affected203 at risk EG00115 affected199 at risk EG0022 affected17 at risk
Feeling hot	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00013 affected203 at risk EG0015 affected199 at risk EG0020 affected17 at risk
Influenza like illness	General disorders	MedDRA 15.1	Systematic Assessment	EG00055 affected203 at risk EG00159 affected199 at risk EG0021 affected17 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0009 affected203 at risk EG0012 affected199 at risk EG0022 affected17 at risk
Mucosal dryness	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected203 at risk EG0012 affected199 at risk EG0021 affected17 at risk
Ocular hyperaemia	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00055 affected203 at risk EG00163 affected199 at risk EG0023 affected17 at risk
Tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0006 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00016 affected203 at risk EG00114 affected199 at risk EG0020 affected17 at risk
Crying	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Eyelid disorder	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected203 at risk EG0013 affected199 at risk EG0021 affected17 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected203 at risk EG0016 affected199 at risk EG0021 affected17 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0012 affected199 at risk EG0021 affected17 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Irritability	General disorders	MedDRA 15.1	Systematic Assessment	EG00029 affected203 at risk EG00142 affected199 at risk EG0023 affected17 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0009 affected203 at risk EG00112 affected199 at risk EG0021 affected17 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0009 affected203 at risk EG0017 affected199 at risk EG0021 affected17 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG00010 affected203 at risk EG00111 affected199 at risk EG0020 affected17 at risk
Cataract	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Drug dependence	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Dysgeusia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00010 affected203 at risk EG00112 affected199 at risk EG0021 affected17 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Fatigue	General disorders	MedDRA 15.1	Systematic Assessment	EG00081 affected203 at risk EG00191 affected199 at risk EG00210 affected17 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00071 affected203 at risk EG00163 affected199 at risk EG0027 affected17 at risk
Injection site rash	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected203 at risk EG0010 affected199 at risk EG0021 affected17 at risk
Lacrimation increased	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected203 at risk EG0011 affected199 at risk EG0021 affected17 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00013 affected203 at risk EG00119 affected199 at risk EG0022 affected17 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected203 at risk EG0015 affected199 at risk EG0021 affected17 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG00019 affected203 at risk EG00123 affected199 at risk EG0023 affected17 at risk

ID	Term
D006526	Hepatitis C

Ancestor Terms

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
C549273	daclatasvir
C100416	peginterferon alfa-2a
D012254	Ribavirin

Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.

Data was not analyzed as no participant was evaluable at the specified time-point.

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides