Efficacy and Safety of BI 201335 (Faldaprevir) in Combina... | NCT01358864

NCT01358864

ID	Type	Description	Link
2010-021715-17	EudraCT Number	EudraCT

Status Module

Description 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
Placebo/PegIFN/RBV	Active Comparator	patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks	Drug: Pegylated Interferon-alpha (IFN) Drug: Ribavirin (RBV) Drug: Placebo
BI201335 12 weeks	Experimental	patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks	Drug: BI 201335 Drug: Pegylated Interferon-alpha (IFN) Drug: Ribavirin (RBV)
BI201335 24 weeks	Experimental	patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks	Drug: BI 201335 Drug: Pegylated Interferon-alpha (IFN) Drug: Ribavirin (RBV)

Name	Type	Description	Arm Group Labels	Other Names
BI 201335	Drug	BI 201335 once a day (QD) for 24 weeks	BI201335 12 weeks BI201335 24 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sustained Virological Response 12 Weeks Post Treatment (SVR12)	Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.	12 weeks post treatment, up to 60 weeks

Secondary Outcomes

Measure	Description	Time Frame
Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)	Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.	24 weeks post treatment, up to 72 weeks

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1220.7.0091 Boehringer Ingelheim Investigational Site		North Little Rock	Arkansas		United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
BG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
BG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
BG003	Partial:Placebo	Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
BG004	Partial:Faldaprevir 12 Weeks	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
BG005	Partial:Faldaprevir 24 Weeks	Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
BG006	Null:Faldaprevir 12 Weeks	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
BG007	Null:Faldaprevir 24 Weeks	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
BG008	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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00010.3(3.5 to 17.0) OG00163.5(55.9 to 71.0) OG00259.5(51.8 to 67.1) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		<0.0001	Adjusted for genotype and previous response to treatment	Adjusted percent difference	52.8			2-Sided	95	42.4	63.2				No	Superiority or Other
OG000 OG002		Cochran-Mantel-Haenszel

Secondary

Early Treatment Success (ETS)

Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.

FAS

Posted

Number

percentage of participants

Week 4 and Week 8

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Primary

Sustained Virological Response 12 Weeks Post Treatment (SVR12)

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

FAS

Posted

Number

95% Confidence Interval

percentage of participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Relapser & Partial: Placebo	Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser & Partial: Faldaprevir 12 Weeks	Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
OG002	Relapser & Partial: Faldaprevir 24 Weeks

Secondary

ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO

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

FAS

Posted

Number

participants

End of treatment, up to 48 weeks

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Secondary

ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES

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

FAS

Posted

Number

participants

End of treatment, up to 48 weeks

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Secondary

AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO

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

FAS

Posted

Number

participants

End of treatment, up to 48 weeks

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Secondary

AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES

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

FAS

Posted

Number

participants

End of treatment, up to 48 weeks

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Secondary

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

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

FAS

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Secondary

ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES

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

FAS

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Secondary

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

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

FAS

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Secondary

AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES

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

FAS

Posted

Number

participants

12 weeks post treatment, up to 60 weeks

ID	Title	Description
OG000	Relapser:Placebo	Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
OG001	Relapser:Faldaprevir 12 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
OG002	Relapser:Faldaprevir 24 Weeks	Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Relapser & Partial: Placebo	Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.	1	78	74	78
EG001	Relapser & Partial: Faldaprevir 12 Weeks	Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	14	156	148	156
EG002	Relapser & Partial: Faldaprevir 24 Weeks	Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).	13	158	156	158
EG003	Null:Faldaprevir 12 Weeks	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.	16	145	142	145
EG004	Null:Faldaprevir 24 Weeks	Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.	11	140	139	140

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0021 affected158 at risk EG0032 affected145 at risk EG0041 affected140 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Leukopenia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0023 affected158 at risk EG003
Atrial fibrillation	Cardiac disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Bradycardia	Cardiac disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Cardiac failure congestive	Cardiac disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Keratosis follicular	Congenital, familial and genetic disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Abdominal pain	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Ascites	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Diarrhoea	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Haematochezia	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Nausea	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0021 affected158 at risk EG003
Oral lichen planus	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Pancreatitis	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Peritoneal haemorrhage	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Vomiting	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0012 affected156 at risk EG0020 affected158 at risk EG003
Asthenia	General disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Chest pain	General disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Fatigue	General disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Malaise	General disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Pyrexia	General disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0013 affected156 at risk EG0021 affected158 at risk EG003
Biliary colic	Hepatobiliary disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Cholelithiasis	Hepatobiliary disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Hepatic failure	Hepatobiliary disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Hepatorenal failure	Hepatobiliary disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Jaundice	Hepatobiliary disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Appendicitis	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Cellulitis	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Gastroenteritis	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Gastroenteritis viral	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Peritonitis bacterial	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Pneumonia	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0021 affected158 at risk EG003
Sepsis	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Streptococcal infection	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Viral infection	Infections and infestations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Fall	Injury, poisoning and procedural complications	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Blood lactate dehydrogenase increased	Investigations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
International normalised ratio abnormal	Investigations	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Dehydration	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Fasciitis	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Joint instability	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Coma	Nervous system disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Headache	Nervous system disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Presyncope	Nervous system disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0021 affected158 at risk EG003
Anxiety	Psychiatric disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Depression	Psychiatric disorders	17.0	Systematic Assessment	EG0001 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Psychiatric decompensation	Psychiatric disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Renal colic	Renal and urinary disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG0001 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Hypertensive crisis	Vascular disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Hypotension	Vascular disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003
Venous thrombosis	Vascular disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0011 affected156 at risk EG0020 affected158 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0020 affected158 at risk EG003
Traumatic haemothorax	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0010 affected156 at risk EG0021 affected158 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0008 affected78 at risk EG00130 affected156 at risk EG00227 affected158 at risk EG00322 affected145 at risk EG00419 affected140 at risk
Neutropenia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG00012 affected78 at risk EG00118 affected156 at risk EG00218 affected158 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0003 affected78 at risk EG0014 affected156 at risk EG0026 affected158 at risk EG003
Vertigo	Ear and labyrinth disorders	17.0	Systematic Assessment	EG0003 affected78 at risk EG0014 affected156 at risk EG0024 affected158 at risk EG003
Dry eye	Eye disorders	17.0	Systematic Assessment	EG0005 affected78 at risk EG0016 affected156 at risk EG0027 affected158 at risk EG003
Ocular icterus	Eye disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG0018 affected156 at risk EG0026 affected158 at risk EG003
Abdominal pain	Gastrointestinal disorders	17.0	Systematic Assessment	EG0002 affected78 at risk EG0018 affected156 at risk EG00214 affected158 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	17.0	Systematic Assessment	EG0004 affected78 at risk EG00116 affected156 at risk EG00215 affected158 at risk EG003
Constipation	Gastrointestinal disorders	17.0	Systematic Assessment	EG0003 affected78 at risk EG00114 affected156 at risk EG0028 affected158 at risk EG003
Diarrhoea	Gastrointestinal disorders	17.0	Systematic Assessment	EG00010 affected78 at risk EG00145 affected156 at risk EG00259 affected158 at risk EG003
Dyspepsia	Gastrointestinal disorders	17.0	Systematic Assessment	EG0006 affected78 at risk EG00113 affected156 at risk EG00213 affected158 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	17.0	Systematic Assessment	EG0005 affected78 at risk EG0013 affected156 at risk EG0020 affected158 at risk EG003
Nausea	Gastrointestinal disorders	17.0	Systematic Assessment	EG00018 affected78 at risk EG00178 affected156 at risk EG00288 affected158 at risk EG003
Vomiting	Gastrointestinal disorders	17.0	Systematic Assessment	EG0005 affected78 at risk EG00141 affected156 at risk EG00247 affected158 at risk EG003
Asthenia	General disorders	17.0	Systematic Assessment	EG00021 affected78 at risk EG00128 affected156 at risk EG00228 affected158 at risk EG003
Chills	General disorders	17.0	Systematic Assessment	EG0005 affected78 at risk EG0019 affected156 at risk EG00214 affected158 at risk EG003
Fatigue	General disorders	17.0	Systematic Assessment	EG00016 affected78 at risk EG00153 affected156 at risk EG00259 affected158 at risk EG003
Influenza like illness	General disorders	17.0	Systematic Assessment	EG00015 affected78 at risk EG00128 affected156 at risk EG00229 affected158 at risk EG003
Injection site erythema	General disorders	17.0	Systematic Assessment	EG0004 affected78 at risk EG0011 affected156 at risk EG0023 affected158 at risk EG003
Malaise	General disorders	17.0	Systematic Assessment	EG0004 affected78 at risk EG0015 affected156 at risk EG00210 affected158 at risk EG003
Pain	General disorders	17.0	Systematic Assessment	EG0004 affected78 at risk EG0015 affected156 at risk EG0027 affected158 at risk EG003
Pyrexia	General disorders	17.0	Systematic Assessment	EG00014 affected78 at risk EG00124 affected156 at risk EG00225 affected158 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	17.0	Systematic Assessment	EG0000 affected78 at risk EG00111 affected156 at risk EG00211 affected158 at risk EG003
Jaundice	Hepatobiliary disorders	17.0	Systematic Assessment	EG0001 affected78 at risk EG00129 affected156 at risk EG00227 affected158 at risk EG003
Influenza	Infections and infestations	17.0	Systematic Assessment	EG0004 affected78 at risk EG0014 affected156 at risk EG0026 affected158 at risk EG003
Nasopharyngitis	Infections and infestations	17.0	Systematic Assessment	EG0007 affected78 at risk EG00114 affected156 at risk EG00213 affected158 at risk EG003
Haemoglobin decreased	Investigations	17.0	Systematic Assessment	EG0002 affected78 at risk EG0016 affected156 at risk EG0024 affected158 at risk EG003
Weight decreased	Investigations	17.0	Systematic Assessment	EG0003 affected78 at risk EG0017 affected156 at risk EG0022 affected158 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG00010 affected78 at risk EG00133 affected156 at risk EG00232 affected158 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0007 affected78 at risk EG00114 affected156 at risk EG00221 affected158 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0008 affected78 at risk EG00114 affected156 at risk EG00212 affected158 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0002 affected78 at risk EG0017 affected156 at risk EG0028 affected158 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0008 affected78 at risk EG00120 affected156 at risk EG00219 affected158 at risk EG003
Disturbance in attention	Nervous system disorders	17.0	Systematic Assessment	EG0001 affected78 at risk EG0014 affected156 at risk EG0029 affected158 at risk EG003
Dizziness	Nervous system disorders	17.0	Systematic Assessment	EG0006 affected78 at risk EG00112 affected156 at risk EG00211 affected158 at risk EG003
Dysgeusia	Nervous system disorders	17.0	Systematic Assessment	EG0004 affected78 at risk EG0018 affected156 at risk EG00212 affected158 at risk EG003
Headache	Nervous system disorders	17.0	Systematic Assessment	EG00022 affected78 at risk EG00139 affected156 at risk EG00246 affected158 at risk EG003
Anxiety	Psychiatric disorders	17.0	Systematic Assessment	EG0003 affected78 at risk EG0019 affected156 at risk EG00212 affected158 at risk EG003
Depression	Psychiatric disorders	17.0	Systematic Assessment	EG00010 affected78 at risk EG00111 affected156 at risk EG00212 affected158 at risk EG003
Insomnia	Psychiatric disorders	17.0	Systematic Assessment	EG00013 affected78 at risk EG00136 affected156 at risk EG00235 affected158 at risk EG003
Sleep disorder	Psychiatric disorders	17.0	Systematic Assessment	EG0003 affected78 at risk EG0014 affected156 at risk EG0025 affected158 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG00016 affected78 at risk EG00125 affected156 at risk EG00227 affected158 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG0007 affected78 at risk EG00116 affected156 at risk EG00216 affected158 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG0004 affected78 at risk EG0015 affected156 at risk EG0023 affected158 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0004 affected78 at risk EG00116 affected156 at risk EG00216 affected158 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG00012 affected78 at risk EG00129 affected156 at risk EG00229 affected158 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0004 affected78 at risk EG0018 affected156 at risk EG0029 affected158 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG00023 affected78 at risk EG00154 affected156 at risk EG00261 affected158 at risk EG003
Rash	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG00016 affected78 at risk EG00137 affected156 at risk EG00244 affected158 at risk EG003
Irritability	Psychiatric disorders	17.0	Systematic Assessment	EG00011 affected78 at risk EG00110 affected156 at risk EG00216 affected158 at risk EG003

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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