Phase III Trial of BI 201335 (Faldaprevir) in Treatment N... | NCT01399619

ID	Type	Description	Link
2010-021734-59	EudraCT Number	EudraCT

Label	Type	Description	Intervention Names
BI201335 12W	Experimental	patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks	Drug: PegIFN/RBV Drug: BI201335
BI 201335 24W	Experimental	patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks	Drug: BI201335 24W Drug: PegIFN/RBV
BI 201335 24 W	Experimental	patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks	Drug: PegIFN/RBV Drug: Bi 201335

Name	Type	Description	Arm Group Labels	Other Names
PegIFN/RBV	Drug	PegIFN/RBV for 24 or 48w	BI 201335 24 W
PegIFN/RBV

Measure	Description	Time Frame
Sustained Virological Response (SVR12)	Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.	60 weeks

Measure	Description	Time Frame
Virological Response 24 Weeks Post Treatment (SVR24)	Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.	72 weeks
Early Treatment Success (ETS)

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1220.19.0045 Boehringer Ingelheim Investigational Site		Birmingham	Alabama		United States
1220.19.0007 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
25710287	Derived	Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

ID	Title	Description
FG000	Faldaprevir 120mg -24W	Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Sustained Virological Response (SVR12)

Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue BI 201335 to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG003	Faldaprevir 240mg -T	Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
OG004	Faldaprevir - Total	Total subjects who were treated with Faldaprevir.

Units	Counts
Participants	OG000123 OG00184 OG00286 OG003

Title

Denominators

Categories

Title	Measurements
	OG00070.7(62.7 to 78.8) OG00178.6(69.8 to 87.3) OG00276.7(67.8 to 85.7) 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
OG004	the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.	normal approximation		<0.0001	p-value corresponds to a two sided test against the historical rate of 40%.					2-Sided							No	Superiority or Other

Secondary

Virological Response 24 Weeks Post Treatment (SVR24)

Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.

FAS

Posted

Number

95% Confidence Interval

percentage of participants

72 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

Early Treatment Success (ETS)

Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8

FAS

Posted

Number

participants

Week 4, week 8 and week 60

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg -12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes

The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.

FAS

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no

The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.

FAS

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg -12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes

The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.

FAS

Posted

Number

participants

60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg -24W	Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg -12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no

The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.

FAS

Posted

Number

participants

60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes

The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.

FAS

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no

The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.

FAS

Posted

Number

participants

48 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes

The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.

FAS

Posted

Number

participants

60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Secondary

The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no

The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.

FAS

Posted

Number

participants

60 weeks

ID	Title	Description
OG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
OG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0021 affected86 at risk EG0032 affected185 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0021 affected86 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected84 at risk EG0020 affected86 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0011 affected84 at risk EG0021 affected86 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Enterovesical fistula	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected84 at risk EG0020 affected86 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Asthenia	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected84 at risk EG0020 affected86 at risk EG003
Sarcoidosis	Immune system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Appendicitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected84 at risk EG0020 affected86 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected84 at risk EG0020 affected86 at risk EG003
Infected cyst	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Leishmaniasis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0021 affected86 at risk EG003
Neurosyphilis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Sepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Urosepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0021 affected86 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0021 affected86 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected84 at risk EG0020 affected86 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Substance use	Social circumstances	MedDRA 16.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003
Haematoma	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected84 at risk EG0020 affected86 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG00027 affected123 at risk EG00113 affected84 at risk EG00215 affected86 at risk EG00330 affected185 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG00027 affected123 at risk EG0016 affected84 at risk EG00215 affected86 at risk EG003
Dry eye	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected123 at risk EG0015 affected84 at risk EG0020 affected86 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0007 affected123 at risk EG00111 affected84 at risk EG0024 affected86 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0007 affected123 at risk EG0017 affected84 at risk EG0023 affected86 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0008 affected123 at risk EG0014 affected84 at risk EG0023 affected86 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00031 affected123 at risk EG00124 affected84 at risk EG00223 affected86 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected123 at risk EG0015 affected84 at risk EG0022 affected86 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected123 at risk EG0014 affected84 at risk EG0027 affected86 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00034 affected123 at risk EG00138 affected84 at risk EG00236 affected86 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00012 affected123 at risk EG00114 affected84 at risk EG00223 affected86 at risk EG003
Asthenia	General disorders	MedDRA 16.0	Systematic Assessment	EG00031 affected123 at risk EG00121 affected84 at risk EG00217 affected86 at risk EG003
Chills	General disorders	MedDRA 16.0	Systematic Assessment	EG0005 affected123 at risk EG0012 affected84 at risk EG0027 affected86 at risk EG003
Fatigue	General disorders	MedDRA 16.0	Systematic Assessment	EG00039 affected123 at risk EG00129 affected84 at risk EG00230 affected86 at risk EG003
Influenza like illness	General disorders	MedDRA 16.0	Systematic Assessment	EG00014 affected123 at risk EG00117 affected84 at risk EG00212 affected86 at risk EG003
Injection site reaction	General disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected123 at risk EG0012 affected84 at risk EG0026 affected86 at risk EG003
Irritability	General disorders	MedDRA 16.0	Systematic Assessment	EG00019 affected123 at risk EG0018 affected84 at risk EG0025 affected86 at risk EG003
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG00029 affected123 at risk EG00111 affected84 at risk EG00210 affected86 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0007 affected123 at risk EG0018 affected84 at risk EG00210 affected86 at risk EG003
Oral herpes	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0008 affected123 at risk EG0010 affected84 at risk EG0022 affected86 at risk EG003
Weight decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG00016 affected123 at risk EG00110 affected84 at risk EG00213 affected86 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00029 affected123 at risk EG00114 affected84 at risk EG00218 affected86 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00011 affected123 at risk EG0016 affected84 at risk EG0026 affected86 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected123 at risk EG0013 affected84 at risk EG0026 affected86 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00017 affected123 at risk EG0019 affected84 at risk EG00215 affected86 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0009 affected123 at risk EG00110 affected84 at risk EG0026 affected86 at risk EG003
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG00029 affected123 at risk EG00121 affected84 at risk EG00222 affected86 at risk EG003
Lethargy	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected123 at risk EG0013 affected84 at risk EG0025 affected86 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0009 affected123 at risk EG0015 affected84 at risk EG0022 affected86 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected123 at risk EG0014 affected84 at risk EG0027 affected86 at risk EG003
Depression	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG00011 affected123 at risk EG0019 affected84 at risk EG00213 affected86 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG00029 affected123 at risk EG00111 affected84 at risk EG00214 affected86 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0004 affected123 at risk EG0013 affected84 at risk EG0025 affected86 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG00013 affected123 at risk EG0018 affected84 at risk EG00210 affected86 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG00012 affected123 at risk EG0018 affected84 at risk EG0023 affected86 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected123 at risk EG0016 affected84 at risk EG0022 affected86 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0007 affected123 at risk EG0014 affected84 at risk EG0026 affected86 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00017 affected123 at risk EG0019 affected84 at risk EG00218 affected86 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0008 affected123 at risk EG0015 affected84 at risk EG0025 affected86 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0007 affected123 at risk EG0016 affected84 at risk EG0023 affected86 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00019 affected123 at risk EG00116 affected84 at risk EG00217 affected86 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG00022 affected123 at risk EG00116 affected84 at risk EG00213 affected86 at risk EG003

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	Title	Description
BG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
BG001	Faldaprevir 240mg -T	patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Faldaprevir 120mg - 24W	Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.	17	123	116	123
EG001	Faldaprevir 240mg - 12W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.	5	84	80	84
EG002	Faldaprevir 240mg - 24W	Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.	5	86	84	86
EG003	Faldaprevir 240mg -T	Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.	15	185	178	185