Trial Outcomes & Findings for Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3) (NCT NCT00984620)

Last Updated: 2015-09-07

Results Overview

Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

160 participants

Primary outcome timeframe

28 weeks

Results posted on

2015-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	Faldaprevir 120mg (12 Weeks) Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120mg (24 Weeks) Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Study STARTED	81	79
Overall Study COMPLETED	75	67
Overall Study NOT COMPLETED	6	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Faldaprevir 120mg (12 Weeks) Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120mg (24 Weeks) Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Overall Study Adverse Event	5	5
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	0	2
Overall Study reason other than listed above	0	4

Baseline Characteristics

Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Total n=160 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 9.4 • n=5 Participants	44.9 years STANDARD_DEVIATION 11.9 • n=7 Participants	46.5 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	45 Participants n=7 Participants	99 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 weeks

Population: Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations.

Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=78 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Virological Response at Week 28 (W28VR)	61 participants	60 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: PPS

Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=78 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Rapid Virological Response at Week 4 (RVR)	48 participants	56 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: PPS

virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=78 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Virological Response at Week 24 (W24VR)	59 participants	63 participants

SECONDARY outcome

Timeframe: 36 weeks

Population: PPS

Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=78 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Virological Response at Week 36 (W36VR)	55 participants	58 participants

SECONDARY outcome

Timeframe: up to 48 weeks

Population: PPS

End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=78 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
End of Treatment Response (ETR)	65 participants	67 participants

SECONDARY outcome

Timeframe: 72 weeks

Population: PPS

Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=78 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy	54 participants	58 participants

SECONDARY outcome

Timeframe: From baseline to 72 weeks

Population: PPS

Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=78 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 2, change from baseline (N=76, N=78)	-4.724 IU/mL Standard Deviation 0.9059	-4.866 IU/mL Standard Deviation 0.8664
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 4, change from baseline (N=76, N=77)	-4.993 IU/mL Standard Deviation 1.1168	-5.081 IU/mL Standard Deviation 1.1195
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 8, change from baseline (N=75, N=76)	-5.128 IU/mL Standard Deviation 1.1159	-5.088 IU/mL Standard Deviation 1.3150
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 12, change from baseline (N=76, N=76)	-5.117 IU/mL Standard Deviation 1.1495	-5.107 IU/mL Standard Deviation 1.2852
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 16, change from baseline (N=18, N=13)	-5.363 IU/mL Standard Deviation 1.2341	-5.262 IU/mL Standard Deviation 0.5820
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 20, change from baseline (N=52, N=57)	-5.056 IU/mL Standard Deviation 1.0894	-5.366 IU/mL Standard Deviation 0.7319
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 24, change from baseline (N=12, N=8)	-4.176 IU/mL Standard Deviation 2.1635	-4.740 IU/mL Standard Deviation 1.6576
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up End of TRT, change from baseline (N=80, N=78)	-4.910 IU/mL Standard Deviation 1.4690	-5.017 IU/mL Standard Deviation 1.4434
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 28, change from baseline (N=4, N=4)	-5.723 IU/mL Standard Deviation 0.6795	-4.369 IU/mL Standard Deviation 2.2917
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up week 36, change from baseline (N=4, N=2)	-5.624 IU/mL Standard Deviation 0.7059	-5.958 IU/mL Standard Deviation 0.1909
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up 4 wks after TRT, change from baseline (N=75, N=77)	-4.296 IU/mL Standard Deviation 2.2499	-4.367 IU/mL Standard Deviation 2.1849
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up 12 wks after TRT, change from baseline (N=75,N=75)	-4.154 IU/mL Standard Deviation 2.3356	-4.353 IU/mL Standard Deviation 2.1588
Viral Load (HCV RNA) at All Visits During Treatment and Follow-up 24 wks after TRT, change from baseline (N=73,N=75)	-4.103 IU/mL Standard Deviation 2.3673	-4.250 IU/mL Standard Deviation 2.2439

SECONDARY outcome

Timeframe: 48 weeks

Population: PPS

Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=78 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Time to Reach a Plasma HCV RNA Level BLD While on Treatment	4.1 week Interval 4.0 to 8.0	4.1 week Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.

Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Laboratory Test Abnormalities and Study Medication Tolerabilities Red blood cell count: low (N=81, N=79)	9 participants	8 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities haematocrit: low (N=81, N=79)	30 participants	21 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities haematocrit: high(N=81, N=79)	0 participants	1 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities platelets: low(N=81, N=78)	5 participants	2 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities eosinophils: high (N=81, N=79)	1 participants	5 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities PT-INR: high (N=81, N=79)	1 participants	1 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities sodium: low (N=81, N=79)	1 participants	1 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities bicarbonate: high (N=79, N=74)	1 participants	1 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities AST/GOT, SGOT: high (N=75, N=71)	3 participants	3 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities ALT/GPT, SGPT: high (N=68, N=64)	3 participants	5 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities alkaline phosphatase: high (N=80, N=79)	1 participants	0 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities GGT: high (N=74, N=72)	4 participants	8 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities creatine kinase: high (N=80, N=79)	0 participants	3 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities lipase: high (N=79, N=79)	1 participants	3 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities amylase: high (N=81, N=79)	1 participants	2 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities glucose: low (N=80, N=79)	0 participants	2 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities cholesterol, total: high (N=80, N=75)	6 participants	2 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities triglyceride: high (N=74, N=71)	13 participants	18 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities white blood cell count: low(N=81, N=79)	56 participants	60 participants
Laboratory Test Abnormalities and Study Medication Tolerabilities bicarbonate: low (N=79, N=74)	6 participants	11 participants

SECONDARY outcome

Timeframe: 48 weeks

Population: TS

No number of participants with clinically relevant abnormalities in vital signs and physical examination.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination	0 participants with abnormality	0 participants with abnormality

SECONDARY outcome

Timeframe: baseline and 48 weeks

Population: TS

Change from baseline (CFB) in Red blood cells.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, wk2 (N=75,N=77)	-0.3 10^12 cells/L Standard Deviation 0.5	-0.4 10^12 cells/L Standard Deviation 0.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, wk4(N=74, N=76)	-0.8 10^12 cells/L Standard Deviation 0.5	-0.8 10^12 cells/L Standard Deviation 0.6
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, wk8(N=75, N=74)	-1.0 10^12 cells/L Standard Deviation 0.5	-1.0 10^12 cells/L Standard Deviation 0.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, wk12(N=74,N=74)	-1.1 10^12 cells/L Standard Deviation 0.6	-1.2 10^12 cells/L Standard Deviation 0.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, wk24(N=12, N=4)	-1.2 10^12 cells/L Standard Deviation 0.7	-0.9 10^12 cells/L Standard Deviation 0.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, wk28(N=4, N=3)	-1.1 10^12 cells/L Standard Deviation 0.4	-0.9 10^12 cells/L Standard Deviation 0.7
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB,Day 1(N=77,N=75)	0.0 10^12 cells/L Standard Deviation 0.3	-0.1 10^12 cells/L Standard Deviation 0.3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, wk18(N=66,N=69)	-1.2 10^12 cells/L Standard Deviation 0.6	-1.2 10^12 cells/L Standard Deviation 0.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, wk36(N=4, N=2)	-0.9 10^12 cells/L Standard Deviation 0.9	-1.4 10^12 cells/L Standard Deviation 0.2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) Red blood cell (10^12cells/L) CFB, EoT(N=67, N=73)	-1.2 10^12 cells/L Standard Deviation 0.6	-1.2 10^12 cells/L Standard Deviation 0.5

SECONDARY outcome

Timeframe: baseline and 48 weeks

Population: TS

Change from baseline (CFB) in haematocrit and Eosinophils.

Outcome measures

SECONDARY outcome

Timeframe: baseline and 48 weeks

Population: TS

Change from baseline (CFB) in Platelets and white blood cells.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, Day 1 (N=77, N=73)	3 10^9 cells/L Standard Deviation 35	2 10^9 cells/L Standard Deviation 29
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, wk2 (N=74, N=74)	-35 10^9 cells/L Standard Deviation 40	-35 10^9 cells/L Standard Deviation 34
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, wk4 (N=73, N=74)	-35 10^9 cells/L Standard Deviation 41	-39 10^9 cells/L Standard Deviation 42
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, wk8 (N=73, N=71)	-55 10^9 cells/L Standard Deviation 37	-48 10^9 cells/L Standard Deviation 38
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, wk24 (N=12, N=3)	-46 10^9 cells/L Standard Deviation 37	-50 10^9 cells/L Standard Deviation 43
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, wk28 (N=4, N=2)	-22 10^9 cells/L Standard Deviation 77	-83 10^9 cells/L Standard Deviation 6
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, wk2 (N=75, N=77)	-2.2 10^9 cells/L Standard Deviation 1.5	-1.8 10^9 cells/L Standard Deviation 1.9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, wk4 (N=74, N=76)	-2.6 10^9 cells/L Standard Deviation 1.5	-2.6 10^9 cells/L Standard Deviation 1.9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, wk8 (N=75, N=74)	-3.2 10^9 cells/L Standard Deviation 1.5	-2.9 10^9 cells/L Standard Deviation 1.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, wk12 (N=74, N=74)	-3.4 10^9 cells/L Standard Deviation 1.5	-2.8 10^9 cells/L Standard Deviation 1.8
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, wk18 (N=66, N=69)	-3.2 10^9 cells/L Standard Deviation 1.4	-3.1 10^9 cells/L Standard Deviation 1.6
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, wk24 (N=12, N=4)	-4.0 10^9 cells/L Standard Deviation 1.3	-2.0 10^9 cells/L Standard Deviation 1.7
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, wk28 (N=4, N=3)	-2.8 10^9 cells/L Standard Deviation 1.0	-1.9 10^9 cells/L Standard Deviation 2.0
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, wk36 (N=4, N=2)	-2.5 10^9 cells/L Standard Deviation 0.9	-3.0 10^9 cells/L Standard Deviation 1.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, EoT (N=67, N=73)	-3.4 10^9 cells/L Standard Deviation 1.5	-3.1 10^9 cells/L Standard Deviation 1.6
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, wk12 (N=72, N=72)	-61 10^9 cells/L Standard Deviation 38	-50 10^9 cells/L Standard Deviation 40
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, wk18 (N=66, N=68)	-55 10^9 cells/L Standard Deviation 46	-51 10^9 cells/L Standard Deviation 45
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, wk36 (N=4, N=2)	-47 10^9 cells/L Standard Deviation 31	-85 10^9 cells/L Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) Platelets CFB, EoT (N=67, N=71)	-59 10^9 cells/L Standard Deviation 46	-50 10^9 cells/L Standard Deviation 48
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) white blood cell CFB, day1 (N=77, N=75)	-0.1 10^9 cells/L Standard Deviation 1.1	0.3 10^9 cells/L Standard Deviation 1.3

SECONDARY outcome

Timeframe: baseline and 48 weeks

Population: TS

Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, wk18 (N=68, N=70)	0 mmol/L Standard Deviation 2	0 mmol/L Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, wk24 (N=12, N=4)	-1 mmol/L Standard Deviation 2	0 mmol/L Standard Deviation 1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, wk28 (N=5, N=3)	-2 mmol/L Standard Deviation 2	-1 mmol/L Standard Deviation 3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, wk36 (N=4, N=2)	-1 mmol/L Standard Deviation 2	-1 mmol/L Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, EoT (N=67, N=73)	0 mmol/L Standard Deviation 2	0 mmol/L Standard Deviation 3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, day1 (N=76, N=75)	0.1 mmol/L Standard Deviation 1.4	0.2 mmol/L Standard Deviation 1.3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, wk2 (N=75, N=78)	-0.2 mmol/L Standard Deviation 1.4	0.0 mmol/L Standard Deviation 1.3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, wk4 (N=74, N=77)	-0.1 mmol/L Standard Deviation 1.3	-0.1 mmol/L Standard Deviation 1.3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, wk8 (N=74, N=76)	-0.1 mmol/L Standard Deviation 1.3	0.0 mmol/L Standard Deviation 1.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, wk12 (N=74, N=76)	-0.3 mmol/L Standard Deviation 1.2	-0.4 mmol/L Standard Deviation 1.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, wk18 (N=66, N=69)	-0.3 mmol/L Standard Deviation 1.6	-0.4 mmol/L Standard Deviation 1.3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, wk24 (N=12, N=4)	-0.4 mmol/L Standard Deviation 1.4	-0.5 mmol/L Standard Deviation 1.9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, wk28 (N=4, N=3)	-1.2 mmol/L Standard Deviation 2.1	-0.2 mmol/L Standard Deviation 0.9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, wk36 (N=4, N=2)	-2.6 mmol/L Standard Deviation 2.3	-1.0 mmol/L Standard Deviation 0.7
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Bicarbonate (mmol/L), CFB, EoT (N=64, N=71)	-0.2 mmol/L Standard Deviation 1.6	-0.1 mmol/L Standard Deviation 1.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, day1 (n=77, N=75)	0.03 mmol/L Standard Deviation 0.47	-0.05 mmol/L Standard Deviation 0.48
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, wk2 (n=76, N=78)	-0.48 mmol/L Standard Deviation 0.57	-0.54 mmol/L Standard Deviation 0.57
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, wk4 (n=76, N=77)	-0.51 mmol/L Standard Deviation 0.55	-0.67 mmol/L Standard Deviation 0.68
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, wk12 (n=75, N=76)	-0.64 mmol/L Standard Deviation 0.62	-0.74 mmol/L Standard Deviation 0.63
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, wk18 (n=68, N=70)	-0.51 mmol/L Standard Deviation 0.64	-0.80 mmol/L Standard Deviation 0.69
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, day1 (N=77, N=75)	-0.1 mmol/L Standard Deviation 0.5	-0.1 mmol/L Standard Deviation 0.3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, wk2 (N=76, N=78)	0.1 mmol/L Standard Deviation 0.5	0.1 mmol/L Standard Deviation 0.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, wk4 (N=76, N=77)	0.1 mmol/L Standard Deviation 0.5	0.2 mmol/L Standard Deviation 0.6
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, wk8 (N=75, N=76)	0.1 mmol/L Standard Deviation 0.5	0.1 mmol/L Standard Deviation 0.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, wk12 (N=75, N=76)	0.1 mmol/L Standard Deviation 0.6	0.1 mmol/L Standard Deviation 0.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, wk18 (N=68, N=70)	0.0 mmol/L Standard Deviation 0.5	0.2 mmol/L Standard Deviation 0.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, wk24 (N=12, N=4)	-0.2 mmol/L Standard Deviation 0.7	0.2 mmol/L Standard Deviation 0.3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, wk28 (N=5, N=3)	0.0 mmol/L Standard Deviation 1.3	0.4 mmol/L Standard Deviation 0.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, EoT (N=67, N=73)	0.1 mmol/L Standard Deviation 0.6	0.1 mmol/L Standard Deviation 0.6
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, day1 (N=76, N=75)	-0.1 mmol/L Standard Deviation 1.3	0.2 mmol/L Standard Deviation 0.9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, wk2 (N=75, N=78)	-0.1 mmol/L Standard Deviation 1.3	0.1 mmol/L Standard Deviation 1.0
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, wk4 (N=74, N=77)	-0.2 mmol/L Standard Deviation 1.3	0.1 mmol/L Standard Deviation 0.9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, wk8 (N=74, N=76)	-0.1 mmol/L Standard Deviation 1.3	0.1 mmol/L Standard Deviation 0.9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, wk12 (N=73, N=76)	-0.3 mmol/L Standard Deviation 1.1	-0.1 mmol/L Standard Deviation 1.0
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, wk18 (N=67, N=70)	-0.4 mmol/L Standard Deviation 1.2	-0.1 mmol/L Standard Deviation 0.7
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, wk24 (N=12, N=4)	-0.7 mmol/L Standard Deviation 1.3	-0.4 mmol/L Standard Deviation 0.7
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, Day 1(N=77, N=74)	0 mmol/L Standard Deviation 2	1 mmol/L Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, wk2 (N=76, N=78)	0 mmol/L Standard Deviation 2	0 mmol/L Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, wk4 (N=76, N=77)	0 mmol/L Standard Deviation 2	0 mmol/L Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, wk8 (N=73, N=76)	1 mmol/L Standard Deviation 3	1 mmol/L Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Sodium (mmol/L) CFB, wk12 (N=75, N=76)	0 mmol/L Standard Deviation 2	1 mmol/L Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, wk8 (n=75, N=76)	-0.58 mmol/L Standard Deviation 0.59	-0.60 mmol/L Standard Deviation 0.62
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, wk24 (n=12, N=4)	-0.36 mmol/L Standard Deviation 0.46	-0.37 mmol/L Standard Deviation 0.30
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, wk28 (n=5, N=3)	0.10 mmol/L Standard Deviation 0.53	-0.09 mmol/L Standard Deviation 0.20
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, wk36 (n=4, N=2)	-0.35 mmol/L Standard Deviation 0.14	-0.23 mmol/L Standard Deviation 0.20
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Cholesterol tot. (mmol/L), CFB, EoT (n=67, N=73)	-0.43 mmol/L Standard Deviation 0.70	-0.74 mmol/L Standard Deviation 0.68
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Triglyceride (mmol/L), CFB, wk36 (N=4, N=2)	-0.3 mmol/L Standard Deviation 0.7	0.1 mmol/L Standard Deviation 0.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, wk28 (N=5, N=3)	-0.4 mmol/L Standard Deviation 1.1	0.1 mmol/L Standard Deviation 0.7
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, wk36 (N=4, N=2)	-0.1 mmol/L Standard Deviation 0.7	-0.1 mmol/L Standard Deviation 0.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) Glucose (mmol/L), CFB, EoT (N=66, N=71)	-0.4 mmol/L Standard Deviation 1.2	-0.1 mmol/L Standard Deviation 1.3

SECONDARY outcome

Timeframe: baseline and 48 weeks

Population: TS

Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, wk28 (N=5, N=3)	-20 U/L Standard Deviation 27	-16 U/L Standard Deviation 24
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, wk36 (N=4, N=2)	-21 U/L Standard Deviation 40	11 U/L Standard Deviation 4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, EoT (N=66, N=71)	-25 U/L Standard Deviation 41	-27 U/L Standard Deviation 49
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, day1 (N=76, N=75)	1 U/L Standard Deviation 24	-2 U/L Standard Deviation 22
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, wk2 (N=75, N=78)	-37 U/L Standard Deviation 36	-34 U/L Standard Deviation 40
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, wk4 (N=74, N=77)	-37 U/L Standard Deviation 40	-34 U/L Standard Deviation 50
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, wk8 (N=74, N=76)	-36 U/L Standard Deviation 43	-35 U/L Standard Deviation 49
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, wk12 (N=74, N=76)	-37 U/L Standard Deviation 36	-36 U/L Standard Deviation 48
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, wk18 (N=67, N=70)	-41 U/L Standard Deviation 40	-42 U/L Standard Deviation 52
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, wk24 (N=12, N=4)	-40 U/L Standard Deviation 50	-24 U/L Standard Deviation 22
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, wk28 (N=5, N=3)	-45 U/L Standard Deviation 38	-22 U/L Standard Deviation 15
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, wk36 (N=4, N=2)	-47 U/L Standard Deviation 46	-6 U/L Standard Deviation 4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) ALT/GPT (U/L), CFB, EoT (N=66, N=71)	-42 U/L Standard Deviation 42	-42 U/L Standard Deviation 45
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, day1 (n=77, N=75)	1 U/L Standard Deviation 11	1 U/L Standard Deviation 13
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, wk12 (N=75, N=76)	-71 U/L Standard Deviation 103	-69 U/L Standard Deviation 150
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, wk18 (N=68, N=70)	-62 U/L Standard Deviation 105	-64 U/L Standard Deviation 146
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, wk24 (N=12, N=4)	-118 U/L Standard Deviation 200	-131 U/L Standard Deviation 50
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, wk28 (N=5, N=3)	-52 U/L Standard Deviation 126	-113 U/L Standard Deviation 42
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, wk36 (N=4, N=2)	-23 U/L Standard Deviation 132	-14 U/L Standard Deviation 73
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, EoT (N=67, N=73)	-39 U/L Standard Deviation 106	-59 U/L Standard Deviation 148
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, wk24 (N=12, N=4)	-69 U/L Standard Deviation 78	-42 U/L Standard Deviation 30
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, wk28 (N=5, N=3)	-48 U/L Standard Deviation 75	-32 U/L Standard Deviation 26
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, wk36 (N=4, N=2)	-68 U/L Standard Deviation 83	-37 U/L Standard Deviation 22
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, wk8 (N=75, N=76)	-11 U/L Standard Deviation 69	2 U/L Standard Deviation 57
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, wk12 (N=75, N=75)	-12 U/L Standard Deviation 70	4 U/L Standard Deviation 90
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, day1 (N=77, N=75)	1 U/L Standard Deviation 26	7 U/L Standard Deviation 68
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, wk2 (N=76, N=78)	5 U/L Standard Deviation 41	3 U/L Standard Deviation 23
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, wk4 (N=76, N=77)	2 U/L Standard Deviation 30	5 U/L Standard Deviation 27
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, wk8 (N=75, N=76)	-5 U/L Standard Deviation 33	-2 U/L Standard Deviation 29
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, wk24 (N=12, N=4)	-14 U/L Standard Deviation 35	-16 U/L Standard Deviation 23
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, wk28 (N=5, N=3)	-21 U/L Standard Deviation 34	-8 U/L Standard Deviation 7
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, wk36 (N=4, N=2)	-35 U/L Standard Deviation 24	-19 U/L Standard Deviation 9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, EoT (N=67, N=73)	0 U/L Standard Deviation 37	-4 U/L Standard Deviation 27
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, Day 1(N=74, N=75)	0 U/L Standard Deviation 28	-5 U/L Standard Deviation 29
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, wk2 (N=75, N=78)	-24 U/L Standard Deviation 30	-29 U/L Standard Deviation 43
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, wk4 (N=74, N=76)	-25 U/L Standard Deviation 31	-29 U/L Standard Deviation 49
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, wk8 (N=74, N=76)	-22 U/L Standard Deviation 36	-27 U/L Standard Deviation 47
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, wk12 (N=74, N=76)	-24 U/L Standard Deviation 29	-27 U/L Standard Deviation 44
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, wk18 (N=67, N=70)	-25 U/L Standard Deviation 33	-30 U/L Standard Deviation 50
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) AST/GOT (U/L), CFB, wk24 (N=12, N=4)	-23 U/L Standard Deviation 60	-10 U/L Standard Deviation 15
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, wk2 (n=76, N=78)	5 U/L Standard Deviation 10	7 U/L Standard Deviation 11
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, wk4 (n=76, N=77)	7 U/L Standard Deviation 13	10 U/L Standard Deviation 13
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, wk8 (n=75, N=76)	7 U/L Standard Deviation 13	9 U/L Standard Deviation 15
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, wk12 (n=75, N=76)	5 U/L Standard Deviation 14	6 U/L Standard Deviation 14
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, wk18 (n=68, N=70)	-2 U/L Standard Deviation 20	5 U/L Standard Deviation 14
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, wk24 (n=12, N=4)	-14 U/L Standard Deviation 24	13 U/L Standard Deviation 13
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, wk28 (n=5, N=3)	-2 U/L Standard Deviation 14	15 U/L Standard Deviation 3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, wk36 (n=4, N=2)	-5 U/L Standard Deviation 16	18 U/L Standard Deviation 4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Alka. phosphatase (U/L), CFB, EoT (n=67, N=73)	1 U/L Standard Deviation 22	5 U/L Standard Deviation 16
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, day1 (N=77, N=75)	-5 U/L Standard Deviation 39	-5 U/L Standard Deviation 88
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, wk2 (N=76, N=78)	-34 U/L Standard Deviation 71	-38 U/L Standard Deviation 117
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, wk4 (N=76, N=77)	-59 U/L Standard Deviation 86	-60 U/L Standard Deviation 135
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) GGT (U/L), CFB, wk8 (N=75, N=76)	-76 U/L Standard Deviation 96	-70 U/L Standard Deviation 143
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, day1 (N=76, N=75)	-2 U/L Standard Deviation 140	30 U/L Standard Deviation 308
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, wk2 (N=75, N=78)	-59 U/L Standard Deviation 158	-41 U/L Standard Deviation 118
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, wk4 (N=74, N=77)	-69 U/L Standard Deviation 173	-62 U/L Standard Deviation 134
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, wk8 (N=74, N=76)	-92 U/L Standard Deviation 176	-75 U/L Standard Deviation 131
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, wk12 (N=74, N=75)	-98 U/L Standard Deviation 186	-84 U/L Standard Deviation 132
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, wk18 (N=67, N=70)	-93 U/L Standard Deviation 202	-60 U/L Standard Deviation 216
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Creatine kinase (U/L), CFB, EoT (N=66, N=71)	-89 U/L Standard Deviation 187	-21 U/L Standard Deviation 331
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, day1 (N=77, N=75)	-2 U/L Standard Deviation 52	26 U/L Standard Deviation 239
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, wk2 (N=76, N=78)	5 U/L Standard Deviation 65	9 U/L Standard Deviation 30
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, wk4 (N=76, N=76)	-1 U/L Standard Deviation 52	6 U/L Standard Deviation 36
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, wk18 (N=68, N=70)	-13 U/L Standard Deviation 64	-4 U/L Standard Deviation 32
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, wk24 (N=12, N=4)	2 U/L Standard Deviation 31	-17 U/L Standard Deviation 22
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, wk28 (N=5, N=3)	-1 U/L Standard Deviation 13	0 U/L Standard Deviation 11
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, wk36 (N=4, N=2)	-4 U/L Standard Deviation 12	-15 U/L Standard Deviation 0
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Lipase (U/L). CFB, EoT (N=67, N=73)	-6 U/L Standard Deviation 82	-5 U/L Standard Deviation 27
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, wk12 (N=75, N=75)	-10 U/L Standard Deviation 33	-4 U/L Standard Deviation 33
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) Amylase (U/L), CFB, wk18 (N=68, N=70)	-7 U/L Standard Deviation 34	-7 U/L Standard Deviation 28

SECONDARY outcome

Timeframe: baseline and 48 weeks

Population: TS

Change from baseline (CFB) in PT-INR (ratio).

Outcome measures

Outcome measures
Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, Day 1(N=77, N=72)	0.0 ratio Standard Deviation 0.2	0.0 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, wk2 (N=76, N=78)	0.0 ratio Standard Deviation 0.1	0.0 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, wk4(N=74, N=76)	0.0 ratio Standard Deviation 0.1	0.0 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, wk8(N=73, N=75)	0.0 ratio Standard Deviation 0.1	0.0 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, wk12(N=74, N=72)	0.0 ratio Standard Deviation 0.1	0.0 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, wk18(N=69, N=70)	0.0 ratio Standard Deviation 0.1	0.0 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, wk24(N=12, N=4)	0.0 ratio Standard Deviation 0.1	0.1 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, wk28(N=5, N=3)	-0.1 ratio Standard Deviation 0.1	0.0 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, wk36(N=4, N=2)	0.0 ratio Standard Deviation 0.1	-0.1 ratio Standard Deviation 0.1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) PT-INR (ratio), CFB, EoT(N=68, N=73)	0.0 ratio Standard Deviation 0.1	0.0 ratio Standard Deviation 0.1

Adverse Events

Faldaprevir 120 mg (12 Weeks)

Serious events: 3 serious events

Other events: 73 other events

Deaths: 0 deaths

Faldaprevir 120 mg (24 Weeks)

Serious events: 3 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Faldaprevir 120 mg (12 Weeks) n=80 participants at risk Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 participants at risk Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).
Blood and lymphatic system disorders Anaemia	2.5% 2/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	1.3% 1/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Blood and lymphatic system disorders Neutropenia	0.00% 0/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	1.3% 1/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Infections and infestations Sepsis	1.2% 1/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	0.00% 0/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Nervous system disorders Epilepsy	0.00% 0/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	1.3% 1/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Psychiatric disorders Depression	1.2% 1/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	0.00% 0/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Renal and urinary disorders Renal failure	1.2% 1/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	0.00% 0/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.2% 1/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	0.00% 0/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	1.3% 1/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Vascular disorders Hypotension	1.2% 1/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	0.00% 0/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.

Other adverse events

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Faldaprevir 120 mg (12 Weeks) n=81 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 Participants Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, wk4 (N=74, N=76)	-8.0 % of laboratory test substance Standard Deviation 4.9	-7.9 % of laboratory test substance Standard Deviation 4.5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, wk8 (N=75, N=74)	-8.4 % of laboratory test substance Standard Deviation 4.6	-7.1 % of laboratory test substance Standard Deviation 4.0
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, wk12 (N=72, N=74)	-8.5 % of laboratory test substance Standard Deviation 4.9	-7.8 % of laboratory test substance Standard Deviation 3.9
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, wk18 (N=66, N=69)	-7.3 % of laboratory test substance Standard Deviation 5.4	-6.5 % of laboratory test substance Standard Deviation 4.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, wk24 (N=11, N=4)	-6.6 % of laboratory test substance Standard Deviation 6.2	-2.7 % of laboratory test substance Standard Deviation 2.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, EoT (N=66, N=70)	-6.0 % of laboratory test substance Standard Deviation 4.7	-6.0 % of laboratory test substance Standard Deviation 4.6
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, day1 (N=77, N=75)	0 % of laboratory test substance Standard Deviation 1	0 % of laboratory test substance Standard Deviation 1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, wk2 (N=75, N=76)	0 % of laboratory test substance Standard Deviation 2	0 % of laboratory test substance Standard Deviation 1
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, wk4 (N=73, N=74)	-1 % of laboratory test substance Standard Deviation 1	0 % of laboratory test substance Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, wk8 (N=74, N=73)	0 % of laboratory test substance Standard Deviation 2	0 % of laboratory test substance Standard Deviation 5
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, wk12 (N=72, N=72)	0 % of laboratory test substance Standard Deviation 2	0 % of laboratory test substance Standard Deviation 3
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, wk18 (N=62, N=65)	0 % of laboratory test substance Standard Deviation 3	0 % of laboratory test substance Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, wk24 (N=12, N=4)	-1 % of laboratory test substance Standard Deviation 1	-1 % of laboratory test substance Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, Day1 (N=77, N=75)	-0.9 % of laboratory test substance Standard Deviation 3.0	-1.3 % of laboratory test substance Standard Deviation 2.7
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, wk2 (N=75, N=77)	-4.3 % of laboratory test substance Standard Deviation 4.4	-4.7 % of laboratory test substance Standard Deviation 4.2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, wk28 (N=4, N=3)	-3.8 % of laboratory test substance Standard Deviation 3.9	-1.2 % of laboratory test substance Standard Deviation 4.4
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) haematocrit (%) CFB, wk36 (N=4, N=2)	-3.0 % of laboratory test substance Standard Deviation 8.0	-3.6 % of laboratory test substance Standard Deviation 0.0
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, wk28 (N=4, N=3)	-1 % of laboratory test substance Standard Deviation 1	-2 % of laboratory test substance Standard Deviation 2
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, wk36 (N=4, N=2)	-1 % of laboratory test substance Standard Deviation 1	-1 % of laboratory test substance Standard Deviation 0
Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) Eosinophils(%), CFB, EoT (N=66, N=70)	0 % of laboratory test substance Standard Deviation 2	1 % of laboratory test substance Standard Deviation 5

Measure	Faldaprevir 120 mg (12 Weeks) n=80 participants at risk Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks.	Faldaprevir 120 mg (24 Weeks) n=79 participants at risk Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).
Blood and lymphatic system disorders Anaemia	7.5% 6/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	16.5% 13/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Blood and lymphatic system disorders Neutropenia	3.8% 3/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	8.9% 7/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Ear and labyrinth disorders Vertigo	6.2% 5/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	0.00% 0/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Eye disorders Dry eye	2.5% 2/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	5.1% 4/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Gastrointestinal disorders Abdominal pain	5.0% 4/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	6.3% 5/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Gastrointestinal disorders Abdominal pain upper	5.0% 4/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	5.1% 4/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Gastrointestinal disorders Constipation	5.0% 4/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	5.1% 4/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Gastrointestinal disorders Diarrhoea	5.0% 4/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	19.0% 15/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Gastrointestinal disorders Dry mouth	8.8% 7/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	2.5% 2/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Gastrointestinal disorders Nausea	33.8% 27/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	21.5% 17/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Gastrointestinal disorders Vomiting	13.8% 11/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	8.9% 7/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
General disorders Asthenia	22.5% 18/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	16.5% 13/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
General disorders Fatigue	21.2% 17/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	16.5% 13/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
General disorders Influenza like illness	6.2% 5/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	8.9% 7/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
General disorders Irritability	5.0% 4/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	8.9% 7/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Hepatobiliary disorders Jaundice	3.8% 3/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	5.1% 4/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Infections and infestations Bronchitis	2.5% 2/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	6.3% 5/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Metabolism and nutrition disorders Decreased appetite	17.5% 14/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	16.5% 13/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 6/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	11.4% 9/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Musculoskeletal and connective tissue disorders Back pain	8.8% 7/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	3.8% 3/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 5/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	5.1% 4/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Nervous system disorders Disturbance in attention	3.8% 3/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	7.6% 6/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Nervous system disorders Dizziness	5.0% 4/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	5.1% 4/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Nervous system disorders Headache	17.5% 14/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	22.8% 18/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Psychiatric disorders Anxiety	3.8% 3/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	8.9% 7/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Psychiatric disorders Depression	8.8% 7/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	16.5% 13/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Psychiatric disorders Insomnia	11.2% 9/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	19.0% 15/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Psychiatric disorders Sleep disorder	3.8% 3/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	6.3% 5/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Respiratory, thoracic and mediastinal disorders Cough	16.2% 13/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	10.1% 8/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.2% 9/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	7.6% 6/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.5% 2/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	5.1% 4/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Skin and subcutaneous tissue disorders Alopecia	5.0% 4/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	16.5% 13/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Skin and subcutaneous tissue disorders Dry skin	15.0% 12/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	20.3% 16/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Skin and subcutaneous tissue disorders Eczema	3.8% 3/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	6.3% 5/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Skin and subcutaneous tissue disorders Pruritus	30.0% 24/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	32.9% 26/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
Skin and subcutaneous tissue disorders Rash	22.5% 18/80 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.	21.5% 17/79 • up to 24 weeks + 30 days washout. One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.