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Trial record 19 of 20 for:    Genotype 1 | BI 201335 OR faldaprevir

Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00793793
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : September 17, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: BI201335
Drug: Placebo
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg Per Day (QD) TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Period Title: Overall Study
Started 8 6 7 7 6 6 7 6 15 15 6 7
Completed 8 5 5 4 4 4 3 6 6 6 3 1
Not Completed 0 1 2 3 2 2 4 0 9 9 3 6
Reason Not Completed
Adverse Event             0             0             1             1             0             1             2             0             0             0             0             2
Protocol Violation             0             0             0             1             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             1             0             0             0             0             0             1             3             1             0
Withdrawal by Subject             0             0             0             0             1             0             0             0             1             0             0             0
reason not specified             0             1             0             1             1             1             2             0             7             6             2             4
Arm/Group Title Treatment Naive (TN): Placebo TN: 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC Total
Hide Arm/Group Description TN patient to receive Placebo + PegIFN/RBV for 28 days TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days Total of all reporting groups
Overall Number of Baseline Participants 8 6 7 7 6 6 7 6 15 15 6 7 96
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All randomized patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 7 participants 7 participants 6 participants 6 participants 7 participants 6 participants 15 participants 15 participants 6 participants 7 participants 96 participants
49.88  (8.36) 51.00  (7.97) 47.14  (13.84) 48.57  (16.31) 47.83  (9.26) 46.83  (11.82) 46.71  (4.79) 49.33  (10.11) 50.93  (8.13) 48.93  (13.10) 53.67  (5.32) 53.57  (8.36) 49.59  (10.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 7 participants 7 participants 6 participants 6 participants 7 participants 6 participants 15 participants 15 participants 6 participants 7 participants 96 participants
Female
2
  25.0%
0
   0.0%
2
  28.6%
2
  28.6%
1
  16.7%
2
  33.3%
3
  42.9%
3
  50.0%
5
  33.3%
7
  46.7%
1
  16.7%
2
  28.6%
30
  31.3%
Male
6
  75.0%
6
 100.0%
5
  71.4%
5
  71.4%
5
  83.3%
4
  66.7%
4
  57.1%
3
  50.0%
10
  66.7%
8
  53.3%
5
  83.3%
5
  71.4%
66
  68.8%
1.Primary Outcome
Title Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)
Hide Description Efficacy endpoint: VR (virologic response) of >=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).
Time Frame Baseline and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
0.00
(0.000 to 33.627)
83.33
(42.128 to 96.331)
100.00
(63.058 to 100.000)
100.00
(63.058 to 100.000)
100.00
(59.038 to 100.000)
100.00
(59.038 to 100.000)
100.00
(63.058 to 100.000)
100.00
(59.038 to 100.000)
100.00
(79.409 to 100.000)
100.00
(79.409 to 100.000)
100.00
(59.038 to 100.000)
100.00
(63.058 to 100.000)
2.Primary Outcome
Title Occurrence of Adverse Events (AEs) During BI201335 + Washout Period
Hide Description Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.
Time Frame from day 1 and up to 4 weeks + 4 days washout
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of participants with AEs
62.5 100.0 100.0 57.1 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
3.Primary Outcome
Title Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period
Hide Description Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.
Time Frame from day 1 and up to 4 weeks + 4 days washout
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of participants with SAEs
0.0 16.7 14.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 28.6
4.Primary Outcome
Title Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time
Hide Description

Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.

ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT).

Time Frame Baseline and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: participants with grade 3 or 4 abnormal
ALT/GPT SGPT increase, with grade 3 or 4 abnormal 0 0 1 0 0 0 0 0 0 0 1 0
AST/GOT SGOT increase, with grade 3 or 4 abnormal 0 0 1 0 0 0 0 0 0 0 2 1
Lipase increase, with grade 3 or 4 abnormal 0 0 0 0 0 0 0 0 0 1 0 0
Bilirubin total increa, with grade 3 or 4 abnormal 0 0 0 1 2 0 0 1 8 12 5 5
Uric acid increase, with grade 3 or 4 abnormal 0 0 0 0 0 0 0 0 0 0 0 1
Triglyceride increase, with grade 3 or 4 abnormal 0 0 0 0 0 0 0 0 1 0 0 1
5.Secondary Outcome
Title Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients
Hide Description Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.
Time Frame Baseline and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (as randomised)
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Median (Inter-Quartile Range)
Unit of Measure: log10 IU/mL
-0.060
(-0.216 to 0.012)
-3.049
(-3.376 to -2.181)
-3.624
(-3.744 to -3.359)
-3.740
(-3.869 to -3.426)
-4.413
(-4.438 to -3.943)
-5.023
(-5.150 to -4.342)
-5.244
(-5.796 to -4.035)
-5.334
(-5.692 to -4.916)
-5.246
(-5.621 to -5.133)
-5.404
(-5.469 to -4.936)
-4.841
(-5.322 to -4.763)
-5.476
(-5.544 to -3.853)
6.Secondary Outcome
Title Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients
Hide Description Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.
Time Frame Baseline and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (as randomised) including patients with available viral load data.
Arm/Group Title Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg Per Day (QD) TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 5 15 15 6 6
Median (Inter-Quartile Range)
Unit of Measure: Log10 IU/mL
0.209
(0.165 to 0.321)
-1.226
(-1.492 to -0.831)
-1.539
(-2.885 to -0.782)
-0.781
(-1.967 to -0.046)
-2.449
(-3.502 to -1.360)
-5.023
(-5.150 to -3.049)
-5.244
(-5.800 to -4.035)
-5.386
(-5.692 to -5.283)
-5.246
(-5.621 to -5.133)
-5.404
(-5.469 to -4.797)
-4.782
(-5.322 to -4.628)
-5.497
(-5.544 to -5.300)
7.Secondary Outcome
Title Rapid Virologic Response (RVR)
Hide Description Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (as randomized)
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
0.00
(0.000 to 33.627)
0.00
(0.000 to 40.962)
28.57
(8.523 to 65.086)
14.29
(3.185 to 52.651)
16.67
(3.669 to 57.872)
33.33
(9.899 to 70.958)
14.29
(3.185 to 52.651)
16.67
(3.669 to 57.872)
26.67
(11.017 to 52.377)
26.67
(11.017 to 52.377)
66.67
(29.042 to 90.101)
14.29
(3.185 to 52.651)
8.Secondary Outcome
Title Early Virologic Response (EVR)
Hide Description Early Virologic Response (EVR): >=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of responders
0.0 100.0 100.0 85.7 83.3 83.3 71.4 100.0 86.7 86.7 100.0 71.4
9.Secondary Outcome
Title Complete EVR1 (cEVR1)
Hide Description VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks
Time Frame week 4 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg Per Day (QD) TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of responders
0.0 16.7 28.6 28.6 50.0 50.0 57.1 83.3 53.3 60.0 83.3 57.1
10.Secondary Outcome
Title Complete EVR2 (cEVR2)
Hide Description VL below the limit of detection at both 4 weeks and 12 weeks
Time Frame week 4 and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg Per Day (QD) TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of responders
0.0 0.0 28.6 14.3 33.3 50.0 14.3 16.7 33.3 20.0 33.3 28.6
11.Secondary Outcome
Title End of Treatment Response (ETR)
Hide Description End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of responders
0.0 83.3 57.1 57.1 66.7 33.3 57.1 66.7 53.3 40.0 50.0 14.3
12.Secondary Outcome
Title Sustained Virologic Response (SVR)
Hide Description Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).
Time Frame week 72
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of responders
0.0 50.0 42.9 42.9 50.0 50.0 42.9 50.0 46.7 40.0 50.0 14.3
13.Secondary Outcome
Title Achievement of an HCV RNA Level Below the Limit of Detection Over Time
Hide Description Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time
Time Frame from day 1 and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg BID SGC TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 28.6 14.3 16.7 33.3 14.3 16.7 26.7 26.7 66.7 14.3
14.Secondary Outcome
Title Achievement of an HCV RNA Level Below the Limit of Quantification Over Time
Hide Description Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time
Time Frame from day 1 and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg BID SGC TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of participants
0.0 16.7 28.6 28.6 50.0 50.0 57.1 83.3 66.7 60.0 83.3 85.7
15.Secondary Outcome
Title Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time
Hide Description Achievement of a >= 2 log10 reduction in plasma HCV RNA level from baseline over time.
Time Frame from day 1 and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg BID SGC TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of participants
0.0 83.3 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0
16.Secondary Outcome
Title Occurrence of AEs, by Action Taken With Regard to Study Medication
Hide Description Occurrence of AEs, by action taken with regard to study medication.
Time Frame from day 1 and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE patient non-cirrhotic to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of participants
Action taken: decreasing dose 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 6.7 16.7 0.0
Action taken: stop trial medication 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 28.6
17.Secondary Outcome
Title Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period
Hide Description Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.
Time Frame from day 1 and up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title TN: Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive Placebo +/- PegIFN/RBV for 28 days
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 8 6 7 7 6 6 7 6 15 15 6 7
Measure Type: Number
Unit of Measure: percentage of participants discontinued
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 28.6
18.Secondary Outcome
Title PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)
Hide Description

PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).

.

Time Frame Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 7 6 6 7 6 15 15 6 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
45.3
(53.9%)
170
(21.3%)
964
(66.1%)
2910
(51.6%)
164
(58.1%)
954
(30.5%)
2360
(48.3%)
7220
(48.8%)
7110
(86.8%)
5970
(162%)
7660
(68.1%)
19.Secondary Outcome
Title PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)
Hide Description PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).
Time Frame Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 7 6 6 7 6 15 15 6 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
7.07
(29.0%)
2.48
(149%)
2.12
(56.6%)
3.89
(44.1%)
3.89
(162%)
2.25
(59.1%)
3.23
(27.9%)
5.24
(49.2%)
5.30
(34.6%)
6.61
(14.9%)
5.63
(87.4%)
20.Secondary Outcome
Title PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)
Hide Description PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).
Time Frame Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 7 6 6 7 6 15 15 6 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
736
(57.0%)
2650
(16.5%)
11600
(52.9%)
35700
(48.2%)
2550
(48.3%)
12300
(47.5%)
27700
(59.9%)
108000
(55.5%)
52800
(82.6%)
78400
(157%)
56800
(55.7%)
21.Secondary Outcome
Title PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)
Hide Description PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available Cmax,ss data
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
150
(52.1%)
616
(62.4%)
4050
(43.3%)
15400
(40.4%)
478
(19.3%)
4170
(71.7%)
15400
(59.8%)
17700
(81.7%)
32200
(74.1%)
16400
(98.3%)
60400
(55.8%)
22.Secondary Outcome
Title PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )
Hide Description PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available tmax,ss data
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
4.89
(52.0%)
3.38
(109%)
2.75
(27.6%)
3.36
(67.5%)
2.15
(45.5%)
1.94
(33.6%)
1.99
(46.7%)
3.23
(59.3%)
14.6
(14.1%)
4.12
(53.1%)
17.4
(18.2%)
23.Secondary Outcome
Title PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)
Hide Description PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available Cmin,ss data
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
68.0
(52.4%)
199
(64.0%)
1120
(42.5%)
4040
(23.3%)
147
(43.6%)
863
(88.3%)
3640
(105%)
4970
(124%)
25500
(80.4%)
5870
(94.0%)
45400
(43.1%)
24.Secondary Outcome
Title PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)
Hide Description PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available AUCτ,ss data
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 7 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
2460
(53.9%)
8520
(55.6%)
49400
(42.8%)
185000
(21.1%)
6820
(22.1%)
43400
(75.9%)
164000
(83.8%)
221000
(82.2%)
350000
(75.6%)
243000
(75.8%)
642000
(46.1%)
25.Secondary Outcome
Title PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available t1/2,ss data
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
30.5
(17.0%)
38.8
(41.2%)
25.5
(25.5%)
19.3
(12.4%)
33.2
(8.58%)
22.5
(17.4%)
22.1
(27.3%)
19.9
(25.0%)
27.3
(61.5%)
22.7
(33.0%)
41.5
(63.4%)
26.Secondary Outcome
Title PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)
Hide Description PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration [h] )
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available MRTpo,ss data
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
44.4
(17.0%)
60.2
(61.9%)
33.3
(23.5%)
26.7
(19.3%)
39.7
(14.0%)
26.6
(22.0%)
27.2
(37.4%)
30.7
(32.5%)
50.5
(59.9%)
34.2
(34.9%)
82.0
(71.6%)
27.Secondary Outcome
Title PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )
Hide Description PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration [mL/min] )
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available CL/F,ss data
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
136
(53.9%)
93.9
(55.6%)
40.4
(42.8%)
21.6
(21.1%)
117
(22.1%)
46.1
(75.9%)
24.4
(83.8%)
18.1
(82.2%)
11.4
(75.6%)
16.4
(75.8%)
6.23
(46.1%)
28.Secondary Outcome
Title PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )
Hide Description PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration [L] )
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available Vz/F,ss data
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
358
(46.7%)
315
(69.0%)
89.4
(34.1%)
36.1
(17.9%)
337
(26.7%)
89.9
(80.4%)
46.7
(65.3%)
31.0
(67.4%)
27.0
(54.4%)
32.3
(40.0%)
22.4
(27.1%)
29.Secondary Outcome
Title PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )
Hide Description PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
Hide Outcome Measure Data
Hide Analysis Population Description
TS (for TN patients only)
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
1970
(46.5%)
8740
(52.1%)
45800
(85.4%)
180000
(42.0%)
30.Secondary Outcome
Title PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss
Hide Description PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
Hide Outcome Measure Data
Hide Analysis Population Description
TS (for TN patients only)
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
106
(47.5%)
693
(61.1%)
3880
(82.8%)
13100
(38.2%)
31.Secondary Outcome
Title PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss
Hide Description PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.
Time Frame Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)
Hide Outcome Measure Data
Hide Analysis Population Description
TS (for TN patients only)
Arm/Group Title Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD
Hide Arm/Group Description:
TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
57.8
(46.2%)
185
(64.8%)
1010
(97.9%)
4320
(42.3%)
32.Secondary Outcome
Title Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax
Hide Description For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
Time Frame Day 1, Day 14, and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available RAcmax data
Arm/Group Title Treatment Naive(TN): 20mg Per Day (QD) TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
2.34
(29.1%)
4.08
(66.6%)
3.74
(32.5%)
4.49
(36.2%)
2.91
(58.7%)
4.37
(50.6%)
6.53
(75.7%)
2.45
(89.4%)
4.53
(96.0%)
2.74
(90.5%)
6.81
(154%)
33.Secondary Outcome
Title Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc
Hide Description For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.
Time Frame Day 1, Day 14, and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
TS including patients with available RAauc data
Arm/Group Title Treatment Naive(TN): 20mg Per Day (QD) TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description:
TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
Overall Number of Participants Analyzed 6 7 6 6 6 7 6 15 15 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
2.68
(19.6%)
3.30
(49.9%)
3.61
(42.0%)
5.03
(45.3%)
2.68
(36.2%)
3.52
(34.0%)
5.90
(56.6%)
2.05
(88.8%)
6.62
(88.8%)
3.11
(96.6%)
10.0
(111%)
Time Frame day 1 and up to 4 weeks + washout
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Hide Arm/Group Description TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
All-Cause Mortality
Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   1/6 (16.67%)   1/7 (14.29%)   0/7 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/7 (0.00%)   0/6 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/6 (0.00%)   2/7 (28.57%) 
Eye disorders                         
Cataract  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Gastrointestinal disorders                         
Ascites  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
General disorders                         
Asthenia  1  0/8 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Metabolism and nutrition disorders                         
Hypoalbuminaemia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Metabolic disorder  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Naive (TN): Placebo Treatment Naive(TN): 20mg QD TN: 48mg QD TN: 120mg QD TN: 240mg QD Treatment Experienced (TE) Non-cirrhotic: 48 mg QD TE Non-cirrhotic: 120 mg QD TE Non-cirrhotic: 240 mg QD TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) TE Non-cirrhotic: 240 mg BID SGC TE With Cirrhosis: 240 mg QD SGC TE With Cirrhosis: 240 mg BID SGC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/8 (62.50%)   6/6 (100.00%)   7/7 (100.00%)   4/7 (57.14%)   6/6 (100.00%)   6/6 (100.00%)   7/7 (100.00%)   6/6 (100.00%)   15/15 (100.00%)   15/15 (100.00%)   6/6 (100.00%)   7/7 (100.00%) 
Blood and lymphatic system disorders                         
Anaemia  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  3/15 (20.00%)  2/15 (13.33%)  0/6 (0.00%)  0/7 (0.00%) 
Neutropenia  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  2/15 (13.33%)  2/15 (13.33%)  1/6 (16.67%)  0/7 (0.00%) 
Thrombocytopenia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Cardiac disorders                         
Arrhythmia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Palpitations  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Supraventricular extrasystoles  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Ear and labyrinth disorders                         
Tinnitus  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Vertigo  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  2/7 (28.57%) 
Eye disorders                         
Abnormal sensation in eye  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Conjunctivitis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Dry eye  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  2/15 (13.33%)  0/6 (0.00%)  0/7 (0.00%) 
Erythema of eyelid  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Eyelids pruritus  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Ocular icterus  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  2/15 (13.33%)  0/6 (0.00%)  0/7 (0.00%) 
Photophobia  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Vision blurred  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Visual impairment  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Gastrointestinal disorders                         
Abdominal pain  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  2/7 (28.57%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  1/6 (16.67%)  0/7 (0.00%) 
Abdominal pain lower  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Abdominal pain upper  1  0/8 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/15 (6.67%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Anal pruritus  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Aphthous stomatitis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Cheilitis  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Colitis  1  1/8 (12.50%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Constipation  1  1/8 (12.50%)  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  1/15 (6.67%)  1/15 (6.67%)  1/6 (16.67%)  1/7 (14.29%) 
Diarrhoea  1  1/8 (12.50%)  1/6 (16.67%)  2/7 (28.57%)  0/7 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  1/7 (14.29%)  2/6 (33.33%)  8/15 (53.33%)  5/15 (33.33%)  4/6 (66.67%)  2/7 (28.57%) 
Dry mouth  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Dyspepsia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  1/6 (16.67%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Faeces discoloured  1  1/8 (12.50%)  1/6 (16.67%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Flatulence  1  1/8 (12.50%)  1/6 (16.67%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Irritable bowel syndrome  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Lip dry  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Nausea  1  2/8 (25.00%)  1/6 (16.67%)  3/7 (42.86%)  2/7 (28.57%)  1/6 (16.67%)  0/6 (0.00%)  3/7 (42.86%)  2/6 (33.33%)  8/15 (53.33%)  8/15 (53.33%)  4/6 (66.67%)  6/7 (85.71%) 
Periodontitis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Stomatitis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Vomiting  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  2/7 (28.57%)  1/6 (16.67%)  2/15 (13.33%)  6/15 (40.00%)  0/6 (0.00%)  5/7 (71.43%) 
General disorders                         
Asthenia  1  2/8 (25.00%)  3/6 (50.00%)  3/7 (42.86%)  0/7 (0.00%)  4/6 (66.67%)  1/6 (16.67%)  2/7 (28.57%)  1/6 (16.67%)  3/15 (20.00%)  5/15 (33.33%)  2/6 (33.33%)  4/7 (57.14%) 
Chest pain  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  2/15 (13.33%)  0/6 (0.00%)  0/7 (0.00%) 
Chills  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  1/6 (16.67%)  4/15 (26.67%)  2/15 (13.33%)  4/6 (66.67%)  0/7 (0.00%) 
Exercise tolerance decreased  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Fatigue  1  0/8 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  2/7 (28.57%)  3/6 (50.00%)  11/15 (73.33%)  3/15 (20.00%)  3/6 (50.00%)  1/7 (14.29%) 
Feeling abnormal  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Feeling cold  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Hyperthermia  1  0/8 (0.00%)  3/6 (50.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Influenza like illness  1  0/8 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  0/7 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  2/7 (28.57%)  1/6 (16.67%)  0/15 (0.00%)  1/15 (6.67%)  2/6 (33.33%)  3/7 (42.86%) 
Injection site erythema  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Injection site pruritus  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Injection site rash  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Injection site reaction  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Irritability  1  0/8 (0.00%)  1/6 (16.67%)  3/7 (42.86%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Mucosal dryness  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  2/15 (13.33%)  2/15 (13.33%)  0/6 (0.00%)  1/7 (14.29%) 
Mucosal ulceration  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Oedema peripheral  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Pain  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Pyrexia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  1/6 (16.67%)  0/15 (0.00%)  2/15 (13.33%)  4/6 (66.67%)  2/7 (28.57%) 
Hepatobiliary disorders                         
Hepatic pain  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Hyperbilirubinaemia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  1/7 (14.29%) 
Jaundice  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  6/15 (40.00%)  2/6 (33.33%)  1/7 (14.29%) 
Infections and infestations                         
Bronchitis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Gastroenteritis  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Gingival abscess  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Herpes simplex  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Herpes virus infection  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Influenza  1  2/8 (25.00%)  0/6 (0.00%)  3/7 (42.86%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  2/15 (13.33%)  0/6 (0.00%)  0/7 (0.00%) 
Nasopharyngitis  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Oral herpes  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Rhinitis  1  1/8 (12.50%)  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Sinusitis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Tonsillitis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Tooth abscess  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Upper respiratory tract infection  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Urinary tract infection  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Injury, poisoning and procedural complications                         
Radius fracture  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Scratch  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Sunburn  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Investigations                         
Blood bilirubin increased  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  2/15 (13.33%)  1/15 (6.67%)  0/6 (0.00%)  1/7 (14.29%) 
Body temperature increased  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Breath sounds abnormal  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Cardiac murmur  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Haemoglobin decreased  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Weight decreased  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  1/7 (14.29%) 
Metabolism and nutrition disorders                         
Decreased appetite  1  0/8 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  2/15 (13.33%)  1/15 (6.67%)  1/6 (16.67%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders                         
Arthralgia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  2/15 (13.33%)  1/6 (16.67%)  0/7 (0.00%) 
Back pain  1  2/8 (25.00%)  0/6 (0.00%)  2/7 (28.57%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/15 (6.67%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Bone pain  1  0/8 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Fibromyalgia  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Muscle spasms  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Myalgia  1  0/8 (0.00%)  2/6 (33.33%)  1/7 (14.29%)  1/7 (14.29%)  3/6 (50.00%)  0/6 (0.00%)  3/7 (42.86%)  2/6 (33.33%)  2/15 (13.33%)  3/15 (20.00%)  4/6 (66.67%)  1/7 (14.29%) 
Neck pain  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Pain in extremity  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  2/15 (13.33%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Nervous system disorders                         
Amnesia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Disturbance in attention  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  1/7 (14.29%) 
Dizziness  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  1/15 (6.67%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Headache  1  2/8 (25.00%)  1/6 (16.67%)  2/7 (28.57%)  1/7 (14.29%)  2/6 (33.33%)  2/6 (33.33%)  3/7 (42.86%)  3/6 (50.00%)  9/15 (60.00%)  10/15 (66.67%)  4/6 (66.67%)  3/7 (42.86%) 
Memory impairment  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Migraine  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Paraesthesia  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Somnolence  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Syncope  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Tremor  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Psychiatric disorders                         
Affect lability  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Aggression  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Agitation  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Anxiety  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  1/15 (6.67%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Depressed mood  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Depression  1  1/8 (12.50%)  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Insomnia  1  1/8 (12.50%)  2/6 (33.33%)  2/7 (28.57%)  0/7 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  5/15 (33.33%)  2/15 (13.33%)  3/6 (50.00%)  1/7 (14.29%) 
Mood altered  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  2/15 (13.33%)  0/6 (0.00%)  0/7 (0.00%) 
Mood swings  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders                         
Chromaturia  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Nephrolithiasis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Pollakiuria  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Renal pain  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Urine odour abnormal  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Reproductive system and breast disorders                         
Testicular pain  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders                         
Cough  1  1/8 (12.50%)  0/6 (0.00%)  1/7 (14.29%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/6 (0.00%)  2/15 (13.33%)  3/15 (20.00%)  1/6 (16.67%)  1/7 (14.29%) 
Dyspnoea  1  0/8 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  2/15 (13.33%)  2/15 (13.33%)  2/6 (33.33%)  2/7 (28.57%) 
Epistaxis  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/15 (0.00%)  1/15 (6.67%)  1/6 (16.67%)  2/7 (28.57%) 
Larynx irritation  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Nasal congestion  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Productive cough  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders                         
Alopecia  1  0/8 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/6 (0.00%)  0/7 (0.00%) 
Cold sweat  1  0/8 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Dry skin  1  0/8 (0.00%)  2/6 (33.33%)  2/7 (28.57%)  1/7 (14.29%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%)  3/6 (50.00%)