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Trial record 5 of 16 for:    IU/mL | BI 201335 OR faldaprevir

Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

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: NCT01132313
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: BI 207127
Drug: BI 201335
Drug: Ribavirin
Drug: BI 207217
Enrollment 488
Recruitment Details  
Pre-assignment Details This trial was conducted in 4 parts, each consisting of randomised, open-label treatments.
Arm/Group Title Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w
Hide Arm/Group Description Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period) Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period) Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Period Title: Overall Study
Started 17 17 81 80 79 79 49 32 26 25 1 2
Completed 14 17 61 48 34 54 19 24 5 5 0 2
Not Completed 3 0 20 32 45 25 30 8 21 20 1 0
Reason Not Completed
Lack of Efficacy             1             0             0             0             0             0             0             3             14             16             0             0
Not treated             2             0             0             0             2             1             3             0             0             0             0             0
Adverse Event             0             0             4             10             19             6             5             3             7             2             0             0
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             1             0             0             0             0
Withdrawal by Subject             0             0             3             3             6             0             1             0             0             2             0             0
Lack of antiviral response             0             0             12             18             18             18             21             0             0             0             1             0
Other reason not defined above             0             0             0             0             0             0             0             1             0             0             0             0
Arm/Group Title Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w Total
Hide Arm/Group Description Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period) Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period) Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Total of all reporting groups
Overall Number of Baseline Participants 15 17 81 80 77 78 46 32 26 25 1 2 480
Hide Baseline Analysis Population Description
Treated set which included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 81 participants 80 participants 77 participants 78 participants 46 participants 32 participants 26 participants 25 participants 1 participants 2 participants 480 participants
50.8  (10.0) 50.8  (11.5) 48.6  (11.3) 47.3  (11.2) 48.9  (10.7) 47.9  (11.1) 45.3  (13.0) 48.9  (11.8) 47.2  (13.4) 46.5  (12.5) 59.0 [1]   (NA) 52.5  (4.9) 48.1  (11.4)
[1]
Not calculable due to only one patient in treatment group
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 81 participants 80 participants 77 participants 78 participants 46 participants 32 participants 26 participants 25 participants 1 participants 2 participants 480 participants
Female
7
  46.7%
7
  41.2%
36
  44.4%
39
  48.8%
41
  53.2%
37
  47.4%
22
  47.8%
20
  62.5%
11
  42.3%
11
  44.0%
1
 100.0%
2
 100.0%
234
  48.8%
Male
8
  53.3%
10
  58.8%
45
  55.6%
41
  51.2%
36
  46.8%
41
  52.6%
24
  52.2%
12
  37.5%
15
  57.7%
14
  56.0%
0
   0.0%
0
   0.0%
246
  51.2%
1.Primary Outcome
Title Part 1: Rapid Virological Response (RVR)
Hide Description Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS which included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w
Hide Arm/Group Description:
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
Overall Number of Participants Analyzed 15 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
73.3
(47.6 to 89.0)
100.0
(84.7 to 100.0)
2.Primary Outcome
Title Part 2: Sustained Virological Response (SVR)
Hide Description Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment
Time Frame From drug administration until 12 weeks after end of treatment, up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Hide Arm/Group Description:
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Overall Number of Participants Analyzed 81 80 77 78 46
Measure Type: Number
Unit of Measure: Percentage of participants
59.3 58.8 51.9 69.2 39.1
3.Primary Outcome
Title Part 3 and 4: Sustained Virological Response (SVR)
Hide Description Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment
Time Frame From drug administration until 12 weeks after end of treatment, up to 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w
Hide Arm/Group Description:
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Overall Number of Participants Analyzed 32 26 25 1 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
65.6
(46.8 to 81.4)
19.2
(6.6 to 39.4)
12.0
(2.5 to 31.2)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The study was stopped before data were collected from the participants in Part 4
4.Secondary Outcome
Title Part 1: Time to Virological Response
Hide Description Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Time Frame From drug administration until end of drug administration, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w
Hide Arm/Group Description:
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
Overall Number of Participants Analyzed 15 17
Measure Type: Number
Unit of Measure: Percentage of participants
<= 2 weeks 6.7 11.8
<= 4 weeks 20.0 47.1
<= 8 weeks 53.3 41.2
<= 12 weeks 0.0 0.0
<= 16 weeks 6.7 0.0
<= 28 weeks 0.0 0.0
<= 32 weeks 6.7 0.0
<= 40 weeks 0.0 0.0
> 40 weeks 0.0 0.0
Never 6.7 0.0
5.Secondary Outcome
Title Part 2: Time to Virological Response
Hide Description Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Time Frame From drug administration until end of drug administration, up to 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Hide Arm/Group Description:
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Overall Number of Participants Analyzed 81 80 77 78 46
Measure Type: Number
Unit of Measure: Percentage of participants
Day 0 (N=81, 80, 77, 78, 46) 0.0 0.0 0.0 0.0 0.0
Day 8(N=75, 72, 72, 75, 44) 3.8 7.7 1.4 2.6 2.2
Day 15 (N=62, 61, 63, 60, 33) 19.4 20.7 9.9 22.1 19.3
Day 29 (N=29, 32, 27, 32, 21) 61.5 55.5 59.4 57.7 48.6
Day 43 (N=16, 12, 13, 18, 12) 78.8 83.3 80.5 76.2 70.7
Day 57 (N=9, 8, 9, 11, 9) 88.1 88.9 85.1 85.5 78.0
Day 85 (N=9, 7, 8, 11, 9) 88.1 90.3 86.8 85.5 78.0
Day 113 (N=9, 7, 8, 11, 8) 88.1 90.3 86.8 85.5 80.4
Day 141 (N=9, 7, 8, 11, 8) 88.1 90.3 86.8 85.5 80.4
Day 169 (N=9, 7, 8, 11, 8) 88.1 90.3 86.8 85.5 80.4
Day 197 (N=9, 7, 8, 11, 8) 88.1 90.3 86.8 85.5 80.4
6.Secondary Outcome
Title Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
Hide Description Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Hide Arm/Group Description:
Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Overall Number of Participants Analyzed 15 17 81 80 77 78 46
Measure Type: Number
Unit of Measure: Percentage of participants
20.0 70.6 65.4 60.0 63.6 56.4 50.0
7.Secondary Outcome
Title Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Hide Description Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
Time Frame 4 weeks and 24 weeks after the end of treatment, up to 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w
Hide Arm/Group Description:
Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Overall Number of Participants Analyzed 81 80 77 78 46
Measure Type: Number
Unit of Measure: Percentage of participants
SVR4 60.5 62.5 54.5 69.2 43.5
SVR24 58.0 58.8 49.4 69.2 39.1
8.Secondary Outcome
Title Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
Hide Description Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment
Time Frame Week 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w
Hide Arm/Group Description:
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Overall Number of Participants Analyzed 32 26 25 1 2
Measure Type: Number
Unit of Measure: Percentage of participants
75.0 26.9 32.0 NA [1]  NA [1] 
[1]
The study was stopped before data were collected from the participants in Part 4
9.Secondary Outcome
Title Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Hide Description Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
Time Frame up to 28 weeks
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Hide Analysis Population Description
FAS
Arm/Group Title Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w
Hide Arm/Group Description:
Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
Overall Number of Participants Analyzed 32 26 25 1 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
75.0
(56.6 to 88.5)
19.2
(6.6 to 39.4)
12.0
(2.5 to 31.2)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The study was stopped before data were collected from the participants in Part 4
Time Frame From first drug administration until 30 days after last drug administration for parts 1, 2 and 4 and until 28 days after last drug administration for part 3, up to 361 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w
Hide Arm/Group Description Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period) Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period) Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks. Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
All-Cause Mortality
Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w
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
Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w
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   0/15 (0.00%)   0/17 (0.00%)   3/81 (3.70%)   8/80 (10.00%)   6/77 (7.79%)   8/78 (10.26%)   3/46 (6.52%)   1/32 (3.13%)   3/26 (11.54%)   2/25 (8.00%)   0/1 (0.00%)   0/2 (0.00%) 
Blood and lymphatic system disorders                         
Anaemia  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Febrile neutropenia  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Cardiac disorders                         
Acute myocardial infarction  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Angina unstable  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Bundle branch block left  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Cardiac arrest  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Cardiopulmonary failure  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Coronary artery disease  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Coronary artery stenosis  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Myocardial infarction  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Ventricular fibrillation  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Eye disorders                         
Retinal tear  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                         
Abdominal pain  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Diarrhoea  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  1/77 (1.30%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Gastritis  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Haemorrhoids  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  1/77 (1.30%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Nausea  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Vomiting  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  1/77 (1.30%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
General disorders                         
Asthenia  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  1/77 (1.30%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Hepatobiliary disorders                         
Cholecystitis  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Infections and infestations                         
Cellulitis pharyngeal  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Gastroenteritis  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Herpes zoster  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications                         
Accident at work  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Gun shot wound  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Limb traumatic amputation  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Radius fracture  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Investigations                         
Blood potassium decreased  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  1/77 (1.30%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Electrocardiogram QT prolonged  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders                         
Dehydration  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  1/32 (3.13%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
B-cell lymphoma  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Nervous system disorders                         
Brain injury  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Convulsion  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Syncope  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Psychiatric disorders                         
Depression  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Psychotic disorder  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  1/77 (1.30%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Renal and urinary disorders                         
Prerenal failure  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Renal failure acute  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders                         
Pulmonary embolism  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Respiratory failure  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders                         
Drug eruption  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Dry skin  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  1/77 (1.30%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Erythema nodosum  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Photosensitivity reaction  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Purpura  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Rash  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Toxic skin eruption  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  1/77 (1.30%)  0/78 (0.00%)  1/46 (2.17%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: 400mg DBV and 120mg FDV - 4w Part 1: 600mg DBV and 120mg FDV - 4w Part 2: 600mg DBV and 120mg FDV - 16w Part 2: 600mg DBV TID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV - 40w Part 2: 600mg DBV BID and 120mg FDV - 28w Part 2: 600mg DBV and 120mg FDV, no RBV - 28w Part 3: 600mg DBV and 120mg FDV - 16w Part 3: 800mg DBV and 120mg FDV - 24w Part 3: 600mg DBV and 120mg FDV - 24w Part 4: 600 mg DBV and 120mg FDV - 16w Part 4: 600 mg DBV and 120mg FDV - 24w
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   0/15 (0.00%)   0/17 (0.00%)   76/81 (93.83%)   71/80 (88.75%)   74/77 (96.10%)   73/78 (93.59%)   43/46 (93.48%)   30/32 (93.75%)   26/26 (100.00%)   25/25 (100.00%)   1/1 (100.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders                         
Anaemia  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  9/80 (11.25%)  10/77 (12.99%)  7/78 (8.97%)  0/46 (0.00%)  8/32 (25.00%)  3/26 (11.54%)  2/25 (8.00%)  1/1 (100.00%)  0/2 (0.00%) 
Ear and labyrinth disorders                         
Tinnitus  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  2/32 (6.25%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Eye disorders                         
Dry eye  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  3/77 (3.90%)  1/78 (1.28%)  0/46 (0.00%)  2/32 (6.25%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Ocular icterus  1  0/15 (0.00%)  0/17 (0.00%)  2/81 (2.47%)  0/80 (0.00%)  3/77 (3.90%)  5/78 (6.41%)  0/46 (0.00%)  2/32 (6.25%)  2/26 (7.69%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                         
Abdominal discomfort  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  1/80 (1.25%)  1/77 (1.30%)  6/78 (7.69%)  0/46 (0.00%)  4/32 (12.50%)  2/26 (7.69%)  2/25 (8.00%)  0/1 (0.00%)  0/2 (0.00%) 
Abdominal distension  1  0/15 (0.00%)  0/17 (0.00%)  4/81 (4.94%)  3/80 (3.75%)  7/77 (9.09%)  4/78 (5.13%)  3/46 (6.52%)  1/32 (3.13%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Abdominal pain  1  0/15 (0.00%)  0/17 (0.00%)  7/81 (8.64%)  7/80 (8.75%)  6/77 (7.79%)  12/78 (15.38%)  8/46 (17.39%)  0/32 (0.00%)  3/26 (11.54%)  3/25 (12.00%)  0/1 (0.00%)  0/2 (0.00%) 
Abdominal pain upper  1  0/15 (0.00%)  0/17 (0.00%)  6/81 (7.41%)  15/80 (18.75%)  12/77 (15.58%)  2/78 (2.56%)  2/46 (4.35%)  3/32 (9.38%)  5/26 (19.23%)  2/25 (8.00%)  0/1 (0.00%)  1/2 (50.00%) 
Constipation  1  0/15 (0.00%)  0/17 (0.00%)  4/81 (4.94%)  1/80 (1.25%)  6/77 (7.79%)  3/78 (3.85%)  1/46 (2.17%)  4/32 (12.50%)  4/26 (15.38%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Diarrhoea  1  0/15 (0.00%)  0/17 (0.00%)  34/81 (41.98%)  33/80 (41.25%)  36/77 (46.75%)  29/78 (37.18%)  12/46 (26.09%)  7/32 (21.88%)  9/26 (34.62%)  9/25 (36.00%)  0/1 (0.00%)  0/2 (0.00%) 
Dry mouth  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  4/77 (5.19%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Dyspepsia  1  0/15 (0.00%)  0/17 (0.00%)  6/81 (7.41%)  5/80 (6.25%)  8/77 (10.39%)  14/78 (17.95%)  4/46 (8.70%)  6/32 (18.75%)  4/26 (15.38%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Flatulence  1  0/15 (0.00%)  0/17 (0.00%)  3/81 (3.70%)  5/80 (6.25%)  4/77 (5.19%)  4/78 (5.13%)  2/46 (4.35%)  2/32 (6.25%)  1/26 (3.85%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Gastrooesophageal reflux disease  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  4/80 (5.00%)  2/77 (2.60%)  2/78 (2.56%)  0/46 (0.00%)  1/32 (3.13%)  2/26 (7.69%)  2/25 (8.00%)  0/1 (0.00%)  1/2 (50.00%) 
Hypoaesthesia oral  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  1/46 (2.17%)  1/32 (3.13%)  0/26 (0.00%)  2/25 (8.00%)  0/1 (0.00%)  0/2 (0.00%) 
Lip dry  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  2/80 (2.50%)  1/77 (1.30%)  1/78 (1.28%)  4/46 (8.70%)  0/32 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Nausea  1  0/15 (0.00%)  0/17 (0.00%)  41/81 (50.62%)  43/80 (53.75%)  41/77 (53.25%)  39/78 (50.00%)  26/46 (56.52%)  18/32 (56.25%)  16/26 (61.54%)  18/25 (72.00%)  1/1 (100.00%)  1/2 (50.00%) 
Vomiting  1  0/15 (0.00%)  0/17 (0.00%)  24/81 (29.63%)  29/80 (36.25%)  23/77 (29.87%)  20/78 (25.64%)  13/46 (28.26%)  11/32 (34.38%)  6/26 (23.08%)  5/25 (20.00%)  0/1 (0.00%)  0/2 (0.00%) 
General disorders                         
Asthenia  1  0/15 (0.00%)  0/17 (0.00%)  24/81 (29.63%)  28/80 (35.00%)  25/77 (32.47%)  21/78 (26.92%)  7/46 (15.22%)  7/32 (21.88%)  4/26 (15.38%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Chest pain  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  2/32 (6.25%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  1/2 (50.00%) 
Chills  1  0/15 (0.00%)  0/17 (0.00%)  5/81 (6.17%)  2/80 (2.50%)  3/77 (3.90%)  2/78 (2.56%)  2/46 (4.35%)  1/32 (3.13%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Fatigue  1  0/15 (0.00%)  0/17 (0.00%)  18/81 (22.22%)  14/80 (17.50%)  22/77 (28.57%)  21/78 (26.92%)  7/46 (15.22%)  9/32 (28.13%)  9/26 (34.62%)  10/25 (40.00%)  1/1 (100.00%)  0/2 (0.00%) 
Influenza like illness  1  0/15 (0.00%)  0/17 (0.00%)  2/81 (2.47%)  6/80 (7.50%)  5/77 (6.49%)  5/78 (6.41%)  2/46 (4.35%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Irritability  1  0/15 (0.00%)  0/17 (0.00%)  8/81 (9.88%)  6/80 (7.50%)  4/77 (5.19%)  2/78 (2.56%)  1/46 (2.17%)  0/32 (0.00%)  1/26 (3.85%)  2/25 (8.00%)  0/1 (0.00%)  0/2 (0.00%) 
Oedema peripheral  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  2/80 (2.50%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  2/32 (6.25%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Pyrexia  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  4/80 (5.00%)  4/77 (5.19%)  4/78 (5.13%)  1/46 (2.17%)  1/32 (3.13%)  2/26 (7.69%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Hepatobiliary disorders                         
Hyperbilirubinaemia  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  2/80 (2.50%)  3/77 (3.90%)  0/78 (0.00%)  0/46 (0.00%)  3/32 (9.38%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  1/2 (50.00%) 
Jaundice  1  0/15 (0.00%)  0/17 (0.00%)  25/81 (30.86%)  22/80 (27.50%)  15/77 (19.48%)  16/78 (20.51%)  2/46 (4.35%)  6/32 (18.75%)  5/26 (19.23%)  4/25 (16.00%)  0/1 (0.00%)  0/2 (0.00%) 
Infections and infestations                         
Nasopharyngitis  1  0/15 (0.00%)  0/17 (0.00%)  4/81 (4.94%)  8/80 (10.00%)  7/77 (9.09%)  6/78 (7.69%)  6/46 (13.04%)  2/32 (6.25%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Urinary tract infection  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  2/80 (2.50%)  0/77 (0.00%)  2/78 (2.56%)  1/46 (2.17%)  2/32 (6.25%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications                         
Sunburn  1  0/15 (0.00%)  0/17 (0.00%)  6/81 (7.41%)  4/80 (5.00%)  9/77 (11.69%)  6/78 (7.69%)  8/46 (17.39%)  1/32 (3.13%)  2/26 (7.69%)  4/25 (16.00%)  0/1 (0.00%)  0/2 (0.00%) 
Investigations                         
Weight decreased  1  0/15 (0.00%)  0/17 (0.00%)  8/81 (9.88%)  6/80 (7.50%)  11/77 (14.29%)  8/78 (10.26%)  4/46 (8.70%)  0/32 (0.00%)  2/26 (7.69%)  2/25 (8.00%)  0/1 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders                         
Decreased appetite  1  0/15 (0.00%)  0/17 (0.00%)  4/81 (4.94%)  15/80 (18.75%)  10/77 (12.99%)  8/78 (10.26%)  0/46 (0.00%)  3/32 (9.38%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders                         
Arthralgia  1  0/15 (0.00%)  0/17 (0.00%)  4/81 (4.94%)  5/80 (6.25%)  4/77 (5.19%)  4/78 (5.13%)  3/46 (6.52%)  0/32 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Back pain  1  0/15 (0.00%)  0/17 (0.00%)  3/81 (3.70%)  3/80 (3.75%)  1/77 (1.30%)  6/78 (7.69%)  0/46 (0.00%)  1/32 (3.13%)  1/26 (3.85%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Muscle spasms  1  0/15 (0.00%)  0/17 (0.00%)  4/81 (4.94%)  1/80 (1.25%)  6/77 (7.79%)  3/78 (3.85%)  1/46 (2.17%)  1/32 (3.13%)  2/26 (7.69%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Myalgia  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  4/80 (5.00%)  4/77 (5.19%)  3/78 (3.85%)  1/46 (2.17%)  2/32 (6.25%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Pain in extremity  1  0/15 (0.00%)  0/17 (0.00%)  2/81 (2.47%)  1/80 (1.25%)  2/77 (2.60%)  3/78 (3.85%)  1/46 (2.17%)  1/32 (3.13%)  2/26 (7.69%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Nervous system disorders                         
Disturbance in attention  1  0/15 (0.00%)  0/17 (0.00%)  3/81 (3.70%)  4/80 (5.00%)  4/77 (5.19%)  3/78 (3.85%)  3/46 (6.52%)  1/32 (3.13%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Dizziness  1  0/15 (0.00%)  0/17 (0.00%)  4/81 (4.94%)  3/80 (3.75%)  5/77 (6.49%)  3/78 (3.85%)  1/46 (2.17%)  5/32 (15.63%)  1/26 (3.85%)  3/25 (12.00%)  0/1 (0.00%)  1/2 (50.00%) 
Dysgeusia  1  0/15 (0.00%)  0/17 (0.00%)  3/81 (3.70%)  4/80 (5.00%)  5/77 (6.49%)  2/78 (2.56%)  2/46 (4.35%)  0/32 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Headache  1  0/15 (0.00%)  0/17 (0.00%)  11/81 (13.58%)  8/80 (10.00%)  15/77 (19.48%)  11/78 (14.10%)  7/46 (15.22%)  4/32 (12.50%)  3/26 (11.54%)  2/25 (8.00%)  0/1 (0.00%)  2/2 (100.00%) 
Hypoaesthesia  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  1/77 (1.30%)  2/78 (2.56%)  0/46 (0.00%)  0/32 (0.00%)  1/26 (3.85%)  3/25 (12.00%)  0/1 (0.00%)  0/2 (0.00%) 
Lethargy  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  1/80 (1.25%)  2/77 (2.60%)  1/78 (1.28%)  1/46 (2.17%)  2/32 (6.25%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Paraesthesia  1  0/15 (0.00%)  0/17 (0.00%)  10/81 (12.35%)  9/80 (11.25%)  6/77 (7.79%)  4/78 (5.13%)  5/46 (10.87%)  0/32 (0.00%)  3/26 (11.54%)  2/25 (8.00%)  0/1 (0.00%)  0/2 (0.00%) 
Somnolence  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  2/80 (2.50%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  1/32 (3.13%)  4/26 (15.38%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Syncope  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  2/80 (2.50%)  5/77 (6.49%)  6/78 (7.69%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Tremor  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  1/77 (1.30%)  1/78 (1.28%)  1/46 (2.17%)  2/32 (6.25%)  0/26 (0.00%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Psychiatric disorders                         
Anxiety  1  0/15 (0.00%)  0/17 (0.00%)  3/81 (3.70%)  4/80 (5.00%)  7/77 (9.09%)  4/78 (5.13%)  0/46 (0.00%)  2/32 (6.25%)  2/26 (7.69%)  0/25 (0.00%)  0/1 (0.00%)  1/2 (50.00%) 
Depressed mood  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  2/80 (2.50%)  5/77 (6.49%)  2/78 (2.56%)  0/46 (0.00%)  0/32 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Depression  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  10/80 (12.50%)  5/77 (6.49%)  5/78 (6.41%)  1/46 (2.17%)  0/32 (0.00%)  2/26 (7.69%)  2/25 (8.00%)  0/1 (0.00%)  1/2 (50.00%) 
Insomnia  1  0/15 (0.00%)  0/17 (0.00%)  11/81 (13.58%)  8/80 (10.00%)  12/77 (15.58%)  7/78 (8.97%)  2/46 (4.35%)  4/32 (12.50%)  3/26 (11.54%)  5/25 (20.00%)  0/1 (0.00%)  0/2 (0.00%) 
Sleep disorder  1  0/15 (0.00%)  0/17 (0.00%)  3/81 (3.70%)  4/80 (5.00%)  7/77 (9.09%)  4/78 (5.13%)  2/46 (4.35%)  0/32 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders                         
Cough  1  0/15 (0.00%)  0/17 (0.00%)  7/81 (8.64%)  4/80 (5.00%)  10/77 (12.99%)  9/78 (11.54%)  2/46 (4.35%)  2/32 (6.25%)  2/26 (7.69%)  2/25 (8.00%)  0/1 (0.00%)  0/2 (0.00%) 
Dyspnoea  1  0/15 (0.00%)  0/17 (0.00%)  2/81 (2.47%)  8/80 (10.00%)  10/77 (12.99%)  4/78 (5.13%)  0/46 (0.00%)  0/32 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  1/2 (50.00%) 
Epistaxis  1  0/15 (0.00%)  0/17 (0.00%)  1/81 (1.23%)  1/80 (1.25%)  4/77 (5.19%)  1/78 (1.28%)  0/46 (0.00%)  0/32 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders                         
Alopecia  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  7/80 (8.75%)  2/77 (2.60%)  7/78 (8.97%)  4/46 (8.70%)  1/32 (3.13%)  2/26 (7.69%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Dermatitis  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  0/26 (0.00%)  2/25 (8.00%)  0/1 (0.00%)  0/2 (0.00%) 
Dry skin  1  0/15 (0.00%)  0/17 (0.00%)  12/81 (14.81%)  12/80 (15.00%)  11/77 (14.29%)  18/78 (23.08%)  7/46 (15.22%)  3/32 (9.38%)  2/26 (7.69%)  2/25 (8.00%)  0/1 (0.00%)  0/2 (0.00%) 
Eczema  1  0/15 (0.00%)  0/17 (0.00%)  2/81 (2.47%)  3/80 (3.75%)  2/77 (2.60%)  4/78 (5.13%)  3/46 (6.52%)  0/32 (0.00%)  1/26 (3.85%)  1/25 (4.00%)  0/1 (0.00%)  0/2 (0.00%) 
Erythema  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  1/80 (1.25%)  1/77 (1.30%)  2/78 (2.56%)  0/46 (0.00%)  1/32 (3.13%)  1/26 (3.85%)  3/25 (12.00%)  0/1 (0.00%)  0/2 (0.00%) 
Pain of skin  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  0/32 (0.00%)  1/26 (3.85%)  2/25 (8.00%)  0/1 (0.00%)  1/2 (50.00%) 
Papule  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  1/78 (1.28%)  0/46 (0.00%)  2/32 (6.25%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Photosensitivity reaction  1  0/15 (0.00%)  0/17 (0.00%)  20/81 (24.69%)  23/80 (28.75%)  23/77 (29.87%)  19/78 (24.36%)  11/46 (23.91%)  4/32 (12.50%)  3/26 (11.54%)  8/25 (32.00%)  0/1 (0.00%)  1/2 (50.00%) 
Pruritus  1  0/15 (0.00%)  0/17 (0.00%)  16/81 (19.75%)  24/80 (30.00%)  31/77 (40.26%)  23/78 (29.49%)  14/46 (30.43%)  7/32 (21.88%)  6/26 (23.08%)  7/25 (28.00%)  0/1 (0.00%)  2/2 (100.00%) 
Rash  1  0/15 (0.00%)  0/17 (0.00%)  21/81 (25.93%)  11/80 (13.75%)  28/77 (36.36%)  15/78 (19.23%)  13/46 (28.26%)  0/32 (0.00%)  9/26 (34.62%)  10/25 (40.00%)  0/1 (0.00%)  2/2 (100.00%) 
Rash papulosquamous  1  0/15 (0.00%)  0/17 (0.00%)  0/81 (0.00%)  0/80 (0.00%)  0/77 (0.00%)  0/78 (0.00%)  0/46 (0.00%)  2/32 (6.25%)  1/26 (3.85%)  0/25 (0.00%)  0/1 (0.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.1
There were only 3 patients entered in part 4 of the trial, therefore no formal analyses of efficacy data were performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01132313     History of Changes
Other Study ID Numbers: 1241.21
2009-018197-66 ( EudraCT Number: EudraCT )
First Submitted: May 3, 2010
First Posted: May 28, 2010
Results First Submitted: October 29, 2015
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016