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An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT01447446
Recruitment Status : Completed
First Posted : October 6, 2011
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis C, Chronic
Interventions Drug: Peg-IFN Alfa-2a
Drug: Peg-IFN Alfa-2b
Drug: Ribavirin
Drug: Boceprevir
Drug: Telaprevir
Enrollment 4442
Recruitment Details A total of 4442 participants were enrolled in the study, one participant had double enrollment. Out of 4442 participants, analyses were restricted to only core population, which included 4100 participants.
Pre-assignment Details  
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Period Title: Overall Study
Started 2312 [1] 496 292 93 821 86
Completed 1590 [2] 331 [3] 192 60 610 54
Not Completed 722 165 100 33 211 32
Reason Not Completed
Death             6             3             2             1             7             0
Adverse Event             3             0             1             0             2             0
Failure to Return/Consent Withdrawn             357             78             31             7             69             9
Insuff. VR/TRT too Short to Expect VR             300             71             52             21             92             14
Administrative/Other             34             9             10             2             33             4
SVR12 Assessment             13             1             2             1             5             5
New Treatment Started             8             2             1             0             2             0
Reason not Specified             1             1             1             1             1             0
[1]
Started means participants who started treatment and included in core population.
[2]
Completed means the participants who completed the 24- weeks of follow-up period.
[3]
Insuff.=Insufficient VR= Virological response TRT.=Treatment SVR= Sustained Virological Response
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin Total
Hide Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Total of all reporting groups
Overall Number of Baseline Participants 2312 496 292 93 821 86 4100
Hide Baseline Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2312 participants 496 participants 292 participants 93 participants 821 participants 86 participants 4100 participants
Less Than or Equal to (<=) 45 Years 987 178 73 21 184 14 1457
Greater (>) 45 years 1325 318 219 72 637 72 2643
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2312 participants 496 participants 292 participants 93 participants 821 participants 86 participants 4100 participants
Female
910
  39.4%
250
  50.4%
108
  37.0%
37
  39.8%
331
  40.3%
43
  50.0%
1679
  41.0%
Male
1402
  60.6%
246
  49.6%
184
  63.0%
56
  60.2%
490
  59.7%
43
  50.0%
2421
  59.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
Hide Description SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.
Time Frame 24 weeks after end of treatment (up to 118 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 2312 496 292 93 821 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.1
(50.1 to 54.2)
49.4
(44.9 to 53.9)
46.6
(40.7 to 52.5)
50.5
(40.0 to 61.1)
57.7
(54.3 to 61.1)
47.7
(36.8 to 58.7)
2.Primary Outcome
Title Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
Hide Description SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.
Time Frame 12 weeks after end of treatment (up to 118 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 2312 496 292 93 821 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.3
(52.2 to 56.3)
51.0
(46.5 to 55.5)
50.0
(44.1 to 55.9)
53.8
(43.1 to 64.2)
62.0
(58.6 to 65.3)
57.0
(45.8 to 67.6)
3.Secondary Outcome
Title Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
Hide Description Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.
Time Frame Week 4, 12 and End of treatment (EOT) (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 2312 496 292 93 821 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
VR by Week 4
39.5
(37.5 to 41.5)
40.1
(35.8 to 44.6)
9.9
(6.8 to 14.0)
9.7
(4.5 to 17.6)
49.8
(46.3 to 53.3)
51.2
(40.1 to 62.1)
VR by Week 12
71.3
(69.4 to 73.2)
67.7
(63.4 to 71.8)
56.8
(51.0 to 62.6)
59.1
(48.5 to 69.2)
80.8
(77.9 to 83.4)
73.3
(62.6 to 82.2)
VR by EOT
73.6
(71.7 to 75.4)
70.6
(66.3 to 74.5)
67.1
(61.4 to 72.5)
72.0
(61.8 to 80.9)
74.9
(71.8 to 77.8)
66.3
(55.3 to 76.1)
4.Secondary Outcome
Title Virological Relapse After End of Treatment
Hide Description Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).
Time Frame Up to 24 weeks after EOT (up to 118 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 1521 314 181 63 581 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.4
(16.5 to 20.4)
19.7
(15.5 to 24.6)
21.0
(15.3 to 27.7)
20.6
(11.5 to 32.7)
13.8
(11.1 to 16.8)
7.5
(2.1 to 18.2)
5.Secondary Outcome
Title Virological Breakthrough
Hide Description Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.
Time Frame Up to EOT (up to 118 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 2079 437 275 88 785 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.4
(4.5 to 6.4)
4.8
(3.0 to 7.3)
8.7
(5.7 to 12.7)
15.9
(9.0 to 25.2)
15.0
(12.6 to 17.7)
21.6
(12.9 to 32.7)
6.Secondary Outcome
Title Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
Hide Description SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.
Time Frame Up to first 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 116 33 29 7 79 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR at Week 12 After EOT
37.1
(28.3 to 46.5)
27.3
(13.3 to 45.5)
20.7
(8.0 to 39.7)
14.3
(0.4 to 57.9)
35.4
(25.0 to 47.0)
44.4
(13.7 to 78.8)
SVR at Week 24 EOT
35.3
(26.7 to 44.8)
24.2
(11.1 to 42.3)
17.2
(5.8 to 35.8)
14.3
(0.4 to 57.9)
34.2
(23.9 to 45.7)
44.4
(13.7 to 78.8)
7.Secondary Outcome
Title Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks
Hide Description Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The data for all of the above mentioned virological responses were not collected and was not analyzed.
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)
Hide Description Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.
Time Frame Up to 98 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 292 93 821 86
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.7
(32.1 to 43.5)
32.3
(22.9 to 42.7)
45.6
(42.1 to 49.0)
47.7
(36.8 to 58.7)
9.Secondary Outcome
Title Duration of Overall Treatment
Hide Description Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.
Time Frame Up to 118 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 2312 496 292 93 821 86
Mean (Standard Deviation)
Unit of Measure: Weeks
34.2  (16.04) 31.3  (15.73) 35.2  (17.48) 35.3  (15.27) 33.2  (15.03) 31.2  (15.95)
10.Secondary Outcome
Title Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)
Hide Description [Not Specified]
Time Frame Up to 118 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this outcome measure were not collected and analyzed because the standard of care has changed significantly since the development of the study protocol, this comparison was no longer of practical value.
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)
Hide Description Participants who prolonged the treatment period from 72 weeks were not reported.
Time Frame Up to 72 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 2312 496 292 93 821 86
Measure Type: Number
Unit of Measure: percentage of participants
Discontinued PEG-IFN During Week 1 to Week 12 5.7 8.3 9.2 9.7 9.9 11.6
Discontinued RBV During Week 1 to Week 12 6.3 9.1 9.6 10.8 10.8 12.8
Discontinued PEG-IFN During Week 13 to Week 24 13.5 17.1 16.8 14.0 10.2 12.8
Discontinued RBV During Week 13 to Week 24 22.1 22.4 17.1 16.1 13.9 19.8
Discontinued PEG-IFN During Week 25 to Week 48 41.7 41.3 30.1 29.0 41.0 43.0
Discontinued RBV During Week 25 to Week 48 43.0 46.6 41.1 41.9 44.9 41.9
Discontinued PEG-IFN During Week 49 to Week 72 36.2 32.1 41.1 47.3 38.9 32.6
Discontinued RBV During Week 49 to Week 72 26.6 21.0 29.1 31.2 30.3 25.6
12.Secondary Outcome
Title Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)
Hide Description Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).
Time Frame Up to 72 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 292 93 821 86
Measure Type: Number
Unit of Measure: percentage of participants
Discontinued DAA During Week 1 to Week 2 6.8 7.5 1.7 4.7
Discontinued DAA During Week 3 to Week 4 2.1 1.1 1.5 4.7
Discontinued DAA During Week 5 to Week 12 13.4 8.6 24.7 22.1
Discontinued DAA During Week 13 to Week 24 16.1 18.3 71.7 68.6
Discontinued DAA During Week 25 to Week 48 59.2 64.5 0.4 0.0
13.Secondary Outcome
Title Percentage of Participants With Concomitant Medical Condition at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 2312 496 292 93 821 86
Measure Type: Number
Unit of Measure: percentage of participants
48.1 50.4 65.8 68.8 67.2 41.9
14.Secondary Outcome
Title Percentage of Participants With Adverse Events (AE)
Hide Description An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
Time Frame Up to 118 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description:
Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Overall Number of Participants Analyzed 2312 496 292 93 821 86
Measure Type: Number
Unit of Measure: percentage of participants
60.3 65.7 76.7 88.2 90.7 87.2
Time Frame Up to 118 weeks
Adverse Event Reporting Description An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
 
Arm/Group Title Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Hide Arm/Group Description Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy. Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
All-Cause Mortality
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
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
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   148/2312 (6.40%)   33/496 (6.65%)   43/292 (14.73%)   9/93 (9.68%)   163/821 (19.85%)   4/86 (4.65%) 
Blood and lymphatic system disorders             
Acquired haemophilia  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Agranulocytosis  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Anaemia  1  25/2312 (1.08%)  2/496 (0.40%)  9/292 (3.08%)  3/93 (3.23%)  57/821 (6.94%)  1/86 (1.16%) 
Aplasia pure red cell  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Bone marrow failure  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Disseminated intravascular coagulation  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Haemolysis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Haemolytic anaemia  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Immune thrombocytopenic purpura  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Leukopenia  1  1/2312 (0.04%)  0/496 (0.00%)  2/292 (0.68%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Neutropenia  1  12/2312 (0.52%)  1/496 (0.20%)  4/292 (1.37%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Pancytopenia  1  5/2312 (0.22%)  0/496 (0.00%)  0/292 (0.00%)  1/93 (1.08%)  5/821 (0.61%)  0/86 (0.00%) 
Thrombocytopenia  1  5/2312 (0.22%)  2/496 (0.40%)  2/292 (0.68%)  1/93 (1.08%)  4/821 (0.49%)  0/86 (0.00%) 
Thrombotic thrombocytopenic purpura  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Cardiac disorders             
Acute coronary syndrome  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Acute myocardial infarction  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  1/93 (1.08%)  0/821 (0.00%)  0/86 (0.00%) 
Angina unstable  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Atrial fibrillation  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Atrial flutter  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Atrioventricular block  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Bundle branch block left  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Cardiac failure  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  4/821 (0.49%)  0/86 (0.00%) 
Cardiac failure congestive  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Cardiovascular insufficiency  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Coronary artery disease  1  0/2312 (0.00%)  1/496 (0.20%)  1/292 (0.34%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Coronary artery occlusion  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Myocardial infarction  1  1/2312 (0.04%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Palpitations  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Tricuspid valve incompetence  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Congenital, familial and genetic disorders             
Cerebrovascular arteriovenous malformation  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Ear and labyrinth disorders             
Deafness  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Vertigo  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Endocrine disorders             
Hypothyroidism  1  1/2312 (0.04%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Thyroiditis  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Eye disorders             
Blindness unilateral  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Eye oedema  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Retinal detachment  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Retinal vein thrombosis  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Retinopathy  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Visual acuity reduced  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Gastrointestinal disorders             
Abdominal discomfort  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Abdominal pain  1  2/2312 (0.09%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Abdominal pain lower  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Abdominal pain upper  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Alcoholic pancreatitis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Anal fissure  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Ascites  1  2/2312 (0.09%)  1/496 (0.20%)  1/292 (0.34%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Chronic gastritis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Colitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Constipation  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Diarrhoea  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  1/821 (0.12%)  1/86 (1.16%) 
Dysphagia  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Enterocolitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Gastric ulcer perforation  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Gastritis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Gastrointestinal haemorrhage  1  2/2312 (0.09%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Haemorrhoidal haemorrhage  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Intestinal obstruction  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Nausea  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Oesophageal varices haemorrhage  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Oesophagitis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Pancreatitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Pancreatitis acute  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Rectal haemorrhage  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Reflux gastritis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Retroperitoneal haemorrhage  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Varices oesophageal  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Vomiting  1  0/2312 (0.00%)  1/496 (0.20%)  2/292 (0.68%)  0/93 (0.00%)  3/821 (0.37%)  1/86 (1.16%) 
General disorders             
Asthenia  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  1/86 (1.16%) 
Chest discomfort  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Death  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Fatigue  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
General physical health deterioration  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  6/821 (0.73%)  0/86 (0.00%) 
Malaise  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Oedema  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Oedema peripheral  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Pyrexia  1  1/2312 (0.04%)  1/496 (0.20%)  1/292 (0.34%)  1/93 (1.08%)  3/821 (0.37%)  0/86 (0.00%) 
Systemic inflammatory response syndrome  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Vascular stent restenosis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Hepatobiliary disorders             
Bile duct stone  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Cholangitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Cholecystitis acute  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Cholelithiasis  1  2/2312 (0.09%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Hepatic cirrhosis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  6/821 (0.73%)  0/86 (0.00%) 
Hepatic failure  1  2/2312 (0.09%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Hepatitis acute  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Hepatocellular injury  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Hepatorenal syndrome  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Immune system disorders             
Drug hypersensitivity  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Hypersensitivity  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Infections and infestations             
Abdominal abscess  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Abscess  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Acinetobacter infection  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Appendicitis  1  3/2312 (0.13%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Arthritis bacterial  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Atypical mycobacterial infection  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Brain abscess  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Cellulitis  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Clostridium difficile colitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Dermo-hypodermitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
End stage AIDS  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Endocarditis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Enteritis infectious  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  1/93 (1.08%)  0/821 (0.00%)  0/86 (0.00%) 
Erysipelas  1  2/2312 (0.09%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Escherichia sepsis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Extradural abscess  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Gastroenteritis  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  3/821 (0.37%)  0/86 (0.00%) 
Hepatitis B  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Infected dermal cyst  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Infectious pleural effusion  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Listeria sepsis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Lower respiratory tract infection  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Lung abscess  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Lung infection  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Meningitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Neutropenic sepsis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Orchitis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Peritonitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Peritonitis bacterial  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Peritonsillar abscess  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Pneumonia  1  12/2312 (0.52%)  2/496 (0.40%)  1/292 (0.34%)  0/93 (0.00%)  6/821 (0.73%)  0/86 (0.00%) 
Pulmonary sepsis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Pulmonary tuberculosis  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Pyelonephritis  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  5/821 (0.61%)  0/86 (0.00%) 
Pyelonephritis acute  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Sepsis  1  1/2312 (0.04%)  2/496 (0.40%)  1/292 (0.34%)  0/93 (0.00%)  4/821 (0.49%)  0/86 (0.00%) 
Septic arthritis staphylococcal  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Septic shock  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  4/821 (0.49%)  0/86 (0.00%) 
Sinusitis  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Staphylococcal abscess  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Staphylococcal sepsis  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Streptococcal endocarditis  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Subcutaneous abscess  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Tracheobronchitis mycoplasmal  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Tuberculosis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Upper respiratory tract infection  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Urinary tract infection  1  5/2312 (0.22%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Urosepsis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Injury, poisoning and procedural complications             
Alcohol poisoning  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Ankle fracture  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Cervical vertebral fracture  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Craniocerebral injury  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Cystitis radiation  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Facial bones fracture  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Fall  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Femoral neck fracture  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Fractured sacrum  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Head injury  1  0/2312 (0.00%)  1/496 (0.20%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Humerus fracture  1  2/2312 (0.09%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Multiple injuries  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Overdose  1  2/2312 (0.09%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Pneumocephalus  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Road traffic accident  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Skull fractured base  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Spinal fracture  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Subdural haematoma  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Synovial rupture  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
VIIIth nerve injury  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Investigations             
Alpha 1 foetoprotein increased  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Blood creatinine increased  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Blood pressure increased  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Blood urea increased  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Weight decreased  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Metabolism and nutrition disorders             
Cachexia  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Decreased appetite  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Dehydration  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Diabetes mellitus  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Diabetes mellitus inadequate control  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Diabetic ketoacidosis  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Hypokalaemia  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Malnutrition  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Tetany  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Type 1 diabetes mellitus  1  2/2312 (0.09%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Type 2 diabetes mellitus  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Musculoskeletal and connective tissue disorders             
Compartment syndrome  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Muscle haemorrhage  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Muscular weakness  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Musculoskeletal pain  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Neck mass  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Osteitis  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Osteoarthritis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Psoriatic arthropathy  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Rheumatoid arthritis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Sacroiliitis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Anogenital warts  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
B-cell lymphoma recurrent  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Breast cancer  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Cardiac myxoma  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Cholangiocarcinoma  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Diffuse large B-cell lymphoma  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Hepatic cancer  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Hepatic cancer recurrent  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  1/93 (1.08%)  1/821 (0.12%)  0/86 (0.00%) 
Hepatocellular carcinoma  1  7/2312 (0.30%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  5/821 (0.61%)  0/86 (0.00%) 
Lung neoplasm malignant  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Metastases to lung  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Non-hodgkin's lymphoma  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Oesophageal squamous cell carcinoma  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Papillary cystadenoma lymphomatosum  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Papillary thyroid cancer  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Pituitary tumour benign  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Prostate cancer  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Nervous system disorders             
Carotid artery stenosis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Cognitive disorder  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Complex partial seizures  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Diabetic encephalopathy  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Diabetic hyperglycaemic coma  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Dysarthria  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Epilepsy  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Facial paresis  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Haemorrhage intracranial  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Hemiplegia  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Hepatic encephalopathy  1  1/2312 (0.04%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Ischaemic stroke  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Loss of consciousness  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Metabolic encephalopathy  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Occipital neuralgia  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Optic neuritis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  1/86 (1.16%) 
Presyncope  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Sensorimotor disorder  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Subarachnoid haemorrhage  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Syncope  1  0/2312 (0.00%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Toxic leukoencephalopathy  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Transient ischaemic attack  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Wernicke's encephalopathy  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Psychiatric disorders             
Acute psychosis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Alcoholism  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Bipolar disorder  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Confusional state  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Delirium  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Depression  1  5/2312 (0.22%)  2/496 (0.40%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Irritability  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Mental disorder  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Panic attack  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Persecutory delusion  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Restlessness  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Somatoform disorder  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Suicide attempt  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Renal and urinary disorders             
Acute kidney injury  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  5/821 (0.61%)  0/86 (0.00%) 
Calculus ureteric  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Haematuria  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Lupus nephritis  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Renal failure  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  3/821 (0.37%)  1/86 (1.16%) 
Urethral stenosis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Reproductive system and breast disorders             
Menometrorrhagia  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Prostatitis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Acute pulmonary oedema  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Bronchospasm  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Dyspnoea  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  2/821 (0.24%)  0/86 (0.00%) 
Lung infiltration  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Pneumonia aspiration  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Pneumonitis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  1/93 (1.08%)  0/821 (0.00%)  0/86 (0.00%) 
Pulmonary arterial hypertension  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Pulmonary embolism  1  1/2312 (0.04%)  0/496 (0.00%)  1/292 (0.34%)  1/93 (1.08%)  2/821 (0.24%)  0/86 (0.00%) 
Respiratory distress  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis allergic  1  2/2312 (0.09%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Eczema  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Erythema multiforme  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Excessive granulation tissue  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Pruritus  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Psoriasis  1  1/2312 (0.04%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Purpura  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Rash  1  1/2312 (0.04%)  0/496 (0.00%)  2/292 (0.68%)  0/93 (0.00%)  6/821 (0.73%)  1/86 (1.16%) 
Rash generalised  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Toxic skin eruption  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Vascular purpura  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Social circumstances             
Victim of homicide  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Surgical and medical procedures             
Polypectomy  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Vascular disorders             
Aortic aneurysm  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Deep vein thrombosis  1  2/2312 (0.09%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Hypertensive crisis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Peripheral venous disease  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  1/93 (1.08%)  0/821 (0.00%)  0/86 (0.00%) 
Shock haemorrhagic  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Temporal arteritis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  0/93 (0.00%)  1/821 (0.12%)  0/86 (0.00%) 
Venous thrombosis  1  0/2312 (0.00%)  0/496 (0.00%)  0/292 (0.00%)  1/93 (1.08%)  0/821 (0.00%)  0/86 (0.00%) 
Venous thrombosis limb  1  0/2312 (0.00%)  0/496 (0.00%)  1/292 (0.34%)  0/93 (0.00%)  0/821 (0.00%)  0/86 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin Dual Therapy: Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1225/2312 (52.98%)   287/496 (57.86%)   207/292 (70.89%)   79/93 (84.95%)   709/821 (86.36%)   72/86 (83.72%) 
Blood and lymphatic system disorders             
Anaemia  1  435/2312 (18.81%)  141/496 (28.43%)  112/292 (38.36%)  42/93 (45.16%)  351/821 (42.75%)  43/86 (50.00%) 
Neutropenia  1  258/2312 (11.16%)  64/496 (12.90%)  35/292 (11.99%)  25/93 (26.88%)  84/821 (10.23%)  24/86 (27.91%) 
Leukopenia  1  129/2312 (5.58%)  47/496 (9.48%)  8/292 (2.74%)  6/93 (6.45%)  59/821 (7.19%)  31/86 (36.05%) 
Thrombocytopenia  1  138/2312 (5.97%)  26/496 (5.24%)  31/292 (10.62%)  5/93 (5.38%)  94/821 (11.45%)  23/86 (26.74%) 
Gastrointestinal disorders             
Nausea  1  85/2312 (3.68%)  30/496 (6.05%)  36/292 (12.33%)  24/93 (25.81%)  134/821 (16.32%)  11/86 (12.79%) 
Diarrhoea  1  59/2312 (2.55%)  8/496 (1.61%)  17/292 (5.82%)  11/93 (11.83%)  78/821 (9.50%)  4/86 (4.65%) 
Anal pruritus  1  1/2312 (0.04%)  0/496 (0.00%)  0/292 (0.00%)  2/93 (2.15%)  61/821 (7.43%)  4/86 (4.65%) 
Vomiting  1  26/2312 (1.12%)  9/496 (1.81%)  8/292 (2.74%)  5/93 (5.38%)  47/821 (5.72%)  6/86 (6.98%) 
Haemorrhoids  1  9/2312 (0.39%)  1/496 (0.20%)  5/292 (1.71%)  2/93 (2.15%)  47/821 (5.72%)  6/86 (6.98%) 
Abdominal pain  1  32/2312 (1.38%)  2/496 (0.40%)  10/292 (3.42%)  6/93 (6.45%)  39/821 (4.75%)  0/86 (0.00%) 
Dry mouth  1  21/2312 (0.91%)  3/496 (0.60%)  7/292 (2.40%)  4/93 (4.30%)  27/821 (3.29%)  5/86 (5.81%) 
General disorders             
Asthenia  1  236/2312 (10.21%)  72/496 (14.52%)  53/292 (18.15%)  23/93 (24.73%)  245/821 (29.84%)  8/86 (9.30%) 
Fatigue  1  244/2312 (10.55%)  53/496 (10.69%)  68/292 (23.29%)  23/93 (24.73%)  170/821 (20.71%)  13/86 (15.12%) 
Influenza like illness  1  167/2312 (7.22%)  38/496 (7.66%)  31/292 (10.62%)  17/93 (18.28%)  97/821 (11.81%)  7/86 (8.14%) 
Pyrexia  1  147/2312 (6.36%)  45/496 (9.07%)  13/292 (4.45%)  10/93 (10.75%)  33/821 (4.02%)  4/86 (4.65%) 
Investigations             
Weight decreased  1  97/2312 (4.20%)  28/496 (5.65%)  14/292 (4.79%)  9/93 (9.68%)  47/821 (5.72%)  1/86 (1.16%) 
Haemoglobin decreased  1  22/2312 (0.95%)  9/496 (1.81%)  1/292 (0.34%)  0/93 (0.00%)  16/821 (1.95%)  13/86 (15.12%) 
Neutrophil count increased  1  6/2312 (0.26%)  1/496 (0.20%)  0/292 (0.00%)  0/93 (0.00%)  7/821 (0.85%)  5/86 (5.81%) 
Metabolism and nutrition disorders             
Decreased appetite  1  101/2312 (4.37%)  47/496 (9.48%)  25/292 (8.56%)  16/93 (17.20%)  118/821 (14.37%)  8/86 (9.30%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  45/2312 (1.95%)  19/496 (3.83%)  18/292 (6.16%)  6/93 (6.45%)  53/821 (6.46%)  5/86 (5.81%) 
Myalgia  1  76/2312 (3.29%)  19/496 (3.83%)  8/292 (2.74%)  8/93 (8.60%)  53/821 (6.46%)  3/86 (3.49%) 
Nervous system disorders             
Headache  1  102/2312 (4.41%)  39/496 (7.86%)  33/292 (11.30%)  15/93 (16.13%)  94/821 (11.45%)  5/86 (5.81%) 
Dysgeusia  1  13/2312 (0.56%)  5/496 (1.01%)  33/292 (11.30%)  14/93 (15.05%)  40/821 (4.87%)  1/86 (1.16%) 
Dizziness  1  40/2312 (1.73%)  19/496 (3.83%)  9/292 (3.08%)  8/93 (8.60%)  24/821 (2.92%)  2/86 (2.33%) 
Psychiatric disorders             
Insomnia  1  121/2312 (5.23%)  40/496 (8.06%)  18/292 (6.16%)  7/93 (7.53%)  100/821 (12.18%)  4/86 (4.65%) 
Depression  1  82/2312 (3.55%)  32/496 (6.45%)  15/292 (5.14%)  8/93 (8.60%)  70/821 (8.53%)  3/86 (3.49%) 
Irritability  1  48/2312 (2.08%)  7/496 (1.41%)  10/292 (3.42%)  4/93 (4.30%)  49/821 (5.97%)  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  103/2312 (4.46%)  23/496 (4.64%)  23/292 (7.88%)  10/93 (10.75%)  72/821 (8.77%)  1/86 (1.16%) 
Dyspnoea  1  54/2312 (2.34%)  16/496 (3.23%)  18/292 (6.16%)  9/93 (9.68%)  72/821 (8.77%)  4/86 (4.65%) 
Oropharyngeal pain  1  10/2312 (0.43%)  4/496 (0.81%)  5/292 (1.71%)  5/93 (5.38%)  9/821 (1.10%)  0/86 (0.00%) 
Skin and subcutaneous tissue disorders             
Pruritus  1  160/2312 (6.92%)  55/496 (11.09%)  37/292 (12.67%)  16/93 (17.20%)  240/821 (29.23%)  10/86 (11.63%) 
Rash  1  85/2312 (3.68%)  25/496 (5.04%)  24/292 (8.22%)  9/93 (9.68%)  155/821 (18.88%)  9/86 (10.47%) 
Dry skin  1  51/2312 (2.21%)  11/496 (2.22%)  22/292 (7.53%)  10/93 (10.75%)  66/821 (8.04%)  3/86 (3.49%) 
Alopecia  1  69/2312 (2.98%)  20/496 (4.03%)  14/292 (4.79%)  10/93 (10.75%)  51/821 (6.21%)  2/86 (2.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01447446     History of Changes
Other Study ID Numbers: MV25599
First Submitted: October 4, 2011
First Posted: October 6, 2011
Results First Submitted: September 27, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017