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Trial record 25 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype (CONCISE)

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ClinicalTrials.gov Identifier: NCT01459913
Recruitment Status : Terminated (The study was terminated early by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.)
First Posted : October 26, 2011
Results First Posted : February 11, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Telaprevir
Drug: Pegylated Interferon Alfa-2a
Drug: Ribavirin
Enrollment 239
Recruitment Details  
Pre-assignment Details Subjects received telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a)/ ribavirin (RBV). Planned duration of telaprevir treatment was 12 weeks. Minimum planned duration of Peg-IFN-alfa-2a/RBV treatment was 12 weeks; however, was dependent on virologic response during initial 12 weeks of telaprevir plus Peg-IFN-alfa-2a/RBV.
Arm/Group Title Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Hide Arm/Group Description Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
Period Title: Overall Study
Started 106 52 19 62
Completed 65 32 6 29
Not Completed 41 20 13 33
Reason Not Completed
Adverse Event             0             0             0             3
Withdrawal by Subject             4             0             0             5
Lost to Follow-up             7             4             1             8
Death             0             0             0             1
Non- Compliance             0             0             0             3
Physician Decision             0             1             0             0
Study Terminated by Sponsor             30             15             9             11
Other             0             0             3             1
Did Not Meet Inclusion Criteria             0             0             0             1
Arm/Group Title Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) Total
Hide Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned. Total of all reporting groups
Overall Number of Baseline Participants 106 52 19 61 238
Hide Baseline Analysis Population Description
Full Analysis (FA) Set included all subjects who received at least 1 dose of study drug and fulfilled all relevant inclusion criteria. One subject from “Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)” was excluded from the FA Set due to having HCV Genotype 6.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 52 participants 19 participants 61 participants 238 participants
46.1  (12.82) 44.8  (12.89) 54.4  (8.70) 49.8  (10.56) 47.4  (12.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 52 participants 19 participants 61 participants 238 participants
Female
39
  36.8%
16
  30.8%
11
  57.9%
29
  47.5%
95
  39.9%
Male
67
  63.2%
36
  69.2%
8
  42.1%
32
  52.5%
143
  60.1%
1.Primary Outcome
Title Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
Hide Description SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
Time Frame 12 weeks after last planned dose of study drug (up to Week 36)
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Hide Analysis Population Description
Full Analysis (FA) Set.
Arm/Group Title Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Overall Number of Participants Analyzed 106 52
Measure Type: Number
Unit of Measure: percentage of participants
88.7 96.2
2.Secondary Outcome
Title Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
Hide Description SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
Time Frame 4 weeks after last planned dose of study drug (up to Week 28)
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Overall Number of Participants Analyzed 106 52
Measure Type: Number
Unit of Measure: percentage of participants
89.6 98.1
3.Secondary Outcome
Title Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
Hide Description SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
Time Frame 24 weeks after last planned dose of study drug (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Overall Number of Participants Analyzed 106 52
Measure Type: Number
Unit of Measure: percentage of participants
85.8 92.3
4.Secondary Outcome
Title Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
Hide Description SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to ‘Study Terminated by the Sponsor’ are excluded from this analysis.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Overall Number of Participants Analyzed 76 37
Measure Type: Number
Unit of Measure: percentage of participants
72.4 86.5
5.Secondary Outcome
Title Percentage of Subjects With Viral Relapse
Hide Description Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
Time Frame After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Overall Number of Participants Analyzed 106 52
Measure Type: Number
Unit of Measure: percentage of participants
4 Weeks 1.9 0.0
12 Weeks 7.5 0.0
24 Weeks 10.4 0.0
6.Secondary Outcome
Title Percentage of Subjects With On-Treatment Virologic Failure
Hide Description On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, up to 48 weeks.
Overall Number of Participants Analyzed 106 52 19 61 238
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 3.3 0.8
7.Secondary Outcome
Title Number of Subjects With Rapid Viral Response (RVR)
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Overall Number of Participants Analyzed 106 52
Measure Type: Number
Unit of Measure: participants
106 52
8.Secondary Outcome
Title Number of Subjects With Extended Rapid Viral Response (eRVR)
Hide Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FA Set.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Overall Number of Participants Analyzed 106 52
Measure Type: Number
Unit of Measure: participants
105 51
9.Secondary Outcome
Title Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents administered during the course of the study.
Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set included all subjects who received at least 1 dose of study drug.
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Hide Arm/Group Description:
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
Overall Number of Participants Analyzed 106 52 19 62
Measure Type: Number
Unit of Measure: participants
AEs 104 51 19 61
SAEs 5 4 3 13
Time Frame Baseline up to Week 48
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Hide Arm/Group Description Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
All-Cause Mortality
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/106 (4.72%)   4/52 (7.69%)   3/19 (15.79%)   13/62 (20.97%) 
Blood and lymphatic system disorders         
Anaemia  1  2/106 (1.89%)  3/52 (5.77%)  2/19 (10.53%)  7/62 (11.29%) 
Gastrointestinal disorders         
Colitis microscopic  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pancreatitis  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Pancreatitis chronic  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
General disorders         
Asthenia  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Chest pain  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Fatigue  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Pyrexia  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Infections and infestations         
Abscess oral  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Bacteraemia  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Perirectal abscess  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Pneumonia  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  3/62 (4.84%) 
Injury, poisoning and procedural complications         
Alcohol poisoning  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Nervous system disorders         
Syncope  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Psychiatric disorders         
Anxiety  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders         
Hypoxia  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Pulmonary embolism  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders         
Drug reaction with eosinophilia and systemic symptoms  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Vascular disorders         
Deep vein thrombosis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hypotension  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Thrombosis  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   104/106 (98.11%)   51/52 (98.08%)   19/19 (100.00%)   61/62 (98.39%) 
Blood and lymphatic system disorders         
Anaemia  1  42/106 (39.62%)  22/52 (42.31%)  10/19 (52.63%)  20/62 (32.26%) 
Neutropenia  1  5/106 (4.72%)  4/52 (7.69%)  4/19 (21.05%)  1/62 (1.61%) 
Leukopenia  1  1/106 (0.94%)  2/52 (3.85%)  0/19 (0.00%)  2/62 (3.23%) 
Lymphopenia  1  2/106 (1.89%)  1/52 (1.92%)  1/19 (5.26%)  1/62 (1.61%) 
Thrombocytopenia  1  3/106 (2.83%)  0/52 (0.00%)  1/19 (5.26%)  1/62 (1.61%) 
Lymphadenopathy  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Increased tendency to bruise  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Pancytopenia  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Cardiac disorders         
Palpitations  1  3/106 (2.83%)  1/52 (1.92%)  2/19 (10.53%)  2/62 (3.23%) 
Tachycardia  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  3/62 (4.84%) 
Arrhythmia supraventricular  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Atrial fibrillation  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Sinus bradycardia  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Supraventricular extrasystoles  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  4/106 (3.77%)  2/52 (3.85%)  0/19 (0.00%)  4/62 (6.45%) 
Tinnitus  1  2/106 (1.89%)  1/52 (1.92%)  0/19 (0.00%)  2/62 (3.23%) 
Ear pruritus  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Ear discomfort  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Ear pain  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hyperacusis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hypoacusis  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Otorrhoea  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Endocrine disorders         
Hypothyroidism  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Eye disorders         
Vision blurred  1  8/106 (7.55%)  2/52 (3.85%)  3/19 (15.79%)  2/62 (3.23%) 
Photophobia  1  6/106 (5.66%)  3/52 (5.77%)  0/19 (0.00%)  0/62 (0.00%) 
Dry eye  1  4/106 (3.77%)  0/52 (0.00%)  0/19 (0.00%)  4/62 (6.45%) 
Eye pruritus  1  3/106 (2.83%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Ocular hyperaemia  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Visual impairment  1  0/106 (0.00%)  2/52 (3.85%)  0/19 (0.00%)  1/62 (1.61%) 
Diplopia  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Eye irritation  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Eye pain  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Retinal exudates  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Abnormal sensation in eye  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Conjunctival haemorrhage  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Conjunctivitis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Eye haemorrhage  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Eyelid oedema  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Ocular discomfort  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Periorbital oedema  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Retinal haemorrhage  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Retinopathy  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Vitreous floaters  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Gastrointestinal disorders         
Nausea  1  49/106 (46.23%)  19/52 (36.54%)  13/19 (68.42%)  33/62 (53.23%) 
Diarrhoea  1  19/106 (17.92%)  6/52 (11.54%)  6/19 (31.58%)  11/62 (17.74%) 
Vomiting  1  17/106 (16.04%)  6/52 (11.54%)  6/19 (31.58%)  11/62 (17.74%) 
Anorectal discomfort  1  22/106 (20.75%)  9/52 (17.31%)  3/19 (15.79%)  5/62 (8.06%) 
Anal pruritus  1  10/106 (9.43%)  8/52 (15.38%)  3/19 (15.79%)  4/62 (6.45%) 
Haemorrhoids  1  8/106 (7.55%)  4/52 (7.69%)  1/19 (5.26%)  6/62 (9.68%) 
Dry mouth  1  5/106 (4.72%)  3/52 (5.77%)  3/19 (15.79%)  7/62 (11.29%) 
Dyspepsia  1  9/106 (8.49%)  2/52 (3.85%)  1/19 (5.26%)  3/62 (4.84%) 
Proctalgia  1  5/106 (4.72%)  4/52 (7.69%)  0/19 (0.00%)  3/62 (4.84%) 
Constipation  1  4/106 (3.77%)  1/52 (1.92%)  3/19 (15.79%)  3/62 (4.84%) 
Abdominal pain upper  1  3/106 (2.83%)  0/52 (0.00%)  0/19 (0.00%)  5/62 (8.06%) 
Abdominal pain  1  3/106 (2.83%)  2/52 (3.85%)  0/19 (0.00%)  1/62 (1.61%) 
Aphthous stomatitis  1  2/106 (1.89%)  2/52 (3.85%)  0/19 (0.00%)  1/62 (1.61%) 
Cheilitis  1  2/106 (1.89%)  2/52 (3.85%)  0/19 (0.00%)  0/62 (0.00%) 
Flatulence  1  3/106 (2.83%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Gastrooesophageal reflux disease  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  4/62 (6.45%) 
Haematochezia  1  2/106 (1.89%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Rectal haemorrhage  1  0/106 (0.00%)  2/52 (3.85%)  1/19 (5.26%)  1/62 (1.61%) 
Stomatitis  1  2/106 (1.89%)  1/52 (1.92%)  1/19 (5.26%)  0/62 (0.00%) 
Abdominal discomfort  1  3/106 (2.83%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Abdominal distension  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  2/62 (3.23%) 
Gingival bleeding  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Toothache  1  1/106 (0.94%)  1/52 (1.92%)  1/19 (5.26%)  0/62 (0.00%) 
Anal haemorrhage  1  0/106 (0.00%)  1/52 (1.92%)  1/19 (5.26%)  0/62 (0.00%) 
Epigastric discomfort  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Glossodynia  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Oral pain  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Proctitis  1  1/106 (0.94%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Retching  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Abdominal pain lower  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Abdominal tenderness  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Anal fissure  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Ascites  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Bowel movement irregularity  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Duodenal ulcer  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Eructation  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Faeces pale  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Frequent bowel movements  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Gastrointestinal motility disorder  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Gingival pain  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Glossitis  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Haemorrhoidal haemorrhage  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hyperchlorhydria  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Lip dry  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Lip pain  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Oral discomfort  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Oral disorder  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Perianal erythema  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Sensitivity of teeth  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Steatorrhoea  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Swollen tongue  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Tongue coated  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Tongue disorder  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Tooth impacted  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
General disorders         
Fatigue  1  55/106 (51.89%)  25/52 (48.08%)  12/19 (63.16%)  26/62 (41.94%) 
Pyrexia  1  26/106 (24.53%)  13/52 (25.00%)  4/19 (21.05%)  15/62 (24.19%) 
Influenza like illness  1  28/106 (26.42%)  10/52 (19.23%)  8/19 (42.11%)  9/62 (14.52%) 
Asthenia  1  14/106 (13.21%)  8/52 (15.38%)  3/19 (15.79%)  13/62 (20.97%) 
Irritability  1  9/106 (8.49%)  7/52 (13.46%)  2/19 (10.53%)  9/62 (14.52%) 
Chills  1  6/106 (5.66%)  6/52 (11.54%)  0/19 (0.00%)  9/62 (14.52%) 
Injection site erythema  1  5/106 (4.72%)  4/52 (7.69%)  0/19 (0.00%)  3/62 (4.84%) 
Pain  1  5/106 (4.72%)  3/52 (5.77%)  1/19 (5.26%)  3/62 (4.84%) 
Malaise  1  0/106 (0.00%)  1/52 (1.92%)  1/19 (5.26%)  5/62 (8.06%) 
Oedema peripheral  1  1/106 (0.94%)  4/52 (7.69%)  1/19 (5.26%)  1/62 (1.61%) 
Chest pain  1  2/106 (1.89%)  2/52 (3.85%)  1/19 (5.26%)  0/62 (0.00%) 
Injection site reaction  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  4/62 (6.45%) 
Injection site rash  1  1/106 (0.94%)  2/52 (3.85%)  0/19 (0.00%)  2/62 (3.23%) 
Chest discomfort  1  0/106 (0.00%)  4/52 (7.69%)  0/19 (0.00%)  0/62 (0.00%) 
Injection site pruritus  1  1/106 (0.94%)  2/52 (3.85%)  1/19 (5.26%)  0/62 (0.00%) 
Local swelling  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Thirst  1  1/106 (0.94%)  0/52 (0.00%)  1/19 (5.26%)  1/62 (1.61%) 
Feeling abnormal  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Injection site bruising  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Enanthema  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Feeling cold  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Feeling hot  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Injection site pain  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Non-cardiac chest pain  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Temperature intolerance  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Periportal oedema  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Immune system disorders         
Seasonal allergy  1  0/106 (0.00%)  4/52 (7.69%)  0/19 (0.00%)  0/62 (0.00%) 
Infections and infestations         
Urinary tract infection  1  5/106 (4.72%)  1/52 (1.92%)  2/19 (10.53%)  3/62 (4.84%) 
Nasopharyngitis  1  2/106 (1.89%)  1/52 (1.92%)  1/19 (5.26%)  2/62 (3.23%) 
Pneumonia  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Upper respiratory tract infection  1  0/106 (0.00%)  3/52 (5.77%)  1/19 (5.26%)  0/62 (0.00%) 
Cellulitis  1  0/106 (0.00%)  3/52 (5.77%)  0/19 (0.00%)  0/62 (0.00%) 
Ear infection  1  1/106 (0.94%)  2/52 (3.85%)  0/19 (0.00%)  0/62 (0.00%) 
Oral herpes  1  3/106 (2.83%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Cystitis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Influenza  1  1/106 (0.94%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Sinusitis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Skin infection  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Tooth abscess  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Vulvovaginal candidiasis  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Bronchitis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Candida infection  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Dermatitis infected  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Folliculitis  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Genital herpes  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Gingivitis  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Herpes pharyngitis  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Parotitis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Rash pustular  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Rhinitis  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Scrotal abscess  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Subcutaneous abscess  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Tinea cruris  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Tooth infection  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Vulvovaginal mycotic infection  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Laceration  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Scratch  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Arthropod bite  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Excoriation  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Procedural pain  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Investigations         
Weight decreased  1  8/106 (7.55%)  2/52 (3.85%)  2/19 (10.53%)  4/62 (6.45%) 
Lymphocyte count decreased  1  3/106 (2.83%)  1/52 (1.92%)  1/19 (5.26%)  1/62 (1.61%) 
Blood uric acid increased  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  3/62 (4.84%) 
Blood pressure increased  1  1/106 (0.94%)  0/52 (0.00%)  1/19 (5.26%)  1/62 (1.61%) 
Haemoglobin decreased  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Platelet count decreased  1  1/106 (0.94%)  0/52 (0.00%)  2/19 (10.53%)  0/62 (0.00%) 
Amylase increased  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Blood potassium decreased  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Blood thyroid stimulating hormone increased  1  1/106 (0.94%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Blood urine present  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Neutrophil count decreased  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Transaminases increased  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
White blood cell count decreased  1  1/106 (0.94%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Alanine aminotransferase increased  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Aspartate aminotransferase increased  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Blood alkaline phosphatase increased  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Blood calcium decreased  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Blood creatinine increased  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Body temperature increased  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Electrocardiogram QT prolonged  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Electrocardiogram ST-T change  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Eosinophil count increased  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Haematocrit decreased  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Haemoglobin increased  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Lipase increased  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Liver function test abnormal  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Red blood cell count decreased  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Respiratory rate increased  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Metabolism and nutrition disorders         
Decreased appetite  1  21/106 (19.81%)  6/52 (11.54%)  4/19 (21.05%)  10/62 (16.13%) 
Dehydration  1  3/106 (2.83%)  1/52 (1.92%)  0/19 (0.00%)  2/62 (3.23%) 
Hyponatraemia  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Abnormal loss of weight  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Gout  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Hyperuricaemia  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Hypocalcaemia  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Hypokalaemia  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Hypomagnesaemia  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  9/106 (8.49%)  7/52 (13.46%)  2/19 (10.53%)  8/62 (12.90%) 
Myalgia  1  6/106 (5.66%)  7/52 (13.46%)  0/19 (0.00%)  11/62 (17.74%) 
Back pain  1  6/106 (5.66%)  2/52 (3.85%)  0/19 (0.00%)  4/62 (6.45%) 
Muscle spasms  1  3/106 (2.83%)  4/52 (7.69%)  0/19 (0.00%)  1/62 (1.61%) 
Pain in extremity  1  2/106 (1.89%)  2/52 (3.85%)  1/19 (5.26%)  3/62 (4.84%) 
Joint swelling  1  1/106 (0.94%)  2/52 (3.85%)  0/19 (0.00%)  1/62 (1.61%) 
Muscular weakness  1  1/106 (0.94%)  1/52 (1.92%)  2/19 (10.53%)  0/62 (0.00%) 
Musculoskeletal pain  1  2/106 (1.89%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Bone pain  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Neck pain  1  3/106 (2.83%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Musculoskeletal chest pain  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Costochondritis  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Joint stiffness  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Musculoskeletal discomfort  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Musculoskeletal stiffness  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Plantar fasciitis  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Spinal pain  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant melanoma  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Melanocytic naevus  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Nervous system disorders         
Headache  1  30/106 (28.30%)  16/52 (30.77%)  5/19 (26.32%)  17/62 (27.42%) 
Dizziness  1  17/106 (16.04%)  6/52 (11.54%)  6/19 (31.58%)  14/62 (22.58%) 
Dysgeusia  1  13/106 (12.26%)  2/52 (3.85%)  2/19 (10.53%)  5/62 (8.06%) 
Hypoaesthesia  1  2/106 (1.89%)  5/52 (9.62%)  0/19 (0.00%)  1/62 (1.61%) 
Migraine  1  2/106 (1.89%)  3/52 (5.77%)  1/19 (5.26%)  1/62 (1.61%) 
Disturbance in attention  1  3/106 (2.83%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Memory impairment  1  3/106 (2.83%)  2/52 (3.85%)  0/19 (0.00%)  0/62 (0.00%) 
Hyperaesthesia  1  1/106 (0.94%)  1/52 (1.92%)  1/19 (5.26%)  0/62 (0.00%) 
Paraesthesia  1  2/106 (1.89%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Somnolence  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Syncope  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Lethargy  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Burning sensation  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Carpal tunnel syndrome  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Cognitive disorder  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Dizziness exertional  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Drooling  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Mental impairment  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Neuropathy peripheral  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Parosmia  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Sciatica  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Tremor  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Psychiatric disorders         
Insomnia  1  22/106 (20.75%)  11/52 (21.15%)  6/19 (31.58%)  12/62 (19.35%) 
Depression  1  12/106 (11.32%)  8/52 (15.38%)  4/19 (21.05%)  10/62 (16.13%) 
Anxiety  1  6/106 (5.66%)  2/52 (3.85%)  2/19 (10.53%)  3/62 (4.84%) 
Depressed mood  1  4/106 (3.77%)  2/52 (3.85%)  0/19 (0.00%)  0/62 (0.00%) 
Mood swings  1  2/106 (1.89%)  2/52 (3.85%)  0/19 (0.00%)  1/62 (1.61%) 
Affect lability  1  2/106 (1.89%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Agitation  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Anger  1  1/106 (0.94%)  2/52 (3.85%)  0/19 (0.00%)  0/62 (0.00%) 
Mood altered  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Sleep disorder  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Apathy  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Drug dependence  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Emotional disorder  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Initial insomnia  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Nervousness  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Restlessness  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Aggression  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Confusional state  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Disorientation  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Libido decreased  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Loss of libido  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Personality disorder  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Suicide attempt  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Renal and urinary disorders         
Urinary retention  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Dysuria  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Reproductive system and breast disorders         
Menorrhagia  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Metrorrhagia  1  0/106 (0.00%)  2/52 (3.85%)  0/19 (0.00%)  0/62 (0.00%) 
Amenorrhoea  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Erectile dysfunction  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Menstrual disorder  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pruritus genital  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Scrotal erythema  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Scrotal pain  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  18/106 (16.98%)  11/52 (21.15%)  5/19 (26.32%)  9/62 (14.52%) 
Cough  1  9/106 (8.49%)  5/52 (9.62%)  0/19 (0.00%)  9/62 (14.52%) 
Oropharyngeal pain  1  7/106 (6.60%)  1/52 (1.92%)  1/19 (5.26%)  2/62 (3.23%) 
Dyspnoea exertional  1  5/106 (4.72%)  0/52 (0.00%)  1/19 (5.26%)  3/62 (4.84%) 
Epistaxis  1  3/106 (2.83%)  1/52 (1.92%)  1/19 (5.26%)  3/62 (4.84%) 
Nasal congestion  1  0/106 (0.00%)  1/52 (1.92%)  2/19 (10.53%)  0/62 (0.00%) 
Rhinorrhoea  1  1/106 (0.94%)  1/52 (1.92%)  1/19 (5.26%)  0/62 (0.00%) 
Productive cough  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Respiratory tract congestion  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Sinus congestion  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Sneezing  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Dysphonia  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Hiccups  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Nasal discomfort  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Nasal disorder  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Nasal dryness  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Nasal inflammation  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Nasal mucosal disorder  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Oropharyngeal discomfort  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Painful respiration  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Paranasal sinus discomfort  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Pharyngeal oedema  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Rales  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Respiration abnormal  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  44/106 (41.51%)  17/52 (32.69%)  8/19 (42.11%)  24/62 (38.71%) 
Rash  1  31/106 (29.25%)  15/52 (28.85%)  9/19 (47.37%)  13/62 (20.97%) 
Alopecia  1  13/106 (12.26%)  11/52 (21.15%)  4/19 (21.05%)  7/62 (11.29%) 
Dry skin  1  11/106 (10.38%)  11/52 (21.15%)  6/19 (31.58%)  4/62 (6.45%) 
Pruritus generalised  1  4/106 (3.77%)  3/52 (5.77%)  3/19 (15.79%)  3/62 (4.84%) 
Rash maculo-papular  1  5/106 (4.72%)  2/52 (3.85%)  3/19 (15.79%)  3/62 (4.84%) 
Rash papular  1  5/106 (4.72%)  1/52 (1.92%)  4/19 (21.05%)  3/62 (4.84%) 
Rash erythematous  1  4/106 (3.77%)  1/52 (1.92%)  2/19 (10.53%)  4/62 (6.45%) 
Rash pruritic  1  2/106 (1.89%)  2/52 (3.85%)  2/19 (10.53%)  1/62 (1.61%) 
Dermatitis  1  1/106 (0.94%)  2/52 (3.85%)  0/19 (0.00%)  2/62 (3.23%) 
Rash generalised  1  1/106 (0.94%)  2/52 (3.85%)  1/19 (5.26%)  1/62 (1.61%) 
Swelling face  1  2/106 (1.89%)  0/52 (0.00%)  2/19 (10.53%)  1/62 (1.61%) 
Erythema  1  1/106 (0.94%)  1/52 (1.92%)  1/19 (5.26%)  1/62 (1.61%) 
Night sweats  1  2/106 (1.89%)  1/52 (1.92%)  0/19 (0.00%)  1/62 (1.61%) 
Psoriasis  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Eczema  1  2/106 (1.89%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Rash macular  1  2/106 (1.89%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Skin irritation  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Urticaria  1  1/106 (0.94%)  1/52 (1.92%)  1/19 (5.26%)  0/62 (0.00%) 
Drug eruption  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Drug reaction with eosinophilia and systemic symptoms  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hyperhidrosis  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Blister  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Dermatitis acneiform  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Hair growth abnormal  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hair texture abnormal  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Onychoclasis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Pain of skin  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Photosensitivity reaction  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Purpura  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Rash follicular  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Rash vesicular  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Scab  1  0/106 (0.00%)  0/52 (0.00%)  1/19 (5.26%)  0/62 (0.00%) 
Seborrhoea  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Seborrhoeic dermatitis  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Skin burning sensation  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Skin exfoliation  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Skin fragility  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Skin lesion  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Stasis dermatitis  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Telangiectasia  1  0/106 (0.00%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Vascular disorders         
Hypotension  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Pallor  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Circulatory collapse  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  2/62 (3.23%) 
Hot flush  1  2/106 (1.89%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Hypertension  1  1/106 (0.94%)  1/52 (1.92%)  0/19 (0.00%)  0/62 (0.00%) 
Orthostatic hypotension  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Haematoma  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Orthostatic hypertension  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Peripheral coldness  1  1/106 (0.94%)  0/52 (0.00%)  0/19 (0.00%)  0/62 (0.00%) 
Vascular pain  1  0/106 (0.00%)  0/52 (0.00%)  0/19 (0.00%)  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
The study was terminated early at the primary efficacy endpoint (SVR12), by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.
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.
PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Monitor
Organization: Vertex Pharmaceuticals Incorporated
Phone: 617-341-6777
EMail: medicalinfo@vrtx.com
Layout table for additonal information
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01459913     History of Changes
Other Study ID Numbers: VX11-950-114
First Submitted: October 24, 2011
First Posted: October 26, 2011
Results First Submitted: January 26, 2015
Results First Posted: February 11, 2015
Last Update Posted: June 10, 2015