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A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT01995071
Collaborator
(none)
89
Enrollment
12
Arms
19
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1 Non-cirrhotic

ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Drug: ABT-493
Tablet
Other Names:
  • glecaprevir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 2 Non-cirrhotic

    ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 3 Non-cirrhotic

    ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 4 Non-cirrhotic

    ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 5 Compensated cirrhotic

    ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 6 Non-cirrhotic

    ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 7 Non-cirrhotic

    ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 8 Non-cirrhotic

    ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 9 Non-cirrhotic

    ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 10 Compensated cirrhotic

    ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 11 Non-cirrhotic

    ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet
    Experimental: Arm 12 Non-cirrhotic

    ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir

    • Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK

    • Drug: Ribavirin (RBV)
    Tablet

    Outcome Measures

    Primary Outcome Measures

    1. Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment [Day 1 through prior to first dose of the combination regimen on Study Day 4]

      Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1.

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [12 weeks after last actual dose of combination study drug]

      SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of combination study drug.

    2. Percentage of Participants With On-treatment Virologic Failure [Up to 87 days]

      On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment.

    3. Percentage of Participants With Post-treatment Relapse [From the end of treatment through 12 weeks after the last dose of combination study drug]

      Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Chronic HCV infection prior to study enrollment.

    • Screening laboratory result indicating HCV genotype 1-infection.

    • Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

    • Per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis.

    Exclusion Criteria:

    • History of severe, life-threatening or other significant sensitivity to any drug.

    • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus antibody (HIV Ab).

    • Prior therapy for the treatment of HCV.

    • Any current or past clinical evidence of Child Pugh B or C classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.

    • Any cause of liver disease other than chronic HCV infection.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01995071
    Other Study ID Numbers:
    • M13-595
    First Posted:
    Nov 26, 2013
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by AbbVie
    Chronic Hepatitis C
    Cirrhosis
    Child Pugh A
    Hepatitis C virus
    Compensated Cirrhosis
    Hepatitis C Genotype 1
    Hepatitis C
    Interferon-Free
    Cirrhotic
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Hepatitis, Chronic
    Liver Cirrhosis
    Fibrosis
    Ribavirin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic Arm 12 Non-cirrhotic
    Arm/Group Description ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Period Title: Overall Study
    STARTED 8 8 9 8 8 8 8 8 8 8 8 0
    COMPLETED 7 8 8 8 7 8 7 6 7 8 7 0
    NOT COMPLETED 1 0 1 0 1 0 1 2 1 0 1 0

    Baseline Characteristics

    Arm/Group Title Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic Arm 12 Non-cirrhotic Total
    Arm/Group Description ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks Total of all reporting groups
    Overall Participants 8 8 9 8 8 8 8 8 8 8 8 0 89
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53.8
    (5.20)
    55.8
    (9.53)
    50.3
    (9.04)
    52.6
    (6.37)
    58.6
    (6.14)
    53.9
    (9.34)
    50.6
    (12.60)
    49.4
    (15.31)
    60.5
    (5.61)
    55.3
    (9.63)
    54.6
    (5.15)
    54.1
    (9.17)
    Sex: Female, Male (Count of Participants)
    Female
    3
    37.5%
    2
    25%
    0
    0%
    3
    37.5%
    1
    12.5%
    3
    37.5%
    0
    0%
    2
    25%
    2
    25%
    3
    37.5%
    4
    50%
    23
    Infinity
    Male
    5
    62.5%
    6
    75%
    9
    100%
    5
    62.5%
    7
    87.5%
    5
    62.5%
    8
    100%
    6
    75%
    6
    75%
    5
    62.5%
    4
    50%
    66
    Infinity

    Outcome Measures

    1. Primary Outcome
    Title Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment
    Description Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1.
    Time Frame Day 1 through prior to first dose of the combination regimen on Study Day 4

    Outcome Measure Data

    Analysis Population Description
    Monotherapy Analysis Sets for Substudy 1 (Arms 1-5, 11) and SubStudy 2 (Arms 6-10, 12) are defined as all participants who received at least 1 dose of monotherapy and have a baseline and at least 1 postbaseline measurement of HCV RNA during monotherapy. Data for subjects who received the same treatment (Arms 4+5; Arms 7+10) were analyzed together.
    Arm/Group Title Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic + Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic + Arm 10 Compensated Cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 11 Non-cirrhotic Arm 12 Non-cirrhotic
    Arm/Group Description ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose D or Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose B or Dose E (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Measure Participants 8 8 9 16 8 16 8 8 8 0
    Mean (Standard Deviation) [Log10 IU/mL]
    -4.11
    (0.47)
    -4.02
    (0.66)
    -4.31
    (0.26)
    -4.06
    (0.56)
    -3.38
    (0.77)
    -4.21
    (0.42)
    -4.25
    (0.49)
    -4.08
    (0.45)
    -3.79
    (1.21)
    2. Secondary Outcome
    Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
    Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of combination study drug.
    Time Frame 12 weeks after last actual dose of combination study drug

    Outcome Measure Data

    Analysis Population Description
    Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV; participants with missing data after backwards imputation were counted as nonresponders.
    Arm/Group Title Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic Arm 12 Non-cirrhotic
    Arm/Group Description ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Measure Participants 8 8 8 8 8 8 8 8 8 8 8 0
    Number [percentage of participants]
    87.5
    1093.8%
    100
    1250%
    87.5
    972.2%
    100
    1250%
    100
    1250%
    100
    1250%
    87.5
    1093.8%
    87.5
    1093.8%
    100
    1250%
    100
    1250%
    100
    1250%
    3. Secondary Outcome
    Title Percentage of Participants With On-treatment Virologic Failure
    Description On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment.
    Time Frame Up to 87 days

    Outcome Measure Data

    Analysis Population Description
    Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV.
    Arm/Group Title Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic Arm 12 Non-cirrhotic
    Arm/Group Description ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Measure Participants 8 8 8 8 8 8 8 8 8 8 8 0
    Number (95% Confidence Interval) [participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    12.5
    156.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4. Secondary Outcome
    Title Percentage of Participants With Post-treatment Relapse
    Description Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment.
    Time Frame From the end of treatment through 12 weeks after the last dose of combination study drug

    Outcome Measure Data

    Analysis Population Description
    Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.
    Arm/Group Title Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic Arm 12 Non-cirrhotic
    Arm/Group Description ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Measure Participants 7 7 8 8 8 8 7 6 8 8 8 0
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16.5 weeks).
    Adverse Event Reporting Description TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
    Arm/Group Title Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic
    Arm/Group Description ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    All Cause Mortality
    Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    Hepatobiliary disorders
    CHOLECYSTITIS ACUTE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Psychiatric disorders
    MANIA 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Renal and urinary disorders
    RENAL FAILURE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    Respiratory, thoracic and mediastinal disorders
    PNEUMONITIS 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Other (Not Including Serious) Adverse Events
    Arm 1 Non-cirrhotic Arm 2 Non-cirrhotic Arm 3 Non-cirrhotic Arm 4 Non-cirrhotic Arm 5 Compensated Cirrhotic Arm 6 Non-cirrhotic Arm 7 Non-cirrhotic Arm 8 Non-cirrhotic Arm 9 Non-cirrhotic Arm 10 Compensated Cirrhotic Arm 11 Non-cirrhotic
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/8 (100%) 7/8 (87.5%) 7/9 (77.8%) 8/8 (100%) 7/8 (87.5%) 7/8 (87.5%) 8/8 (100%) 4/8 (50%) 5/8 (62.5%) 7/8 (87.5%) 7/8 (87.5%)
    Blood and lymphatic system disorders
    ANAEMIA 2/8 (25%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%)
    ANAEMIA MACROCYTIC 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    LEUKOCYTOSIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    THROMBOCYTOPENIA 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Cardiac disorders
    PALPITATIONS 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%)
    Ear and labyrinth disorders
    EAR PAIN 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    TINNITUS 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    VERTIGO 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    Eye disorders
    DRY EYE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    VISION BLURRED 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT 1/8 (12.5%) 1/8 (12.5%) 1/9 (11.1%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    ABDOMINAL DISTENSION 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    ABDOMINAL PAIN 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    ABDOMINAL PAIN UPPER 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    CHEILITIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    CONSTIPATION 1/8 (12.5%) 2/8 (25%) 0/9 (0%) 2/8 (25%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    DENTAL CARIES 0/8 (0%) 1/8 (12.5%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    DIARRHOEA 2/8 (25%) 2/8 (25%) 1/9 (11.1%) 2/8 (25%) 1/8 (12.5%) 1/8 (12.5%) 2/8 (25%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    DRY MOUTH 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    DYSPEPSIA 1/8 (12.5%) 1/8 (12.5%) 0/9 (0%) 1/8 (12.5%) 3/8 (37.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    FAECAL VOLUME INCREASED 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    FAECES DISCOLOURED 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    FLATULENCE 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    GASTROOESOPHAGEAL REFLUX DISEASE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    GINGIVAL PAIN 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    GINGIVAL RECESSION 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    HAEMATEMESIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    HAEMORRHOIDS 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    NAUSEA 2/8 (25%) 0/8 (0%) 1/9 (11.1%) 2/8 (25%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 2/8 (25%) 1/8 (12.5%)
    STOMATITIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    TOOTHACHE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    VOMITING 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%)
    General disorders
    ASTHENIA 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    CHEST DISCOMFORT 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    CHEST PAIN 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    CHILLS 1/8 (12.5%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    DISCOMFORT 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    DRUG WITHDRAWAL SYNDROME 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    FATIGUE 4/8 (50%) 2/8 (25%) 2/9 (22.2%) 5/8 (62.5%) 2/8 (25%) 3/8 (37.5%) 2/8 (25%) 0/8 (0%) 3/8 (37.5%) 2/8 (25%) 1/8 (12.5%)
    FEELING ABNORMAL 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    INFLUENZA LIKE ILLNESS 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    NON-CARDIAC CHEST PAIN 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    OEDEMA PERIPHERAL 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    PAIN 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    PERIPHERAL SWELLING 0/8 (0%) 2/8 (25%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    PYREXIA 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    SECRETION DISCHARGE 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    THIRST 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    Hepatobiliary disorders
    CHOLELITHIASIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Immune system disorders
    DRUG HYPERSENSITIVITY 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    SEASONAL ALLERGY 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Infections and infestations
    BRONCHITIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    BURSITIS INFECTIVE 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    CONJUNCTIVITIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    CYSTITIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    GASTROENTERITIS 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    GASTROENTERITIS VIRAL 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    INFLUENZA 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    LIP INFECTION 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    NASOPHARYNGITIS 0/8 (0%) 1/8 (12.5%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    PYURIA 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    RESPIRATORY TRACT INFECTION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    SINUSITIS 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    TINEA CRURIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    TOOTH INFECTION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    UPPER RESPIRATORY TRACT INFECTION 3/8 (37.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    URINARY TRACT INFECTION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 2/8 (25%)
    Injury, poisoning and procedural complications
    ANIMAL BITE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    CLAVICLE FRACTURE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    LACERATION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    PROCEDURAL ANXIETY 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    PROCEDURAL PAIN 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Investigations
    ASPARTATE AMINOTRANSFERASE INCREASED 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    BLOOD BILIRUBIN INCREASED 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    BLOOD BILIRUBIN UNCONJUGATED INCREASED 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    BLOOD URIC ACID INCREASED 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%)
    BLOOD URINE PRESENT 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    GAMMA-GLUTAMYLTRANSFERASE INCREASED 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    HAEMOGLOBIN DECREASED 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%)
    HEART RATE INCREASED 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    LYMPHOCYTE COUNT DECREASED 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Metabolism and nutrition disorders
    DECREASED APPETITE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 0/8 (0%)
    DEHYDRATION 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    HYPERGLYCAEMIA 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    HYPERURICAEMIA 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    HYPOKALAEMIA 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    HYPONATRAEMIA 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    INCREASED APPETITE 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 1/8 (12.5%)
    BACK PAIN 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    JOINT SWELLING 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    MUSCLE SPASMS 1/8 (12.5%) 0/8 (0%) 1/9 (11.1%) 2/8 (25%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    MUSCULAR WEAKNESS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    MUSCULOSKELETAL DISCOMFORT 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    MUSCULOSKELETAL PAIN 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    MUSCULOSKELETAL STIFFNESS 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    MYALGIA 0/8 (0%) 2/8 (25%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    NECK PAIN 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    PAIN IN EXTREMITY 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    Nervous system disorders
    BURNING SENSATION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    DIZZINESS 1/8 (12.5%) 1/8 (12.5%) 1/9 (11.1%) 1/8 (12.5%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 3/8 (37.5%) 0/8 (0%)
    DYSARTHRIA 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    HEAD DISCOMFORT 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    HEADACHE 4/8 (50%) 3/8 (37.5%) 0/9 (0%) 1/8 (12.5%) 4/8 (50%) 1/8 (12.5%) 2/8 (25%) 1/8 (12.5%) 2/8 (25%) 3/8 (37.5%) 1/8 (12.5%)
    MIGRAINE 0/8 (0%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    NERVE COMPRESSION 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    PARAESTHESIA 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    PRESYNCOPE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    SOMNOLENCE 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Psychiatric disorders
    AGGRESSION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    AGITATION 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    ANGER 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    ANXIETY 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    BIPOLAR DISORDER 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    DEPRESSION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    EMOTIONAL DISORDER 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    INSOMNIA 1/8 (12.5%) 2/8 (25%) 1/9 (11.1%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 1/8 (12.5%) 1/8 (12.5%)
    IRRITABILITY 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 1/8 (12.5%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%)
    LIBIDO DECREASED 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    LIBIDO INCREASED 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    MOOD SWINGS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    RESTLESSNESS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    Renal and urinary disorders
    HAEMATURIA 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    NOCTURIA 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    RENAL FAILURE 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Reproductive system and breast disorders
    VAGINAL DISCHARGE 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 1/8 (12.5%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    DYSPNOEA 0/8 (0%) 1/8 (12.5%) 2/9 (22.2%) 2/8 (25%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%)
    DYSPNOEA EXERTIONAL 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%)
    EPISTAXIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    NASAL DISCOMFORT 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    OROPHARYNGEAL PAIN 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    RHINORRHOEA 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    SINUS CONGESTION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Skin and subcutaneous tissue disorders
    DERMATITIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    DERMATITIS CONTACT 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    ECCHYMOSIS 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    HAIR GROWTH ABNORMAL 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    HYPERHIDROSIS 0/8 (0%) 0/8 (0%) 1/9 (11.1%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    PHOTOSENSITIVITY REACTION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    PRURITUS 1/8 (12.5%) 2/8 (25%) 0/9 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    PRURITUS GENERALISED 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 3/8 (37.5%) 0/8 (0%)
    RASH 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 2/8 (25%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    RASH MACULAR 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%)
    SKIN EXFOLIATION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%)
    SWELLING FACE 1/8 (12.5%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Surgical and medical procedures
    TOOTH EXTRACTION 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    Vascular disorders
    FLUSHING 0/8 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    HOT FLUSH 0/8 (0%) 1/8 (12.5%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)
    HYPERTENSION 2/8 (25%) 0/8 (0%) 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization AbbVie
    Phone 800-633-9110
    Email
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT01995071
    Other Study ID Numbers:
    • M13-595
    First Posted:
    Nov 26, 2013
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021