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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)

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ClinicalTrials.gov Identifier: NCT01995071
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C
Hepatitis C Virus
Compensated Cirrhosis
Interventions Drug: ABT-493
Drug: ABT-530
Drug: ABT-450/r/ABT-267, ABT-333
Drug: Ribavirin (RBV)
Enrollment 89
Recruitment Details  
Pre-assignment Details  
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
Hide 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 [1] 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
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0             0             0             0             0
Moved             0             0             1             0             1             0             0             0             0             0             1             0
Lost to Follow-up             1             0             0             0             0             0             0             1             1             0             0             0
Incarcerated             0             0             0             0             0             0             0             1             0             0             0             0
[1]
The safety population: all participants who received at least 1 dose of any study drug.
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
Hide 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 Number of Baseline Participants 8 8 9 8 8 8 8 8 8 8 8 0 89
Hide Baseline Analysis Population Description
The safety population: all participants who received at least 1 dose of any study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 9 participants 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 0 participants 89 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 0 participants 89 participants
Female
3
  37.5%
2
  25.0%
0
   0.0%
3
  37.5%
1
  12.5%
3
  37.5%
0
   0.0%
2
  25.0%
2
  25.0%
3
  37.5%
4
  50.0%
23
  25.8%
Male
5
  62.5%
6
  75.0%
9
 100.0%
5
  62.5%
7
  87.5%
5
  62.5%
8
 100.0%
6
  75.0%
6
  75.0%
5
  62.5%
4
  50.0%
66
  74.2%
1.Primary Outcome
Title Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 8 8 9 16 8 16 8 8 8 0
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 8 8 8 0
Measure Type: Number
Unit of Measure: percentage of participants
87.5 100 87.5 100 100 100 87.5 87.5 100 100 100
3.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 8 8 8 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
12.5
(0.3 to 52.7)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
4.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 7 7 8 8 8 8 7 6 8 8 8 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
0
(0.0 to 0.0)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   0/8 (0.00%)   0/9 (0.00%)   0/8 (0.00%)   1/8 (12.50%)   0/8 (0.00%)   0/8 (0.00%)   1/8 (12.50%)   1/8 (12.50%)   0/8 (0.00%)   0/8 (0.00%) 
Hepatobiliary disorders                       
CHOLECYSTITIS ACUTE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Psychiatric disorders                       
MANIA  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Renal and urinary disorders                       
RENAL FAILURE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
PNEUMONITIS  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   7/8 (87.50%)   7/9 (77.78%)   8/8 (100.00%)   7/8 (87.50%)   7/8 (87.50%)   8/8 (100.00%)   4/8 (50.00%)   5/8 (62.50%)   7/8 (87.50%)   7/8 (87.50%) 
Blood and lymphatic system disorders                       
ANAEMIA  1  2/8 (25.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%) 
ANAEMIA MACROCYTIC  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
LEUKOCYTOSIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
THROMBOCYTOPENIA  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Cardiac disorders                       
PALPITATIONS  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
Ear and labyrinth disorders                       
EAR PAIN  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
TINNITUS  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
VERTIGO  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Eye disorders                       
DRY EYE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
VISION BLURRED  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Gastrointestinal disorders                       
ABDOMINAL DISCOMFORT  1  1/8 (12.50%)  1/8 (12.50%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
ABDOMINAL DISTENSION  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
ABDOMINAL PAIN  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
ABDOMINAL PAIN UPPER  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
CHEILITIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
CONSTIPATION  1  1/8 (12.50%)  2/8 (25.00%)  0/9 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
DENTAL CARIES  1  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
DIARRHOEA  1  2/8 (25.00%)  2/8 (25.00%)  1/9 (11.11%)  2/8 (25.00%)  1/8 (12.50%)  1/8 (12.50%)  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
DRY MOUTH  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
DYSPEPSIA  1  1/8 (12.50%)  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  3/8 (37.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
FAECAL VOLUME INCREASED  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
FAECES DISCOLOURED  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
FLATULENCE  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
GINGIVAL PAIN  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
GINGIVAL RECESSION  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
HAEMATEMESIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
HAEMORRHOIDS  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
NAUSEA  1  2/8 (25.00%)  0/8 (0.00%)  1/9 (11.11%)  2/8 (25.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  1/8 (12.50%) 
STOMATITIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
TOOTHACHE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
VOMITING  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
General disorders                       
ASTHENIA  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
CHEST DISCOMFORT  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
CHEST PAIN  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
CHILLS  1  1/8 (12.50%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
DISCOMFORT  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
DRUG WITHDRAWAL SYNDROME  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
FATIGUE  1  4/8 (50.00%)  2/8 (25.00%)  2/9 (22.22%)  5/8 (62.50%)  2/8 (25.00%)  3/8 (37.50%)  2/8 (25.00%)  0/8 (0.00%)  3/8 (37.50%)  2/8 (25.00%)  1/8 (12.50%) 
FEELING ABNORMAL  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
INFLUENZA LIKE ILLNESS  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
NON-CARDIAC CHEST PAIN  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
OEDEMA PERIPHERAL  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
PAIN  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
PERIPHERAL SWELLING  1  0/8 (0.00%)  2/8 (25.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
PYREXIA  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
SECRETION DISCHARGE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
THIRST  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
Hepatobiliary disorders                       
CHOLELITHIASIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Immune system disorders                       
DRUG HYPERSENSITIVITY  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
SEASONAL ALLERGY  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Infections and infestations                       
BRONCHITIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
BURSITIS INFECTIVE  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
CONJUNCTIVITIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
CYSTITIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
GASTROENTERITIS  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
GASTROENTERITIS VIRAL  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
INFLUENZA  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
LIP INFECTION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
NASOPHARYNGITIS  1  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
PYURIA  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
RESPIRATORY TRACT INFECTION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
SINUSITIS  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
TINEA CRURIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
TOOTH INFECTION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
UPPER RESPIRATORY TRACT INFECTION  1  3/8 (37.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
URINARY TRACT INFECTION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  2/8 (25.00%) 
Injury, poisoning and procedural complications                       
ANIMAL BITE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
CLAVICLE FRACTURE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
LACERATION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
PROCEDURAL ANXIETY  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
PROCEDURAL PAIN  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Investigations                       
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
BLOOD BILIRUBIN INCREASED  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
BLOOD BILIRUBIN UNCONJUGATED INCREASED  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
BLOOD URIC ACID INCREASED  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%) 
BLOOD URINE PRESENT  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
HAEMOGLOBIN DECREASED  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
HEART RATE INCREASED  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
LYMPHOCYTE COUNT DECREASED  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Metabolism and nutrition disorders                       
DECREASED APPETITE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%) 
DEHYDRATION  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
HYPERGLYCAEMIA  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
HYPERURICAEMIA  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
HYPOKALAEMIA  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
HYPONATRAEMIA  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
INCREASED APPETITE  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders                       
ARTHRALGIA  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  1/8 (12.50%) 
BACK PAIN  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
JOINT SWELLING  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
MUSCLE SPASMS  1  1/8 (12.50%)  0/8 (0.00%)  1/9 (11.11%)  2/8 (25.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
MUSCULAR WEAKNESS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
MUSCULOSKELETAL DISCOMFORT  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
MUSCULOSKELETAL PAIN  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
MUSCULOSKELETAL STIFFNESS  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
MYALGIA  1  0/8 (0.00%)  2/8 (25.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
NECK PAIN  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
PAIN IN EXTREMITY  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Nervous system disorders                       
BURNING SENSATION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
DIZZINESS  1  1/8 (12.50%)  1/8 (12.50%)  1/9 (11.11%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  3/8 (37.50%)  0/8 (0.00%) 
DYSARTHRIA  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
HEAD DISCOMFORT  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
HEADACHE  1  4/8 (50.00%)  3/8 (37.50%)  0/9 (0.00%)  1/8 (12.50%)  4/8 (50.00%)  1/8 (12.50%)  2/8 (25.00%)  1/8 (12.50%)  2/8 (25.00%)  3/8 (37.50%)  1/8 (12.50%) 
MIGRAINE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
NERVE COMPRESSION  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
PARAESTHESIA  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
PRESYNCOPE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
SOMNOLENCE  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Psychiatric disorders                       
AGGRESSION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
AGITATION  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
ANGER  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
ANXIETY  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
BIPOLAR DISORDER  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
DEPRESSION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
EMOTIONAL DISORDER  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
INSOMNIA  1  1/8 (12.50%)  2/8 (25.00%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%) 
IRRITABILITY  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%) 
LIBIDO DECREASED  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
LIBIDO INCREASED  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
MOOD SWINGS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
RESTLESSNESS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Renal and urinary disorders                       
HAEMATURIA  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
NOCTURIA  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
RENAL FAILURE  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Reproductive system and breast disorders                       
VAGINAL DISCHARGE  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
COUGH  1  1/8 (12.50%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
DYSPNOEA  1  0/8 (0.00%)  1/8 (12.50%)  2/9 (22.22%)  2/8 (25.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%) 
DYSPNOEA EXERTIONAL  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
EPISTAXIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
NASAL DISCOMFORT  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
OROPHARYNGEAL PAIN  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
RHINORRHOEA  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
SINUS CONGESTION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders                       
DERMATITIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
DERMATITIS CONTACT  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
ECCHYMOSIS  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
HAIR GROWTH ABNORMAL  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
HYPERHIDROSIS  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
PHOTOSENSITIVITY REACTION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
PRURITUS  1  1/8 (12.50%)  2/8 (25.00%)  0/9 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
PRURITUS GENERALISED  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  3/8 (37.50%)  0/8 (0.00%) 
RASH  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
RASH MACULAR  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
SKIN EXFOLIATION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%) 
SWELLING FACE  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Surgical and medical procedures                       
TOOTH EXTRACTION  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Vascular disorders                       
FLUSHING  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
HOT FLUSH  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
HYPERTENSION  1  2/8 (25.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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.
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
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01995071     History of Changes
Other Study ID Numbers: M13-595
First Submitted: November 21, 2013
First Posted: November 26, 2013
Results First Submitted: August 17, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017