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Trial record 1 of 45 for:    abbvie abt-450 hiv hcv
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A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01939197
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : November 17, 2017
Last Update Posted : July 12, 2021
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 Hepatitis C Virus Infection
Human Immunodeficiency Virus Infection
Chronic Hepatitis C
Compensated Cirrhosis and Non-cirrhotics
Interventions Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: ribavirin
Enrollment 318
Recruitment Details Part 2 was not designed to test different treatments on the same subject population. Rather, the arms in Part 2 represent subpopulations with different baseline characteristics (hepatitis C virus [HCV] genotype [GT], cirrhotic status, prior HCV therapy experience). Arms F and G were randomized to regimens without and with ribavirin, respectively.
Pre-assignment Details In Part 2, participants in Arms E, F, H, I, J all had GT1 infection and received 1 consistent treatment regimen based on label recommendations; they were therefore combined and named the "GT1 Analysis Group."
Arm/Group Title Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: GT1 Analysis Group Part 2: Arm G GT4 Analysis Group
Hide Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily Participants with HCV genotype (GT)1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily

Participants with HCV GT4 at screening in Arms K and L (no participants enrolled in Arm L).

Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily

Period Title: Overall Study
Started 31 32 10 12 200 5 28
Completed 30 31 10 11 196 4 26
Not Completed 1 1 0 1 4 1 2
Reason Not Completed
Withdrawal by Subject             1             0             0             0             1             0             0
Lost to Follow-up             0             1             0             1             3             1             2
Arm/Group Title Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: GT1 Analysis Group Part 2: Arm G Part 2: GT4 Analysis Group Total
Hide Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled Total of all reporting groups
Overall Number of Baseline Participants 31 32 10 12 200 5 28 318
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Group Number Analyzed 31 participants 32 participants 10 participants 12 participants 200 participants 5 participants 28 participants 318 participants
< 55 years
23
  74.2%
20
  62.5%
5
  50.0%
8
  66.7%
145
  72.5%
2
  40.0%
24
  85.7%
227
  71.4%
≥ 55 years
8
  25.8%
12
  37.5%
5
  50.0%
4
  33.3%
55
  27.5%
3
  60.0%
4
  14.3%
91
  28.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 10 participants 12 participants 200 participants 5 participants 28 participants 318 participants
Female
2
   6.5%
3
   9.4%
2
  20.0%
3
  25.0%
44
  22.0%
1
  20.0%
2
   7.1%
57
  17.9%
Male
29
  93.5%
29
  90.6%
8
  80.0%
9
  75.0%
156
  78.0%
4
  80.0%
26
  92.9%
261
  82.1%
1.Primary Outcome
Title Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
Hide Description

SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution.

The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).

Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. The primary efficacy endpoint analysis was based on subjects in the GT 1 Analysis Group in Part 2 containing Arms E, F, H, I, and J.
Arm/Group Title Part 2: GT1 Analysis Group
Hide Arm/Group Description:
Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Overall Number of Participants Analyzed 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.0
(93.6 to 98.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: GT1 Analysis Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).
Other Statistical Analysis

The historical SVR rate, as reported in the PHOTON-1 study, for sofosbuvir and RBV in HCV/HIV-1 coinfected adults is 76% (87/114) with a 95% confidence interval of (67%, 84%).

Reference: Sulkowski MS, Naggie S, Lalezari J, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312(4):353-61.

2.Secondary Outcome
Title Percentage of Participants in Part 1a Achieving SVR12
Hide Description SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.
Arm/Group Title Part 1a: Arm A Part 1a: Arm B
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
Overall Number of Participants Analyzed 31 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.5
(79.3 to 98.2)
90.6
(75.8 to 96.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1a: Arm A, Part 1a: Arm B
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants in Part 1b Achieving SVR12
Hide Description SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.
Arm/Group Title Part 1b: Arm C Part 1b: Arm D Part 1b: Total
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily

Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Overall Number of Participants Analyzed 10 12 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(72.2 to 100.0)
100
(75.8 to 100.0)
100
(85.1 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1b: Arm C, Part 1b: Arm D
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis The Fisher exact test was performed as prespecified on the SAP but the p-value couldn't be calculated because SVR12 rates in both arms were 100%, hence p-value appeared as "not available."
4.Secondary Outcome
Title Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12
Hide Description SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.
Arm/Group Title Part 2: Arm F Part 2: Arm G
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Overall Number of Participants Analyzed 4 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.0
(30.1 to 95.4)
80.0
(37.6 to 96.4)
5.Secondary Outcome
Title Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall
Hide Description SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.
Arm/Group Title Part 2: GT4 Analysis Group Part 2: Arm K
Hide Arm/Group Description:
Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
Overall Number of Participants Analyzed 28 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.4
(82.3 to 99.4)
96.4
(82.3 to 99.4)
6.Secondary Outcome
Title Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period
Hide Description Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
Time Frame up to 12 or 24 weeks, based on treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.
Arm/Group Title Part 1a: Arm A Part 1a: Arm B
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
Overall Number of Participants Analyzed 31 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 11.0)
3.1
(0.6 to 15.7)
7.Secondary Outcome
Title Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period
Hide Description Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.
Arm/Group Title Part 1b: Arm C Part 1b: Arm D Part 1b: Total
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily

Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Overall Number of Participants Analyzed 10 12 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 27.8)
0
(0.0 to 24.2)
0
(0.0 to 14.9)
8.Secondary Outcome
Title Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period
Hide Description Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
Time Frame up to 12 or 24 weeks, based on treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.
Arm/Group Title Part 2: GT1 Analysis Group Part 2: Arm E Part 2: Arm F Part 2: Arm I Part 2: Arm J Part 2: GT4 Analysis Group Group 2: Arm K
Hide Arm/Group Description:
Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
Overall Number of Participants Analyzed 200 42 4 135 19 28 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.5
(0.1 to 2.8)
0
(0.0 to 8.4)
25.0
(4.6 to 69.9)
0
(0.0 to 2.8)
0
(0.0 to 16.8)
0
(0.0 to 12.1)
0
(0.0 to 12.1)
9.Secondary Outcome
Title Percentage of Participants in Part 1a With Relapse12
Hide Description Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.
Time Frame up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.
Arm/Group Title Part 1a: Arm A Part 1a: Arm B
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.3
(0.6 to 16.7)
0
(0.0 to 11.0)
10.Secondary Outcome
Title Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall
Hide Description Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.
Time Frame up to 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all Part 1b randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.
Arm/Group Title Part 1b: Arm C Part 1b: Arm D Part 1b: Total
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily

Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Overall Number of Participants Analyzed 10 12 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 27.8)
0
(0.0 to 24.2)
0
(0.0 to 14.9)
11.Secondary Outcome
Title Percentage of Participants in Part 2 With Relapse12
Hide Description Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.
Time Frame up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received ≥1 dose of study drug, who completed treatment with HCV RNA < LLOQ at final treatment visit, and had ≥1 post-treatment HCV RNA value. Arm G data was not analyzed (see Outcome Measure 8).
Arm/Group Title Part 2: GT1 Analysis Group Part 2: Arm E Part 2: Arm F Part 2: Arm I Part 2: Arm J Part 2: GT4 Analysis Group Group 2: Arm K
Hide Arm/Group Description:
Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
Overall Number of Participants Analyzed 192 42 3 131 16 27 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.5
(0.1 to 2.9)
0
(0.0 to 8.4)
0
(0.0 to 56.1)
0.8
(0.1 to 4.2)
0
(0.0 to 19.4)
0
(0.0 to 12.5)
0
(0.0 to 12.5)
12.Secondary Outcome
Title Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
Hide Description HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
Time Frame End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126)
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Hide Analysis Population Description
Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.
Arm/Group Title Part 1a: Arm A Part 1a: Arm B
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
Overall Number of Participants Analyzed 31 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
End of Treatment
93.5
(79.3 to 98.2)
90.6
(75.8 to 96.8)
Post-Treatment Week 12
96.8
(83.8 to 99.4)
93.8
(79.9 to 98.3)
13.Secondary Outcome
Title Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
Hide Description HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
Time Frame End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.
Arm/Group Title Part 1b: Arm C Part 1b: Arm D Part 1b Total
Hide Arm/Group Description:
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Arm C: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily

Arm D: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily

Overall Number of Participants Analyzed 10 12 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
End of Treatment
100
(72.2 to 100.0)
83.3
(55.2 to 95.3)
90.9
(72.2 to 97.5)
Post-Treatment Week 12
100
(72.2 to 100.0)
75.0
(46.8 to 91.1)
86.4
(66.7 to 95.3)
14.Secondary Outcome
Title Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
Hide Description HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
Time Frame End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.
Arm/Group Title Part 2: GT1 Analysis Group Part 2: Arm E Part 2: Arm F Part 2: Arm I Part 2: Arm J Part 2: GT4 Analysis Group Group 2: Arm K
Hide Arm/Group Description:
Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Arm K: ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily Arm L: no participants enrolled
ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
Overall Number of Participants Analyzed 200 42 4 135 19 28 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
End of Treatment
89
(83.9 to 92.6)
90.5
(77.9 to 96.2)
100
(51.0 to 100.0)
89.6
(83.3 to 93.7)
78.9
(56.7 to 91.5)
85.7
(68.5 to 94.3)
85.7
(68.5 to 94.3)
Post-Treatment Week 12
93
(88.6 to 95.8)
97.6
(87.7 to 99.6)
100
(51.0 to 100.0)
91.9
(86.0 to 95.4)
89.5
(68.6 to 97.1)
92.9
(77.4 to 98.0)
92.9
(77.4 to 98.0)
Time Frame Protocol-related treatment-emergent adverse events were collected from the first dose of study drug through end of treatment Week 12 and Week 24; treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30.
Adverse Event Reporting Description A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: Arm E Part 2: Arm F Part 2: Arm G Part 2: Arm I Part 2: Arm J Part 2: Arm K
Hide Arm/Group Description ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
All-Cause Mortality
Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: Arm E Part 2: Arm F Part 2: Arm G Part 2: Arm I Part 2: Arm J Part 2: Arm K
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   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: Arm E Part 2: Arm F Part 2: Arm G Part 2: Arm I Part 2: Arm J Part 2: Arm K
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/32 (0.00%)   0/10 (0.00%)   1/12 (8.33%)   1/42 (2.38%)   0/4 (0.00%)   0/5 (0.00%)   6/135 (4.44%)   2/19 (10.53%)   1/28 (3.57%) 
Blood and lymphatic system disorders                     
ANAEMIA  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
Cardiac disorders                     
ANGINA UNSTABLE  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
PERICARDITIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders                     
ABDOMINAL PAIN  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
COLITIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
RECTAL PERFORATION  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
Infections and infestations                     
APPENDICITIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
INFLUENZA  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
Injury, poisoning and procedural complications                     
OVERDOSE  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
Metabolism and nutrition disorders                     
DEHYDRATION  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
Psychiatric disorders                     
DEPRESSION  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
DRUG DEPENDENCE  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  1/28 (3.57%) 
Renal and urinary disorders                     
URETEROLITHIASIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
Vascular disorders                     
HYPERTENSIVE CRISIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1a: Arm A Part 1a: Arm B Part 1b: Arm C Part 1b: Arm D Part 2: Arm E Part 2: Arm F Part 2: Arm G Part 2: Arm I Part 2: Arm J Part 2: Arm K
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   28/31 (90.32%)   27/32 (84.38%)   10/10 (100.00%)   10/12 (83.33%)   23/42 (54.76%)   3/4 (75.00%)   4/5 (80.00%)   109/135 (80.74%)   18/19 (94.74%)   23/28 (82.14%) 
Blood and lymphatic system disorders                     
ANAEMIA  1  1/31 (3.23%)  3/32 (9.38%)  1/10 (10.00%)  2/12 (16.67%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  6/135 (4.44%)  1/19 (5.26%)  0/28 (0.00%) 
Cardiac disorders                     
VENTRICULAR EXTRASYSTOLES  1  0/31 (0.00%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
Eye disorders                     
BLEPHAROSPASM  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
DRY EYE  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  1/19 (5.26%)  0/28 (0.00%) 
EYE DISCHARGE  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
EYE PRURITUS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  1/19 (5.26%)  0/28 (0.00%) 
EYELID HAEMATOMA  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  1/19 (5.26%)  0/28 (0.00%) 
EYELID PTOSIS  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
OCULAR DISCOMFORT  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
OCULAR HYPERAEMIA  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
OCULAR ICTERUS  1  5/31 (16.13%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  3/135 (2.22%)  0/19 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders                     
ABDOMINAL DISCOMFORT  1  2/31 (6.45%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
ABDOMINAL DISTENSION  1  0/31 (0.00%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  3/135 (2.22%)  1/19 (5.26%)  1/28 (3.57%) 
ABDOMINAL PAIN  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  2/42 (4.76%)  0/4 (0.00%)  0/5 (0.00%)  3/135 (2.22%)  1/19 (5.26%)  1/28 (3.57%) 
ABDOMINAL PAIN UPPER  1  1/31 (3.23%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  2/42 (4.76%)  1/4 (25.00%)  0/5 (0.00%)  5/135 (3.70%)  0/19 (0.00%)  3/28 (10.71%) 
APHTHOUS ULCER  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/135 (1.48%)  0/19 (0.00%)  0/28 (0.00%) 
BARRETT'S OESOPHAGUS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
CONSTIPATION  1  2/31 (6.45%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  7/135 (5.19%)  2/19 (10.53%)  2/28 (7.14%) 
DIARRHOEA  1  1/31 (3.23%)  4/32 (12.50%)  1/10 (10.00%)  2/12 (16.67%)  4/42 (9.52%)  1/4 (25.00%)  0/5 (0.00%)  26/135 (19.26%)  1/19 (5.26%)  1/28 (3.57%) 
DIVERTICULUM  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
DRY MOUTH  1  2/31 (6.45%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  2/28 (7.14%) 
DYSPEPSIA  1  1/31 (3.23%)  3/32 (9.38%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  10/135 (7.41%)  0/19 (0.00%)  3/28 (10.71%) 
FAECES SOFT  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  2/31 (6.45%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  2/135 (1.48%)  1/19 (5.26%)  0/28 (0.00%) 
NAUSEA  1  5/31 (16.13%)  6/32 (18.75%)  2/10 (20.00%)  2/12 (16.67%)  3/42 (7.14%)  1/4 (25.00%)  0/5 (0.00%)  34/135 (25.19%)  4/19 (21.05%)  5/28 (17.86%) 
ORAL PAIN  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
VOMITING  1  1/31 (3.23%)  2/32 (6.25%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  11/135 (8.15%)  1/19 (5.26%)  3/28 (10.71%) 
General disorders                     
ASTHENIA  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  1/4 (25.00%)  0/5 (0.00%)  13/135 (9.63%)  2/19 (10.53%)  3/28 (10.71%) 
CHEST PAIN  1  0/31 (0.00%)  2/32 (6.25%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
EARLY SATIETY  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
FATIGUE  1  18/31 (58.06%)  12/32 (37.50%)  5/10 (50.00%)  4/12 (33.33%)  2/42 (4.76%)  0/4 (0.00%)  0/5 (0.00%)  40/135 (29.63%)  6/19 (31.58%)  5/28 (17.86%) 
INFLUENZA LIKE ILLNESS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  3/135 (2.22%)  1/19 (5.26%)  0/28 (0.00%) 
OEDEMA PERIPHERAL  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
PAIN  1  1/31 (3.23%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  4/135 (2.96%)  0/19 (0.00%)  0/28 (0.00%) 
PERIPHERAL SWELLING  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
PYREXIA  1  0/31 (0.00%)  1/32 (3.13%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/135 (1.48%)  1/19 (5.26%)  2/28 (7.14%) 
TEMPERATURE INTOLERANCE  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
TENDERNESS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
VESSEL PUNCTURE SITE BRUISE  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
Hepatobiliary disorders                     
HYPERBILIRUBINAEMIA  1  4/31 (12.90%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  4/135 (2.96%)  1/19 (5.26%)  0/28 (0.00%) 
JAUNDICE  1  2/31 (6.45%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  7/135 (5.19%)  0/19 (0.00%)  1/28 (3.57%) 
Immune system disorders                     
SEASONAL ALLERGY  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
Infections and infestations                     
ACUTE SINUSITIS  1  0/31 (0.00%)  1/32 (3.13%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
BRONCHITIS  1  0/31 (0.00%)  0/32 (0.00%)  3/10 (30.00%)  0/12 (0.00%)  1/42 (2.38%)  1/4 (25.00%)  0/5 (0.00%)  6/135 (4.44%)  0/19 (0.00%)  1/28 (3.57%) 
GASTROENTERITIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/135 (1.48%)  1/19 (5.26%)  1/28 (3.57%) 
GASTROENTERITIS VIRAL  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
HERPES ZOSTER  1  0/31 (0.00%)  1/32 (3.13%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
HERPES ZOSTER OTICUS  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
NASOPHARYNGITIS  1  1/31 (3.23%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  12/135 (8.89%)  4/19 (21.05%)  4/28 (14.29%) 
ORAL HERPES  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/135 (1.48%)  0/19 (0.00%)  2/28 (7.14%) 
PYELONEPHRITIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
PYURIA  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
RHINITIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  2/135 (1.48%)  0/19 (0.00%)  2/28 (7.14%) 
SECONDARY SYPHILIS  1  0/31 (0.00%)  2/32 (6.25%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  4/31 (12.90%)  5/32 (15.63%)  1/10 (10.00%)  0/12 (0.00%)  3/42 (7.14%)  0/4 (0.00%)  0/5 (0.00%)  12/135 (8.89%)  1/19 (5.26%)  1/28 (3.57%) 
URINARY TRACT INFECTION  1  2/31 (6.45%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  6/135 (4.44%)  2/19 (10.53%)  0/28 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
Injury, poisoning and procedural complications                     
ARTHROPOD BITE  1  1/31 (3.23%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
CONTUSION  1  0/31 (0.00%)  2/32 (6.25%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
EXCORIATION  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
FALL  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
MUSCLE STRAIN  1  1/31 (3.23%)  1/32 (3.13%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
Investigations                     
BLOOD BILIRUBIN INCREASED  1  0/31 (0.00%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  3/135 (2.22%)  0/19 (0.00%)  0/28 (0.00%) 
CREATININE RENAL CLEARANCE DECREASED  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  3/135 (2.22%)  1/19 (5.26%)  0/28 (0.00%) 
HAEMOGLOBIN DECREASED  1  3/31 (9.68%)  0/32 (0.00%)  1/10 (10.00%)  4/12 (33.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  13/135 (9.63%)  6/19 (31.58%)  4/28 (14.29%) 
WEIGHT DECREASED  1  1/31 (3.23%)  1/32 (3.13%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  1/28 (3.57%) 
Metabolism and nutrition disorders                     
DECREASED APPETITE  1  1/31 (3.23%)  2/32 (6.25%)  1/10 (10.00%)  2/12 (16.67%)  3/42 (7.14%)  0/4 (0.00%)  1/5 (20.00%)  3/135 (2.22%)  1/19 (5.26%)  1/28 (3.57%) 
GOUT  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
HYPOKALAEMIA  1  1/31 (3.23%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders                     
ARTHRALGIA  1  2/31 (6.45%)  1/32 (3.13%)  1/10 (10.00%)  0/12 (0.00%)  3/42 (7.14%)  1/4 (25.00%)  0/5 (0.00%)  5/135 (3.70%)  0/19 (0.00%)  1/28 (3.57%) 
BACK PAIN  1  1/31 (3.23%)  3/32 (9.38%)  0/10 (0.00%)  1/12 (8.33%)  2/42 (4.76%)  0/4 (0.00%)  0/5 (0.00%)  6/135 (4.44%)  3/19 (15.79%)  1/28 (3.57%) 
JOINT STIFFNESS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
JOINT SWELLING  1  1/31 (3.23%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  1/28 (3.57%) 
MUSCLE SPASMS  1  1/31 (3.23%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/135 (1.48%)  1/19 (5.26%)  1/28 (3.57%) 
MUSCLE TIGHTNESS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
MYALGIA  1  2/31 (6.45%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  4/135 (2.96%)  0/19 (0.00%)  2/28 (7.14%) 
NECK PAIN  1  0/31 (0.00%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  2/28 (7.14%) 
PAIN IN EXTREMITY  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  1/19 (5.26%)  2/28 (7.14%) 
PERIARTHRITIS  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
TENDONITIS  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  0/19 (0.00%)  0/28 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
SKIN PAPILLOMA  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
Nervous system disorders                     
DISTURBANCE IN ATTENTION  1  1/31 (3.23%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  1/19 (5.26%)  0/28 (0.00%) 
DIZZINESS  1  0/31 (0.00%)  2/32 (6.25%)  1/10 (10.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  10/135 (7.41%)  2/19 (10.53%)  1/28 (3.57%) 
HEADACHE  1  6/31 (19.35%)  4/32 (12.50%)  2/10 (20.00%)  1/12 (8.33%)  2/42 (4.76%)  0/4 (0.00%)  1/5 (20.00%)  22/135 (16.30%)  4/19 (21.05%)  5/28 (17.86%) 
MEMORY IMPAIRMENT  1  0/31 (0.00%)  3/32 (9.38%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
NEURALGIA  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
PARAESTHESIA  1  1/31 (3.23%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/135 (1.48%)  1/19 (5.26%)  0/28 (0.00%) 
SINUS HEADACHE  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
Psychiatric disorders                     
AFFECT LABILITY  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  4/135 (2.96%)  1/19 (5.26%)  0/28 (0.00%) 
AGITATION  1  1/31 (3.23%)  0/32 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
ANXIETY  1  0/31 (0.00%)  3/32 (9.38%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  11/135 (8.15%)  1/19 (5.26%)  2/28 (7.14%) 
DEPRESSED MOOD  1  0/31 (0.00%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  4/135 (2.96%)  0/19 (0.00%)  0/28 (0.00%) 
DEPRESSION  1  0/31 (0.00%)  3/32 (9.38%)  1/10 (10.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  3/135 (2.22%)  1/19 (5.26%)  1/28 (3.57%) 
INSOMNIA  1  5/31 (16.13%)  7/32 (21.88%)  1/10 (10.00%)  0/12 (0.00%)  3/42 (7.14%)  0/4 (0.00%)  1/5 (20.00%)  25/135 (18.52%)  2/19 (10.53%)  2/28 (7.14%) 
IRRITABILITY  1  3/31 (9.68%)  3/32 (9.38%)  3/10 (30.00%)  2/12 (16.67%)  0/42 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  7/135 (5.19%)  2/19 (10.53%)  1/28 (3.57%) 
LIBIDO INCREASED  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
STRESS  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
WITHDRAWAL SYNDROME  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  1/28 (3.57%) 
Renal and urinary disorders                     
NEPHROLITHIASIS  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
BRONCHOSPASM  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
COUGH  1  2/31 (6.45%)  5/32 (15.63%)  2/10 (20.00%)  0/12 (0.00%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  7/135 (5.19%)  1/19 (5.26%)  1/28 (3.57%) 
DYSPNOEA  1  1/31 (3.23%)  2/32 (6.25%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  8/135 (5.93%)  2/19 (10.53%)  2/28 (7.14%) 
DYSPNOEA EXERTIONAL  1  1/31 (3.23%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  6/135 (4.44%)  1/19 (5.26%)  1/28 (3.57%) 
NASAL CONGESTION  1  2/31 (6.45%)  1/32 (3.13%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  1/19 (5.26%)  0/28 (0.00%) 
OROPHARYNGEAL PAIN  1  0/31 (0.00%)  2/32 (6.25%)  0/10 (0.00%)  0/12 (0.00%)  2/42 (4.76%)  0/4 (0.00%)  0/5 (0.00%)  3/135 (2.22%)  0/19 (0.00%)  0/28 (0.00%) 
RESPIRATORY TRACT CONGESTION  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
RHINORRHOEA  1  3/31 (9.68%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  3/135 (2.22%)  0/19 (0.00%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders                     
DERMATITIS  1  0/31 (0.00%)  1/32 (3.13%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
DRY SKIN  1  1/31 (3.23%)  1/32 (3.13%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  4/135 (2.96%)  0/19 (0.00%)  1/28 (3.57%) 
PRURITUS  1  6/31 (19.35%)  2/32 (6.25%)  0/10 (0.00%)  1/12 (8.33%)  1/42 (2.38%)  1/4 (25.00%)  0/5 (0.00%)  18/135 (13.33%)  2/19 (10.53%)  1/28 (3.57%) 
PRURITUS GENERALISED  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/42 (2.38%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
RASH  1  1/31 (3.23%)  2/32 (6.25%)  0/10 (0.00%)  1/12 (8.33%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  6/135 (4.44%)  2/19 (10.53%)  1/28 (3.57%) 
RASH MACULAR  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
RASH PRURITIC  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/135 (0.74%)  1/19 (5.26%)  0/28 (0.00%) 
SKIN EXFOLIATION  1  0/31 (0.00%)  0/32 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  0/19 (0.00%)  0/28 (0.00%) 
SKIN FISSURES  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
Vascular disorders                     
HYPERTENSION  1  0/31 (0.00%)  1/32 (3.13%)  1/10 (10.00%)  0/12 (0.00%)  1/42 (2.38%)  1/4 (25.00%)  0/5 (0.00%)  4/135 (2.96%)  0/19 (0.00%)  0/28 (0.00%) 
THROMBOPHLEBITIS SUPERFICIAL  1  0/31 (0.00%)  0/32 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/42 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/135 (0.00%)  1/19 (5.26%)  0/28 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 19.0
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
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01939197    
Other Study ID Numbers: M14-004
2012-005143-24 ( EudraCT Number )
First Submitted: September 6, 2013
First Posted: September 11, 2013
Results First Submitted: July 20, 2017
Results First Posted: November 17, 2017
Last Update Posted: July 12, 2021