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A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients (CORAL-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: NCT01782495
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Drug: ombitasvir/paritaprevir/ritonavir
Drug: ribavirin
Enrollment 129
Recruitment Details  
Pre-assignment Details This study included a 35-day screening period.
Arm/Group Title Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
Hide Arm/Group Description Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant receipts with HCV 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Period Title: Overall Study
Started 34 27 13 4 2 22 12 9 3 2 1
Completed 34 26 13 4 2 22 12 6 3 2 1
Not Completed 0 1 0 0 0 0 0 3 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             2             0             0             0
Withdrew Consent             0             1             0             0             0             0             0             1             0             0             0
Arm/Group Title Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K Total
Hide Arm/Group Description Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 34 27 13 4 2 22 12 9 3 2 1 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 27 participants 13 participants 4 participants 2 participants 22 participants 12 participants 9 participants 3 participants 2 participants 1 participants 129 participants
59.6  (6.62) 58.0  (6.66) 61.8  (5.76) 59.8  (10.78) 78.0  (1.41) 58.3  (9.35) 62.2  (7.64) 58.0  (8.00) 57.3  (9.29) 63.5  (7.78) 50.0 [1]   (NA) 59.6  (7.73)
[1]
The estimated standard deviation of one sample is undefined
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 27 participants 13 participants 4 participants 2 participants 22 participants 12 participants 9 participants 3 participants 2 participants 1 participants 129 participants
Female 7 4 5 0 2 2 2 2 1 0 0 25
Male 27 23 8 4 0 20 10 7 2 2 1 104
1.Primary 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 study drug. Participants with missing data after backward imputation were imputed as nonresponders.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.
Arm/Group Title Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
Hide Arm/Group Description:
Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Overall Number of Participants Analyzed 34 27 13 4 2 22 12 9 3 2 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.1
(85.1 to 99.5)
96.3
(81.7 to 99.3)
100
(77.2 to 100.0)
100
(51.0 to 100.0)
100
(34.2 to 100.0)
95.5
(78.2 to 99.2)
100
(75.8 to 100.0)
66.7
(35.4 to 87.9)
100
(43.9 to 100.0)
100
(34.2 to 100.0)
100
(20.7 to 100.0)
2.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Hide Description SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 24 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.
Time Frame 24 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population).
Arm/Group Title Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
Hide Arm/Group Description:
Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Overall Number of Participants Analyzed 34 27 13 4 2 22 12 9 3 2 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.1
(85.1 to 99.5)
96.3
(81.7 to 99.3)
100
(77.2 to 100.0)
100
(51.0 to 100.0)
100
(34.2 to 100.0)
95.5
(78.2 to 99.2)
100
(75.8 to 100.0)
66.7
(35.4 to 87.9)
100
(43.9 to 100.0)
100
(34.2 to 100.0)
100
(20.7 to 100.0)
3.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide Description On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment.
Time Frame Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population).
Arm/Group Title Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
Hide Arm/Group Description:
Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Overall Number of Participants Analyzed 34 27 13 4 2 22 12 9 3 2 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 10.2)
3.7
(0.7 to 18.3)
0
(0.0 to 22.8)
0
(0.0 to 49.0)
0
(0.0 to 65.8)
0
(0.0 to 14.9)
0
(0.0 to 24.2)
0
(0.0 to 29.9)
0
(0.0 to 56.1)
0
(0.0 to 65.8)
0
(0.0 to 79.3)
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 who completed 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 study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.
Arm/Group Title Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
Hide Arm/Group Description:
Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks.
Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks.
Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
Overall Number of Participants Analyzed 33 26 12 4 2 21 12 6 3 2 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.0
(0.5 to 15.3)
0
(0.0 to 12.9)
0
(0.0 to 24.2)
0
(0.0 to 49.0)
0
(0.0 to 65.8)
4.8
(0.8 to 22.7)
0
(0.0 to 24.2)
0
(0.0 to 39.0)
0
(0.0 to 56.1)
0
(0.0 to 65.8)
0
(0.0 to 79.3)
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
Adverse Event Reporting Description TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days after the last dose of study drug. TEAEs and TESAEs were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title ARM A ARM B ARM C ARM D ARM E ARM F ARM G ARM H ARM I ARM J ARM K
Hide Arm/Group Description Liver transplant recipients with HCV genotype 1 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant recipients with HCV genotype 1a or genotype 1b (dependent on prior treatment experience and response) infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant receipts with HCV genotype 1b infection who were treatment naïve or prior responders to interferon treatment without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 24 weeks. Liver transplant recipients with HCV genotype 1a infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (dosed 1,000 or 1,200 mg daily divided twice a day) for 24 weeks. Liver transplant recipients with HCV genotype 1b infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. Renal transplant recipients with HCV genotype 1a infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Renal transplant recipients with HCV genotype 1b infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) for 12 weeks. Liver transplant recipients with HCV genotype 4 infection without cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 12 weeks. Liver transplant recipients with HCV genotype 4 infection with Child Pugh A cirrhosis received ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) plus weight-based ribavirin (1,000 or 1,200 mg daily divided twice a day) for 24 weeks.
All-Cause Mortality
ARM A ARM B ARM C ARM D ARM E ARM F ARM G ARM H ARM I ARM J 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 (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/27 (0.00%)   0/13 (0.00%)   0/4 (0.00%)   0/2 (0.00%)   0/22 (0.00%)   0/12 (0.00%)   1/9 (11.11%)   0/3 (0.00%)   0/2 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
ARM A ARM B ARM C ARM D ARM E ARM F ARM G ARM H ARM I ARM J 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 (%) Affected / at Risk (%)
Total   2/34 (5.88%)   1/27 (3.70%)   0/13 (0.00%)   0/4 (0.00%)   0/2 (0.00%)   2/22 (9.09%)   1/12 (8.33%)   4/9 (44.44%)   0/3 (0.00%)   0/2 (0.00%)   0/1 (0.00%) 
Blood and lymphatic system disorders                       
LEUKOCYTOSIS  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Cardiac disorders                       
TACHYCARDIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders                       
NAUSEA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
VOMITING  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
General disorders                       
OEDEMA PERIPHERAL  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Infections and infestations                       
ATYPICAL PNEUMONIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PNEUMONIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications                       
OVERDOSE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders                       
HYPONATRAEMIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders                       
PAIN IN EXTREMITY  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Nervous system disorders                       
ISCHAEMIC CEREBRAL INFARCTION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders                       
ACUTE KIDNEY INJURY  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
ACUTE RESPIRATORY FAILURE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Vascular disorders                       
HYPOTENSION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ARM A ARM B ARM C ARM D ARM E ARM F ARM G ARM H ARM I ARM J 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 (%) Affected / at Risk (%)
Total   33/34 (97.06%)   27/27 (100.00%)   12/13 (92.31%)   4/4 (100.00%)   2/2 (100.00%)   22/22 (100.00%)   12/12 (100.00%)   8/9 (88.89%)   3/3 (100.00%)   2/2 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders                       
ANAEMIA  1  8/34 (23.53%)  8/27 (29.63%)  1/13 (7.69%)  3/4 (75.00%)  2/2 (100.00%)  4/22 (18.18%)  0/12 (0.00%)  2/9 (22.22%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
HAEMOLYTIC ANAEMIA  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LEUKOPENIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LYMPHOPENIA  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Cardiac disorders                       
PALPITATIONS  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Ear and labyrinth disorders                       
EAR PAIN  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
VERTIGO  1  0/34 (0.00%)  0/27 (0.00%)  2/13 (15.38%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Eye disorders                       
DIPLOPIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DRY EYE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  1/2 (50.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
EYE PAIN  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
EYE PRURITUS  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  1/2 (50.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
OCULAR DISCOMFORT  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
OCULAR HYPERAEMIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
VISION BLURRED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
VISUAL IMPAIRMENT  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
VITREOUS FLOATERS  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders                       
ABDOMINAL DISCOMFORT  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  3/22 (13.64%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ABDOMINAL DISTENSION  1  3/34 (8.82%)  1/27 (3.70%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ABDOMINAL PAIN  1  5/34 (14.71%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  1/2 (50.00%)  0/22 (0.00%)  2/12 (16.67%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ABDOMINAL PAIN LOWER  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ABDOMINAL PAIN UPPER  1  4/34 (11.76%)  2/27 (7.41%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
ANAL PRURITUS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ANORECTAL DISCOMFORT  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
APHTHOUS ULCER  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BOWEL MOVEMENT IRREGULARITY  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CONSTIPATION  1  2/34 (5.88%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  4/22 (18.18%)  1/12 (8.33%)  2/9 (22.22%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
DENTAL CARIES  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DIARRHOEA  1  9/34 (26.47%)  6/27 (22.22%)  1/13 (7.69%)  1/4 (25.00%)  1/2 (50.00%)  6/22 (27.27%)  2/12 (16.67%)  2/9 (22.22%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DIVERTICULUM INTESTINAL  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DRY MOUTH  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  1/12 (8.33%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DYSPEPSIA  1  3/34 (8.82%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DYSPHAGIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
EPIGASTRIC DISCOMFORT  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FAECES DISCOLOURED  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FLATULENCE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
GINGIVAL BLEEDING  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HAEMORRHOIDS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LIP DRY  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
NAUSEA  1  8/34 (23.53%)  11/27 (40.74%)  2/13 (15.38%)  2/4 (50.00%)  1/2 (50.00%)  4/22 (18.18%)  0/12 (0.00%)  2/9 (22.22%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
OESOPHAGEAL DILATATION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SMALL INTESTINAL OBSTRUCTION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TOOTH IMPACTED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
TOOTHACHE  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
VOMITING  1  4/34 (11.76%)  5/27 (18.52%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  1/22 (4.55%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
General disorders                       
ASTHENIA  1  8/34 (23.53%)  7/27 (25.93%)  1/13 (7.69%)  0/4 (0.00%)  2/2 (100.00%)  2/22 (9.09%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CHEST PAIN  1  0/34 (0.00%)  2/27 (7.41%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CHILLS  1  2/34 (5.88%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
EXERCISE TOLERANCE DECREASED  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FACE OEDEMA  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FATIGUE  1  17/34 (50.00%)  14/27 (51.85%)  4/13 (30.77%)  4/4 (100.00%)  0/2 (0.00%)  14/22 (63.64%)  2/12 (16.67%)  6/9 (66.67%)  1/3 (33.33%)  1/2 (50.00%)  1/1 (100.00%) 
FEELING ABNORMAL  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FEELING COLD  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HERNIA PAIN  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
INFLUENZA LIKE ILLNESS  1  2/34 (5.88%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
NON-CARDIAC CHEST PAIN  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
OEDEMA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
OEDEMA PERIPHERAL  1  5/34 (14.71%)  2/27 (7.41%)  1/13 (7.69%)  1/4 (25.00%)  1/2 (50.00%)  1/22 (4.55%)  1/12 (8.33%)  0/9 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
PAIN  1  3/34 (8.82%)  2/27 (7.41%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PERIPHERAL SWELLING  1  0/34 (0.00%)  2/27 (7.41%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PYREXIA  1  5/34 (14.71%)  2/27 (7.41%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Hepatobiliary disorders                       
HYPERBILIRUBINAEMIA  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
JAUNDICE  1  0/34 (0.00%)  3/27 (11.11%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
Immune system disorders                       
ALLERGY TO ARTHROPOD BITE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LIVER TRANSPLANT REJECTION  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SEASONAL ALLERGY  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Infections and infestations                       
ACARODERMATITIS  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CELLULITIS  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CYTOMEGALOVIRUS VIRAEMIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FOLLICULITIS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FUNGAL INFECTION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
GASTROENTERITIS  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HERPES ZOSTER  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HORDEOLUM  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
IMPETIGO  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
INFLUENZA  1  2/34 (5.88%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LOCALISED INFECTION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ORAL CANDIDIASIS  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ORAL HERPES  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
OTITIS MEDIA  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PHARYNGITIS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PHARYNGITIS STREPTOCOCCAL  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SINUSITIS  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SKIN INFECTION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TINEA CRURIS  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TINEA PEDIS  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TOOTH INFECTION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  2/34 (5.88%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
URINARY TRACT INFECTION  1  4/34 (11.76%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  3/34 (8.82%)  2/27 (7.41%)  2/13 (15.38%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications                       
ACCIDENT  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ARTHROPOD BITE  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ARTHROPOD STING  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CONTUSION  1  2/34 (5.88%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
EXCORIATION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FALL  1  2/34 (5.88%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FEMORAL NECK FRACTURE  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
JOINT INJURY  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LACERATION  1  0/34 (0.00%)  2/27 (7.41%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MUSCLE STRAIN  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
OVERDOSE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
POST-TRAUMATIC NECK SYNDROME  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SCRATCH  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SUNBURN  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SUPERFICIAL INJURY OF EYE  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TOOTH FRACTURE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TRAUMATIC FRACTURE  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Investigations                       
ALANINE AMINOTRANSFERASE INCREASED  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD BICARBONATE DECREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD BILIRUBIN INCREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD CREATININE INCREASED  1  1/34 (2.94%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD GLUCOSE INCREASED  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD POTASSIUM INCREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD PRESSURE INCREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD TRIGLYCERIDES INCREASED  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD UREA INCREASED  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BLOOD URINE PRESENT  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CARDIAC MURMUR  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CYTOMEGALOVIRUS TEST POSITIVE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HAEMATOCRIT DECREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HAEMOGLOBIN DECREASED  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  2/22 (9.09%)  0/12 (0.00%)  2/9 (22.22%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
IMMUNOSUPPRESSANT DRUG LEVEL INCREASED  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LYMPHOCYTE COUNT DECREASED  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
NEUTROPHIL COUNT DECREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
VITAMIN D DECREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
WEIGHT DECREASED  1  3/34 (8.82%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
WEIGHT INCREASED  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
WHITE BLOOD CELL COUNT DECREASED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders                       
DECREASED APPETITE  1  4/34 (11.76%)  3/27 (11.11%)  1/13 (7.69%)  1/4 (25.00%)  1/2 (50.00%)  0/22 (0.00%)  1/12 (8.33%)  2/9 (22.22%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DEHYDRATION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DIABETES MELLITUS  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DIABETES MELLITUS INADEQUATE CONTROL  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
GOUT  1  0/34 (0.00%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPERGLYCAEMIA  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPERKALAEMIA  1  2/34 (5.88%)  0/27 (0.00%)  2/13 (15.38%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPERURICAEMIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPOGLYCAEMIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPOKALAEMIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPOMAGNESAEMIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPONATRAEMIA  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  2/9 (22.22%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders                       
ARTHRALGIA  1  2/34 (5.88%)  2/27 (7.41%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/1 (0.00%) 
ARTHRITIS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
BACK PAIN  1  6/34 (17.65%)  0/27 (0.00%)  1/13 (7.69%)  2/4 (50.00%)  0/2 (0.00%)  1/22 (4.55%)  1/12 (8.33%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
FLANK PAIN  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
GOUTY ARTHRITIS  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
GROIN PAIN  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
LIMB DISCOMFORT  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MUSCLE FATIGUE  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MUSCLE SPASMS  1  7/34 (20.59%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MUSCLE TWITCHING  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MUSCULOSKELETAL CHEST PAIN  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MUSCULOSKELETAL DISCOMFORT  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MYALGIA  1  3/34 (8.82%)  4/27 (14.81%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  2/9 (22.22%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
NECK PAIN  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  1/2 (50.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PAIN IN EXTREMITY  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TENDONITIS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
KERATOACANTHOMA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SQUAMOUS CELL CARCINOMA  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Nervous system disorders                       
BALANCE DISORDER  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CAROTID ARTERY STENOSIS  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DIZZINESS  1  6/34 (17.65%)  4/27 (14.81%)  1/13 (7.69%)  1/4 (25.00%)  1/2 (50.00%)  4/22 (18.18%)  2/12 (16.67%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DYSGEUSIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HEADACHE  1  15/34 (44.12%)  8/27 (29.63%)  2/13 (15.38%)  2/4 (50.00%)  1/2 (50.00%)  6/22 (27.27%)  6/12 (50.00%)  3/9 (33.33%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPERSOMNIA  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPOAESTHESIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MEMORY IMPAIRMENT  1  2/34 (5.88%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MIGRAINE  1  0/34 (0.00%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ORTHOSTATIC INTOLERANCE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PARAESTHESIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
POOR QUALITY SLEEP  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PRESYNCOPE  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SEIZURE  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SINUS HEADACHE  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SYNCOPE  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TENSION HEADACHE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TREMOR  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
TUNNEL VISION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Psychiatric disorders                       
ABNORMAL DREAMS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
AFFECT LABILITY  1  3/34 (8.82%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ANXIETY  1  5/34 (14.71%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
APATHY  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CONFUSIONAL STATE  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DEPRESSED MOOD  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DEPRESSION  1  4/34 (11.76%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
EMOTIONAL DISORDER  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
INSOMNIA  1  9/34 (26.47%)  3/27 (11.11%)  0/13 (0.00%)  1/4 (25.00%)  1/2 (50.00%)  3/22 (13.64%)  2/12 (16.67%)  2/9 (22.22%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
IRRITABILITY  1  4/34 (11.76%)  2/27 (7.41%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
LIBIDO INCREASED  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MANIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
MOOD SWINGS  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
NIGHTMARE  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RESTLESSNESS  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders                       
ANURIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
CHROMATURIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DYSURIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
POLLAKIURIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
POLYURIA  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PROTEINURIA  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
URINARY RETENTION  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Reproductive system and breast disorders                       
ERECTILE DYSFUNCTION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
GENITAL RASH  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PENILE BLISTER  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PROSTATITIS  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PROSTATOMEGALY  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
VULVOVAGINAL PRURITUS  1  0/34 (0.00%)  0/27 (0.00%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
CHOKING  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
COUGH  1  11/34 (32.35%)  5/27 (18.52%)  2/13 (15.38%)  0/4 (0.00%)  1/2 (50.00%)  3/22 (13.64%)  1/12 (8.33%)  3/9 (33.33%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
DRY THROAT  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DYSPHONIA  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DYSPNOEA  1  3/34 (8.82%)  3/27 (11.11%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  2/22 (9.09%)  1/12 (8.33%)  1/9 (11.11%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DYSPNOEA EXERTIONAL  1  5/34 (14.71%)  5/27 (18.52%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
NASAL CONGESTION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
OROPHARYNGEAL PAIN  1  3/34 (8.82%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  3/22 (13.64%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
PARANASAL SINUS DISCOMFORT  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PRODUCTIVE COUGH  1  2/34 (5.88%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  3/22 (13.64%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RESPIRATORY TRACT CONGESTION  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RHINORRHOEA  1  6/34 (17.65%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  1/9 (11.11%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
SINUS CONGESTION  1  2/34 (5.88%)  1/27 (3.70%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SNEEZING  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
THROAT IRRITATION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
UPPER RESPIRATORY TRACT CONGESTION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
UPPER-AIRWAY COUGH SYNDROME  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
WHEEZING  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders                       
ACNE  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
ALOPECIA  1  0/34 (0.00%)  2/27 (7.41%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DERMATITIS CONTACT  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
DRY SKIN  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  2/4 (50.00%)  1/2 (50.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/1 (100.00%) 
ERYTHEMA  1  3/34 (8.82%)  1/27 (3.70%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HAIR GROWTH ABNORMAL  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPERHIDROSIS  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PETECHIAE  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PHOTOSENSITIVITY REACTION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PRURITUS  1  2/34 (5.88%)  4/27 (14.81%)  1/13 (7.69%)  4/4 (100.00%)  2/2 (100.00%)  5/22 (22.73%)  4/12 (33.33%)  1/9 (11.11%)  0/3 (0.00%)  1/2 (50.00%)  0/1 (0.00%) 
PRURITUS GENERALISED  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
PSORIASIS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RASH  1  7/34 (20.59%)  9/27 (33.33%)  0/13 (0.00%)  2/4 (50.00%)  0/2 (0.00%)  4/22 (18.18%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RASH GENERALISED  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RASH MACULAR  1  1/34 (2.94%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RASH MACULO-PAPULAR  1  0/34 (0.00%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RASH PAPULAR  1  2/34 (5.88%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
RASH PRURITIC  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/22 (4.55%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SKIN EXFOLIATION  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SKIN LESION  1  1/34 (2.94%)  2/27 (7.41%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
SKIN TIGHTNESS  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
URTICARIA  1  0/34 (0.00%)  1/27 (3.70%)  0/13 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
Vascular disorders                       
HOT FLUSH  1  1/34 (2.94%)  0/27 (0.00%)  0/13 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
HYPERTENSION  1  3/34 (8.82%)  3/27 (11.11%)  1/13 (7.69%)  0/4 (0.00%)  0/2 (0.00%)  0/22 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01782495    
Other Study ID Numbers: M12-999
2012-004792-39 ( EudraCT Number )
First Submitted: January 22, 2013
First Posted: February 4, 2013
Results First Submitted: October 9, 2017
Results First Posted: November 7, 2017
Last Update Posted: November 7, 2017