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    Clinical Trial Results:
    Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/Ritonavir/ABT-267 With ABT-333 and With or Without RBV in HCV Genotype 1 and ABT-450/r/ABT-267 With RBV in HCV GT4-Infected Adult Liver or Renal Transplant Recipients With Hepatitis C Virus (HCV) Infection (CORAL-I)

    Summary
    EudraCT number
    		 2012-004792-39
    Trial protocol
    		 ES   GB   DE  
    Global end of trial date
    13 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Nov 2017
    First version publication date
    25 Nov 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M12-999
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01782495
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    Emily Dumas, AbbVie, emily.dumas@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection.
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United States: 86
    Worldwide total number of subjects
    129
    EEA total number of subjects
    35
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    97
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study included a 35-day screening period.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 Arm B
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 Arm C
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Arm title
    		 Arm D
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 Arm E
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 Arm F
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 Arm G
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Arm title
    		 Arm H
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 Arm I
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    dasabuvir
    Investigational medicinal product code
    Other name
    Exviera, ABT-333
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dasabuvir 250 mg twice daily

    Arm title
    		 Arm J
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 Arm K
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    Viekirax, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ombitasvir (25 mg) coformulated with paritaprevir (150 mg) and ritonavir (100 mg) twice daily

    Investigational medicinal product name
    ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Number of subjects in period 1
    		Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
    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
         Adverse event
    -
    -
    -
    -
    -
    -
    -
    2
    -
    -
    -
         Withdrew consent
    -
    1
    -
    -
    -
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting 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.

    Reporting group title
    Arm B
    Reporting group description
    		 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.

    Reporting group title
    Arm C
    Reporting group description
    		 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.

    Reporting group title
    Arm D
    Reporting group description
    		 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.

    Reporting group title
    Arm E
    Reporting group description
    		 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.

    Reporting group title
    Arm F
    Reporting group description
    		 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.

    Reporting group title
    Arm G
    Reporting group description
    		 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.

    Reporting group title
    Arm H
    Reporting group description
    		 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.

    Reporting group title
    Arm I
    Reporting group description
    		 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.

    Reporting group title
    Arm J
    Reporting group description
    		 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.

    Reporting group title
    Arm K
    Reporting group description
    		 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.

    Reporting group values
    		 Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K Total
    Number of subjects
    		 34 27 13 4 2 22 12 9 3 2 1 129
    Age categorical
    Units: Subjects
    Age continuous
    Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. 77777=The estimated standard deviation of one sample is undefined
    Units: years
        arithmetic mean (standard deviation)
    		 59.6 ( 6.62 ) 58 ( 6.66 ) 61.8 ( 5.76 ) 59.8 ( 10.78 ) 78 ( 1.41 ) 58.3 ( 9.35 ) 62.2 ( 7.64 ) 58 ( 8 ) 57.3 ( 9.29 ) 63.5 ( 7.78 ) 50 ( 77777 ) -
    Gender categorical
    Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.
    Units: Subjects
        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

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting 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.

    Reporting group title
    Arm B
    Reporting group description
    		 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.

    Reporting group title
    Arm C
    Reporting group description
    		 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.

    Reporting group title
    Arm D
    Reporting group description
    		 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.

    Reporting group title
    Arm E
    Reporting group description
    		 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.

    Reporting group title
    Arm F
    Reporting group description
    		 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.

    Reporting group title
    Arm G
    Reporting group description
    		 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.

    Reporting group title
    Arm H
    Reporting group description
    		 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.

    Reporting group title
    Arm I
    Reporting group description
    		 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.

    Reporting group title
    Arm J
    Reporting group description
    		 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.

    Reporting group title
    Arm K
    Reporting group description
    		 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.

    Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [1]
    End point 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.
    End point type
    Primary
    End point timeframe
    12 weeks after the last actual dose of study drug
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive data are summarized for this end point per protocol.
    End point values
    		 Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
    Number of subjects analysed
    34 [2]
    27 [3]
    13 [4]
    4 [5]
    2 [6]
    22 [7]
    12 [8]
    9 [9]
    3 [10]
    2 [11]
    1 [12]
    Units: percentage of participants
        number (confidence interval 95%)
    97.1 (85.1 to 99.5)
    96.3 (81.7 to 99.3)
    100 (77.2 to 100)
    100 (51 to 100)
    100 (34.2 to 100)
    95.5 (78.2 to 99.2)
    100 (75.8 to 100)
    66.7 (35.4 to 87.9)
    100 (43.9 to 100)
    100 (34.2 to 100)
    100 (20.7 to 100)
    Notes
    [2] - All participants who received at least 1 dose of study drug (ITT population).
    [3] - All participants who received at least 1 dose of study drug (ITT population).
    [4] - All participants who received at least 1 dose of study drug (ITT population).
    [5] - All participants who received at least 1 dose of study drug (ITT population).
    [6] - All participants who received at least 1 dose of study drug (ITT population).
    [7] - All participants who received at least 1 dose of study drug (ITT population).
    [8] - All participants who received at least 1 dose of study drug (ITT population).
    [9] - All participants who received at least 1 dose of study drug (ITT population).
    [10] - All participants who received at least 1 dose of study drug (ITT population).
    [11] - All participants who received at least 1 dose of study drug (ITT population).
    [12] - All participants who received at least 1 dose of study drug (ITT population).
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
    End point 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.
    End point type
    Secondary
    End point timeframe
    24 weeks after the last actual dose of study drug
    End point values
    		 Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
    Number of subjects analysed
    34 [13]
    27 [14]
    13 [15]
    4 [16]
    2 [17]
    22 [18]
    12 [19]
    9 [20]
    3 [21]
    2 [22]
    1 [23]
    Units: percentage of participants
        number (confidence interval 95%)
    97.1 (85.1 to 99.5)
    96.3 (81.7 to 99.3)
    100 (77.2 to 100)
    100 (51 to 100)
    100 (34.2 to 100)
    95.5 (78.2 to 99.2)
    100 (75.8 to 100)
    66.7 (35.4 to 87.9)
    100 (43.9 to 100)
    100 (34.2 to 100)
    100 (20.7 to 100)
    Notes
    [13] - All participants who received at least 1 dose of study drug (ITT population).
    [14] - All participants who received at least 1 dose of study drug (ITT population).
    [15] - All participants who received at least 1 dose of study drug (ITT population).
    [16] - All participants who received at least 1 dose of study drug (ITT population).
    [17] - All participants who received at least 1 dose of study drug (ITT population).
    [18] - All participants who received at least 1 dose of study drug (ITT population).
    [19] - All participants who received at least 1 dose of study drug (ITT population).
    [20] - All participants who received at least 1 dose of study drug (ITT population).
    [21] - All participants who received at least 1 dose of study drug (ITT population).
    [22] - All participants who received at least 1 dose of study drug (ITT population).
    [23] - All participants who received at least 1 dose of study drug (ITT population).
    No statistical analyses for this end point

    Secondary: Percentage of Participants With On-treatment Virologic Failure

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    End point title
    		 Percentage of Participants With On-treatment Virologic Failure
    End point 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.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)
    End point values
    		 Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
    Number of subjects analysed
    34 [24]
    27 [25]
    13 [26]
    4 [27]
    2 [28]
    22 [29]
    12 [30]
    9 [31]
    3 [32]
    2 [33]
    1 [34]
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 10.2)
    3.7 (0.7 to 18.3)
    0 (0 to 22.8)
    0 (0 to 49)
    0 (0 to 65.8)
    0 (0 to 14.9)
    0 (0 to 24.2)
    0 (0 to 29.9)
    0 (0 to 56.1)
    0 (0 to 65.8)
    0 (0 to 79.3)
    Notes
    [24] - All participants who received at least 1 dose of study drug (ITT population).
    [25] - All participants who received at least 1 dose of study drug (ITT population).
    [26] - All participants who received at least 1 dose of study drug (ITT population).
    [27] - All participants who received at least 1 dose of study drug (ITT population).
    [28] - All participants who received at least 1 dose of study drug (ITT population).
    [29] - All participants who received at least 1 dose of study drug (ITT population).
    [30] - All participants who received at least 1 dose of study drug (ITT population).
    [31] - All participants who received at least 1 dose of study drug (ITT population).
    [32] - All participants who received at least 1 dose of study drug (ITT population).
    [33] - All participants who received at least 1 dose of study drug (ITT population).
    [34] - All participants who received at least 1 dose of study drug (ITT population).
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Post-treatment Relapse

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    End point title
    		 Percentage of Participants With Post-treatment Relapse
    End point 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.
    End point type
    Secondary
    End point timeframe
    From the end of treatment through 12 weeks after the last dose of study drug
    End point values
    		 Arm A Arm B Arm C Arm D Arm E Arm F Arm G Arm H Arm I Arm J Arm K
    Number of subjects analysed
    33 [35]
    26 [36]
    12 [37]
    4 [38]
    2 [39]
    21 [40]
    12 [41]
    6 [42]
    3 [43]
    2 [44]
    1 [45]
    Units: percentage of participants
        number (confidence interval 95%)
    3 (0.5 to 15.3)
    0 (0 to 12.9)
    0 (0 to 24.2)
    0 (0 to 49)
    0 (0 to 65.8)
    4.8 (0.8 to 22.7)
    0 (0 to 24.2)
    0 (0 to 39)
    0 (0 to 56.1)
    0 (0 to 65.8)
    0 (0 to 79.3)
    Notes
    [35] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [36] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [37] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [38] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [39] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [40] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [41] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [42] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [43] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [44] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    [45] - Participants received ≥1 dose, completed treatment, had HCV RNA <LLOQ at the final treatment visit
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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 additional 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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting 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.

    Reporting group title
    Arm B
    Reporting group description
    		 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.

    Reporting group title
    Arm C
    Reporting group description
    		 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.

    Reporting group title
    Arm D
    Reporting group description
    		 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.

    Reporting group title
    Arm E
    Reporting group description
    		 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.

    Reporting group title
    Arm F
    Reporting group description
    		 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.

    Reporting group title
    Arm H
    Reporting group description
    		 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.

    Reporting group title
    Arm G
    Reporting group description
    		 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.

    Reporting group title
    Arm J
    Reporting group description
    		 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.

    Reporting group title
    Arm I
    Reporting group description
    		 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.

    Reporting group title
    Arm K
    Reporting group description
    		 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.

    Serious adverse events
    		 Arm A Arm B Arm C Arm D Arm E Arm F Arm H Arm G Arm J Arm I Arm K
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 27 (3.70%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    4 / 9 (44.44%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    OVERDOSE
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    TACHYCARDIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    ISCHAEMIC CEREBRAL INFARCTION
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    LEUKOCYTOSIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    OEDEMA PERIPHERAL
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 27 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 27 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY FAILURE
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    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 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    PAIN IN EXTREMITY
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ATYPICAL PNEUMONIA
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPONATRAEMIA
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B Arm C Arm D Arm E Arm F Arm H Arm G Arm J Arm I Arm K
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 34 (97.06%)
    27 / 27 (100.00%)
    12 / 13 (92.31%)
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    22 / 22 (100.00%)
    8 / 9 (88.89%)
    12 / 12 (100.00%)
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    KERATOACANTHOMA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    HOT FLUSH
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HYPERTENSION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    8 / 34 (23.53%)
    7 / 27 (25.93%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    2 / 2 (100.00%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    11
    13
    1
    0
    3
    2
    0
    1
    0
    0
    0
    CHEST PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CHILLS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    EXERCISE TOLERANCE DECREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    FACE OEDEMA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    FATIGUE
         subjects affected / exposed
    17 / 34 (50.00%)
    14 / 27 (51.85%)
    4 / 13 (30.77%)
    4 / 4 (100.00%)
    0 / 2 (0.00%)
    14 / 22 (63.64%)
    6 / 9 (66.67%)
    2 / 12 (16.67%)
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
         occurrences all number
    20
    16
    4
    8
    0
    14
    6
    2
    1
    1
    1
    FEELING ABNORMAL
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    FEELING COLD
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HERNIA PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    OEDEMA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    5 / 34 (14.71%)
    2 / 27 (7.41%)
    1 / 13 (7.69%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    5
    2
    1
    2
    1
    1
    0
    1
    0
    2
    0
    PAIN
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 27 (7.41%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    3
    0
    0
    0
    1
    0
    1
    0
    0
    0
    PERIPHERAL SWELLING
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    PYREXIA
         subjects affected / exposed
    5 / 34 (14.71%)
    2 / 27 (7.41%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    7
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Immune system disorders
    ALLERGY TO ARTHROPOD BITE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    LIVER TRANSPLANT REJECTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    SEASONAL ALLERGY
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    ERECTILE DYSFUNCTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    GENITAL RASH
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PENILE BLISTER
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PROSTATITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PROSTATOMEGALY
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    VULVOVAGINAL PRURITUS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    CHOKING
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    COUGH
         subjects affected / exposed
    11 / 34 (32.35%)
    5 / 27 (18.52%)
    2 / 13 (15.38%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    3 / 22 (13.64%)
    3 / 9 (33.33%)
    1 / 12 (8.33%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    14
    6
    3
    0
    1
    3
    3
    1
    1
    0
    0
    DRY THROAT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    DYSPHONIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    DYSPNOEA
         subjects affected / exposed
    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 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    4
    0
    3
    0
    6
    1
    1
    0
    0
    0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    5
    0
    0
    0
    1
    0
    0
    0
    0
    0
    NASAL CONGESTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    4
    0
    0
    1
    0
    0
    PARANASAL SINUS DISCOMFORT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PRODUCTIVE COUGH
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    3
    0
    0
    0
    0
    0
    RESPIRATORY TRACT CONGESTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RHINORRHOEA
         subjects affected / exposed
    6 / 34 (17.65%)
    0 / 27 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    SINUS CONGESTION
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    0
    0
    1
    0
    0
    0
    SNEEZING
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    THROAT IRRITATION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    UPPER RESPIRATORY TRACT CONGESTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    UPPER-AIRWAY COUGH SYNDROME
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    WHEEZING
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    ABNORMAL DREAMS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    AFFECT LABILITY
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ANXIETY
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    APATHY
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CONFUSIONAL STATE
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    DEPRESSED MOOD
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    DEPRESSION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    EMOTIONAL DISORDER
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    INSOMNIA
         subjects affected / exposed
    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 / 9 (22.22%)
    2 / 12 (16.67%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    9
    3
    0
    1
    1
    3
    2
    2
    0
    0
    0
    IRRITABILITY
         subjects affected / exposed
    4 / 34 (11.76%)
    2 / 27 (7.41%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    0
    0
    1
    1
    0
    0
    LIBIDO INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MANIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MOOD SWINGS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    NIGHTMARE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RESTLESSNESS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD BICARBONATE DECREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    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 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    BLOOD GLUCOSE INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD POTASSIUM INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    BLOOD PRESSURE INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD UREA INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD URINE PRESENT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CARDIAC MURMUR
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    CYTOMEGALOVIRUS TEST POSITIVE
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    HAEMATOCRIT DECREASED
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    HAEMOGLOBIN DECREASED
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 27 (3.70%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 22 (9.09%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    2
    3
    0
    0
    0
    0
    IMMUNOSUPPRESSANT DRUG LEVEL INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    VITAMIN D DECREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    WEIGHT DECREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    WEIGHT INCREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    ACCIDENT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ARTHROPOD BITE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    ARTHROPOD STING
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CONTUSION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    EXCORIATION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    FALL
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    JOINT INJURY
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    LACERATION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    MUSCLE STRAIN
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 27 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    OVERDOSE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    POST-TRAUMATIC NECK SYNDROME
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SCRATCH
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SUNBURN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SUPERFICIAL INJURY OF EYE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    TOOTH FRACTURE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    TRAUMATIC FRACTURE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    PALPITATIONS
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 27 (3.70%)
    0 / 13 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    BALANCE DISORDER
         subjects affected / exposed
    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 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    CAROTID ARTERY STENOSIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    DIZZINESS
         subjects affected / exposed
    6 / 34 (17.65%)
    4 / 27 (14.81%)
    1 / 13 (7.69%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    4 / 22 (18.18%)
    1 / 9 (11.11%)
    2 / 12 (16.67%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    7
    4
    1
    1
    1
    4
    1
    2
    0
    0
    0
    DYSGEUSIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HEADACHE
         subjects affected / exposed
    15 / 34 (44.12%)
    8 / 27 (29.63%)
    2 / 13 (15.38%)
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    6 / 22 (27.27%)
    3 / 9 (33.33%)
    6 / 12 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    20
    9
    3
    3
    2
    6
    4
    7
    0
    0
    0
    HYPERSOMNIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HYPOAESTHESIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    MEMORY IMPAIRMENT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    MIGRAINE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    ORTHOSTATIC INTOLERANCE
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    PARAESTHESIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    POOR QUALITY SLEEP
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PRESYNCOPE
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    SEIZURE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SINUS HEADACHE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SYNCOPE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    TENSION HEADACHE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    TREMOR
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    TUNNEL VISION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    8 / 34 (23.53%)
    8 / 27 (29.63%)
    1 / 13 (7.69%)
    3 / 4 (75.00%)
    2 / 2 (100.00%)
    4 / 22 (18.18%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    8
    9
    1
    3
    3
    4
    4
    0
    0
    1
    0
    HAEMOLYTIC ANAEMIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    LEUKOPENIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    LYMPHOPENIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    EAR PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    VERTIGO
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    DIPLOPIA
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    DRY EYE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    EYE PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    EYE PRURITUS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    OCULAR DISCOMFORT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    OCULAR HYPERAEMIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    VISION BLURRED
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    VISUAL IMPAIRMENT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    VITREOUS FLOATERS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 27 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 22 (13.64%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    ABDOMINAL DISTENSION
         subjects affected / exposed
    3 / 34 (8.82%)
    1 / 27 (3.70%)
    0 / 13 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    0
    1
    0
    1
    2
    0
    0
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    5 / 34 (14.71%)
    0 / 27 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    1
    0
    1
    0
    0
    2
    0
    0
    0
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 27 (3.70%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    2
    1
    0
    0
    0
    0
    0
    1
    0
    0
    ANAL PRURITUS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ANORECTAL DISCOMFORT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    APHTHOUS ULCER
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    BOWEL MOVEMENT IRREGULARITY
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CONSTIPATION
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 27 (3.70%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 22 (18.18%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    2
    1
    1
    0
    0
    4
    2
    1
    0
    0
    1
    DENTAL CARIES
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    DIARRHOEA
         subjects affected / exposed
    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 / 9 (22.22%)
    2 / 12 (16.67%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    17
    7
    1
    1
    1
    6
    2
    2
    0
    0
    0
    DIVERTICULUM INTESTINAL
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    DRY MOUTH
         subjects affected / exposed
    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 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    DYSPEPSIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    2
    1
    0
    0
    1
    0
    0
    0
    0
    0
    DYSPHAGIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    EPIGASTRIC DISCOMFORT
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    FAECES DISCOLOURED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    FLATULENCE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    GINGIVAL BLEEDING
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HAEMORRHOIDS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    LIP DRY
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    NAUSEA
         subjects affected / exposed
    8 / 34 (23.53%)
    11 / 27 (40.74%)
    2 / 13 (15.38%)
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    4 / 22 (18.18%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    9
    14
    2
    2
    1
    4
    3
    0
    0
    0
    0
    OESOPHAGEAL DILATATION
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    TOOTH IMPACTED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    TOOTHACHE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    VOMITING
         subjects affected / exposed
    4 / 34 (11.76%)
    5 / 27 (18.52%)
    0 / 13 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    6
    8
    0
    1
    0
    1
    0
    1
    1
    0
    0
    Hepatobiliary disorders
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    JAUNDICE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    6
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ALOPECIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    DERMATITIS CONTACT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    DRY SKIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    0
    0
    4
    1
    1
    0
    0
    0
    0
    1
    ERYTHEMA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    HAIR GROWTH ABNORMAL
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HYPERHIDROSIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    PETECHIAE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PHOTOSENSITIVITY REACTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PRURITUS
         subjects affected / exposed
    2 / 34 (5.88%)
    4 / 27 (14.81%)
    1 / 13 (7.69%)
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    5 / 22 (22.73%)
    1 / 9 (11.11%)
    4 / 12 (33.33%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    6
    1
    8
    4
    5
    2
    4
    1
    0
    0
    PRURITUS GENERALISED
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    PSORIASIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RASH
         subjects affected / exposed
    7 / 34 (20.59%)
    9 / 27 (33.33%)
    0 / 13 (0.00%)
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    4 / 22 (18.18%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    10
    12
    0
    4
    0
    4
    0
    1
    0
    0
    0
    RASH GENERALISED
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    RASH MACULAR
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RASH MACULO-PAPULAR
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    RASH PAPULAR
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RASH PRURITIC
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    SKIN EXFOLIATION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SKIN LESION
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 27 (7.41%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    SKIN TIGHTNESS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    URTICARIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    ANURIA
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    CHROMATURIA
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    DYSURIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    POLLAKIURIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    POLYURIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PROTEINURIA
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    URINARY RETENTION
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 27 (7.41%)
    0 / 13 (0.00%)
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    0
    1
    0
    1
    0
    ARTHRITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BACK PAIN
         subjects affected / exposed
    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 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    7
    0
    1
    2
    0
    1
    1
    1
    0
    0
    0
    FLANK PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    GOUTY ARTHRITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    GROIN PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    LIMB DISCOMFORT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCLE FATIGUE
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCLE SPASMS
         subjects affected / exposed
    7 / 34 (20.59%)
    1 / 27 (3.70%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    8
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    MUSCLE TWITCHING
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCULOSKELETAL DISCOMFORT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    MYALGIA
         subjects affected / exposed
    3 / 34 (8.82%)
    4 / 27 (14.81%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    4
    0
    0
    0
    0
    2
    0
    1
    0
    0
    NECK PAIN
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    PAIN IN EXTREMITY
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    TENDONITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    ACARODERMATITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    CELLULITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    CYTOMEGALOVIRUS VIRAEMIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    FOLLICULITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    FUNGAL INFECTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    GASTROENTERITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    HERPES ZOSTER
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HORDEOLUM
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    IMPETIGO
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    INFLUENZA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    LOCALISED INFECTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    ORAL CANDIDIASIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    ORAL HERPES
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    OTITIS MEDIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    PHARYNGITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PHARYNGITIS STREPTOCOCCAL
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SINUSITIS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SKIN INFECTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    TINEA CRURIS
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    TINEA PEDIS
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    TOOTH INFECTION
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 34 (8.82%)
    2 / 27 (7.41%)
    2 / 13 (15.38%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    3
    2
    2
    0
    0
    0
    1
    0
    0
    1
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    4 / 34 (11.76%)
    3 / 27 (11.11%)
    1 / 13 (7.69%)
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 22 (0.00%)
    2 / 9 (22.22%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    3
    1
    1
    1
    0
    2
    1
    0
    0
    0
    DEHYDRATION
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    DIABETES MELLITUS
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    DIABETES MELLITUS INADEQUATE CONTROL
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    GOUT
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    HYPERKALAEMIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    HYPERURICAEMIA
         subjects affected / exposed
    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 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    HYPOGLYCAEMIA
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    HYPOKALAEMIA
         subjects affected / exposed
    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 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    HYPOMAGNESAEMIA
         subjects affected / exposed
    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 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 27 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 22 (0.00%)
    2 / 9 (22.22%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Feb 2013
    The primary purpose of this amendment was to clarify requirements for rescreening subjects; clarify management of calcineurin inhibitor medications; update inclusion (clarify contraceptives/pregnancy, liver biopsy timeframes) and exclusion criteria (prior history including pegylated interferon [pegIFN] therapy, liver disease, other organ transplant, dietary habits); and clarify study activities.
    08 Apr 2013
    The primary purpose of this amendment was to prohibit the use of hormonal contraceptives during study drug administration.
    12 Dec 2013
    The primary purpose of this amendment was to update the introduction to reflect current case studies and analyses of study data; increase enrollment to 70 subjects; add study arms and further define cohorts 1 and 2; allow enrollment of subjects with interferon (IFN)/ribavirin(RBV) treatment failure, non-cirrhotic subjects with fibrosis scores up to F3 by Metavir Scale (or equivalent score by another scoring system), and subjects with subgenotype 1b who are treatment-naïve or treatment responders; make related updates to the study plan and inclusion and exclusion criteria); update cyclosporine and tacrolimus recommendations based on pharmacokinetic data; clarify blood sample collection; and add hepatitis C virus (HCV) treatment history and response to treatment definitions and collection criteria.
    03 Oct 2014
    The primary purpose of this amendment was to increase enrollment to 145 subjects; add ten study arms (Arms D through M) and further define Cohorts 3, 4, 5, and 6; allow enrollment of subjects with compensated cirrhosis (Child-Pugh A) after liver transplant, subjects who are 3 – 6 months post liver transplant, subjects who are more than 6 and less than 12 months post liver transplant with HCV-related elevation of liver enzymes (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]), and subjects with chronic HCV who are at least 12 months post renal transplant; and make related updates to the study plan, rescreening criteria, and inclusion and exclusion criteria.
    08 Dec 2014
    The primary purpose of this amendment was to increase enrollment to 175 subjects; remove Arms H and K and combine Arms F and I and Arms G and J into a single Cohort (Cohort 4); combine Cohorts 4 and 5 to allow enrollment of subjects ≥ 3 months post liver transplant; change Cohort 6 (Renal Transplant) to Cohort 5; remove language limiting enrollment of renal transplant recipients with a Metavir score of F3 to 5 subjects; and make related update to the study plan and inclusion and exclusion criteria.
    13 Jul 2015
    The primary purpose of this amendment was to increase enrollment to 195; add Cohort 6 (HCV genotype 4-infected subjects post liver transplant); and make related updates to the study and inclusion and exclusion criteria.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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