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    Clinical Trial Results:
    A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

    Summary
    EudraCT number
    		 2013-000604-41
    Trial protocol
    		 IT   CZ   SE   AT   BE   GB   DE   NL   ES   IE   DK  
    Global end of trial date
    07 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2016
    First version publication date
    23 Oct 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VX12-809-105
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01931839
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, Massachusetts, United States, 02210-1862
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, + 1 617-341-6777, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, + 1 617-341-6777, medicalinfo@vrtx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001582-PIP01-13
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long term safety and tolerability of lumacaftor (LUM) in combination with ivacaftor (IVA) in subjects with cystic fibrosis (CF), homozygous or heterozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, who were in the Part A and Part B Treatment Cohorts.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Oct 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 103
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Belgium: 36
    Country: Number of subjects enrolled
    Canada: 41
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    Denmark: 9
    Country: Number of subjects enrolled
    France: 70
    Country: Number of subjects enrolled
    Germany: 83
    Country: Number of subjects enrolled
    Ireland: 13
    Country: Number of subjects enrolled
    Italy: 51
    Country: Number of subjects enrolled
    Netherlands: 18
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    United States: 649
    Country: Number of subjects enrolled
    United Kingdom: 41
    Worldwide total number of subjects
    1163
    EEA total number of subjects
    370
    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)
    283
    Adults (18-64 years)
    880
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study conducted in 2 parts: A and B. Part A consisted of Treatment Cohorts and an Observational Cohort, which enrolled subjects from Study VX12-809-103 and Study VX12-809-104. Part B consisted of Treatment Cohorts which enrolled subjects from Cohort 4 of Study VX09-809-102. Of 1164 subjects enrolled, 1163 were dosed and included in EudraCT results.

    Pre-assignment
    Screening details
    		 As per planned analysis, endpoint evaluation may also include subjects from the parent study VX12-809-103 (2012-003989-40), VX12-809-104 (2012-003990-24) or Cohort 4 of VX09-809-102 (2010-020413-90) irrespective of whether they were enrolled in the current study or not.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h
    Arm description
    		 Subjects who received LUM 600 milligram (mg) once daily (qd) in fixed dose combination with IVA 250 mg every 12 hours (q12h) in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received the same treatment in this study VX12-809-105 (2013-000604-41) up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor Plus Ivacaftor Combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LUM 600 mg plus IVA 250 mg as a fixed dose combination in morning up to Week 96.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    VX-770
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor 250 mg in evening up to Week 96.

    Arm title
    		 Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h
    Arm description
    		 Subjects who received placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 600 mg qd in fixed dose combintion with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor Plus Ivacaftor Combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LUM 600 mg plus IVA 250 mg as a fixed dose combination in morning up to Week 96.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    VX-770
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor 250 mg in evening up to Week 96.

    Arm title
    		 Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h
    Arm description
    		 Subjects who received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received the same treatment in this study VX12-809-105 (2013-000604-41) up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor Plus Ivacaftor Combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LUM 400 mg plus IVA 250 mg as a fixed dose combination in morning and evening up to Week 96.

    Arm title
    		 Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Arm description
    		 Subjects who received placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor Plus Ivacaftor Combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LUM 400 mg plus IVA 250 mg as a fixed dose combination in morning and evening up to Week 96.

    Arm title
    		 Arm 5: Part A Observational Cohort
    Arm description
    		 Subjects who received either LUM 600 mg qd in fixed dose combination with IVA 250 mg q12h or LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h or placebo matched to LUM and IVA q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), were observed (did not receive study drug) in this study VX12-809-105 (2013-000604-41) for up to 2 years.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h
    Arm description
    		 Subjects who received LUM 400 mg q12h in fixed dose combination with IVA 250 q12h in Cohort 4 of the previous study VX09-809-102 (2010-020413-90), received the same treatment in this VX12-809-105 (2013-000604-41) up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor Plus Ivacaftor Combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LUM 400 mg plus IVA 250 mg as a fixed dose combination in morning and evening up to Week 96.

    Arm title
    		 Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Arm description
    		 Subjects who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (2010-020413-90), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor Plus Ivacaftor Combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LUM 400 mg plus IVA 250 mg as a fixed dose combination in morning and evening up to Week 96.

    Number of subjects in period 1
    		Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h Arm 5: Part A Observational Cohort Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Started
    335
    178
    340
    176
    19
    55
    60
    Completed
    294
    152
    301
    162
    18
    50
    56
    Not completed
    41
    26
    39
    14
    1
    5
    4
         Physician decision
    1
    -
    1
    -
    -
    -
    1
         Other
    4
    2
    6
    -
    -
    -
    -
         Death
    -
    1
    2
    -
    -
    -
    -
         Adverse event
    9
    4
    1
    3
    -
    -
    1
         Withdrawal of consent
    -
    -
    -
    -
    1
    -
    -
         Lost to follow-up
    1
    2
    4
    5
    -
    -
    -
         Other non-compliance
    15
    9
    12
    3
    -
    3
    -
         Withdrawal of consent (not due to AE)
    11
    8
    13
    3
    -
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 600 milligram (mg) once daily (qd) in fixed dose combination with IVA 250 mg every 12 hours (q12h) in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received the same treatment in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 600 mg qd in fixed dose combintion with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received the same treatment in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 5: Part A Observational Cohort
    Reporting group description
    		 Subjects who received either LUM 600 mg qd in fixed dose combination with IVA 250 mg q12h or LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h or placebo matched to LUM and IVA q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), were observed (did not receive study drug) in this study VX12-809-105 (2013-000604-41) for up to 2 years.

    Reporting group title
    Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 400 mg q12h in fixed dose combination with IVA 250 q12h in Cohort 4 of the previous study VX09-809-102 (2010-020413-90), received the same treatment in this VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (2010-020413-90), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h Arm 5: Part A Observational Cohort Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h Total
    Number of subjects
    		 335 178 340 176 19 55 60 1163
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.1 ( 8.97 ) 25.7 ( 10.74 ) 25.1 ( 9.35 ) 24.9 ( 10.1 ) 27.2 ( 11.08 ) 29.3 ( 7.82 ) 31 ( 8.98 ) -
    Gender categorical
    Units: Subjects
        Female
    		 166 89 164 86 12 25 31 573
        Male
    		 169 89 176 90 7 30 29 590

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 600 milligram (mg) once daily (qd) in fixed dose combination with IVA 250 mg every 12 hours (q12h) in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received the same treatment in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 600 mg qd in fixed dose combintion with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received the same treatment in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 5: Part A Observational Cohort
    Reporting group description
    		 Subjects who received either LUM 600 mg qd in fixed dose combination with IVA 250 mg q12h or LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h or placebo matched to LUM and IVA q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), were observed (did not receive study drug) in this study VX12-809-105 (2013-000604-41) for up to 2 years.

    Reporting group title
    Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 400 mg q12h in fixed dose combination with IVA 250 q12h in Cohort 4 of the previous study VX09-809-102 (2010-020413-90), received the same treatment in this VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (2010-020413-90), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Subject analysis set title
    Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who were randomized to LUM 600 milligram (mg) once daily (qd) in fixed dose combination with IVA 250 mg every 12 hours (q12h) in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24).

    Subject analysis set title
    Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who were randomized to placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 600 mg qd in fixed dose combintion with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Subject analysis set title
    Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who were randomized to LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24).

    Subject analysis set title
    Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who were randomized to placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Subject analysis set title
    Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who were randomized to LUM 400 mg q12h in fixed dose combination with IVA 250 q12h in Cohort 4 of the previous study VX09-809-102 (2010-020413-90).

    Subject analysis set title
    Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who were randomized to placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (2010-020413-90).

    Primary: Part A Treatment Cohort: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Part A Treatment Cohort: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [1] [2]
    End point description
    AE: as any untoward medical occurrence in a subject during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to 28 days after last dose of study drug was considered treatment-emergent. Safety Set (study 105) included all subjects in Treatment Cohort Part A who were exposed to any amount of study drug.
    End point type
    Primary
    End point timeframe
    Day 1 up to Week 105
    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: Only descriptive statistics were reported, inferential statistics were not planned for primary endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    335
    178
    340
    176
    Units: subjects
        Subjects with AEs
    331
    177
    333
    176
        Subjects with SAEs
    156
    77
    143
    89
    No statistical analyses for this end point

    Primary: Part B Treatment Cohort: Number of Subjects With Treatment-Emergent AEs and SAEs

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    End point title
    		 Part B Treatment Cohort: Number of Subjects With Treatment-Emergent AEs and SAEs [3] [4]
    End point description
    AE: as any untoward medical occurrence in a subject during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to 28 days after last dose of study drug was considered treatment-emergent. Safety Set (study 105) included all subjects in the Treatment Cohort Part B who were exposed to any amount of study drug.
    End point type
    Primary
    End point timeframe
    Day 1 up to Week 105
    Notes
    [3] - 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: Only descriptive statistics were reported, inferential statistics were not planned for primary endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    55
    60
    Units: subjects
        Subjects with AEs
    52
    57
        Subjects with SAEs
    18
    21
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) At Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part A Treatment Cohort: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) At Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [5]
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 12 to 17 years and for female subjects aged 12 to 15 years. Full Analysis Set (FAS) study 105 (2013-000604-41) included all subjects randomized in the Part A Treatment Cohort and dosed. Analysis was performed using baseline of the previous study VX12-809-103 (2012-003989-40) and Study VX12-809-104 (2012-003990-24) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (2013-000604-41) for Arm 2 and 4. Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    319
    173
    317
    165
    Units: percent predicted of FEV1
    least squares mean (standard error)
        Absolute Change at Day 15 (n= 319, 173, 317, 165)
    3 ( 0.5 )
    2.8 ( 0.6 )
    2.8 ( 0.5 )
    3 ( 0.6 )
        Absolute Change at Week 8 (n= 309, 164, 316, 165)
    3.1 ( 0.5 )
    2.8 ( 0.6 )
    3.4 ( 0.5 )
    4.2 ( 0.6 )
        Absolute Change at Week 16 (n= 307, 166, 313, 160)
    2.6 ( 0.5 )
    2.7 ( 0.6 )
    2.5 ( 0.5 )
    3.6 ( 0.7 )
        Absolute Change at Week 24 (n= 291, 158, 295, 154)
    2.9 ( 0.5 )
    2.4 ( 0.6 )
    2.7 ( 0.5 )
    3.4 ( 0.7 )
        Absolute Change at Week 36 (n= 292, 155, 294, 150)
    2.7 ( 0.5 )
    2.2 ( 0.7 )
    1.9 ( 0.5 )
    3.1 ( 0.7 )
        Absolute Change at Week 48 (n= 279, 153, 286, 143)
    1.5 ( 0.5 )
    1.8 ( 0.7 )
    1.4 ( 0.5 )
    2.1 ( 0.7 )
        Absolute Change at Week 60 (n= 276, 146, 282, 140)
    1.7 ( 0.5 )
    2.1 ( 0.7 )
    1.6 ( 0.5 )
    1.4 ( 0.7 )
        Absolute Change at Week 72 (n= 275, 146, 273, 134)
    1.2 ( 0.5 )
    1.9 ( 0.7 )
    0.5 ( 0.5 )
    1.5 ( 0.7 )
    No statistical analyses for this end point

    Secondary: Part B Treatment Cohort: Absolute Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part B Treatment Cohort: Absolute Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [6]
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 12 to 17 years and for female subjects aged 12 to 15 years. FAS (study 105) included all subjects randomized in the Part B Treatment Cohort and dosed. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (2010-020413-90) for Arm 6 and 7.Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    52
    57
    Units: percent predicted of FEV1
    arithmetic mean (standard deviation)
        Absolute Change at Day 15 (n= 52, 57)
    -2 ( 8 )
    -3.4 ( 6.6 )
        Absolute Change at Week 8 (n= 49, 55)
    -3.9 ( 7.4 )
    -1.8 ( 6.4 )
        Absolute Change at Week 16 (n= 50, 52)
    -3.1 ( 9 )
    -2.8 ( 6.8 )
        Absolute Change at Week 24 (n= 36, 36)
    -2.9 ( 7.7 )
    -2.5 ( 7.3 )
        Absolute Change at Week 36 (n= 20, 19)
    -3.2 ( 7.9 )
    -2.3 ( 7.9 )
        Absolute Change at Week 48 (n= 15, 17)
    -5.4 ( 11.2 )
    -2 ( 6 )
        Absolute Change at Week 60 (n= 12, 16)
    -1.8 ( 10.1 )
    -1.9 ( 8.2 )
        Absolute Change at Week 72 (n= 11, 15)
    -2.8 ( 9.2 )
    -7.8 ( 8.3 )
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part A Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [7]
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 12 to 17 years and for female subjects aged 12 to 15 years. FAS study 105 (2013-000604-41) included all subjects randomized in the Part A Treatment Cohort and dosed. Analysis was performed using baseline of the previous study VX12-809-103 (2012-003989-40) and Study VX12-809-104 (2012-003990-24) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (2013-000604-41) for Arm 2 and 4. Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    319
    173
    317
    165
    Units: percent change
    least squares mean (standard error)
        Relative Change at Day 15 (n= 319, 173, 317, 165)
    5.3 ( 0.9 )
    5.1 ( 1.2 )
    5.3 ( 0.9 )
    4.8 ( 1.2 )
        Relative Change at Week 8 (n= 309, 164, 316, 165)
    5.6 ( 0.9 )
    5.6 ( 1.2 )
    6.2 ( 0.9 )
    7.1 ( 1.2 )
        Relative Change at Week 16 (n= 307, 166, 313, 160)
    4.9 ( 0.9 )
    5.4 ( 1.2 )
    4.8 ( 0.9 )
    6.5 ( 1.2 )
        Relative Change at Week 24 (n= 291, 158, 295, 154)
    5.1 ( 0.9 )
    4.9 ( 1.2 )
    5 ( 0.9 )
    6.1 ( 1.2 )
        Relative Change at Week 36 (n= 292, 155, 294, 150)
    4.7 ( 0.9 )
    4 ( 1.2 )
    3.6 ( 0.9 )
    5.5 ( 1.2 )
        Relative Change at Week 48 (n= 279, 153, 286, 143)
    2.7 ( 0.9 )
    3.6 ( 1.2 )
    2.9 ( 0.9 )
    3.6 ( 1.2 )
        Relative Change at Week 60 (n= 276, 146, 282, 140)
    2.9 ( 0.9 )
    4.1 ( 1.2 )
    2.7 ( 0.9 )
    3.1 ( 1.2 )
        Relative Change at Week 72 (n= 275, 146, 273, 134)
    2.4 ( 0.9 )
    3.8 ( 1.2 )
    1.4 ( 0.9 )
    2.6 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Part B Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part B Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [8]
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 12 to 17 years and for female subjects aged 12 to 15 years. FAS (study 105) included all subjects randomized in the Part B Treatment Cohort and dosed. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (2010-020413-90) for Arm 6 and 7.Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    52
    57
    Units: percent change
    arithmetic mean (standard deviation)
        Relative Change at Day 15 (n= 52, 57)
    -2.2 ( 13.6 )
    -5.8 ( 11.4 )
        Relative Change at Week 8 (n= 49, 55)
    -5.2 ( 12.8 )
    -3.1 ( 11.4 )
        Relative Change at Week 16 (n= 50, 52)
    -4.2 ( 15.8 )
    -4.9 ( 11.8 )
        Relative Change at Week 24 (n= 36, 36)
    -3.4 ( 13.2 )
    -4.2 ( 12.6 )
        Relative Change at Week 36 (n= 20, 19)
    -4.1 ( 12.5 )
    -3.5 ( 14.2 )
        Relative Change at Week 48 (n= 15, 17)
    -6.9 ( 15.9 )
    -2.8 ( 10.6 )
        Relative Change at Week 60 (n= 12, 16)
    -0.7 ( 16.6 )
    -2.6 ( 13.9 )
        Relative Change at Week 72 (n= 11, 15)
    -3.3 ( 13.3 )
    -11.8 ( 10.7 )
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Absolute Change From Baseline in Body Mass Index (BMI) at Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part A Treatment Cohort: Absolute Change From Baseline in Body Mass Index (BMI) at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [9]
    End point description
    BMI = (Weight in kilogram [kg]) divided by (Stature in meters [m]) ^2. FAS study 105 (2013-000604-41) included all subjects randomized in the Part A Treatment Cohort and dosed. Analysis was performed using baseline of the previous study VX12-809-103 (2012-003989-40) and Study VX12-809-104 (2012-003990-24) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (2013-000604-41) for Arm 2 and 4. Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    329
    178
    338
    175
    Units: Kilogram per square meter (kg/m^2)
    least squares mean (standard error)
        Absolute Change at Day 15 (n= 328, 178, 338, 175)
    0.56 ( 0.06 )
    0.06 ( 0.08 )
    0.5 ( 0.06 )
    0.1 ( 0.08 )
        Absolute Change at Week 8 (n= 329, 173, 331, 172)
    0.58 ( 0.06 )
    0.14 ( 0.08 )
    0.55 ( 0.06 )
    0.27 ( 0.08 )
        Absolute Change at Week 16 (n= 321, 173, 325, 170)
    0.58 ( 0.06 )
    0.19 ( 0.08 )
    0.53 ( 0.06 )
    0.35 ( 0.08 )
        Absolute Change at Week 24 (n= 312, 169, 319, 165)
    0.61 ( 0.06 )
    0.22 ( 0.08 )
    0.62 ( 0.06 )
    0.41 ( 0.08 )
        Absolute Change at Week 36 (n= 304, 165, 315, 160)
    0.66 ( 0.06 )
    0.33 ( 0.08 )
    0.72 ( 0.06 )
    0.59 ( 0.08 )
        Absolute Change at Week 48 (n= 299, 162, 307, 151)
    0.63 ( 0.06 )
    0.42 ( 0.08 )
    0.71 ( 0.06 )
    0.62 ( 0.09 )
        Absolute Change at Week 60 (n= 296, 158, 298, 147)
    0.71 ( 0.06 )
    0.54 ( 0.08 )
    0.8 ( 0.06 )
    0.62 ( 0.09 )
        Absolute Change at Week 72 (n= 287, 152, 289, 145)
    0.72 ( 0.06 )
    0.52 ( 0.08 )
    0.69 ( 0.06 )
    0.62 ( 0.09 )
    No statistical analyses for this end point

    Secondary: Part B Treatment Cohort: Absolute Change From Baseline in BMI at Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part B Treatment Cohort: Absolute Change From Baseline in BMI at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [10]
    End point description
    BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. FAS (study 105) included all subjects randomized in the Part B Treatment Cohort and dosed. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (2010-020413-90) for Arm 6 and 7. Here "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    55
    60
    Units: kg/m^2
    arithmetic mean (standard deviation)
        Absolute Change at Day 15 (n= 55, 60)
    -0.05 ( 0.52 )
    -0.03 ( 0.69 )
        Absolute Change at Week 8 (n= 54, 57)
    -0.01 ( 0.82 )
    0.14 ( 0.84 )
        Absolute Change at Week 16 (n= 51, 53)
    0.08 ( 1.02 )
    0.2 ( 1.09 )
        Absolute Change at Week 24 (n= 39, 37)
    0.04 ( 0.92 )
    0.14 ( 1.08 )
        Absolute Change at Week 36 (n= 20, 20)
    0.07 ( 0.54 )
    0.85 ( 1.23 )
        Absolute Change at Week 48 (n= 17, 17)
    0.05 ( 0.64 )
    0.81 ( 1.55 )
        Absolute Change at Week 60 (n= 12, 16)
    0.08 ( 0.7 )
    0.58 ( 1.23 )
        Absolute Change at Week 72 (n= 13, 15)
    0.08 ( 0.71 )
    0.41 ( 1.28 )
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Number of Pulmonary Exacerbations Events per Patient-Year

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    End point title
    		 Part A Treatment Cohort: Number of Pulmonary Exacerbations Events per Patient-Year
    End point description
    Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events per patient year were reported, where patient years = total number of days on study/336. FAS (Study 103/104) was used for Arm 1 and 3, and included all subjects randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all subjects randomized in the Part A Treatment Cohort and dosed in current study 105. Analysis includes all events in the Cumulative Study Period for Arm 1 and 3, and all events in the Current Study period (Study 105) for Arm 2 and 4. Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    368
    179
    369
    176
    Units: events per patient year
        number (confidence interval 95%)
    0.38 (0.32 to 0.46)
    0.42 (0.33 to 0.54)
    0.32 (0.26 to 0.38)
    0.37 (0.29 to 0.49)
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Absolute Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72

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    End point title
    		 Part A Treatment Cohort: Absolute Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72 [11]
    End point description
    The CFQ-R is a validated subject-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. FAS study 105 (2013-000604-41) included all subjects randomized in the Part A Treatment Cohort and dosed. Analysis was performed using baseline of the previous study VX12-809-103 (2012-003989-40) and Study VX12-809-104 (2012-003990-24) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (2013-000604-41) for Arm 2 and 4. Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 48, 72 (Study 105)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    324
    174
    325
    170
    Units: units on a scale
    least squares mean (standard error)
        Absolute Change at Day 15 (n= 324, 174, 325, 170)
    5.9 ( 0.9 )
    2.3 ( 1.2 )
    6.2 ( 0.9 )
    3.5 ( 1.2 )
        Absolute Change at Week 8 (n= 323, 164, 319, 166)
    5 ( 0.9 )
    4.1 ( 1.2 )
    5.1 ( 0.9 )
    6.8 ( 1.2 )
        Absolute Change at Week 16 (n= 313, 167, 312, 160)
    4.1 ( 0.9 )
    2.8 ( 1.2 )
    6.4 ( 0.9 )
    7 ( 1.2 )
        Absolute Change at Week 24 (n= 305, 161, 304, 155)
    6 ( 0.9 )
    3.8 ( 1.2 )
    6.1 ( 0.9 )
    4.7 ( 1.3 )
        Absolute Change at Week 48 (n= 290, 152, 290, 140)
    2 ( 0.9 )
    3.1 ( 1.3 )
    3.7 ( 0.9 )
    1.5 ( 1.3 )
        Absolute Change at Week 72 (n= 265, 141, 269, 135)
    3.2 ( 0.9 )
    3.3 ( 1.3 )
    5.7 ( 0.9 )
    3.3 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Part B Treatment Cohort: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72

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    End point title
    		 Part B Treatment Cohort: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72 [12]
    End point description
    The CFQ-R is a validated subject-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.FAS (study 105) included all subjects randomized in the Part B Treatment Cohort and dosed. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (2010-020413-90) for Arm 6 and 7.Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 102 Study), Day 15, Week 8, 16, 24, 48, 72 (Study 105)
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    55
    59
    Units: units on a scale
    arithmetic mean (standard deviation)
        Absolute Change at Day 15 (n= 55, 59)
    3.9 ( 18 )
    -4.1 ( 18.1 )
        Absolute Change at Week 8 (n= 54, 57)
    4.8 ( 18.6 )
    1 ( 18.2 )
        Absolute Change at Week 16 (n= 51, 53)
    6.2 ( 17.2 )
    -0.2 ( 17 )
        Absolute Change at Week 24 (n= 39, 37)
    6.8 ( 19.1 )
    -1.2 ( 17.9 )
        Absolute Change at Week 48 (n= 19, 17)
    2 ( 14 )
    4.9 ( 15.6 )
        Absolute Change at Week 72 (n= 13, 15)
    8.5 ( 21.8 )
    2.2 ( 18.8 )
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Absolute Change From Baseline in BMI z-score at Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part A Treatment Cohort: Absolute Change From Baseline in BMI z-score at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [13]
    End point description
    z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to +infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the pediatric population. FAS study 105 (2013-000604-41) included all subjects randomized in the Part A Treatment Cohort and dosed. Analysis was performed using baseline of the previous study VX12-809-103 (2012-003989-40) and Study VX12-809-104 (2012-003990-24) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (2013-000604-41) for Arm 2 and 4. Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm,
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    117
    56
    109
    60
    Units: z-score
    least squares mean (standard error)
        Absolute Change at Day 15 (n= 117, 56, 109, 60)
    0.16 ( 0.04 )
    -0.01 ( 0.06 )
    0.14 ( 0.04 )
    -0.02 ( 0.05 )
        Absolute Change at Week 8 (n= 114, 53, 105, 60)
    0.15 ( 0.04 )
    0.04 ( 0.06 )
    0.16 ( 0.04 )
    0.08 ( 0.05 )
        Absolute Change at Week 16 (n= 112, 53, 101, 58)
    0.12 ( 0.04 )
    0.08 ( 0.06 )
    0.15 ( 0.04 )
    0.07 ( 0.05 )
        Absolute Change at Week 24 (n= 110, 49, 100, 56)
    0.14 ( 0.04 )
    0.08 ( 0.06 )
    0.17 ( 0.04 )
    0.1 ( 0.05 )
        Absolute Change at Week 36 (n= 100, 46, 100, 52)
    0.14 ( 0.04 )
    0.13 ( 0.06 )
    0.16 ( 0.04 )
    0.14 ( 0.05 )
        Absolute Change at Week 48 (n= 95, 46, 97, 47)
    0.09 ( 0.04 )
    0.13 ( 0.06 )
    0.11 ( 0.04 )
    0.12 ( 0.06 )
        Absolute Change at Week 60 (n= 91, 45, 90, 44)
    0.11 ( 0.04 )
    0.16 ( 0.06 )
    0.14 ( 0.04 )
    0.13 ( 0.06 )
        Absolute Change at Week 72 (n= 85, 45, 89, 42)
    0.06 ( 0.04 )
    0.12 ( 0.06 )
    0.04 ( 0.04 )
    0.08 ( 0.06 )
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part A Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [14]
    End point description
    Full Analysis Set (FAS) study 105 (2013-000604-41) included all subjects randomized in the Part A Treatment Cohort and dosed. Analysis was performed using baseline of the previous study VX12-809-103 (2012-003989-40) and Study VX12-809-104 (2012-003990-24) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (2013-000604-41) for Arm 2 and 4. Here "Number of subjects analysed" = those subjects who were evaluable for this endpoint and "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    329
    178
    338
    175
    Units: kilograms (kg)
    arithmetic mean (standard deviation)
        Absolute Change at Day 15 (n= 328, 178, 338, 175)
    1.7 ( 2.6 )
    -0.1 ( 1.8 )
    1.3 ( 2.9 )
    0.1 ( 1.2 )
        Absolute Change at Week 8 (n= 329, 173, 331, 172)
    1.8 ( 2.9 )
    0.2 ( 2.1 )
    1.5 ( 3.1 )
    0.6 ( 1.9 )
        Absolute Change at Week 16 (n= 321, 173, 325, 170)
    1.9 ( 3.2 )
    0.4 ( 2.6 )
    1.6 ( 3.3 )
    1 ( 2.5 )
        Absolute Change at Week 24 (n= 312, 169, 319, 165)
    2.2 ( 3.5 )
    0.6 ( 2.6 )
    2 ( 3.6 )
    1.2 ( 2.8 )
        Absolute Change at Week 36 (n= 304, 165, 315, 160)
    2.3 ( 3.8 )
    1 ( 3.4 )
    2.4 ( 3.8 )
    1.9 ( 3.4 )
        Absolute Change at Week 48 (n= 299, 162, 307, 151)
    2.4 ( 4.2 )
    1.3 ( 3.7 )
    2.5 ( 4.3 )
    2.1 ( 3.7 )
        Absolute Change at Week 60 (n= 296, 158, 298, 147)
    2.7 ( 4.6 )
    1.7 ( 4.2 )
    2.9 ( 4.6 )
    2.2 ( 4.4 )
        Absolute Change at Week 72 (n= 287, 152, 289, 145)
    2.9 ( 4.9 )
    1.7 ( 4.8 )
    2.7 ( 4.9 )
    2.3 ( 4.7 )
    No statistical analyses for this end point

    Secondary: Part B Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72

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    End point title
    		 Part B Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72 [15]
    End point description
    FAS (study 105) included all subjects randomized in the Part B Treatment Cohort and dosed. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (2010-020413-90) for Arm 6 and 7.Here "n" = those subjects who were evaluable at the specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    55
    60
    Units: Kg
    arithmetic mean (standard deviation)
        Absolute Change at Day 15 (n= 55, 60)
    -0.1 ( 1.5 )
    -0.1 ( 1.8 )
        Absolute Change at Week 8 (n= 54, 57)
    0 ( 2.3 )
    0.4 ( 2.3 )
        Absolute Change at Week 16 (n= 51, 53)
    0.3 ( 2.8 )
    0.6 ( 2.9 )
        Absolute Change at Week 24 (n= 39, 37)
    0.2 ( 2.6 )
    0.4 ( 3 )
        Absolute Change at Week 36 (n= 20, 20)
    0.3 ( 1.7 )
    2.3 ( 3.3 )
        Absolute Change at Week 48 (n= 17, 17)
    0.2 ( 2 )
    2.2 ( 4.3 )
        Absolute Change at Week 60 (n= 12, 16)
    0.3 ( 2.3 )
    1.5 ( 3.3 )
        Absolute Change at Week 72 (n= 13, 15)
    0.2 ( 2.3 )
    1.1 ( 3.4 )
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Time-to-First Pulmonary Exacerbation

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    End point title
    		 Part A Treatment Cohort: Time-to-First Pulmonary Exacerbation
    End point description
    Time-to-first pulmonary exacerbation was analyzed using the Kaplan-Meier estimates. Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. FAS (Study 103/104) was used for Arm 1 and 3, and included all subjects randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all subjects randomized in the Part A Treatment Cohort and dosed in current study 105. Analysis was performed for the the Cumulative Study Period for Arm 1 and 3, and for the current study period (Study 105) for Arm 2 and 4. Here, 99999 represents data for Q3 inter-quartile range was not available.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    368
    179
    369
    176
    Units: Days
        median (inter-quartile range (Q1-Q3))
    364 (99 to 99999)
    505 (111 to 99999)
    481 (132 to 99999)
    466 (153 to 99999)
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Percentage of Subjects With at Least 1 Pulmonary Exacerbation

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    End point title
    		 Part A Treatment Cohort: Percentage of Subjects With at Least 1 Pulmonary Exacerbation
    End point description
    Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. FAS (Study 103/104) was used for Arm 1 and 3, and included all subjects randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all subjects randomized in the Part A Treatment Cohort and dosed in current study 105. Analysis was performed for the the Cumulative Study Period for Arm 1 and 3, and for the current study period (Study 105) for Arm 2 and 4.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    368
    179
    369
    176
    Units: percentage of subjects
        number (confidence interval 95%)
    64.7 (59.8 to 69.6)
    53.6 (46.3 to 60.9)
    59.9 (54.9 to 64.9)
    55.7 (48.3 to 63)
    No statistical analyses for this end point

    Secondary: Part A Treatment Cohort: Percentage of Subjects With Response Based on Relative Change in Percent Predicted FEV1 From Baseline

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    End point title
    		 Part A Treatment Cohort: Percentage of Subjects With Response Based on Relative Change in Percent Predicted FEV1 From Baseline
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). Percentage of subjects with at least 5% and 10% relative change in percent predicted FEV1 from Baseline were reported. FAS (Study 103/104) was used for Arm 1 and 3, and included all subjects randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all subjects randomized in the Part A Treatment Cohort and dosed in current study 105. Analysis was performed using baseline of the previous study VX12-809-103 (2012-003989-40) or Study VX12-809-104 (2012-003990-24) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (2013-000604-41) for Arm 2 and 4.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60, 72, 84, 96 (Study 105)
    End point values
    		 Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    368
    179
    369
    176
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Day 15: >=5% Change
    39.4 (34.4 to 44.4)
    42.5 (35.2 to 49.7)
    40.9 (35.9 to 45.9)
    42.6 (35.3 to 49.9)
        Day 15: >=10% Change
    25 (20.6 to 29.4)
    26.8 (20.3 to 33.3)
    24.7 (20.3 to 29.1)
    26.7 (20.2 to 33.2)
        Week 8: >=5% Change
    39.7 (34.7 to 44.7)
    38 (30.9 to 45.1)
    39.3 (34.3 to 44.3)
    48.9 (41.5 to 56.2)
        Week 8: >=10% Change
    26.9 (22.4 to 31.4)
    23.5 (17.3 to 29.7)
    26.6 (22.1 to 31.1)
    35.8 (28.7 to 42.9)
        Week 16: >=5% Change
    37.2 (32.3 to 42.2)
    36.9 (29.8 to 43.9)
    36.9 (31.9 to 41.8)
    46.6 (39.2 to 54)
        Week 16: >=10% Change
    25.5 (21.1 to 30)
    25.1 (18.8 to 31.5)
    26.3 (21.8 to 30.8)
    28.4 (21.7 to 35.1)
        Week 24: >=5% Change
    35.6 (30.7 to 40.5)
    38 (30.9 to 45.1)
    33.6 (28.8 to 38.4)
    42.6 (35.3 to 49.9)
        Week 24: >=10% Change
    24.5 (20.1 to 28.8)
    21.8 (15.7 to 27.8)
    22.5 (18.2 to 26.8)
    32.4 (25.5 to 39.3)
        Week 36: >=5% Change
    35.3 (30.4 to 40.2)
    32.4 (25.5 to 39.3)
    31.7 (27 to 36.5)
    38.6 (31.4 to 45.8)
        Week 36: >=10% Change
    23.4 (19 to 27.7)
    22.9 (16.7 to 29.1)
    22.2 (18 to 26.5)
    27.3 (20.7 to 33.9)
        Week 48: >=5% Change
    30.2 (25.5 to 34.9)
    32.4 (25.5 to 39.3)
    30.9 (26.2 to 35.6)
    36.4 (29.3 to 43.5)
        Week 48: >=10% Change
    21.7 (17.5 to 26)
    21.8 (15.7 to 27.8)
    21.4 (17.2 to 25.6)
    19.9 (14 to 25.8)
        Week 60: >=5% Change
    30.4 (25.7 to 35.1)
    32.4 (25.5 to 39.3)
    29.3 (24.6 to 33.9)
    38.6 (31.4 to 45.8)
        Week 60: >=10% Change
    20.4 (16.3 to 24.5)
    25.1 (18.8 to 31.5)
    19.2 (15.2 to 23.3)
    24.4 (18.1 to 30.8)
        Week 72: >=5% Change
    29.3 (24.7 to 34)
    34.6 (27.7 to 41.6)
    25.5 (21 to 29.9)
    33 (26 to 39.9)
        Week 72: >=10% Change
    18.2 (14.3 to 22.1)
    22.3 (16.2 to 28.4)
    18.2 (14.2 to 22.1)
    23.3 (17.1 to 29.5)
        Week 84: >=5% Change
    23.1 (18.8 to 27.4)
    28.5 (21.9 to 35.1)
    23.3 (19 to 27.6)
    26.1 (19.6 to 32.6)
        Week 84: >=10% Change
    14.9 (11.3 to 18.6)
    21.2 (15.2 to 27.2)
    15.7 (12 to 19.4)
    19.9 (14 to 25.8)
        Week 96: >=5% Change
    15.5 (11.8 to 19.2)
    14.5 (9.4 to 19.7)
    13.8 (10.3 to 17.3)
    15.3 (10 to 20.7)
        Week 96: >=10% Change
    8.7 (5.8 to 11.6)
    10.1 (5.7 to 14.5)
    10.3 (7.2 to 13.4)
    9.1 (4.8 to 13.3)
    No statistical analyses for this end point

    Secondary: Part B Treatment Cohort: Percentage of Subjects With Response Based on Relative Change in Percent Predicted FEV1 From Baseline

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    End point title
    		 Part B Treatment Cohort: Percentage of Subjects With Response Based on Relative Change in Percent Predicted FEV1 From Baseline
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). Percentage of subjects with at least 5% relative change in percent predicted FEV1 from Baseline were reported. FAS (Study 102) was used for Arm 6 and 7, and included all subjects randomized in the cohort 4 of study 102 and dosed. Analysis was performed using baseline of the previous study VX09-809-102 (2010-020413-90) for Arm 6 and 7.
    End point type
    Secondary
    End point timeframe
    Baseline (Study 102); Day 15, Week 8, 16, 24, 36, 48, 60, 72, 84, 96 (Study 105)
    End point values
    		 Arm 6: Part B - LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h
    Number of subjects analysed
    62
    63
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Day 15: >=5% Change
    21 (10.8 to 31.1)
    12.7 (4.5 to 20.9)
        Week 8: >=5% Change
    11.3 (3.4 to 19.2)
    19 (9.4 to 28.7)
        Week 16: >=5% Change
    19.4 (9.5 to 29.2)
    15.9 (6.8 to 24.9)
        Week 24: >=5% Change
    12.9 (4.6 to 21.2)
    12.7 (4.5 to 20.9)
        Week 36: >=5% Change
    6.5 (0.3 to 12.6)
    6.3 (0.3 to 12.4)
        Week 48: >=5% Change
    6.5 (0.3 to 12.6)
    4.8 (0 to 10)
        Week 60: >=5% Change
    6.5 (0.3 to 12.6)
    6.3 (0.3 to 12.4)
        Week 72: >=5% Change
    3.2 (0 to 7.6)
    0 (0 to 0)
        Week 84: >=5% Change
    1.6 (0 to 4.7)
    1.6 (0 to 4.7)
        Week 96: >=5% Change
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Part A Observation Cohort: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Part A Observation Cohort: Number of Subjects With Serious Adverse Events (SAEs) [16]
    End point description
    AE: as any untoward medical occurrence in a subject during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Safety Set (study 105) included all subjects who were enrolled in Part A Observation Cohort.
    End point type
    Secondary
    End point timeframe
    up to 2 years
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arms which are applicable to the endpoint are reported.
    End point values
    		 Arm 5: Part A Observational Cohort
    Number of subjects analysed
    19
    Units: subjects
        number (not applicable)
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Week 105
    Adverse event reporting additional description
    Non-SAEs were not collected for Arm 5: Part A Observational Cohort. Only SAEs were collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Arm 1: Part A LUM 600 mg qd/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 600 mg qd in fixed dose combination with IVA 250 mg in the previous study VX12-809-103 (2012-003989-40) and VX12-809-104 (2012-003990-24), received the same treatment in this study 105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 2: Part A PlaceboLUM 600 mg qd/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 600 mg qd in fixed dose combintion with IVA 250 mg q12h in this study 105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 3: Part A LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received the same treatment in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 4: Part A - Placebo - LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA n the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study 105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 5: Part A Observational Cohort
    Reporting group description
    		 Subjects who received either LUM 600 mg qd in fixed dose combination with IVA 250 mg q12h or LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h or placebo matched to LUM and IVA q12h in the previous study VX12-809-103 (2012-003989-40) or VX12-809-104 (2012-003990-24), were observed (did not receive study drug) in this study VX12-809-105 (2013-000604-41) for up to 2 years.

    Reporting group title
    Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received LUM 400 mg q12h in fixed dose combination with IVA 250 q12h in Cohort 4 of the previous study VX09-809-102 (2010-020413-90), received the same treatment in this VX12-809-105 (2013-000604-41) up to Week 96.

    Reporting group title
    Arm 7: Part B - Placebo - LUM 400 mg q12h/ IVA 250 mg q12h
    Reporting group description
    		 Subjects who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (2010-020413-90), received LUM 400 mg q12h in fixed dose combination with IVA 250 mg q12h in this study VX12-809-105 (2013-000604-41) up to Week 96.

    Serious adverse events
    		 Arm 1: Part A LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A PlaceboLUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo - LUM 400 mg q12h/ IVA 250 mg q12h Arm 5: Part A Observational Cohort Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo - LUM 400 mg q12h/ IVA 250 mg q12h
    Total subjects affected by serious adverse events
         subjects affected / exposed
    156 / 335 (46.57%)
    77 / 178 (43.26%)
    143 / 340 (42.06%)
    89 / 176 (50.57%)
    7 / 19 (36.84%)
    18 / 55 (32.73%)
    21 / 60 (35.00%)
         number of deaths (all causes)
    0
    1
    2
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Hypertensive crisis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Chest pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Fatigue
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Pyrexia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Medical device site thrombosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 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
    Anaphylactic reaction
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Serum sickness
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Type IV hypersensitivity reaction
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    17 / 335 (5.07%)
    7 / 178 (3.93%)
    10 / 340 (2.94%)
    6 / 176 (3.41%)
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    1 / 24
    1 / 7
    0 / 16
    3 / 9
    0 / 1
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    5 / 335 (1.49%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 1
    0 / 5
    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
    Respiration abnormal
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    3 / 3
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    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
    Nasal polyps
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Acute respiratory failure
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Asthma
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Bronchiectasis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Dyspnoea
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    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
    Hypoxia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Lower respiratory tract congestion
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Pleural effusion
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Pleuritic pain
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Pulmonary bulla
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Pulmonary embolism
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory distress
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Respiratory failure
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 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
    Adjustment disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Major depression
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Suicidal ideation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Investigations
    Pulmonary function test decreased
         subjects affected / exposed
    3 / 335 (0.90%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    1 / 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
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    1 / 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
    Bacterial test positive
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    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
    Forced expiratory volume decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 4
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Influenza B virus test positive
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Liver function test increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Weight decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Influenza A virus test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Ligament rupture
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Lower limb fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Pelvic fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Upper limb fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Facial bones fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Cystic fibrosis related diabetes
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystic fibrosis pancreatic
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    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
    Cardiac arrest
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Myocardial ischaemia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Ventricular tachycardia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    Cardiomyopathy
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cauda equina syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Cerebrovascular accident
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Dizziness
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Juvenile myoclonic epilepsy
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Neurological symptom
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Vocal cord paralysis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Blood and lymphatic system disorders
    Haemolytic anaemia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Eye disorders
    Cataract subcapsular
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Gastrointestinal disorders
    Distal intestinal obstruction syndrome
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    6 / 340 (1.76%)
    10 / 176 (5.68%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    1 / 8
    1 / 10
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    5 / 335 (1.49%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 1
    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
    Abdominal pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 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
    Abdominal pain upper
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    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
    Constipation
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    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
    Diarrhoea
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 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
    Intestinal obstruction
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 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
    Gastritis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Faecaloma
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Food poisoning
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Hiatus hernia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Inguinal hernia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Mechanical ileus
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Pancreatitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Biliary colic
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Cholangitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Rash maculo-papular
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 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
    Nephrolithiasis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Renal colic
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 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
    Nephrotic syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Pathological fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Polyarthritis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Rhabdomyolysis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    113 / 335 (33.73%)
    61 / 178 (34.27%)
    111 / 340 (32.65%)
    59 / 176 (33.52%)
    5 / 19 (26.32%)
    15 / 55 (27.27%)
    15 / 60 (25.00%)
         occurrences causally related to treatment / all
    8 / 219
    2 / 130
    4 / 212
    5 / 107
    0 / 11
    2 / 20
    2 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 335 (1.79%)
    4 / 178 (2.25%)
    5 / 340 (1.47%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    3 / 6
    0 / 6
    0 / 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
    Influenza
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    6 / 340 (1.76%)
    3 / 176 (1.70%)
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 6
    0 / 3
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 335 (0.90%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
    0 / 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
    Bronchopulmonary aspergillosis allergic
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    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
    Acute sinusitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 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
    Bronchitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    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
    Device related infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 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
    Device related sepsis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Gastroenteritis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Sepsis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    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
    Tracheobronchitis
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    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
    Anal abscess
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Bacteraemia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Cellulitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Chronic sinusitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastroenteritis viral
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatitis E
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    1 / 19 (5.26%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Lung infection pseudomonal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Mediastinitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Mycobacterium abscessus infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Nasopharyngitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Parotitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Periorbital abscess
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Peritonitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Peritonsillar abscess
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Pneumonia bacterial
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Pneumonia pseudomonal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Post procedural infection
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Pyelonephritis acute
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Rhinovirus infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Sinusitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Tooth abscess
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Kidney infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Dehydration
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Hyperglycaemia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Hypoglycaemia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm 1: Part A LUM 600 mg qd/ IVA 250 mg q12h Arm 2: Part A PlaceboLUM 600 mg qd/ IVA 250 mg q12h Arm 3: Part A LUM 400 mg q12h/ IVA 250 mg q12h Arm 4: Part A - Placebo - LUM 400 mg q12h/ IVA 250 mg q12h Arm 5: Part A Observational Cohort Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h Arm 7: Part B - Placebo - LUM 400 mg q12h/ IVA 250 mg q12h
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    328 / 335 (97.91%)
    177 / 178 (99.44%)
    332 / 340 (97.65%)
    173 / 176 (98.30%)
    0 / 19 (0.00%)
    52 / 55 (94.55%)
    57 / 60 (95.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign breast neoplasm
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Lipoma
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Malignant melanoma
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Metastases to bone
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Neurofibroma
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Skin papilloma
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 335 (0.90%)
    2 / 178 (1.12%)
    4 / 340 (1.18%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    3
    4
    5
    3
    0
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 335 (0.90%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    4
    1
    2
    0
    0
    0
    1
    Hot flush
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    0
    Flushing
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    1
    Haematoma
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Vasodilatation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Thrombosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Surgical and medical procedures
    Ethmoid sinus surgery
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Wisdom teeth removal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    60 / 335 (17.91%)
    27 / 178 (15.17%)
    47 / 340 (13.82%)
    31 / 176 (17.61%)
    0 / 19 (0.00%)
    6 / 55 (10.91%)
    8 / 60 (13.33%)
         occurrences all number
    84
    41
    64
    44
    0
    6
    10
    Fatigue
         subjects affected / exposed
    45 / 335 (13.43%)
    26 / 178 (14.61%)
    36 / 340 (10.59%)
    22 / 176 (12.50%)
    0 / 19 (0.00%)
    7 / 55 (12.73%)
    6 / 60 (10.00%)
         occurrences all number
    57
    32
    47
    26
    0
    9
    6
    Pain
         subjects affected / exposed
    12 / 335 (3.58%)
    5 / 178 (2.81%)
    6 / 340 (1.76%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    13
    6
    6
    3
    0
    1
    1
    Malaise
         subjects affected / exposed
    3 / 335 (0.90%)
    4 / 178 (2.25%)
    9 / 340 (2.65%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    3
    5
    9
    1
    0
    1
    1
    Chest discomfort
         subjects affected / exposed
    7 / 335 (2.09%)
    6 / 178 (3.37%)
    3 / 340 (0.88%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    8
    8
    5
    8
    0
    0
    0
    Chest pain
         subjects affected / exposed
    7 / 335 (2.09%)
    6 / 178 (3.37%)
    2 / 340 (0.59%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    7
    8
    2
    5
    0
    0
    1
    Asthenia
         subjects affected / exposed
    6 / 335 (1.79%)
    2 / 178 (1.12%)
    5 / 340 (1.47%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    8
    2
    5
    2
    0
    0
    1
    Chills
         subjects affected / exposed
    4 / 335 (1.19%)
    3 / 178 (1.69%)
    6 / 340 (1.76%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    5
    4
    6
    2
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    5 / 340 (1.47%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    2
    3
    5
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 335 (0.90%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    0
    Application site vesicles
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Catheter site haematoma
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Exercise tolerance decreased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    2
    Sensation of foreign body
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Application site irritation
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Catheter site rash
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Drug intolerance
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Face oedema
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Facial pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hernia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Hunger
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Infusion site bruising
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Infusion site pruritus
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Mass
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Medical device pain
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Medical device site ulcer
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Temperature intolerance
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vaccination site pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vessel puncture site pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vessel puncture site phlebitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Infusion site inflammation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Local swelling
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Medical device site extravasation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    13 / 335 (3.88%)
    5 / 178 (2.81%)
    19 / 340 (5.59%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    3 / 60 (5.00%)
         occurrences all number
    13
    7
    22
    5
    0
    3
    4
    Drug hypersensitivity
         subjects affected / exposed
    4 / 335 (1.19%)
    3 / 178 (1.69%)
    4 / 340 (1.18%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    6
    3
    4
    4
    0
    0
    2
    Hypersensitivity
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Allergy to animal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    House dust allergy
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Immunisation reaction
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Mycotic allergy
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Reaction to food additive
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Serum sickness
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Smoke sensitivity
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Social circumstances
    Menopause
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    6 / 335 (1.79%)
    3 / 178 (1.69%)
    8 / 340 (2.35%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    7
    3
    15
    6
    0
    0
    1
    Metrorrhagia
         subjects affected / exposed
    6 / 335 (1.79%)
    2 / 178 (1.12%)
    2 / 340 (0.59%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    8
    2
    2
    4
    0
    0
    0
    Abnormal withdrawal bleeding
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Cervical polyp
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    1
    Menstruation irregular
         subjects affected / exposed
    3 / 335 (0.90%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    1
    3
    2
    0
    0
    0
    Menorrhagia
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    2
    2
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    3
    0
    0
    0
    0
    Polycystic ovaries
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    Breast tenderness
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Endometriosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Acquired hydrocele
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Adnexa uteri mass
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Amenorrhoea
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Balanoposthitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Bartholin's cyst
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Gynaecomastia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Ovarian hyperfunction
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Polymenorrhoea
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pruritus genital
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Rectocele
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Testicular cyst
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Testicular pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Uterine prolapse
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Vaginal inflammation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Vulvovaginal discomfort
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Vulvovaginal pain
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    167 / 335 (49.85%)
    92 / 178 (51.69%)
    145 / 340 (42.65%)
    82 / 176 (46.59%)
    0 / 19 (0.00%)
    18 / 55 (32.73%)
    18 / 60 (30.00%)
         occurrences all number
    355
    181
    292
    166
    0
    24
    35
    Sputum increased
         subjects affected / exposed
    75 / 335 (22.39%)
    36 / 178 (20.22%)
    79 / 340 (23.24%)
    37 / 176 (21.02%)
    0 / 19 (0.00%)
    11 / 55 (20.00%)
    18 / 60 (30.00%)
         occurrences all number
    127
    52
    119
    60
    0
    11
    23
    Haemoptysis
         subjects affected / exposed
    61 / 335 (18.21%)
    37 / 178 (20.79%)
    68 / 340 (20.00%)
    29 / 176 (16.48%)
    0 / 19 (0.00%)
    8 / 55 (14.55%)
    10 / 60 (16.67%)
         occurrences all number
    109
    64
    136
    49
    0
    20
    17
    Dyspnoea
         subjects affected / exposed
    52 / 335 (15.52%)
    33 / 178 (18.54%)
    53 / 340 (15.59%)
    36 / 176 (20.45%)
    0 / 19 (0.00%)
    9 / 55 (16.36%)
    13 / 60 (21.67%)
         occurrences all number
    65
    38
    71
    48
    0
    11
    14
    Oropharyngeal pain
         subjects affected / exposed
    45 / 335 (13.43%)
    21 / 178 (11.80%)
    44 / 340 (12.94%)
    22 / 176 (12.50%)
    0 / 19 (0.00%)
    8 / 55 (14.55%)
    7 / 60 (11.67%)
         occurrences all number
    57
    24
    66
    26
    0
    10
    9
    Respiration abnormal
         subjects affected / exposed
    39 / 335 (11.64%)
    30 / 178 (16.85%)
    34 / 340 (10.00%)
    25 / 176 (14.20%)
    0 / 19 (0.00%)
    7 / 55 (12.73%)
    21 / 60 (35.00%)
         occurrences all number
    50
    42
    43
    34
    0
    8
    24
    Nasal congestion
         subjects affected / exposed
    40 / 335 (11.94%)
    20 / 178 (11.24%)
    37 / 340 (10.88%)
    23 / 176 (13.07%)
    0 / 19 (0.00%)
    8 / 55 (14.55%)
    4 / 60 (6.67%)
         occurrences all number
    59
    27
    59
    30
    0
    13
    4
    Productive cough
         subjects affected / exposed
    20 / 335 (5.97%)
    10 / 178 (5.62%)
    21 / 340 (6.18%)
    13 / 176 (7.39%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    2 / 60 (3.33%)
         occurrences all number
    30
    13
    30
    14
    0
    3
    2
    Sinus congestion
         subjects affected / exposed
    22 / 335 (6.57%)
    9 / 178 (5.06%)
    18 / 340 (5.29%)
    12 / 176 (6.82%)
    0 / 19 (0.00%)
    7 / 55 (12.73%)
    3 / 60 (5.00%)
         occurrences all number
    26
    14
    19
    15
    0
    10
    3
    Rhinorrhoea
         subjects affected / exposed
    26 / 335 (7.76%)
    8 / 178 (4.49%)
    12 / 340 (3.53%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    4 / 60 (6.67%)
         occurrences all number
    30
    10
    14
    11
    0
    2
    4
    Wheezing
         subjects affected / exposed
    16 / 335 (4.78%)
    7 / 178 (3.93%)
    13 / 340 (3.82%)
    12 / 176 (6.82%)
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    3 / 60 (5.00%)
         occurrences all number
    20
    9
    18
    13
    0
    3
    3
    Paranasal sinus hypersecretion
         subjects affected / exposed
    14 / 335 (4.18%)
    4 / 178 (2.25%)
    18 / 340 (5.29%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    1 / 60 (1.67%)
         occurrences all number
    17
    4
    25
    7
    0
    3
    1
    Respiratory tract congestion
         subjects affected / exposed
    19 / 335 (5.67%)
    5 / 178 (2.81%)
    14 / 340 (4.12%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    1 / 60 (1.67%)
         occurrences all number
    19
    5
    20
    4
    0
    7
    2
    Asthma
         subjects affected / exposed
    13 / 335 (3.88%)
    6 / 178 (3.37%)
    16 / 340 (4.71%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    15
    6
    22
    5
    0
    3
    1
    Lower respiratory tract congestion
         subjects affected / exposed
    20 / 335 (5.97%)
    3 / 178 (1.69%)
    12 / 340 (3.53%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    4 / 60 (6.67%)
         occurrences all number
    21
    3
    15
    5
    0
    0
    5
    Rales
         subjects affected / exposed
    10 / 335 (2.99%)
    9 / 178 (5.06%)
    10 / 340 (2.94%)
    11 / 176 (6.25%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    2 / 60 (3.33%)
         occurrences all number
    10
    10
    10
    13
    0
    1
    2
    Sputum discoloured
         subjects affected / exposed
    13 / 335 (3.88%)
    4 / 178 (2.25%)
    12 / 340 (3.53%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    14
    4
    13
    7
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    9 / 335 (2.69%)
    2 / 178 (1.12%)
    12 / 340 (3.53%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    9
    2
    16
    8
    0
    0
    1
    Dysphonia
         subjects affected / exposed
    10 / 335 (2.99%)
    2 / 178 (1.12%)
    10 / 340 (2.94%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    13
    2
    12
    8
    0
    0
    3
    Bronchospasm
         subjects affected / exposed
    7 / 335 (2.09%)
    4 / 178 (2.25%)
    8 / 340 (2.35%)
    8 / 176 (4.55%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    9
    5
    12
    9
    0
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    9 / 335 (2.69%)
    10 / 178 (5.62%)
    7 / 340 (2.06%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    10
    10
    7
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    10 / 335 (2.99%)
    2 / 178 (1.12%)
    10 / 340 (2.94%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    13
    2
    10
    4
    0
    1
    0
    Nasal polyps
         subjects affected / exposed
    5 / 335 (1.49%)
    3 / 178 (1.69%)
    8 / 340 (2.35%)
    9 / 176 (5.11%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    5
    3
    9
    9
    0
    1
    0
    Pleuritic pain
         subjects affected / exposed
    10 / 335 (2.99%)
    5 / 178 (2.81%)
    4 / 340 (1.18%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    4 / 60 (6.67%)
         occurrences all number
    11
    5
    4
    6
    0
    1
    7
    Dyspnoea exertional
         subjects affected / exposed
    8 / 335 (2.39%)
    4 / 178 (2.25%)
    6 / 340 (1.76%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    9
    5
    7
    4
    0
    1
    3
    Increased viscosity of bronchial secretion
         subjects affected / exposed
    7 / 335 (2.09%)
    6 / 178 (3.37%)
    4 / 340 (1.18%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    9
    7
    4
    2
    0
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    5 / 340 (1.47%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    5
    2
    0
    1
    0
    Increased bronchial secretion
         subjects affected / exposed
    4 / 335 (1.19%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    5
    1
    3
    1
    0
    0
    0
    Painful respiration
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    5 / 340 (1.47%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    2
    1
    5
    1
    0
    2
    1
    Throat irritation
         subjects affected / exposed
    4 / 335 (1.19%)
    0 / 178 (0.00%)
    5 / 340 (1.47%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    5
    0
    0
    0
    0
    Nasal discharge discolouration
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    4 / 340 (1.18%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    5
    1
    0
    0
    0
    Bronchiectasis
         subjects affected / exposed
    3 / 335 (0.90%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    3
    2
    1
    0
    0
    1
    1
    Hypoxia
         subjects affected / exposed
    4 / 335 (1.19%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    4
    1
    0
    0
    0
    0
    2
    Paranasal sinus discomfort
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    2
    2
    3
    1
    0
    1
    1
    Bronchial hyperreactivity
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    3
    0
    0
    1
    0
    Lung infiltration
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    Nocturnal dyspnoea
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Obstructive airways disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Oropharyngeal discomfort
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Rhinalgia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Bronchial obstruction
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    5
    0
    0
    0
    Bronchial secretion retention
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    0
    0
    Increased upper airway secretion
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    2
    1
    0
    0
    0
    Sneezing
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    0
    0
    Nasal oedema
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    0
    0
    Nasal mucosal disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    3
    0
    0
    0
    0
    Pleurisy
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    Pulmonary pain
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    0
    2
    0
    0
    0
    Sinus disorder
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    1
    1
    1
    0
    0
    0
    Sputum retention
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    2
    0
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    0
    0
    Nasal dryness
         subjects affected / exposed
    3 / 335 (0.90%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    Nasal inflammation
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Nasal obstruction
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    Pharyngeal erythema
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    Allergic sinusitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Lung disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Nasal septum deviation
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Pleural effusion
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Rhonchi
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    Sinus polyp
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Acquired diaphragmatic eventration
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Allergic cough
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Allergic respiratory disease
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Allergic respiratory symptom
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Bronchial irritation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Bronchostenosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Hyperventilation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Hypopnoea
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Increased viscosity of upper respiratory secretion
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Lung consolidation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Lung hyperinflation
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Nasal discomfort
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Nasal turbinate hypertrophy
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Orthopnoea
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Paranasal cyst
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pharyngeal oedema
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pleural fibrosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pneumomediastinum
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Pneumonitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pulmonary bulla
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Reflux laryngitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Respiratory tract haemorrhage
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Respiratory tract inflammation
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Respiratory tract irritation
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Tachypnoea
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Throat tightness
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Tonsillolith
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Tracheal disorder
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Tracheal inflammation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    14 / 335 (4.18%)
    5 / 178 (2.81%)
    9 / 340 (2.65%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    16
    5
    9
    4
    0
    1
    0
    Insomnia
         subjects affected / exposed
    7 / 335 (2.09%)
    9 / 178 (5.06%)
    9 / 340 (2.65%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    7
    12
    10
    2
    0
    0
    1
    Depressed mood
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    3
    2
    0
    0
    0
    Panic attack
         subjects affected / exposed
    4 / 335 (1.19%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    1
    0
    0
    0
    0
    0
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    Stress
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Adjustment disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Adjustment disorder with anxiety
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Agitation
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Decreased interest
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Disturbance in social behaviour
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Encopresis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Food aversion
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Hallucination, visual
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Intentional self-injury
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Listless
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Nervousness
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Obsessive-compulsive disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Somnambulism
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Suicidal ideation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Depression
         subjects affected / exposed
    7 / 335 (2.09%)
    4 / 178 (2.25%)
    8 / 340 (2.35%)
    10 / 176 (5.68%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    2 / 60 (3.33%)
         occurrences all number
    7
    4
    8
    10
    0
    1
    2
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    Device occlusion
         subjects affected / exposed
    4 / 335 (1.19%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    1
    2
    0
    0
    0
    0
    Device leakage
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Jaundice
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Cholelithiasis
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    Biliary colic
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    Hepatomegaly
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    0
    0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hepatic pain
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Hepatic steatosis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Investigations
    Pulmonary function test decreased
         subjects affected / exposed
    35 / 335 (10.45%)
    23 / 178 (12.92%)
    29 / 340 (8.53%)
    15 / 176 (8.52%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    3 / 60 (5.00%)
         occurrences all number
    42
    28
    35
    17
    0
    2
    3
    Blood creatine phosphokinase increased
         subjects affected / exposed
    26 / 335 (7.76%)
    23 / 178 (12.92%)
    23 / 340 (6.76%)
    15 / 176 (8.52%)
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    10 / 60 (16.67%)
         occurrences all number
    33
    29
    38
    18
    0
    5
    10
    Forced expiratory volume decreased
         subjects affected / exposed
    26 / 335 (7.76%)
    12 / 178 (6.74%)
    28 / 340 (8.24%)
    15 / 176 (8.52%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    7 / 60 (11.67%)
         occurrences all number
    31
    13
    31
    22
    0
    2
    7
    Bacterial test positive
         subjects affected / exposed
    29 / 335 (8.66%)
    7 / 178 (3.93%)
    30 / 340 (8.82%)
    11 / 176 (6.25%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    42
    9
    42
    15
    0
    2
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    10 / 335 (2.99%)
    14 / 178 (7.87%)
    14 / 340 (4.12%)
    15 / 176 (8.52%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    4 / 60 (6.67%)
         occurrences all number
    12
    15
    18
    18
    0
    2
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    12 / 335 (3.58%)
    13 / 178 (7.30%)
    15 / 340 (4.41%)
    13 / 176 (7.39%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    7 / 60 (11.67%)
         occurrences all number
    13
    14
    20
    14
    0
    1
    7
    Blood glucose decreased
         subjects affected / exposed
    4 / 335 (1.19%)
    1 / 178 (0.56%)
    4 / 340 (1.18%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    4
    1
    4
    2
    0
    2
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    2
    1
    6
    2
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    16 / 335 (4.78%)
    7 / 178 (3.93%)
    18 / 340 (5.29%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    0 / 60 (0.00%)
         occurrences all number
    16
    7
    20
    3
    0
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    5 / 335 (1.49%)
    6 / 178 (3.37%)
    3 / 340 (0.88%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    8
    8
    3
    8
    0
    1
    1
    Blood glucose increased
         subjects affected / exposed
    5 / 335 (1.49%)
    7 / 178 (3.93%)
    2 / 340 (0.59%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    5
    7
    2
    6
    0
    0
    1
    Fungal test positive
         subjects affected / exposed
    5 / 335 (1.49%)
    4 / 178 (2.25%)
    6 / 340 (1.76%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    6
    7
    8
    2
    0
    1
    0
    Vitamin D decreased
         subjects affected / exposed
    6 / 335 (1.79%)
    3 / 178 (1.69%)
    3 / 340 (0.88%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    6
    3
    3
    5
    0
    0
    0
    Liver function test increased
         subjects affected / exposed
    1 / 335 (0.30%)
    6 / 178 (3.37%)
    3 / 340 (0.88%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    8
    3
    2
    0
    0
    2
    White blood cell count increased
         subjects affected / exposed
    4 / 335 (1.19%)
    5 / 178 (2.81%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    4
    5
    2
    1
    0
    0
    1
    Atypical mycobacterium test positive
         subjects affected / exposed
    3 / 335 (0.90%)
    5 / 178 (2.81%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    5
    2
    1
    0
    0
    0
    Influenza A virus test positive
         subjects affected / exposed
    3 / 335 (0.90%)
    3 / 178 (1.69%)
    3 / 340 (0.88%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    3
    3
    3
    2
    0
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    2 / 335 (0.60%)
    3 / 178 (1.69%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    2
    4
    4
    2
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 335 (0.90%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    3
    1
    3
    0
    0
    0
    2
    Blood magnesium decreased
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    0
    0
    Clostridium test positive
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    3
    1
    0
    0
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    1
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    0
    Blood immunoglobulin E increased
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    0
    Crystal urine present
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    0
    Protein urine present
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    0
    Staphylococcus test positive
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    0
    Blood calcium increased
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Blood potassium increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    Blood pressure systolic increased
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    0
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    Blood urea increased
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    Breath sounds abnormal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    Forced vital capacity decreased
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    Glucose urine present
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    2
    0
    0
    0
    Monocyte count increased
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Pseudomonas test positive
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Candida test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Glucose tolerance test abnormal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Heart rate increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Human rhinovirus test positive
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    Influenza B virus test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Blood albumin decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Blood immunoglobulin G increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Blood iron decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Helicobacter test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Influenza virus test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Lymphocyte count increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    2
    Reticulocyte percentage increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Sputum abnormal
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Platelet count increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Respiratory syncytial virus test positive
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Weight increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Aspergillus test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Blood androstenedione increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Blood cortisol decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Blood glucose fluctuation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Blood magnesium increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Blood phosphorus increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Blood sodium increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Blood testosterone decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Blood testosterone increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Blood urine present
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Burkholderia test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Citrobacter test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Coronavirus test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Creatinine renal clearance increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Dehydroepiandrosterone increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Electrocardiogram PR shortened
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Epstein-Barr virus antibody positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Escherichia test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Grip strength decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Haemoglobin increased
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Human metapneumovirus test positive
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Human papilloma virus test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Mean cell volume increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Myoglobin blood increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Precancerous cells present
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Red blood cells urine positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Reticulocyte count increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Rubulavirus test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Ultrasound liver abnormal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Urine bilirubin increased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Urine ketone body present
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Viral test positive
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Vitamin A decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Vitamin B12 decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Vitamin E decreased
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    7 / 335 (2.09%)
    3 / 178 (1.69%)
    8 / 340 (2.35%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    7
    3
    9
    3
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    10 / 335 (2.99%)
    3 / 178 (1.69%)
    8 / 340 (2.35%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    12
    3
    9
    0
    0
    0
    3
    Ligament sprain
         subjects affected / exposed
    5 / 335 (1.49%)
    2 / 178 (1.12%)
    5 / 340 (1.47%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    0 / 60 (0.00%)
         occurrences all number
    6
    3
    5
    8
    0
    2
    0
    Muscle strain
         subjects affected / exposed
    5 / 335 (1.49%)
    4 / 178 (2.25%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    5
    4
    2
    1
    0
    1
    1
    Arthropod bite
         subjects affected / exposed
    4 / 335 (1.19%)
    3 / 178 (1.69%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    0 / 60 (0.00%)
         occurrences all number
    4
    3
    3
    1
    0
    2
    0
    Laceration
         subjects affected / exposed
    2 / 335 (0.60%)
    3 / 178 (1.69%)
    5 / 340 (1.47%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    2
    3
    5
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    5 / 340 (1.47%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    5
    1
    0
    0
    0
    Joint dislocation
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    1
    4
    1
    0
    0
    0
    Joint injury
         subjects affected / exposed
    3 / 335 (0.90%)
    0 / 178 (0.00%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    4
    0
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    4 / 335 (1.19%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    2
    2
    0
    0
    0
    Concussion
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    1
    1
    0
    0
    0
    Sunburn
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    1
    0
    2
    1
    Ligament rupture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Limb injury
         subjects affected / exposed
    4 / 335 (1.19%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    2
    0
    0
    1
    0
    Periorbital haemorrhage
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Post procedural swelling
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    1
    Tooth fracture
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    1
    0
    Foot fracture
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    1
    2
    0
    0
    0
    Road traffic accident
         subjects affected / exposed
    5 / 335 (1.49%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    5
    0
    0
    1
    0
    0
    0
    Chest injury
         subjects affected / exposed
    3 / 335 (0.90%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    2
    0
    0
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    0
    Facial bones fracture
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    0
    0
    Back injury
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Hand fracture
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    Ligament injury
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Meniscus injury
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    0
    Sports injury
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Superficial injury of eye
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Animal bite
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Arthropod sting
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Incisional hernia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Post procedural discomfort
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    0
    Procedural nausea
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Stoma site discomfort
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Stoma site irritation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Thermal burn
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Wrist fracture
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Accidental exposure to product
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Animal scratch
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Ankle fracture
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Avulsion fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Confusion postoperative
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Corneal abrasion
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Ear injury
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Epicondylitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Exposure to toxic agent
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Eye injury
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Face injury
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Forearm fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Head injury
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Heat stroke
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Incision site haematoma
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Limb crushing injury
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Lip injury
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Muscle injury
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Muscle rupture
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Neck injury
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Nerve injury
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Peripheral nerve injury
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Post procedural complication
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Procedural anxiety
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Procedural headache
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Procedural vomiting
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Radius fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Sinus barotrauma
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Soft tissue injury
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Splinter
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Stoma site erythema
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Stoma site pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Stoma site ulcer
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Stress fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Upper limb fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Wound
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Thyroglossal cyst
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Cystic fibrosis related diabetes
         subjects affected / exposed
    10 / 335 (2.99%)
    10 / 178 (5.62%)
    8 / 340 (2.35%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    10
    10
    8
    5
    0
    0
    0
    Cystic fibrosis hepatic disease
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Cystic fibrosis lung
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Dermoid cyst
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Naevus flammeus
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Palpitations
         subjects affected / exposed
    5 / 335 (1.49%)
    0 / 178 (0.00%)
    4 / 340 (1.18%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    5
    0
    4
    3
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    3
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    0
    Sinus arrhythmia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    Extrasystoles
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    58 / 335 (17.31%)
    25 / 178 (14.04%)
    56 / 340 (16.47%)
    22 / 176 (12.50%)
    0 / 19 (0.00%)
    7 / 55 (12.73%)
    7 / 60 (11.67%)
         occurrences all number
    73
    30
    80
    31
    0
    7
    7
    Sinus headache
         subjects affected / exposed
    13 / 335 (3.88%)
    9 / 178 (5.06%)
    11 / 340 (3.24%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    2 / 60 (3.33%)
         occurrences all number
    16
    10
    14
    3
    0
    3
    2
    Dizziness
         subjects affected / exposed
    9 / 335 (2.69%)
    7 / 178 (3.93%)
    6 / 340 (1.76%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    14
    8
    6
    6
    0
    1
    1
    Migraine
         subjects affected / exposed
    6 / 335 (1.79%)
    2 / 178 (1.12%)
    5 / 340 (1.47%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    9
    2
    5
    3
    0
    1
    0
    Lethargy
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    2
    4
    0
    0
    0
    Syncope
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    2
    2
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    3 / 335 (0.90%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    3
    3
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    4 / 335 (1.19%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    3
    0
    0
    0
    0
    Anosmia
         subjects affected / exposed
    3 / 335 (0.90%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    0
    2
    0
    0
    0
    Somnolence
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    Circadian rhythm sleep disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Migraine with aura
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Neuralgia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Presyncope
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Seizure
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Tension headache
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Ageusia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Aphonia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Coordination abnormal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Hypersomnia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hyposmia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Nerve compression
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Nystagmus
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Olfactory nerve disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    7 / 335 (2.09%)
    1 / 178 (0.56%)
    5 / 340 (1.47%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    7
    1
    5
    2
    0
    1
    1
    Eosinophilia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Anaemia
         subjects affected / exposed
    3 / 335 (0.90%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    0
    0
    Splenomegaly
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Bone marrow oedema
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Haemoconcentration
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Increased tendency to bruise
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Macrocytosis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    6 / 335 (1.79%)
    6 / 178 (3.37%)
    5 / 340 (1.47%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    6
    8
    5
    5
    0
    0
    2
    Tinnitus
         subjects affected / exposed
    5 / 335 (1.49%)
    6 / 178 (3.37%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    5
    7
    1
    1
    0
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    3 / 340 (0.88%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    2
    3
    2
    0
    0
    1
    Cerumen impaction
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    3
    1
    0
    0
    0
    Deafness neurosensory
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    Deafness unilateral
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Ear congestion
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Ear pruritus
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    Middle ear effusion
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Motion sickness
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Ototoxicity
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Vestibular disorder
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Ear discomfort
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    4 / 340 (1.18%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    4
    1
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    0
    0
    Dry eye
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    0
    Eye pruritus
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    4
    0
    0
    0
    0
    Eye swelling
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Eye haemorrhage
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Glaucoma
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Myopia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Ulcerative keratitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    46 / 335 (13.73%)
    24 / 178 (13.48%)
    41 / 340 (12.06%)
    28 / 176 (15.91%)
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    9 / 60 (15.00%)
         occurrences all number
    63
    29
    52
    41
    0
    7
    11
    Nausea
         subjects affected / exposed
    45 / 335 (13.43%)
    24 / 178 (13.48%)
    34 / 340 (10.00%)
    27 / 176 (15.34%)
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    4 / 60 (6.67%)
         occurrences all number
    62
    27
    41
    30
    0
    6
    5
    Abdominal pain
         subjects affected / exposed
    42 / 335 (12.54%)
    20 / 178 (11.24%)
    33 / 340 (9.71%)
    15 / 176 (8.52%)
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    2 / 60 (3.33%)
         occurrences all number
    48
    25
    48
    18
    0
    3
    2
    Constipation
         subjects affected / exposed
    28 / 335 (8.36%)
    13 / 178 (7.30%)
    24 / 340 (7.06%)
    10 / 176 (5.68%)
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    3 / 60 (5.00%)
         occurrences all number
    35
    14
    26
    12
    0
    3
    3
    Vomiting
         subjects affected / exposed
    26 / 335 (7.76%)
    6 / 178 (3.37%)
    27 / 340 (7.94%)
    13 / 176 (7.39%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    2 / 60 (3.33%)
         occurrences all number
    33
    6
    29
    16
    0
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    18 / 335 (5.37%)
    9 / 178 (5.06%)
    20 / 340 (5.88%)
    11 / 176 (6.25%)
    0 / 19 (0.00%)
    6 / 55 (10.91%)
    0 / 60 (0.00%)
         occurrences all number
    30
    11
    22
    11
    0
    6
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    16 / 335 (4.78%)
    8 / 178 (4.49%)
    14 / 340 (4.12%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    5 / 55 (9.09%)
    2 / 60 (3.33%)
         occurrences all number
    18
    8
    14
    4
    0
    5
    4
    Flatulence
         subjects affected / exposed
    13 / 335 (3.88%)
    5 / 178 (2.81%)
    7 / 340 (2.06%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    15
    5
    7
    7
    0
    0
    3
    Dyspepsia
         subjects affected / exposed
    8 / 335 (2.39%)
    5 / 178 (2.81%)
    10 / 340 (2.94%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    2 / 60 (3.33%)
         occurrences all number
    9
    6
    12
    6
    0
    1
    2
    Abdominal distension
         subjects affected / exposed
    11 / 335 (3.28%)
    2 / 178 (1.12%)
    10 / 340 (2.94%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    12
    2
    12
    4
    0
    1
    0
    Toothache
         subjects affected / exposed
    3 / 335 (0.90%)
    4 / 178 (2.25%)
    7 / 340 (2.06%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    4
    4
    9
    3
    0
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    4 / 335 (1.19%)
    1 / 178 (0.56%)
    5 / 340 (1.47%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    5
    1
    5
    4
    0
    0
    2
    Distal intestinal obstruction syndrome
         subjects affected / exposed
    3 / 335 (0.90%)
    5 / 178 (2.81%)
    5 / 340 (1.47%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    5
    6
    1
    0
    0
    0
    Dental discomfort
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Lip swelling
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    Pancreatitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Pancreatitis acute
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Post-tussive vomiting
         subjects affected / exposed
    1 / 335 (0.30%)
    3 / 178 (1.69%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    3
    3
    1
    2
    0
    0
    1
    Gastritis
         subjects affected / exposed
    3 / 335 (0.90%)
    3 / 178 (1.69%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    3
    4
    0
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    3
    3
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    4
    0
    0
    0
    0
    Steatorrhoea
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    3
    2
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    1
    2
    0
    0
    0
    Dysphagia
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    0
    0
    Faecaloma
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    Enteritis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    Food poisoning
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    Inguinal hernia
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Tooth impacted
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Bowel movement irregularity
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Breath odour
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Ileus
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Intestinal obstruction
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Varices oesophageal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Abdominal hernia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Abdominal tenderness
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Anal fistula
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Cheilitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Chronic gastritis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Duodenal ulcer
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Enterocolitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Epigastric discomfort
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Eructation
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Faecal volume decreased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Faecal volume increased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Faeces soft
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Gastric mucosal hypertrophy
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gingival erythema
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gingival recession
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Gingivitis ulcerative
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Glossitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Glossodynia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Intussusception
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Malabsorption
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Malpositioned teeth
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Melaena
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Mucous stools
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Oesophageal irritation
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Oesophageal mucosal hyperplasia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Oesophageal pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Oesophagitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Oral disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Oral mucosal blistering
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Oral papule
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pancreatic insufficiency
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Reflux gastritis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Retching
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Tooth delamination
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Umbilical hernia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    10 / 335 (2.99%)
    9 / 178 (5.06%)
    22 / 340 (6.47%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    12
    11
    24
    7
    0
    0
    2
    Acne
         subjects affected / exposed
    3 / 335 (0.90%)
    3 / 178 (1.69%)
    8 / 340 (2.35%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    3
    8
    7
    0
    0
    0
    Pruritus
         subjects affected / exposed
    6 / 335 (1.79%)
    3 / 178 (1.69%)
    6 / 340 (1.76%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    4 / 60 (6.67%)
         occurrences all number
    7
    3
    8
    8
    0
    0
    4
    Night sweats
         subjects affected / exposed
    5 / 335 (1.49%)
    7 / 178 (3.93%)
    4 / 340 (1.18%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    6
    9
    4
    2
    0
    1
    1
    Urticaria
         subjects affected / exposed
    6 / 335 (1.79%)
    5 / 178 (2.81%)
    5 / 340 (1.47%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    8
    5
    5
    2
    0
    0
    0
    Alopecia
         subjects affected / exposed
    4 / 335 (1.19%)
    3 / 178 (1.69%)
    3 / 340 (0.88%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    2 / 60 (3.33%)
         occurrences all number
    4
    3
    3
    4
    0
    2
    2
    Dermatitis contact
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    4 / 340 (1.18%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    4
    7
    0
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    5 / 335 (1.49%)
    1 / 178 (0.56%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    5
    1
    4
    0
    0
    0
    1
    Drug eruption
         subjects affected / exposed
    5 / 335 (1.49%)
    3 / 178 (1.69%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    5
    3
    1
    0
    0
    0
    1
    Eczema
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    3
    1
    0
    0
    0
    Red man syndrome
         subjects affected / exposed
    1 / 335 (0.30%)
    3 / 178 (1.69%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    3
    3
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    3 / 335 (0.90%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    1
    2
    0
    0
    0
    Pruritus allergic
         subjects affected / exposed
    4 / 335 (1.19%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    1
    2
    0
    0
    0
    Rash erythematous
         subjects affected / exposed
    1 / 335 (0.30%)
    4 / 178 (2.25%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    0
    0
    Rash papular
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    5 / 340 (1.47%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    6
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    3
    0
    2
    1
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    1
    2
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    2
    1
    1
    0
    0
    1
    1
    Dermal cyst
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    Ecchymosis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    Pain of skin
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Rash macular
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Hand dermatitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Hyperkeratosis
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Petechiae
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Skin disorder
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Skin mass
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Skin warm
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Solar dermatitis
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Acne cystic
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Blister
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Eczema asteatotic
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Eczema nummular
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Fixed drug eruption
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Hypersensitivity vasculitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Keratosis pilaris
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Madarosis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Onycholysis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Pruritus generalised
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Purpura senile
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Rash morbilliform
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Rosacea
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Scar pain
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Skin irritation
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Skin wrinkling
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Urticarial vasculitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Stress urinary incontinence
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    3 / 335 (0.90%)
    3 / 178 (1.69%)
    2 / 340 (0.59%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    5
    2
    2
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    Chromaturia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Calculus urinary
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Glycosuria
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Haematuria
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hydronephrosis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hypernatriuria
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hypocitraturia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Micturition urgency
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pyelocaliectasis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Renal colic
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Renal failure
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Renal hypertrophy
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Renal pain
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Renal tubular disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Urine abnormality
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Goitre
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Growth hormone deficiency
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Androgen deficiency
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Cushing's syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    20 / 335 (5.97%)
    11 / 178 (6.18%)
    25 / 340 (7.35%)
    13 / 176 (7.39%)
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    8 / 60 (13.33%)
         occurrences all number
    24
    15
    31
    15
    0
    7
    11
    Back pain
         subjects affected / exposed
    20 / 335 (5.97%)
    12 / 178 (6.74%)
    14 / 340 (4.12%)
    10 / 176 (5.68%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    5 / 60 (8.33%)
         occurrences all number
    21
    13
    15
    12
    0
    1
    5
    Myalgia
         subjects affected / exposed
    19 / 335 (5.67%)
    7 / 178 (3.93%)
    13 / 340 (3.82%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    20
    7
    20
    6
    0
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    13 / 335 (3.88%)
    9 / 178 (5.06%)
    12 / 340 (3.53%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    3 / 60 (5.00%)
         occurrences all number
    14
    10
    13
    3
    0
    2
    4
    Musculoskeletal pain
         subjects affected / exposed
    8 / 335 (2.39%)
    6 / 178 (3.37%)
    5 / 340 (1.47%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    12
    6
    5
    7
    0
    0
    2
    Pain in extremity
         subjects affected / exposed
    6 / 335 (1.79%)
    5 / 178 (2.81%)
    7 / 340 (2.06%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    2 / 60 (3.33%)
         occurrences all number
    6
    6
    8
    2
    0
    2
    2
    Muscle spasms
         subjects affected / exposed
    3 / 335 (0.90%)
    2 / 178 (1.12%)
    7 / 340 (2.06%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    2
    9
    0
    0
    0
    0
    Arthritis
         subjects affected / exposed
    4 / 335 (1.19%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    5
    6
    1
    0
    0
    1
    0
    Neck pain
         subjects affected / exposed
    5 / 335 (1.49%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    5
    1
    1
    0
    0
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    1
    1
    0
    0
    0
    Osteopenia
         subjects affected / exposed
    4 / 335 (1.19%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    1
    1
    0
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    4
    0
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    5 / 340 (1.47%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    5
    0
    0
    3
    0
    Arthropathy
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    0
    Osteoporosis
         subjects affected / exposed
    2 / 335 (0.60%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    1
    0
    Bursitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    Costochondritis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    0
    Flank pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Groin pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Joint stiffness
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Pathological fracture
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Tenosynovitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    2
    Medial tibial stress syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    Osteochondrosis
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    Polyarthritis
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Spinal pain
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    2
    0
    0
    0
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Exostosis
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Joint range of motion decreased
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Juvenile idiopathic arthritis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    Muscle contracture
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Muscle tightness
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Myalgia intercostal
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Plantar fasciitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Synovial cyst
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Tendon pain
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Torticollis
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Chondropathy
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Coccydynia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Intervertebral disc annular tear
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Mastication disorder
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Muscle fatigue
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Muscle oedema
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Scoliosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Tendon disorder
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    185 / 335 (55.22%)
    92 / 178 (51.69%)
    173 / 340 (50.88%)
    91 / 176 (51.70%)
    0 / 19 (0.00%)
    18 / 55 (32.73%)
    20 / 60 (33.33%)
         occurrences all number
    436
    191
    349
    193
    0
    32
    28
    Nasopharyngitis
         subjects affected / exposed
    51 / 335 (15.22%)
    31 / 178 (17.42%)
    66 / 340 (19.41%)
    27 / 176 (15.34%)
    0 / 19 (0.00%)
    6 / 55 (10.91%)
    6 / 60 (10.00%)
         occurrences all number
    77
    51
    111
    49
    0
    9
    10
    Upper respiratory tract infection
         subjects affected / exposed
    42 / 335 (12.54%)
    26 / 178 (14.61%)
    49 / 340 (14.41%)
    29 / 176 (16.48%)
    0 / 19 (0.00%)
    7 / 55 (12.73%)
    6 / 60 (10.00%)
         occurrences all number
    69
    41
    74
    38
    0
    12
    9
    Sinusitis
         subjects affected / exposed
    41 / 335 (12.24%)
    19 / 178 (10.67%)
    47 / 340 (13.82%)
    13 / 176 (7.39%)
    0 / 19 (0.00%)
    7 / 55 (12.73%)
    2 / 60 (3.33%)
         occurrences all number
    64
    26
    68
    21
    0
    7
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    34 / 335 (10.15%)
    12 / 178 (6.74%)
    24 / 340 (7.06%)
    10 / 176 (5.68%)
    0 / 19 (0.00%)
    3 / 55 (5.45%)
    4 / 60 (6.67%)
         occurrences all number
    50
    20
    30
    25
    0
    3
    5
    Influenza
         subjects affected / exposed
    20 / 335 (5.97%)
    11 / 178 (6.18%)
    21 / 340 (6.18%)
    15 / 176 (8.52%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    22
    12
    22
    16
    0
    2
    1
    Rhinitis
         subjects affected / exposed
    24 / 335 (7.16%)
    7 / 178 (3.93%)
    21 / 340 (6.18%)
    12 / 176 (6.82%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    36
    9
    29
    20
    0
    1
    1
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    16 / 335 (4.78%)
    14 / 178 (7.87%)
    18 / 340 (5.29%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    17
    19
    28
    8
    0
    2
    1
    Bronchitis
         subjects affected / exposed
    15 / 335 (4.48%)
    8 / 178 (4.49%)
    12 / 340 (3.53%)
    8 / 176 (4.55%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    32
    12
    19
    19
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    21 / 335 (6.27%)
    4 / 178 (2.25%)
    7 / 340 (2.06%)
    9 / 176 (5.11%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    29
    4
    8
    13
    0
    2
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    13 / 335 (3.88%)
    4 / 178 (2.25%)
    14 / 340 (4.12%)
    7 / 176 (3.98%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    2 / 60 (3.33%)
         occurrences all number
    15
    5
    16
    7
    0
    2
    2
    Respiratory tract infection viral
         subjects affected / exposed
    11 / 335 (3.28%)
    4 / 178 (2.25%)
    11 / 340 (3.24%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    11
    5
    16
    6
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    10 / 335 (2.99%)
    3 / 178 (1.69%)
    5 / 340 (1.47%)
    8 / 176 (4.55%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    11
    3
    9
    13
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    8 / 335 (2.39%)
    6 / 178 (3.37%)
    7 / 340 (2.06%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    0 / 60 (0.00%)
         occurrences all number
    10
    7
    10
    6
    0
    3
    0
    Respiratory tract infection
         subjects affected / exposed
    6 / 335 (1.79%)
    6 / 178 (3.37%)
    7 / 340 (2.06%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    7
    10
    17
    10
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    8 / 335 (2.39%)
    2 / 178 (1.12%)
    7 / 340 (2.06%)
    5 / 176 (2.84%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    8
    2
    8
    6
    0
    2
    1
    Bronchopulmonary aspergillosis allergic
         subjects affected / exposed
    9 / 335 (2.69%)
    6 / 178 (3.37%)
    4 / 340 (1.18%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    9
    9
    5
    2
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    4 / 335 (1.19%)
    4 / 178 (2.25%)
    6 / 340 (1.76%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    5
    4
    7
    8
    0
    4
    1
    Otitis media
         subjects affected / exposed
    9 / 335 (2.69%)
    1 / 178 (0.56%)
    8 / 340 (2.35%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    0 / 60 (0.00%)
         occurrences all number
    11
    1
    9
    1
    0
    2
    0
    Gastroenteritis viral
         subjects affected / exposed
    12 / 335 (3.58%)
    2 / 178 (1.12%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    16
    2
    4
    0
    0
    1
    0
    Lung infection pseudomonal
         subjects affected / exposed
    5 / 335 (1.49%)
    3 / 178 (1.69%)
    6 / 340 (1.76%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    6
    3
    6
    3
    0
    0
    0
    Acute sinusitis
         subjects affected / exposed
    5 / 335 (1.49%)
    1 / 178 (0.56%)
    5 / 340 (1.47%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    1 / 60 (1.67%)
         occurrences all number
    5
    1
    7
    4
    0
    3
    1
    Chronic sinusitis
         subjects affected / exposed
    4 / 335 (1.19%)
    4 / 178 (2.25%)
    5 / 340 (1.47%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    5
    4
    6
    2
    0
    2
    0
    Respiratory tract infection bacterial
         subjects affected / exposed
    9 / 335 (2.69%)
    2 / 178 (1.12%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    12
    3
    3
    1
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    5 / 335 (1.49%)
    1 / 178 (0.56%)
    5 / 340 (1.47%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    10
    1
    8
    4
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    6 / 335 (1.79%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    4 / 176 (2.27%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    6
    1
    2
    4
    0
    0
    0
    Viral infection
         subjects affected / exposed
    5 / 335 (1.49%)
    2 / 178 (1.12%)
    5 / 340 (1.47%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    7
    2
    5
    1
    0
    1
    2
    Pharyngitis streptococcal
         subjects affected / exposed
    7 / 335 (2.09%)
    1 / 178 (0.56%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    10
    2
    4
    0
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 335 (0.90%)
    1 / 178 (0.56%)
    5 / 340 (1.47%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    4
    1
    5
    2
    0
    0
    3
    Bacterial disease carrier
         subjects affected / exposed
    3 / 335 (0.90%)
    0 / 178 (0.00%)
    5 / 340 (1.47%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    5
    2
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    4 / 335 (1.19%)
    2 / 178 (1.12%)
    2 / 340 (0.59%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    4
    2
    2
    2
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    2 / 335 (0.60%)
    4 / 178 (2.25%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    4
    4
    1
    0
    0
    0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    4 / 335 (1.19%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    5
    1
    3
    2
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    3
    1
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    4
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    3
    1
    0
    0
    0
    Lower respiratory tract infection viral
         subjects affected / exposed
    3 / 335 (0.90%)
    2 / 178 (1.12%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    2
    1
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    2
    0
    2
    2
    0
    0
    3
    Folliculitis
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    0
    Lung infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    4 / 340 (1.18%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    4
    0
    0
    0
    0
    Bronchitis viral
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    Kidney infection
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    Onychomycosis
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    1
    2
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    3 / 335 (0.90%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    0
    0
    Eye infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    Genital candidiasis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Herpes dermatitis
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    Sinusitis bacterial
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    Stoma site infection
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    Tinea infection
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Herpes zoster
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Mycobacterial disease carrier
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Superinfection bacterial
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Mycobacterium abscessus infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Oropharyngitis fungal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    2
    Otitis externa fungal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Parotitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Vaginal infection
         subjects affected / exposed
    0 / 335 (0.00%)
    2 / 178 (1.12%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    1
    0
    Tracheitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    Varicella
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Wound infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Acarodermatitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Acne pustular
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Adenoiditis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Anal abscess
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Angular cheilitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Arthritis infective
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Atypical mycobacterial lower respiratory tract infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Atypical mycobacterial pneumonia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Bronchitis fungal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Epididymitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Erythema infectiosum
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Febrile infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Furuncle
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Genital herpes
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Genital herpes simplex
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Genital infection fungal
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Groin abscess
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Haemophilus infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Helicobacter infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hepatitis C
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Implant site infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Oral bacterial infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Overgrowth bacterial
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Overgrowth fungal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Papilloma viral infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Post procedural infection
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pseudomonas bronchitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pseudomonas infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Pulpitis dental
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Salpingo-oophoritis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Respiratory tract infection fungal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Sepsis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Skin bacterial infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Small intestinal bacterial overgrowth
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Sputum purulent
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Tracheobronchitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Trichomoniasis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Upper respiratory fungal infection
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vaginitis bacterial
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vulvovaginitis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    11 / 335 (3.28%)
    5 / 178 (2.81%)
    16 / 340 (4.71%)
    6 / 176 (3.41%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    11
    5
    17
    6
    0
    1
    1
    Decreased appetite
         subjects affected / exposed
    12 / 335 (3.58%)
    8 / 178 (4.49%)
    6 / 340 (1.76%)
    9 / 176 (5.11%)
    0 / 19 (0.00%)
    2 / 55 (3.64%)
    3 / 60 (5.00%)
         occurrences all number
    12
    9
    7
    10
    0
    2
    3
    Hypoglycaemia
         subjects affected / exposed
    5 / 335 (1.49%)
    7 / 178 (3.93%)
    3 / 340 (0.88%)
    3 / 176 (1.70%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    2 / 60 (3.33%)
         occurrences all number
    5
    7
    3
    3
    0
    1
    2
    Hyperglycaemia
         subjects affected / exposed
    7 / 335 (2.09%)
    4 / 178 (2.25%)
    3 / 340 (0.88%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    3 / 60 (5.00%)
         occurrences all number
    8
    4
    3
    0
    0
    2
    3
    Iron deficiency
         subjects affected / exposed
    6 / 335 (1.79%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    6
    1
    3
    3
    0
    0
    0
    Glucose tolerance impaired
         subjects affected / exposed
    3 / 335 (0.90%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    3
    1
    2
    2
    0
    0
    1
    Dehydration
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    3 / 340 (0.88%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    3
    1
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    1 / 60 (1.67%)
         occurrences all number
    2
    1
    0
    1
    0
    1
    1
    Alcohol intolerance
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Gout
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    2
    2
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 335 (0.00%)
    3 / 178 (1.69%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    4
    1
    0
    0
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    2 / 176 (1.14%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Hypovitaminosis
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Selenium deficiency
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Vitamin A deficiency
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 178 (0.56%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Vitamin E deficiency
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    1 / 55 (1.82%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    Malnutrition
         subjects affected / exposed
    2 / 335 (0.60%)
    1 / 178 (0.56%)
    2 / 340 (0.59%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    2
    1
    2
    1
    0
    0
    0
    Vitamin K deficiency
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 178 (0.56%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Diabetes mellitus
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Hyponatraemic syndrome
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Underweight
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    1 / 340 (0.29%)
    0 / 176 (0.00%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Weight gain poor
         subjects affected / exposed
    0 / 335 (0.00%)
    0 / 178 (0.00%)
    0 / 340 (0.00%)
    1 / 176 (0.57%)
    0 / 19 (0.00%)
    0 / 55 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2014
    - An additional mandatory testing to monitor the safety of liver function was added as a result of safety findings reported in Council for International Organizations of Medical Sciences (CIOMS) AE-2013-011098, dated 21 January 2014.
    22 Sep 2014
    - Included an exploratory, optional, non-interventional data collection for Part A Treatment Cohort subjects to collect respiratory culture results from the 12 months before the subject’s first dose in Studies 103 (2012-003989-40) or 104 (2012-003990-24) through the end of the treatment period of Study 105 (2013-000604-41). - Reduced the frequency of liver function test (LFT) sample collection after Week 24. These changes were based on the review of interim safety data by both the sponsor and the data monitoring committee. - Updates were made to reflect that given the lack of overall efficacy, all subjects from Part B were to be notified of the results and that Vertex strongly recommended that all subjects from Part B be discontinued from Study 105 (2013-000604-41). If, in the opinion of the investigator, there were certain subjects for whom there was evidence of clinical benefit that outweighed potential risks, the investigator was to contact the Vertex medical monitor for approval to continue an individual subject in the study. - Updated that internal Vertex team could be un-blinded once all subjects reached Week 24 and data lock for interim analysis had occurred.

    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.
    Analysis using baseline values of the current study 105 (2013-000604-41) was not performed for Part B Treatment Cohort .
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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