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    Clinical Trial Results:
    A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2010-020413-90
    Trial protocol
    		 DE   BE   GB   IE  
    Global end of trial date
    29 Apr 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Jul 2016
    First version publication date
    08 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    requires edit to address results section (Secondary Endpoints data , and reporting groups shuffle) affected by system bug which has now been fixed.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VX09-809-102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01225211
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, Massachusetts, United States, 022101862
    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)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cohort 1, Cohort 2, and Cohort 3: To evaluate the safety and tolerability when lumacaftor is administered alone or in combination with ivacaftor; To evaluate the effect of lumacaftor administered alone or in combination with ivacaftor on sweat chloride. Cohort 4: To evaluate the safety and tolerability of lumacaftor in combination with ivacaftor; To evaluate the efficacy of lumacaftor in combination with ivacaftor.
    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
    18 Oct 2010
    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
    Belgium: 6
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    New Zealand: 7
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 227
    Country: Number of subjects enrolled
    Australia: 40
    Worldwide total number of subjects
    311
    EEA total number of subjects
    37
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    311
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants in each cohort are mutually exclusive. A total of 312 participants were randomized of which one participant did not receive any treatment and a total of 311 participants were treated.

    Pre-assignment
    Screening details
    		 Study included 4 cohorts which were studied in sequential manner. For results reporting, combined placebo arm was reported for Cohort 2 and 3 and results for these 2 cohorts are reported collectively.

    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
    		 Cohort 1: Placebo
    Arm description
    		 Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Lumacaftor Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablet qd as described in reporting group description.

    Arm title
    		 Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h
    Arm description
    		 Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor
    Investigational medicinal product code
    Other name
    VX-809, LUM
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lumacaftor tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    Other name
    VX-770, IVA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor tablet qd as described in reporting group description.

    Arm title
    		 Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h
    Arm description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor
    Investigational medicinal product code
    Other name
    VX-809, LUM
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lumacaftor tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    Other name
    VX-770, IVA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor tablet qd as described in reporting group description.

    Arm title
    		 Cohort 2 and 3: Placebo (HO and HE)
    Arm description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Lumacaftor Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablet qd as described in reporting group description.

    Arm title
    		 Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)
    Arm description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor
    Investigational medicinal product code
    Other name
    VX-809, LUM
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lumacaftor tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    Other name
    VX-770, IVA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor tablet qd as described in reporting group description.

    Arm title
    		 Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)
    Arm description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor
    Investigational medicinal product code
    Other name
    VX-809, LUM
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lumacaftor tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    Other name
    VX-770, IVA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor tablet qd as described in reporting group description.

    Arm title
    		 Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)
    Arm description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor
    Investigational medicinal product code
    Other name
    VX-809, LUM
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lumacaftor tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    Other name
    VX-770, IVA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor tablet qd as described in reporting group description.

    Arm title
    		 Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)
    Arm description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor
    Investigational medicinal product code
    Other name
    VX-809, LUM
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lumacaftor tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    Other name
    VX-770, IVA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor tablet qd as described in reporting group description.

    Arm title
    		 Cohort 4: Placebo
    Arm description
    		 Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Lumacaftor Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablet qd as described in reporting group description.

    Arm title
    		 Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Arm description
    		 Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumacaftor
    Investigational medicinal product code
    Other name
    VX-809, LUM
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lumacaftor tablet qd as described in reporting group description.

    Investigational medicinal product name
    Ivacaftor
    Investigational medicinal product code
    Other name
    VX-770, IVA
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ivacaftor tablet qd as described in reporting group description.

    Number of subjects in period 1
    		Cohort 1: Placebo Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h Cohort 2 and 3: Placebo (HO and HE) Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO) Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO) Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE) Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO) Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Started
    21
    20
    21
    27
    23
    21
    42
    11
    63
    62
    Completed
    21
    20
    20
    27
    23
    21
    41
    11
    62
    57
    Not completed
    0
    0
    1
    0
    0
    0
    1
    0
    1
    5
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    -
    1
    -
    1
    3
         Adverse event, non-fatal
    -
    -
    1
    -
    -
    -
    -
    -
    -
    1
         Unspecified
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    		 Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).

    Reporting group title
    Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).

    Reporting group title
    Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).

    Reporting group title
    Cohort 2 and 3: Placebo (HO and HE)
    Reporting group description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)
    Reporting group description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 4: Placebo
    Reporting group description
    		 Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).

    Reporting group title
    Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Reporting group description
    		 Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).

    Reporting group values
    		 Cohort 1: Placebo Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h Cohort 2 and 3: Placebo (HO and HE) Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO) Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO) Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE) Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO) Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h Total
    Number of subjects
    		 21 20 21 27 23 21 42 11 63 62 311
    Age categorical
    Units: Subjects
        <=18 years
    		 0 0 0 0 0 0 0 0 0 0 0
        Between 18 and 65 years
    		 21 20 21 27 23 21 42 11 63 62 311
        >=65 years
    		 0 0 0 0 0 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 10 8 13 9 11 9 19 5 31 29 144
        Male
    		 11 12 8 18 12 12 23 6 32 33 167

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    		 Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).

    Reporting group title
    Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).

    Reporting group title
    Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).

    Reporting group title
    Cohort 2 and 3: Placebo (HO and HE)
    Reporting group description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)
    Reporting group description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 4: Placebo
    Reporting group description
    		 Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).

    Reporting group title
    Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Reporting group description
    		 Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).

    Subject analysis set title
    Cohort 1: Placebo – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).

    Subject analysis set title
    Cohort 1: LUM 200 mg qd – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).

    Subject analysis set title
    Cohort 1: Placebo – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).

    Subject analysis set title
    Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).

    Subject analysis set title
    Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).

    Subject analysis set title
    Cohort 2 and 3: Placebo (HO and HE) – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2: LUM 200 mg qd – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2: LUM 400 mg qd – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 3: LUM 400 mg q12h – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).

    Subject analysis set title
    Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).

    Subject analysis set title
    Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).

    Subject analysis set title
    Cohort 1: Placebo – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).

    Subject analysis set title
    Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 1: Placebo – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).

    Subject analysis set title
    Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 200 mg qd – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 1: LUM 200 mg qd – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).

    Subject analysis set title
    Cohort 2: LUM 400 mg qd – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd (HO) – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd (HE) – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2 and 3: Placebo (HO and HE) – Period 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Subject analysis set title
    Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).

    Primary: Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)

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    End point title
    		 Cohort 1: Safety and Tolerability Based on Adverse Events (AEs) [1]
    End point description
    AE: any untoward medical occurrence during study; irrespective of relationship with treatment, including any newly occurring event or previous condition that has increased in severity/frequency after informed consent. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to 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. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21). Analysis was performed on Cohort 1 Safety Set, which included all participants who received at least 1 dose of study drug in Cohort 1.
    End point type
    Primary
    End point timeframe
    Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)
    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: No statistical analysis was planned for this endpoint.
    End point values
    		 Cohort 1: Placebo – Period 2 Cohort 1: LUM 200 mg qd – Period 1 Cohort 1: Placebo – Period 1 Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2 Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2
    Number of subjects analysed
    21
    41
    21
    20
    20
    Units: participants
    number (not applicable)
        Participants with any AEs
    15
    29
    12
    14
    12
        Participants with SAEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)

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    End point title
    		 Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs) [2]
    End point description
    Detailed description is provided in Outcome Measure 1. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 28) and combination therapy period (Period 2: Day 29 to Day 56). Analysis was performed on Cohort 2 and 3 Safety Set, which included all participants who received at least 1 dose of study drug in Cohort 2 or 3.
    End point type
    Primary
    End point timeframe
    Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)
    Notes
    [2] - 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: No statistical analysis was planned for this endpoint.
    End point values
    		 Cohort 2 and 3: Placebo (HO and HE) – Period 1 Cohort 2: LUM 200 mg qd – Period 1 Cohort 2: LUM 400 mg qd – Period 1 Cohort 2 and 3: Placebo (HO and HE) – Period 2 Cohort 3: LUM 400 mg q12h – Period 1 Cohort 2: LUM 600 mg qd – Period 1 Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2 Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2
    Number of subjects analysed
    27
    23
    21
    27
    11
    42
    21
    20
    38
    11
    Units: participants
    number (not applicable)
        Participants with any AEs
    23
    18
    18
    20
    7
    37
    12
    15
    26
    10
        Participants with SAEs
    1
    2
    0
    4
    2
    3
    0
    1
    4
    1
    No statistical analyses for this end point

    Primary: Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs

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    End point title
    		 Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs [3] [4]
    End point description
    AEs and SAEs are defined in Outcome Measure 1. Analysis was performed on Cohort 4 Safety Set, which included all participants who received at least 1 dose of study drug in Cohort 4.
    End point type
    Primary
    End point timeframe
    Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
    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: No statistical analysis was planned for this 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 related to the specified cohort are reported.
    End point values
    		 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Number of subjects analysed
    63
    62
    Units: participants
    number (not applicable)
        Participants with any AEs
    53
    52
        Participants with SAEs
    5
    9
    No statistical analyses for this end point

    Primary: Cohort 1: Absolute Change from Day 14 in Sweat Chloride at Day 21

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    End point title
    		 Cohort 1: Absolute Change from Day 14 in Sweat Chloride at Day 21
    End point description
    Analysis was performed on Cohort 1 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 1. Results are reported for combination therapy period (Period 2: Day 15 to Day 21).
    End point type
    Primary
    End point timeframe
    Cohort 1: Day 14, Day 21
    End point values
    		 Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2 Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2 Cohort 1: Placebo – Period 2
    Number of subjects analysed
    19
    14
    17
    Units: millimole per liter (mmol/L)
        least squares mean (confidence interval 95%)
    -2.131 (-5.381 to 1.119)
    -9.128 (-12.893 to -5.362)
    0.548 (-2.955 to 4.052)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Cohort 1: Placebo – Period 2 v Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.267
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -2.679
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.484
         upper limit
    		 2.125
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2 v Cohort 1: Placebo – Period 2
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -9.676
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.801
         upper limit
    		 -4.551

    Primary: Cohort 2 And 3: Absolute Change from Day 28 in Sweat Chloride at Day 56

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    End point title
    		 Cohort 2 And 3: Absolute Change from Day 28 in Sweat Chloride at Day 56
    End point description
    Analysis was performed on Cohort 2 and 3 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Results are reported for combination therapy period (Period 2: Day 29 to Day 56).
    End point type
    Primary
    End point timeframe
    Cohort 2 and 3: Day 28, Day 56
    End point values
    		 Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2 Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Number of subjects analysed
    21
    19
    17
    9
    20
    24
    Units: mmol/L
        least squares mean (confidence interval 95%)
    0.321 (-4.208 to 4.849)
    -1.043 (-5.8 to 3.714)
    -1.24 (-6.287 to 3.807)
    -2.154 (-9.177 to 4.87)
    -2.9 (-7.542 to 1.743)
    1.627 (-2.661 to 5.915)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2 v Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.68
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -1.306
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.565
         upper limit
    		 4.953
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2 v Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.409
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -2.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.053
         upper limit
    		 3.712
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2 v Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -4.526
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.888
         upper limit
    		 1.835
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2 v Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.396
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -2.867
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.543
         upper limit
    		 3.81
    Statistical analysis title
    		 Statistical Analysis 5
    Comparison groups
    Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2 v Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.365
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -3.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.028
         upper limit
    		 4.467

    Primary: Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56

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    End point title
    		 Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56 [5]
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Hankinson method. Analysis was performed on Cohort 4 Full Analysis Set, which included all randomized participants who received any amount of study drug in Cohort 4.
    End point type
    Primary
    End point timeframe
    Cohort 4: Baseline, Day 56
    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 related to the specified cohort are reported.
    End point values
    		 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Number of subjects analysed
    60
    55
    Units: percent predicted of FEV1
        least squares mean (standard error)
    -1.23 ( 0.801 )
    -0.62 ( 0.829 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h v Cohort 4: Placebo
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5978
    Method
    		 Mixed Model Repeated Measure (MMRM)
    Parameter type
    		 LS Mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.66
         upper limit
    		 2.86

    Secondary: Cohort 1: Absolute Change from Baseline in Sweat Chloride at Day 14

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    End point title
    		 Cohort 1: Absolute Change from Baseline in Sweat Chloride at Day 14
    End point description
    Analysis was performed on Cohort 1 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 1. Results are reported for monotherapy period (Period 1: Day 1 to Day 14).
    End point type
    Secondary
    End point timeframe
    Cohort 1: Baseline, Day 14
    End point values
    		 Cohort 1: Placebo – Period 1 Cohort 1: LUM 200 mg qd – Period 1
    Number of subjects analysed
    17
    36
    Units: mmol/L
        least squares mean (confidence interval 95%)
    -1.668 (-5.606 to 2.271)
    -4.442 (-7.141 to -1.742)
    No statistical analyses for this end point

    Secondary: Cohort 2 And 3: Absolute Change from Baseline in Sweat Chloride at Day 14

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    End point title
    		 Cohort 2 And 3: Absolute Change from Baseline in Sweat Chloride at Day 14
    End point description
    Analysis was performed on Cohort 2 and 3 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Results are reported for monotherapy period (Period 1: Day 1 to Day 28).
    End point type
    Secondary
    End point timeframe
    Cohort 2: Baseline, Day 14
    End point values
    		 Cohort 3: LUM 400 mg q12h – Period 1 Cohort 2: LUM 200 mg qd – Period 1 Cohort 2: LUM 400 mg qd – Period 1 Cohort 2: LUM 600 mg qd (HO) – Period 1 Cohort 2: LUM 600 mg qd (HE) – Period 1 Cohort 2 and 3: Placebo (HO and HE) – Period 1
    Number of subjects analysed
    11
    19
    17
    21
    17
    25
    Units: mmol/L
        least squares mean (confidence interval 95%)
    -9.179 (-15.47 to -2.888)
    -6.49 (-11.226 to -1.755)
    -5.901 (-10.91 to -0.892)
    -9.442 (-13.953 to -4.931)
    -3.137 (-8.167 to 1.893)
    0.048 (-4.162 to 4.258)
    No statistical analyses for this end point

    Secondary: Cohort 4: Absolute Change from Baseline in Sweat Chloride at Day 56

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    End point title
    		 Cohort 4: Absolute Change from Baseline in Sweat Chloride at Day 56 [6]
    End point description
    Analysis was performed on Cohort 4 Full Analysis Set, which included all randomized participants who received any amount of study drug in Cohort 4.
    End point type
    Secondary
    End point timeframe
    Cohort 4: Baseline, Day 56
    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 related to the specified cohort are reported.
    End point values
    		 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Number of subjects analysed
    59
    54
    Units: mmol/L
        least squares mean (standard error)
    -0.78 ( 1.23 )
    -11.82 ( 1.281 )
    No statistical analyses for this end point

    Secondary: Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21

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    End point title
    		 Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21
    End point description
    FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Analysis was performed on Cohort 1 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 1. Results are reported for combination therapy period (Period 2: Day 15 to Day 21).
    End point type
    Secondary
    End point timeframe
    Cohort 1: Day 14, Day 21
    End point values
    		 Cohort 1: Placebo – Period 2 Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2 Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2
    Number of subjects analysed
    21
    20
    18
    Units: liters
        least squares mean (confidence interval 95%)
    -0.046 (-0.138 to 0.047)
    0.128 (0.03 to 0.225)
    0.015 (-0.094 to 0.124)
    No statistical analyses for this end point

    Secondary: Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21

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    End point title
    		 Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21
    End point description
    FEV1 and ppFEV1 are defined in sixth primary endpoint. Analysis was performed on Cohort 1 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 1. Results are reported for combination therapy period (Period 2: Day 15 to Day 21).
    End point type
    Secondary
    End point timeframe
    Cohort 1: Day 14, Day 21
    End point values
    		 Cohort 1: Placebo – Period 2 Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2 Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2
    Number of subjects analysed
    21
    20
    18
    Units: percent predicted of FEV1
        least squares mean (confidence interval 95%)
    -1.44 (-3.89 to 1.01)
    3.46 (0.87 to 6.05)
    0.63 (-2.2 to 3.46)
    No statistical analyses for this end point

    Secondary: Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56

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    End point title
    		 Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56
    End point description
    FEV1 and ppFEV1 are defined in sixth primary endpoint. Analysis was performed on Cohort 2 and 3 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Results are reported for combination therapy period (Period 2: Day 29 to Day 56).
    End point type
    Secondary
    End point timeframe
    Cohort 2 and 3: Day 28, Day 56
    End point values
    		 Cohort 2 and 3: Placebo (HO and HE) – Period 2 Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2
    Number of subjects analysed
    24
    21
    20
    10
    17
    20
    Units: percent predicted of FEV1
        least squares mean (confidence interval 95%)
    -1.57 (-4.24 to 1.09)
    1.96 (-0.84 to 4.76)
    1.99 (-0.87 to 4.84)
    6.09 (2.02 to 10.16)
    2.29 (-0.82 to 5.39)
    6.15 (3.27 to 9.02)
    No statistical analyses for this end point

    Secondary: Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56

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    End point title
    		 Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56
    End point description
    FEV1 and ppFEV1 are defined in sixth primary endpoint. Analysis was performed on Cohort 2 and 3 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Results are reported for combination therapy period (Period 2: Day 29 to Day 56).
    End point type
    Secondary
    End point timeframe
    Cohort 2 and 3: Day 28, Day 56
    End point values
    		 Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Number of subjects analysed
    21
    20
    10
    17
    20
    24
    Units: percent change
        least squares mean (confidence interval 95%)
    3.13 (-1.29 to 7.54)
    2.98 (-1.52 to 7.48)
    8.24 (1.83 to 14.65)
    4.3 (-0.59 to 9.19)
    9.7 (5.17 to 14.23)
    -2.05 (-6.25 to 2.15)
    No statistical analyses for this end point

    Secondary: Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56

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    End point title
    		 Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56 [7]
    End point description
    FEV1 and ppFEV1 are defined in sixth primary endpoint. Analysis was performed on Cohort 2 and 3 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3.
    End point type
    Secondary
    End point timeframe
    Cohort 2 and 3: Baseline, Day 28 and 56
    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 related to the specified cohort are reported.
    End point values
    		 Cohort 2 and 3: Placebo (HO and HE) Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO) Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO) Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO) Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO) Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)
    Number of subjects analysed
    27
    23
    21
    11
    21
    21
    Units: percent predicted of FEV1
    least squares mean (confidence interval 95%)
        Day 28: (n= 27, 21, 20, 11, 20, 18)
    -0.03 (-2.68 to 2.62)
    0.21 (-2.77 to 3.19)
    -1.35 (-4.39 to 1.69)
    -4.52 (-8.65 to -0.39)
    -2.62 (-5.67 to 0.42)
    -3.82 (-7.03 to -0.61)
        Day 56: (n= 24, 21, 20, 10, 20, 17)
    -2.02 (-4.97 to 0.93)
    1.82 (-1.28 to 4.91)
    0.64 (-2.52 to 3.8)
    2.16 (-2.34 to 6.66)
    3.59 (0.41 to 6.77)
    -1.68 (-5.12 to 1.75)
    No statistical analyses for this end point

    Secondary: Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56

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    End point title
    		 Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56 [8]
    End point description
    FEV1 and ppFEV1 are defined in Outcome Measure 6. Analysis was performed on Cohort 2 and 3 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3.
    End point type
    Secondary
    End point timeframe
    Cohort 2 and 3: Baseline, Day 28 and 56
    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 related to the specified cohort are reported.
    End point values
    		 Cohort 2 and 3: Placebo (HO and HE) Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO) Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO) Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO) Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO) Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)
    Number of subjects analysed
    27
    23
    21
    11
    21
    21
    Units: percent change
    least squares mean (confidence interval 95%)
        Day 28: (n= 27, 21, 20, 11, 20, 18)
    1.89 (-2.12 to 5.9)
    0.24 (-4.27 to 4.75)
    -1.15 (-5.75 to 3.45)
    -6.39 (-12.65 to -0.14)
    -3.13 (-7.74 to 1.48)
    -5.46 (-10.32 to -0.6)
        Day 56: (n= 24, 21, 20, 10, 20, 17)
    -2.42 (-6.91 to 2.08)
    2.51 (-2.21 to 7.23)
    1.72 (-3.09 to 6.53)
    2.96 (-3.9 to 9.81)
    5.55 (0.7 to 10.39)
    -2.34 (-7.57 to 2.89)
    No statistical analyses for this end point

    Secondary: Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56

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    End point title
    		 Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56 [9]
    End point description
    FEV1 and ppFEV1 are defined in sixth primary outcome. Analysis was performed on Cohort 2 and 3 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3.
    End point type
    Secondary
    End point timeframe
    Cohort 4: Baseline, Day 56
    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 related to the specified cohort are reported.
    End point values
    		 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Number of subjects analysed
    60
    55
    Units: percent change
        least squares mean (standard error)
    -2.2 ( 1.373 )
    -0.69 ( 1.423 )
    No statistical analyses for this end point

    Secondary: Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56

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    End point title
    		 Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56
    End point description
    The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Analysis was performed on Cohort 2 and 3 Full Analysis Set, which included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Results are reported for combination therapy period (Period 2: Day 29 to Day 56).
    End point type
    Secondary
    End point timeframe
    Cohort 2 and 3: Day 28, Day 56
    End point values
    		 Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2 Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Number of subjects analysed
    21
    20
    17
    20
    10
    25
    Units: units on a scale
        least squares mean (confidence interval 95%)
    3.3 (-3.6 to 10.1)
    7.9 (0.8 to 14.9)
    5.5 (-2.1 to 13.1)
    8.9 (1.9 to 15.9)
    11.2 (1.3 to 21.1)
    -8.6 (-14.9 to -2.2)
    No statistical analyses for this end point

    Secondary: Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56

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    End point title
    		 Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56 [10]
    End point description
    CFQ-R respiratory domain is defined in previous endpoint. Analysis was performed on Cohort 4 Full Analysis Set, which included all randomized participants who received any amount of study drug in Cohort 4.
    End point type
    Secondary
    End point timeframe
    Cohort 4: Baseline, Day 56
    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 related to the specified cohort are reported.
    End point values
    		 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Number of subjects analysed
    60
    55
    Units: units on a scale
        least squares mean (standard error)
    -0.82 ( 1.802 )
    5.66 ( 1.864 )
    No statistical analyses for this end point

    Secondary: Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56

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    End point title
    		 Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56 [11]
    End point description
    BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2). Analysis was performed on Cohort 4 Full Analysis Set, which included all randomized participants who received any amount of study drug in Cohort 4.
    End point type
    Secondary
    End point timeframe
    Cohort 4: Baseline, Day 56
    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 related to the specified cohort are reported.
    End point values
    		 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Number of subjects analysed
    60
    56
    Units: kg/m^2
        least squares mean (standard error)
    0.08 ( 0.075 )
    -0.04 ( 0.077 )
    No statistical analyses for this end point

    Secondary: Cohort 4: Absolute Change From Baseline in Weight at Day 56

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    End point title
    		 Cohort 4: Absolute Change From Baseline in Weight at Day 56 [12]
    End point description
    Analysis was performed on Cohort 4 Full Analysis Set, which included all randomized participants who received any amount of study drug in Cohort 4.
    End point type
    Secondary
    End point timeframe
    Cohort 4: Baseline, Day 56
    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 related to the specified cohort are reported.
    End point values
    		 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Number of subjects analysed
    60
    56
    Units: kg
        least squares mean (standard error)
    0.16 ( 0.211 )
    -0.11 ( 0.216 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).

    Reporting group title
    Cohort 1: LUM 200 mg qd – Period 1
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).

    Reporting group title
    Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).

    Reporting group title
    Cohort 1: Placebo – Period 1
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).

    Reporting group title
    Cohort 1: Placebo – Period 2
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).

    Reporting group title
    Cohort 2: LUM 200 mg qd – Period 1
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).

    Reporting group title
    Cohort 2: LUM 400 mg qd – Period 1
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).

    Reporting group title
    Cohort 2: LUM 600 mg qd – Period 1
    Reporting group description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).

    Reporting group title
    Cohort 3: LUM 400 mg q12h – Period 1
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).

    Reporting group title
    Cohort 2 and 3: Placebo (HO and HE) – Period 1
    Reporting group description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).

    Reporting group title
    Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2
    Reporting group description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2
    Reporting group description
    		 Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 2 and 3: Placebo (HO and HE) – Period 2
    Reporting group description
    		 Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).

    Reporting group title
    Cohort 4: Placebo
    Reporting group description
    		 Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).

    Reporting group title
    Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Reporting group description
    		 Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).

    Serious adverse events
    		 Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2 Cohort 1: LUM 200 mg qd – Period 1 Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2 Cohort 1: Placebo – Period 1 Cohort 1: Placebo – Period 2 Cohort 2: LUM 200 mg qd – Period 1 Cohort 2: LUM 400 mg qd – Period 1 Cohort 2: LUM 600 mg qd – Period 1 Cohort 3: LUM 400 mg q12h – Period 1 Cohort 2 and 3: Placebo (HO and HE) – Period 1 Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2 Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2 Cohort 2 and 3: Placebo (HO and HE) – Period 2 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 21 (0.00%)
    3 / 42 (7.14%)
    2 / 11 (18.18%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    4 / 38 (10.53%)
    1 / 11 (9.09%)
    4 / 27 (14.81%)
    5 / 63 (7.94%)
    9 / 62 (14.52%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Spirometry abnormal
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    CYSTIC FIBROSIS LUNG
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    1 / 11 (9.09%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    3 / 38 (7.89%)
    1 / 11 (9.09%)
    4 / 27 (14.81%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    1 / 1
    0 / 0
    0 / 1
    0 / 3
    0 / 1
    1 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    HYPERSENSITIVITY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSPNOEA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATION ABNORMAL
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    3 / 63 (4.76%)
    7 / 62 (11.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    		 Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2 Cohort 1: LUM 200 mg qd – Period 1 Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2 Cohort 1: Placebo – Period 1 Cohort 1: Placebo – Period 2 Cohort 2: LUM 200 mg qd – Period 1 Cohort 2: LUM 400 mg qd – Period 1 Cohort 2: LUM 600 mg qd – Period 1 Cohort 3: LUM 400 mg q12h – Period 1 Cohort 2 and 3: Placebo (HO and HE) – Period 1 Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2 Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2 Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2 Cohort 2 and 3: Placebo (HO and HE) – Period 2 Cohort 4: Placebo Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 20 (70.00%)
    29 / 41 (70.73%)
    12 / 20 (60.00%)
    12 / 21 (57.14%)
    15 / 21 (71.43%)
    17 / 23 (73.91%)
    18 / 21 (85.71%)
    37 / 42 (88.10%)
    6 / 11 (54.55%)
    23 / 27 (85.19%)
    12 / 21 (57.14%)
    15 / 20 (75.00%)
    26 / 38 (68.42%)
    10 / 11 (90.91%)
    20 / 27 (74.07%)
    53 / 63 (84.13%)
    51 / 62 (82.26%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    3 / 21 (14.29%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    3 / 42 (7.14%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    6 / 63 (9.52%)
    4 / 62 (6.45%)
         occurrences all number
    1
    1
    0
    1
    3
    0
    1
    4
    0
    1
    0
    1
    1
    0
    1
    6
    6
    PYREXIA
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 41 (7.32%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    6 / 42 (14.29%)
    0 / 11 (0.00%)
    3 / 27 (11.11%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    9 / 63 (14.29%)
    7 / 62 (11.29%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    0
    7
    0
    4
    0
    1
    1
    0
    1
    10
    7
    PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 41 (7.32%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    3 / 63 (4.76%)
    0 / 62 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    APPLICATION SITE PRURITUS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    CATHETER SITE HAEMORRHAGE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CATHETER SITE PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    CHEST DISCOMFORT
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CHILLS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    3
    0
    FEELING HOT
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    INJECTION SITE HAEMORRHAGE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    APPLICATION SITE IRRITATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    FEELING OF BODY TEMPERATURE CHANGE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    1
    0
    Reproductive system and breast disorders
    MENSTRUATION DELAYED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BREAST TENDERNESS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MENOMETRORRHAGIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MENORRHAGIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    MENSTRUAL DISORDER
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    Vulvovaginal burning sensation
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vulvovaginal discomfort
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    4 / 20 (20.00%)
    6 / 41 (14.63%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    4 / 21 (19.05%)
    3 / 23 (13.04%)
    8 / 21 (38.10%)
    12 / 42 (28.57%)
    1 / 11 (9.09%)
    6 / 27 (22.22%)
    3 / 21 (14.29%)
    5 / 20 (25.00%)
    5 / 38 (13.16%)
    3 / 11 (27.27%)
    6 / 27 (22.22%)
    12 / 63 (19.05%)
    13 / 62 (20.97%)
         occurrences all number
    5
    6
    1
    1
    4
    3
    8
    13
    1
    6
    5
    5
    6
    4
    6
    15
    16
    PRODUCTIVE COUGH
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 41 (7.32%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    3 / 21 (14.29%)
    2 / 23 (8.70%)
    2 / 21 (9.52%)
    6 / 42 (14.29%)
    2 / 11 (18.18%)
    5 / 27 (18.52%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
    1 / 38 (2.63%)
    2 / 11 (18.18%)
    1 / 27 (3.70%)
    3 / 63 (4.76%)
    3 / 62 (4.84%)
         occurrences all number
    1
    3
    0
    2
    3
    2
    2
    7
    2
    5
    3
    1
    1
    2
    1
    4
    3
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 41 (4.88%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    2 / 23 (8.70%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    1 / 11 (9.09%)
    1 / 27 (3.70%)
    1 / 21 (4.76%)
    4 / 20 (20.00%)
    0 / 38 (0.00%)
    2 / 11 (18.18%)
    1 / 27 (3.70%)
    5 / 63 (7.94%)
    3 / 62 (4.84%)
         occurrences all number
    1
    2
    2
    0
    2
    2
    0
    1
    1
    1
    1
    5
    0
    2
    1
    6
    3
    NASAL CONGESTION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    3 / 20 (15.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    3 / 27 (11.11%)
    2 / 21 (9.52%)
    3 / 20 (15.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    4 / 63 (6.35%)
    5 / 62 (8.06%)
         occurrences all number
    1
    0
    3
    0
    2
    1
    0
    0
    0
    3
    2
    3
    2
    0
    1
    5
    7
    RHINORRHOEA
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 41 (4.88%)
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    3 / 27 (11.11%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    1 / 27 (3.70%)
    3 / 63 (4.76%)
    4 / 62 (6.45%)
         occurrences all number
    1
    2
    1
    2
    0
    0
    0
    0
    0
    3
    0
    1
    0
    1
    1
    4
    4
    DYSPNOEA
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 41 (7.32%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    10 / 42 (23.81%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    4 / 63 (6.35%)
    9 / 62 (14.52%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    1
    10
    0
    0
    0
    0
    1
    0
    0
    5
    10
    RALES
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    3 / 21 (14.29%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    2 / 62 (3.23%)
         occurrences all number
    0
    1
    0
    0
    4
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    2
    RESPIRATION ABNORMAL
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    2 / 21 (9.52%)
    7 / 42 (16.67%)
    2 / 11 (18.18%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    9 / 63 (14.29%)
    17 / 62 (27.42%)
         occurrences all number
    0
    1
    1
    1
    1
    0
    2
    8
    2
    0
    2
    0
    2
    0
    0
    9
    20
    WHEEZING
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    2 / 21 (9.52%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    2
    2
    0
    2
    1
    0
    1
    0
    0
    2
    0
    0
    0
    0
    LUNG HYPERINFLATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    3 / 21 (14.29%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    RESPIRATORY TRACT CONGESTION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    2 / 27 (7.41%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    6 / 63 (9.52%)
    5 / 62 (8.06%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    1
    0
    2
    0
    0
    1
    1
    0
    6
    6
    BRONCHIAL SECRETION RETENTION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HYPOVENTILATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    INCREASED VISCOSITY OF BRONCHIAL SECRETION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    NASAL MUCOSAL DISORDER
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    NASAL OEDEMA
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    PROLONGED EXPIRATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RHINITIS ALLERGIC
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    RHONCHI
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SINUS CONGESTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    3 / 42 (7.14%)
    0 / 11 (0.00%)
    2 / 27 (7.41%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    2 / 11 (18.18%)
    2 / 27 (7.41%)
    4 / 63 (6.35%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    3
    0
    2
    0
    2
    0
    2
    2
    4
    0
    SINUS DISORDER
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SNEEZING
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    HAEMOPTYSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    4 / 23 (17.39%)
    3 / 21 (14.29%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    3 / 38 (7.89%)
    0 / 11 (0.00%)
    2 / 27 (7.41%)
    7 / 63 (11.11%)
    5 / 62 (8.06%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    3
    2
    0
    0
    1
    0
    3
    0
    2
    10
    5
    PLEURITIC PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    3 / 27 (11.11%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    3
    0
    0
    EPISTAXIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    1
    1
    PARANASAL SINUS HYPERSECRETION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    SPUTUM DISCOLOURED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    1
    0
    OBSTRUCTIVE AIRWAYS DISORDER
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BRONCHOSPASM
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    DYSPHONIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    NASAL INFLAMMATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    PAINFUL RESPIRATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    PULMONARY CONGESTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    SPUTUM INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    12 / 63 (19.05%)
    10 / 62 (16.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    12
    10
    UPPER-AIRWAY COUGH SYNDROME
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    BRONCHIAL OBSTRUCTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    HICCUPS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    NASAL DRYNESS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    PHARYNGEAL OEDEMA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    PLEURISY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    PULMONARY PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    INSOMNIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    1 / 21 (4.76%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    MOOD SWINGS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    DEPRESSED MOOD
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Abnormal dreams
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Investigations
    BLOOD GLUCOSE INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    5 / 42 (11.90%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    5 / 63 (7.94%)
    2 / 62 (3.23%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    0
    5
    0
    0
    0
    0
    0
    0
    0
    6
    2
    GLUCOSE URINE PRESENT
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 41 (4.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    PROTHROMBIN TIME PROLONGED
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    PULMONARY FUNCTION TEST DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 41 (4.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    2 / 11 (18.18%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    2 / 62 (3.23%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    2
    3
    ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    4 / 62 (6.45%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    4
    BLOOD IMMUNOGLOBULIN E INCREASED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD SODIUM DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD URINE PRESENT
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    INTERNATIONAL NORMALISED RATIO INCREASED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Forced expiratory volume decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    4 / 63 (6.35%)
    4 / 62 (6.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    4
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    4 / 62 (6.45%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    1
    0
    0
    1
    4
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 38 (5.26%)
    1 / 11 (9.09%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    2
    1
    1
    0
    3
    Sputum abnormal
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Blood creatinine decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    Blood immunoglobulin G increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Chest X-ray abnormal
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Interleukin level increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    2 / 27 (7.41%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    1
    0
    Protein total increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    WHITE BLOOD CELL COUNT INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD GLUCOSE DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    NEUTROPHIL COUNT INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BACTERIA URINE IDENTIFIED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    BLOOD PHOSPHORUS DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    BLOOD POTASSIUM INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    CULTURE THROAT POSITIVE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ELECTROCARDIOGRAM QT PROLONGED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    FUNGUS SPUTUM TEST POSITIVE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PROTEIN URINE PRESENT
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    URINE KETONE BODY PRESENT
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    WHITE BLOOD CELLS URINE POSITIVE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    CHEST INJURY
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    EXCORIATION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    JOINT SPRAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    LIMB INJURY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCLE STRAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    THERMAL BURN
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Procedural pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Arthropod sting
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    JOINT INJURY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    1
    0
    Rib fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Road traffic accident
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    SUNBURN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    VERTEBRAL INJURY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Animal bite
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    ARTHROPOD BITE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    CYSTIC FIBROSIS LUNG
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 41 (4.88%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    2 / 21 (9.52%)
    7 / 42 (16.67%)
    1 / 11 (9.09%)
    2 / 27 (7.41%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    3 / 38 (7.89%)
    1 / 11 (9.09%)
    4 / 27 (14.81%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    2
    2
    1
    0
    1
    0
    2
    7
    1
    2
    1
    1
    3
    1
    4
    1
    0
    Cystic fibrosis related diabetes
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Cardiac disorders
    SINUS BRADYCARDIA
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    2 / 62 (3.23%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    0
    0
    2
    2
    SINUS HEADACHE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    2
    1
    MIGRAINE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    TREMOR
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    TUNNEL VISION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HEADACHE
         subjects affected / exposed
    0 / 20 (0.00%)
    4 / 41 (9.76%)
    1 / 20 (5.00%)
    4 / 21 (19.05%)
    5 / 21 (23.81%)
    1 / 23 (4.35%)
    4 / 21 (19.05%)
    4 / 42 (9.52%)
    1 / 11 (9.09%)
    5 / 27 (18.52%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    7 / 38 (18.42%)
    2 / 11 (18.18%)
    5 / 27 (18.52%)
    11 / 63 (17.46%)
    3 / 62 (4.84%)
         occurrences all number
    0
    4
    1
    5
    7
    1
    4
    7
    2
    9
    0
    2
    10
    3
    7
    18
    4
    NEURALGIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    PRESYNCOPE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    LETHARGY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    DYSGEUSIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    LYMPHADENOPATHY
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eosinophilia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Increased tendency to bruise
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    EAR PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    EAR DISCOMFORT
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    EAR DISORDER
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    TINNITUS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    Eye disorders
    EYELID OEDEMA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CONJUNCTIVITIS (EYE)
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    VISION BLURRED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 41 (2.44%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    3 / 21 (14.29%)
    5 / 42 (11.90%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    5 / 63 (7.94%)
    7 / 62 (11.29%)
         occurrences all number
    1
    1
    1
    0
    2
    1
    3
    5
    0
    1
    0
    2
    0
    0
    1
    9
    7
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 41 (7.32%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    2 / 23 (8.70%)
    1 / 21 (4.76%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    2 / 27 (7.41%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    2 / 27 (7.41%)
    7 / 63 (11.11%)
    5 / 62 (8.06%)
         occurrences all number
    0
    3
    0
    0
    1
    2
    1
    0
    0
    2
    0
    1
    0
    1
    2
    10
    5
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    2 / 21 (9.52%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    3 / 63 (4.76%)
    1 / 62 (1.61%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    3
    0
    0
    0
    1
    1
    2
    0
    1
    5
    1
    NAUSEA
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 41 (4.88%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    8 / 42 (19.05%)
    1 / 11 (9.09%)
    3 / 27 (11.11%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    3 / 38 (7.89%)
    0 / 11 (0.00%)
    2 / 27 (7.41%)
    7 / 63 (11.11%)
    7 / 62 (11.29%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    3
    8
    1
    3
    0
    2
    3
    0
    2
    9
    7
    VOMITING
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    2 / 63 (3.17%)
    4 / 62 (6.45%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    2
    2
    0
    1
    0
    2
    2
    0
    1
    2
    4
    ABDOMINAL DISTENSION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    FLATULENCE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    3 / 21 (14.29%)
    3 / 42 (7.14%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    3
    3
    0
    0
    1
    0
    0
    0
    0
    0
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    2 / 27 (7.41%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    5 / 62 (8.06%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    1
    0
    0
    0
    7
    HYPOAESTHESIA ORAL
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CONSTIPATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    DISTAL ILEAL OBSTRUCTION SYNDROME
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    DRY MOUTH
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    DYSPEPSIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    3
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    TOOTHACHE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    FREQUENT BOWEL MOVEMENTS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    3
    FAECAL VOLUME INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    DYSPHAGIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    LIP SWELLING
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    POST-TUSSIVE VOMITING
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    STEATORRHOEA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    RASH MACULAR
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 41 (4.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RASH PAPULAR
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    ACNE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    DERMATITIS CONTACT
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    HYPERHIDROSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    HYPOAESTHESIA FACIAL
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    NIGHT SWEATS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    PRURITUS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    RASH FOLLICULAR
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RASH MACULO-PAPULAR
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    URTICARIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Rash generalised
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    RASH
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    1 / 21 (4.76%)
    3 / 42 (7.14%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    1
    3
    0
    0
    1
    0
    1
    1
    0
    0
    0
    ALOPECIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ECCHYMOSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Renal and urinary disorders
    PYURIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chromaturia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Renal failure acute
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    PROTEINURIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    DYSURIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    2
    2
    0
    0
    0
    0
    0
    1
    0
    1
    1
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    6
    0
    0
    0
    1
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCLE SPASMS
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    2 / 27 (7.41%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    MYALGIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    2
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Arthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Clubbing
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    2 / 21 (9.52%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Osteopenia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    MUSCULOSKELETAL DISCOMFORT
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    COSTOCHONDRITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    MEDIAL TIBIAL STRESS SYNDROME
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCLE TIGHTNESS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCULOSKELETAL STIFFNESS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    NECK PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    TORTICOLLIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 38 (5.26%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    2
    0
    1
    0
    0
    Infections and infestations
    VIRAL INFECTION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RHINITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    5 / 23 (21.74%)
    1 / 21 (4.76%)
    2 / 42 (4.76%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    3 / 21 (14.29%)
    2 / 20 (10.00%)
    3 / 38 (7.89%)
    1 / 11 (9.09%)
    4 / 27 (14.81%)
    3 / 63 (4.76%)
    3 / 62 (4.84%)
         occurrences all number
    2
    0
    0
    0
    0
    5
    1
    2
    0
    0
    3
    2
    3
    1
    4
    4
    3
    BACTERIAL DISEASE CARRIER
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CANDIDIASIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ORAL HERPES
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    2 / 42 (4.76%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    4 / 63 (6.35%)
    2 / 62 (3.23%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    4
    2
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    10 / 63 (15.87%)
    7 / 62 (11.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11
    8
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    6 / 63 (9.52%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    6
    2
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    2
    PHARYNGITIS STREPTOCOCCAL
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    2 / 63 (3.17%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Rash pustular
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Acute sinusitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Bronchopulmonary aspergillosis allergic
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    INFLUENZA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    1
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Kidney infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Lung infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    1 / 63 (1.59%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    SINUSITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    1 / 21 (4.76%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    FUNGAL INFECTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    HERPES SIMPLEX
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    LARYNGITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    OTITIS MEDIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    PHARYNGITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    RHINOVIRUS INFECTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    VIRAL RASH
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 38 (2.63%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    0
    1
    3
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    DEHYDRATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 21 (4.76%)
    1 / 42 (2.38%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    2 / 11 (18.18%)
    0 / 27 (0.00%)
    4 / 63 (6.35%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    2
    0
    4
    0
    ANOREXIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    1 / 42 (2.38%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HYPERCALCAEMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    1 / 11 (9.09%)
    0 / 27 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 21 (0.00%)
    0 / 42 (0.00%)
    0 / 11 (0.00%)
    1 / 27 (3.70%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 38 (0.00%)
    0 / 11 (0.00%)
    0 / 27 (0.00%)
    0 / 63 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Aug 2011
    Study design for cohort 2 was modified.
    01 Jun 2012
    Study design was modified to include an additional cohort, Cohort 3.
    17 Jun 2013
    Study design was modified to remove the q8h lumacaftor dose regimen in Cohort 3 based on available preliminary data obtained from the q12h lumacaftor dose regimen. In addition, Cohort 4 was included.
    22 Apr 2014
    The order of the primary and key secondary endpoints in Cohort 4 was switched.

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

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