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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4)

    Summary
    EudraCT number
    		 2013-005366-19
    Trial protocol
    		 GB   HU   IT   ES   RO   PL   FR  
    Global end of trial date
    12 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2018
    First version publication date
    25 Apr 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ARD-3150-1202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02104245
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aradigm Corporation
    Sponsor organisation address
    3929 Point Eden Way, Hayward, California, United States, 94545
    Public contact
    Clinical Operations, Aradigm Corporation, +1 510 265 8895, JacksonA@aradigm.com
    Scientific contact
    Medical and Drug Development, Aradigm Corporation, +1 510 265 8838, froehlichj@aradigm.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
    07 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of Linhaliq compared to placebo in the management of chronic lung infections with P. aeruginosa in subjects with non-cystic fibrosis (non-CF) bronchiectasis by evaluating the time to first pulmonary exacerbation in the Double-Blind Phase.
    Protection of trial subjects
    The study was designed and monitored in accordance with Sponsor procedures, which comply with the ethical principles of Good Clinical Practice (GCP) as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 May 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Israel: 24
    Country: Number of subjects enrolled
    New Zealand: 16
    Country: Number of subjects enrolled
    Georgia: 28
    Country: Number of subjects enrolled
    Serbia: 10
    Country: Number of subjects enrolled
    Korea, Republic of: 14
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Romania: 17
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    United Kingdom: 43
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Australia: 26
    Country: Number of subjects enrolled
    Peru: 21
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    Canada: 10
    Worldwide total number of subjects
    304
    EEA total number of subjects
    119
    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)
    139
    From 65 to 84 years
    162
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 96 clinical sites screened at least one subject for the study. The sites were located in Australia, Canada, France, Georgia, Hungary, Israel, Italy, New Zealand, Peru, Poland, Romania, Serbia, South Korea, Spain, the United Kingdom, and the US. The first subject was screened on 28 May 2014, and the final subject screened on 04 August 2015.

    Pre-assignment
    Screening details
    		 533 were enrolled and screened. Subjects who met all eligibility criteria were randomized in a 2:1 ratio to receive once daily inhaled treatment with Pulmaquin or placebo.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Liquid mixture of liposome-encapsulated and unencapsulated ciprofloxacin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linhaliq
    Investigational medicinal product code
    ARD-3150
    Other name
    Pulmaquin
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    The administered dose was 189 mg (6 mL) of ciprofloxacin comprised of one vial of 135 mg (3mL) liposome-encapsulated ciprofloxacin dispersion and one vial of 54 mg (3mL) free ciprofloxacin solution given once daily by oral inhalation using a nebuliser; the dosing regimen was 6 cycles of 28 days on treatment, followed by 28 days off treatment.

    Arm title
    		 Placebo
    Arm description
    		 Liquid mixture of empty liposomes and normal saline
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    The administered dose was 6 mL placebo, comprised of one vial of 3 mL empty liposomes and one vial of 3 mL normal saline solution once daily by oral inhalation using a nebuliser; the dosing regimen was 6 cycles of 28 days on treatment, followed by 28 days off treatment.

    Number of subjects in period 1
    		Active Placebo
    Started
    206
    98
    Completed
    178
    81
    Not completed
    28
    17
         Adverse event, serious fatal
    1
    2
         Consent withdrawn by subject
    13
    11
         Physician decision
    3
    1
         Adverse event, non-fatal
    4
    2
         Other
    2
    -
         Lost to follow-up
    3
    -
         Lack of efficacy
    1
    -
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Liquid mixture of liposome-encapsulated and unencapsulated ciprofloxacin

    Reporting group title
    Placebo
    Reporting group description
    		 Liquid mixture of empty liposomes and normal saline

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 206 98 304
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    		 65.5 (18 to 90) 67.0 (21 to 86) -
    Gender categorical
    Units: Subjects
        Female
    		 134 63 197
        Male
    		 72 35 107

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Liquid mixture of liposome-encapsulated and unencapsulated ciprofloxacin

    Reporting group title
    Placebo
    Reporting group description
    		 Liquid mixture of empty liposomes and normal saline

    Primary: Time to First Pulmonary Exacerbation

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    End point title
    		 Time to First Pulmonary Exacerbation
    End point description
    Median time to first pulmonary exacerbation
    End point type
    Primary
    End point timeframe
    May 2014 to August 2016
    End point values
    		 Active Placebo
    Number of subjects analysed
    206
    98
    Units: Number of days
        median (confidence interval 95%)
    230.0 (187.0 to 341.0)
    158.0 (79.0 to 238.0)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0323
    Method
    		 Stratified Unweighted Log-Rank Test
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 0.97

    Secondary: Frequency of Pulmonary Exacerbations

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    End point title
    		 Frequency of Pulmonary Exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    May 2014 to August 2016
    End point values
    		 Active Placebo
    Number of subjects analysed
    206
    98
    Units: Number of Pulmonary Exacerbations
        arithmetic mean (standard error)
    0.98 ± 0.09
    1.47 ± 0.11
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 Stratified Negative Binomial Regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.82
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Counting Process
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.76

    Secondary: Frequency of Moderate and Severe Pulmonary Exacerbations

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    End point title
    		 Frequency of Moderate and Severe Pulmonary Exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    May 2014 to August 2016
    End point values
    		 Active Placebo
    Number of subjects analysed
    206
    98
    Units: Number of Pulmonary Exacerbations
        arithmetic mean (standard error)
    0.78 ± 0.10
    1.27 ± 0.12
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Stratified Negative Binomial Regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 0.77
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Counting Process
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 0.71

    Secondary: Frequency of Severe Pulmonary Exacerbations

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    End point title
    		 Frequency of Severe Pulmonary Exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    May 2014 to August 2016
    End point values
    		 Active Placebo
    Number of subjects analysed
    206
    98
    Units: Number of Pulmonary Exacerbations
        arithmetic mean (standard error)
    0.14 ± 0.24
    0.30 ± 0.25
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0031
    Method
    		 Stratified Negative Binomial Regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 0.74
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Counting Process
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 0.71

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    May 2014 to August 2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Liquid mixture of liposome-encapsulated and unencapsulated ciprofloxacin

    Reporting group title
    Placebo
    Reporting group description
    		 Liquid mixture of empty liposomes and normal saline

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 206 (16.99%)
    28 / 98 (28.57%)
         number of deaths (all causes)
    2
    4
         number of deaths resulting from adverse events
    1
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 206 (0.97%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acute respiratory failure
         subjects affected / exposed
    3 / 206 (1.46%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial secretion retention
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cough
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    6 / 206 (2.91%)
    5 / 98 (5.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Increased viscosity of bronchial secretion
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 206 (1.46%)
    4 / 98 (4.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rhonchi
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sputum increased
         subjects affected / exposed
    1 / 206 (0.49%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    3 / 206 (1.46%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Breath sounds abnormal
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Avulsion fracture
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital haematoma
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    7 / 206 (3.40%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin graft infection
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sputum purulent
         subjects affected / exposed
    1 / 206 (0.49%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    179 / 206 (86.89%)
    95 / 98 (96.94%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Basal cell carcinoma
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    3
    1
    Keratoacanthoma
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    2
    Myelofibrosis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Cryoglobulinaemia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    3 / 206 (1.46%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Hypertension
         subjects affected / exposed
    9 / 206 (4.37%)
    3 / 98 (3.06%)
         occurrences all number
    14
    3
    Hypotension
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Application site irritation
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    3 / 206 (1.46%)
    1 / 98 (1.02%)
         occurrences all number
    3
    1
    Chest discomfort
         subjects affected / exposed
    9 / 206 (4.37%)
    7 / 98 (7.14%)
         occurrences all number
    10
    9
    Chest pain
         subjects affected / exposed
    11 / 206 (5.34%)
    4 / 98 (4.08%)
         occurrences all number
    12
    4
    Chills
         subjects affected / exposed
    2 / 206 (0.97%)
    4 / 98 (4.08%)
         occurrences all number
    5
    7
    Crepitations
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Device breakage
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Discomfort
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Exercise tolerance decreased
         subjects affected / exposed
    54 / 206 (26.21%)
    32 / 98 (32.65%)
         occurrences all number
    93
    54
    Fatigue
         subjects affected / exposed
    71 / 206 (34.47%)
    49 / 98 (50.00%)
         occurrences all number
    124
    99
    Hernia pain
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    3 / 206 (1.46%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Malaise
         subjects affected / exposed
    36 / 206 (17.48%)
    14 / 98 (14.29%)
         occurrences all number
    39
    21
    Medical device site irritation
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 206 (0.49%)
    6 / 98 (6.12%)
         occurrences all number
    1
    7
    Pain
         subjects affected / exposed
    4 / 206 (1.94%)
    3 / 98 (3.06%)
         occurrences all number
    4
    4
    Peripheral swelling
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Product taste abnormal
         subjects affected / exposed
    4 / 206 (1.94%)
    0 / 98 (0.00%)
         occurrences all number
    4
    0
    Pyrexia
         subjects affected / exposed
    42 / 206 (20.39%)
    24 / 98 (24.49%)
         occurrences all number
    62
    33
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Vaccination site discomfort
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Food allergy
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Seasonal allergy
         subjects affected / exposed
    4 / 206 (1.94%)
    0 / 98 (0.00%)
         occurrences all number
    4
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Prostatomegaly
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Asphyxia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Asthma
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Asthmatic crisis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Bronchospasm
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    2
    Catarrh
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    137 / 206 (66.50%)
    71 / 98 (72.45%)
         occurrences all number
    285
    192
    Diaphragmalgia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Dry throat
         subjects affected / exposed
    1 / 206 (0.49%)
    3 / 98 (3.06%)
         occurrences all number
    1
    3
    Dysphonia
         subjects affected / exposed
    6 / 206 (2.91%)
    1 / 98 (1.02%)
         occurrences all number
    6
    1
    Dyspnoea
         subjects affected / exposed
    106 / 206 (51.46%)
    53 / 98 (54.08%)
         occurrences all number
    234
    144
    Dyspnoea exertional
         subjects affected / exposed
    2 / 206 (0.97%)
    2 / 98 (2.04%)
         occurrences all number
    2
    2
    Epistaxis
         subjects affected / exposed
    5 / 206 (2.43%)
    0 / 98 (0.00%)
         occurrences all number
    5
    0
    Haemoptysis
         subjects affected / exposed
    25 / 206 (12.14%)
    18 / 98 (18.37%)
         occurrences all number
    36
    30
    Hyperventilation
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Increased viscosity of bronchial secretion
         subjects affected / exposed
    43 / 206 (20.87%)
    24 / 98 (24.49%)
         occurrences all number
    78
    41
    Nasal congestion
         subjects affected / exposed
    5 / 206 (2.43%)
    3 / 98 (3.06%)
         occurrences all number
    5
    3
    Oropharyngeal pain
         subjects affected / exposed
    10 / 206 (4.85%)
    13 / 98 (13.27%)
         occurrences all number
    13
    19
    Painful respiration
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Paranasal sinus discomfort
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Pharyngeal erythema
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Pleurisy
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Pleuritic pain
         subjects affected / exposed
    6 / 206 (2.91%)
    1 / 98 (1.02%)
         occurrences all number
    7
    1
    Pneumothorax
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    9 / 206 (4.37%)
    1 / 98 (1.02%)
         occurrences all number
    11
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Pulmonary pain
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Rales
         subjects affected / exposed
    13 / 206 (6.31%)
    5 / 98 (5.10%)
         occurrences all number
    20
    9
    Respiratory failure
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract congestion
         subjects affected / exposed
    9 / 206 (4.37%)
    8 / 98 (8.16%)
         occurrences all number
    11
    8
    Rhinorrhoea
         subjects affected / exposed
    11 / 206 (5.34%)
    9 / 98 (9.18%)
         occurrences all number
    12
    13
    Rhonchi
         subjects affected / exposed
    3 / 206 (1.46%)
    3 / 98 (3.06%)
         occurrences all number
    4
    6
    Sinus congestion
         subjects affected / exposed
    3 / 206 (1.46%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Sputum discoloured
         subjects affected / exposed
    5 / 206 (2.43%)
    7 / 98 (7.14%)
         occurrences all number
    7
    7
    Sputum increased
         subjects affected / exposed
    99 / 206 (48.06%)
    62 / 98 (63.27%)
         occurrences all number
    186
    155
    Sputum retention
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Tachypnoea
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Throat irritation
         subjects affected / exposed
    4 / 206 (1.94%)
    3 / 98 (3.06%)
         occurrences all number
    4
    6
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    84 / 206 (40.78%)
    48 / 98 (48.98%)
         occurrences all number
    149
    114
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    1 / 206 (0.49%)
    2 / 98 (2.04%)
         occurrences all number
    1
    3
    Anhedonia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    4 / 206 (1.94%)
    1 / 98 (1.02%)
         occurrences all number
    4
    1
    Depressed mood
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Emotional disorder
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 206 (0.00%)
    3 / 98 (3.06%)
         occurrences all number
    0
    3
    Irritability
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Major depression
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Middle insomnia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Mood altered
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Mood swings
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    3
    Anticonvulsant drug level increased
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Aspergillus test positive
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    blood cortisol decreased
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Blood creatine increased
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Body temperature increased
         subjects affected / exposed
    3 / 206 (1.46%)
    1 / 98 (1.02%)
         occurrences all number
    3
    1
    Breath sounds abnormal
         subjects affected / exposed
    61 / 206 (29.61%)
    28 / 98 (28.57%)
         occurrences all number
    86
    52
    C-reactive protein abnormal
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Chest X-ray abnormal
         subjects affected / exposed
    7 / 206 (3.40%)
    2 / 98 (2.04%)
         occurrences all number
    8
    2
    Crystal urine present
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram change
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Forced expiratory volume decreased
         subjects affected / exposed
    70 / 206 (33.98%)
    33 / 98 (33.67%)
         occurrences all number
    114
    55
    Forced vital capacity decreased
         subjects affected / exposed
    48 / 206 (23.30%)
    24 / 98 (24.49%)
         occurrences all number
    80
    38
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Heart rate increased
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio fluctuation
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Liver function test abnormal
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Lymph node palpable
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Lymphocyte count increased
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Medication residue present
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Platelet count increased
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Pseudomonas test positive
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Pulmonary function test decreased
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Spirometry abnormal
         subjects affected / exposed
    4 / 206 (1.94%)
    1 / 98 (1.02%)
         occurrences all number
    5
    1
    Sputum abnormal
         subjects affected / exposed
    24 / 206 (11.65%)
    15 / 98 (15.31%)
         occurrences all number
    38
    30
    Transaminases increased
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 206 (0.49%)
    3 / 98 (3.06%)
         occurrences all number
    2
    3
    White blood cell count decreased
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    White blood cell count increased
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    White blood cells urine positive
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    X-ray abnormal
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Animal scratch
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Arthropod bite
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Arthropod sting
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Avulsion fracture
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Back injury
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    5 / 206 (2.43%)
    0 / 98 (0.00%)
         occurrences all number
    8
    0
    Fall
         subjects affected / exposed
    5 / 206 (2.43%)
    0 / 98 (0.00%)
         occurrences all number
    12
    0
    Foot fracture
         subjects affected / exposed
    1 / 206 (0.49%)
    2 / 98 (2.04%)
         occurrences all number
    1
    2
    Forearm fracture
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Hip fracture
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Joint dislocation
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Joint injury
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Laceration
         subjects affected / exposed
    5 / 206 (2.43%)
    2 / 98 (2.04%)
         occurrences all number
    5
    2
    Ligament sprain
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    2
    Limb injury
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Muscle strain
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Post-traumatic neck syndrome
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Procedural pain
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Rib fracture
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    5
    0
    Wrist fracture
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Arrhythmia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    3 / 206 (1.46%)
    2 / 98 (2.04%)
         occurrences all number
    3
    2
    Bradycardia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Cor pulmonale chronic
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Myocardial infarction
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    5 / 206 (2.43%)
    2 / 98 (2.04%)
         occurrences all number
    6
    2
    Sinus tachycardia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Cluster headache
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Dementia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    dizziness
         subjects affected / exposed
    13 / 206 (6.31%)
    4 / 98 (4.08%)
         occurrences all number
    17
    4
    Dizziness postural
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    13 / 206 (6.31%)
    7 / 98 (7.14%)
         occurrences all number
    36
    7
    Essential tremor
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    23 / 206 (11.17%)
    14 / 98 (14.29%)
         occurrences all number
    33
    24
    Hypogeusia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Lethargy
         subjects affected / exposed
    49 / 206 (23.79%)
    20 / 98 (20.41%)
         occurrences all number
    87
    46
    Migraine
         subjects affected / exposed
    1 / 206 (0.49%)
    2 / 98 (2.04%)
         occurrences all number
    1
    2
    Neuralgia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Parkinson's disease
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Resting tremor
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    2
    Sinus headache
         subjects affected / exposed
    3 / 206 (1.46%)
    0 / 98 (0.00%)
         occurrences all number
    4
    0
    Somnolence
         subjects affected / exposed
    3 / 206 (1.46%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Syncope
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Tremor
         subjects affected / exposed
    2 / 206 (0.97%)
    2 / 98 (2.04%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 206 (1.94%)
    0 / 98 (0.00%)
         occurrences all number
    4
    0
    Eosinophilia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    0 / 206 (0.00%)
    3 / 98 (3.06%)
         occurrences all number
    0
    3
    White blood cell disorder
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    4 / 206 (1.94%)
    5 / 98 (5.10%)
         occurrences all number
    6
    5
    Excessive cerumen production
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    External ear inflammation
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Hypoacusis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Neurosensory hypoacusis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Tinnitus
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Vertigo
         subjects affected / exposed
    3 / 206 (1.46%)
    2 / 98 (2.04%)
         occurrences all number
    3
    2
    Vertigo positional
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    2
    Diplopia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Dry eye
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Eye haemorrhage
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Eye swelling
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Vitreous detachment
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    5 / 206 (2.43%)
    5 / 98 (5.10%)
         occurrences all number
    7
    5
    Abdominal pain upper
         subjects affected / exposed
    3 / 206 (1.46%)
    5 / 98 (5.10%)
         occurrences all number
    3
    5
    Abdominal tenderness
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Anorectal discomfort
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Anorectal varices
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Chronic gastritis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    5 / 206 (2.43%)
    2 / 98 (2.04%)
         occurrences all number
    5
    2
    Dental caries
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    14 / 206 (6.80%)
    10 / 98 (10.20%)
         occurrences all number
    17
    11
    Dry mouth
         subjects affected / exposed
    1 / 206 (0.49%)
    4 / 98 (4.08%)
         occurrences all number
    1
    4
    Dyspepsia
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Dysphagia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Faecaloma
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Faeces soft
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Femoral hernia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 206 (0.49%)
    3 / 98 (3.06%)
         occurrences all number
    1
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 206 (2.43%)
    1 / 98 (1.02%)
         occurrences all number
    5
    1
    Gingival pain
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Intestinal polyp
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Lip pain
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Lip swelling
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    mouth ulceration
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    14 / 206 (6.80%)
    7 / 98 (7.14%)
         occurrences all number
    19
    13
    Odynophagia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Oesophagitis
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Portal hypertensive gastropathy
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Salivary gland enlargement
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Tongue ulceration
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Tooth impacted
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Varices oesophageal
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    6 / 206 (2.91%)
    4 / 98 (4.08%)
         occurrences all number
    6
    5
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    3 / 206 (1.46%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Gallbladder polyp
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Alopecia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Eczema
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Erythema
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Night sweats
         subjects affected / exposed
    3 / 206 (1.46%)
    1 / 98 (1.02%)
         occurrences all number
    3
    1
    Onychomadesis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Pain of skin
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Precancerous skin lesion
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    3 / 206 (1.46%)
    4 / 98 (4.08%)
         occurrences all number
    3
    4
    Purpura
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    7 / 206 (3.40%)
    3 / 98 (3.06%)
         occurrences all number
    7
    5
    Rash generalised
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Skin atrophy
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Skin disorder
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    2 / 206 (0.97%)
    2 / 98 (2.04%)
         occurrences all number
    2
    2
    Skin reaction
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Bladder discomfort
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Micturition disorder
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Pollakiuria
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    13 / 206 (6.31%)
    5 / 98 (5.10%)
         occurrences all number
    14
    5
    Arthritis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    8 / 206 (3.88%)
    3 / 98 (3.06%)
         occurrences all number
    8
    4
    Exostosis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Fibromyalgia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Joint effusion
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
         subjects affected / exposed
    5 / 206 (2.43%)
    1 / 98 (1.02%)
         occurrences all number
    5
    2
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Muscle twitching
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    8 / 206 (3.88%)
    1 / 98 (1.02%)
         occurrences all number
    8
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    5 / 206 (2.43%)
    0 / 98 (0.00%)
         occurrences all number
    5
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    4 / 206 (1.94%)
    7 / 98 (7.14%)
         occurrences all number
    10
    8
    Neck pain
         subjects affected / exposed
    1 / 206 (0.49%)
    4 / 98 (4.08%)
         occurrences all number
    1
    4
    Osteoarthritis
         subjects affected / exposed
    3 / 206 (1.46%)
    1 / 98 (1.02%)
         occurrences all number
    5
    1
    Osteoporosis
         subjects affected / exposed
    1 / 206 (0.49%)
    2 / 98 (2.04%)
         occurrences all number
    1
    2
    pain in extremity
         subjects affected / exposed
    8 / 206 (3.88%)
    2 / 98 (2.04%)
         occurrences all number
    8
    2
    Pain in jaw
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Plantar fasciitis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Spinal pain
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Synovial cyst
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Tendon calcification
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Tendon disorder
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Abdominal hernia infection
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Abscess limb
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    4 / 206 (1.94%)
    0 / 98 (0.00%)
         occurrences all number
    4
    0
    Bronchitis viral
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Candida infection
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Catheter site infection
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Chlamydial infection
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Chronic sinusitis
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    3
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    4 / 206 (1.94%)
    3 / 98 (3.06%)
         occurrences all number
    5
    3
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Fungal infection
         subjects affected / exposed
    2 / 206 (0.97%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Fungal skin infection
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Helicobacter infection
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Infectious disease carrier
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    2 / 206 (0.97%)
    3 / 98 (3.06%)
         occurrences all number
    2
    4
    Labyrinthitis
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Laryngitis
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Localised infection
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Lyme disease
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    13 / 206 (6.31%)
    6 / 98 (6.12%)
         occurrences all number
    15
    7
    Nocardiosis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    3 / 206 (1.46%)
    4 / 98 (4.08%)
         occurrences all number
    3
    6
    Oral herpes
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Otitis media
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Otitis media acute
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    3 / 206 (1.46%)
    0 / 98 (0.00%)
         occurrences all number
    3
    0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    5 / 206 (2.43%)
    4 / 98 (4.08%)
         occurrences all number
    5
    7
    Sepsis
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    13 / 206 (6.31%)
    4 / 98 (4.08%)
         occurrences all number
    16
    6
    Skin candida
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    2
    0
    Sputum purulent
         subjects affected / exposed
    52 / 206 (25.24%)
    35 / 98 (35.71%)
         occurrences all number
    90
    59
    Staphylococcal infection
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Tonsillitis
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Tooth abscess
         subjects affected / exposed
    1 / 206 (0.49%)
    2 / 98 (2.04%)
         occurrences all number
    1
    2
    Tooth infection
         subjects affected / exposed
    3 / 206 (1.46%)
    1 / 98 (1.02%)
         occurrences all number
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 206 (3.88%)
    1 / 98 (1.02%)
         occurrences all number
    8
    1
    Urinary tract infection
         subjects affected / exposed
    10 / 206 (4.85%)
    3 / 98 (3.06%)
         occurrences all number
    13
    5
    Viral infection
         subjects affected / exposed
    3 / 206 (1.46%)
    2 / 98 (2.04%)
         occurrences all number
    3
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 206 (0.00%)
    2 / 98 (2.04%)
         occurrences all number
    0
    2
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 206 (0.97%)
    4 / 98 (4.08%)
         occurrences all number
    2
    5
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 206 (0.49%)
    1 / 98 (1.02%)
         occurrences all number
    2
    2
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    5 / 206 (2.43%)
    0 / 98 (0.00%)
         occurrences all number
    5
    0
    Dehydration
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Fluid retention
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Gout
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 206 (0.97%)
    1 / 98 (1.02%)
         occurrences all number
    2
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Hypophagia
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 206 (0.49%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 206 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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