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    Clinical Trial Results:
    The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler (TRELEGYTM ELLIPTATM) when Compared with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual Care Setting

    Summary
    EudraCT number
    		 2017-004369-29
    Trial protocol
    		 SE   GB   NL   ES  
    Global end of trial date
    10 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Sep 2020
    First version publication date
    04 Sep 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    206854
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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 Dec 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT for the impact of COPD on wellbeing and daily life after 24 weeks treatment.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Apr 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 871
    Country: Number of subjects enrolled
    Netherlands: 638
    Country: Number of subjects enrolled
    Spain: 264
    Country: Number of subjects enrolled
    Sweden: 268
    Country: Number of subjects enrolled
    United Kingdom: 1300
    Worldwide total number of subjects
    3341
    EEA total number of subjects
    3341
    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)
    1148
    From 65 to 84 years
    2128
    85 years and over
    65

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a Phase IV, open-label, randomized study to evaluate the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA multiple inhaler triple therapies (MITT) for chronic obstructive pulmonary disease (COPD) control within the usual clinical practice setting. TRELEGY and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.

    Pre-assignment
    Screening details
    		 A total of 3341 participants were screened and 3109 participants (Par.) were enrolled in this study. Of which, 3092 participants were randomized and received the study treatment. The remaining 17 participants were randomized in error (those who were recorded as screen failures and also randomized) and did not receive investigational product (IP).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI
    Arm description
    		 Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone furoate /Umeclidinium bromide/Vilanterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    A combination of fluticasone furoate blended with lactose in the first strip (100 microgram [mcg] per blister) and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler via inhalation route for a period of 24 weeks.

    Arm title
    		 Non-ELLIPTA MITT
    Arm description
    		 Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Non-ELLIPTA Multiple Inhaler Triple Therapies (MITT)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Inhaled corticosteroid/long-acting muscarinic receptor antagonist/long-acting beta agonist products twice daily as prescribed by the physician for a period of 24 weeks.

    Number of subjects in period 1 [1]
    		FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT
    Started
    1545
    1547
    Randomized but did not start IP
    1 [2]
    0 [3]
    Completed IP
    1256 [4]
    1359 [5]
    Not Completed IP
    288 [6]
    188 [7]
    Withdrew IP (WIP): Lost to follow-up
    15 [8]
    24 [9]
    WIP: Protocol deviation
    0 [10]
    2 [11]
    WIP: Adverse event
    112 [12]
    29 [13]
    WIP: Lack of efficacy
    56 [14]
    28 [15]
    WIP: Physician Decision
    14 [16]
    27 [17]
    WIP: Withdrawal by Participant
    91 [18]
    78 [19]
    Completed
    1498
    1493
    Not completed
    47
    54
         Adverse event, serious fatal
    8
    8
         Physician decision
    2
    1
         Consent withdrawn by subject
    15
    17
         Adverse event, non-fatal
    1
    1
         Lost to follow-up
    18
    25
         Lack of efficacy
    3
    1
         Protocol deviation
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 3341 participants were screened and 3109 participants (Par.) were enrolled in this study. Of which, 3092 participants were randomized and received the study treatment. The remaining 17 participants were randomized in error (those who were recorded as screen failures and also randomized) and did not receive investigational product (IP).
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [18] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.
    [19] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This number indicates the number of participant randomized but did not start investigational product.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI
    Reporting group description
    		 Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.

    Reporting group title
    Non-ELLIPTA MITT
    Reporting group description
    		 Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.

    Reporting group values
    		 FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT Total
    Number of subjects
    		 1545 1547 3092
    Age categorical
    Units: Subjects
        Total Participants
    		 1545 1547 3092
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 67.8 ± 8.78 67.8 ± 8.59 -
    Sex: Female, Male
    Units: Participants
        Female
    		 708 729 1437
        Male
    		 837 818 1655
    Race/Ethnicity, Customized
    Units: Subjects
        Asian- Central/South Asian Heritage
    		 12 7 19
        Asian- East Asian Heritage
    		 0 1 1
        Asian- South East Asian Heritage
    		 1 6 7
        Black or African American
    		 3 4 7
        White- Arabic/North African Heritage
    		 6 7 13
        White- White/Caucasian/European Heritage
    		 1523 1521 3044
        White and Black or African American
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI
    Reporting group description
    		 Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.

    Reporting group title
    Non-ELLIPTA MITT
    Reporting group description
    		 Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.

    Primary: Number of responders and non-responders based on the chronic obstructive pulmonary disease assessment test (CAT) at Week 24 and number of participants with imputed CAT score at Week 24

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    End point title
    		 Number of responders and non-responders based on the chronic obstructive pulmonary disease assessment test (CAT) at Week 24 and number of participants with imputed CAT score at Week 24
    End point description
    The CAT is a 8-item questionnaire. Par. rated their experience as 0 (no impact) to 5 (maximum impact). CAT score was calculated by summing the non-missing scores of the 8 items with a range of 0-40 (higher scores: greater disease impact). Responders had a change from Baseline score >=2 and non-responders had a change from Baseline score <2 at Week 24. Change from Baseline was Week 24 value minus the Baseline value (Day 1). A composite strategy was applied when intercurrent events of randomized treatment modification, change in pulmonary rehabilitation or start of oxygen therapy occurred, otherwise a treatment policy strategy was applied. Missing Week 24 CAT data were imputed assuming missing at random. Intent-to-Treat (ITT) Population comprised of all randomized participants (who received a randomization number), excluding those who were randomized in error (a screen failure and also randomized). Only those participants with non-missing covariates were included in the analysis.
    End point type
    Primary
    End point timeframe
    At Week 24
    End point values
    		 FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT
    Number of subjects analysed
    1539 [1]
    1543 [2]
    Units: Participants
        Responders
    731
    616
        Non-responders
    756
    835
        Participants with imputed CAT score
    52
    92
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical comparison is presented for combined data of responders, non-responders and those with imputed CAT score at Week 24.
    Comparison groups
    FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI v Non-ELLIPTA MITT
    Number of subjects included in analysis
    3082
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.51
    Notes
    [3] - Analysis was performed using logistic regression model with covariates of treatment group, Baseline CAT score, number of exacerbations in the prior year, actual prior medication use strata and country.

    Secondary: Change from Baseline in forced expiratory volume in 1 second (FEV1) at Week 24

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    End point title
    		 Change from Baseline in forced expiratory volume in 1 second (FEV1) at Week 24
    End point description
    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were collected using a spirometer. Baseline was defined as the value recorded at Day 1. Change from Baseline was calculated as FEV1 value at Week 24 minus the Baseline value. A treatment policy strategy was used for the intercurrent events of randomized treatment discontinuation, randomized treatment modification, change of pulmonary rehabilitation status and start of oxygen therapy. Only those participants with non-missing covariates were included in the analysis. FEV1 Population comprised of all participants of the ITT population for whom a spirometry assessment was performed at any of Visit 1 (Day 1) or Visit 2 (Week 24). Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Week 24
    End point values
    		 FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT
    Number of subjects analysed
    691 [4]
    675 [5]
    Units: Liters
        least squares mean (standard error)
    1.446 ± 0.0105
    1.396 ± 0.0108
    Notes
    [4] - FEV1 Population
    [5] - FEV1 Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed using an ANCOVA with covariates of treatment group, Baseline FEV1, actual prior medication use strata, country and timing of spirometry.
    Comparison groups
    FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI v Non-ELLIPTA MITT
    Number of subjects included in analysis
    1366
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.026
         upper limit
    		 0.073
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0121

    Secondary: Percentage of participants making at least 1 critical error in inhalation technique at Week 24

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    End point title
    		 Percentage of participants making at least 1 critical error in inhalation technique at Week 24
    End point description
    Participants were trained on the correct use of their inhaler devices. All participants who had spirometry measured were to have an assessment of inhaler errors. During the assessment, participants were asked to demonstrate inhaler use when taking their regular dose of medication. A critical error is defined as an error that is most likely to result in no or significantly reduced medication being inhaled. These errors were recorded in an error checklist, during the assessment. A hypothetical strategy was used for the intercurrent event of randomized treatment modification. Percentage of participants making at least 1 critical error in inhalation technique at the Week 24 is presented. Critical error Population comprised of all participants of the ITT population for whom a critical error assessment was performed at Visit 2 (Week 24). Only those participants with data available at the specified data points were analyzed.
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI Non-ELLIPTA MITT
    Number of subjects analysed
    653 [6]
    230 [7]
    Units: Percentage of Participants
    6
    3
    Notes
    [6] - Critical error Population
    [7] - Critical error Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis was performed using logistic regression model with covariates of treatment group, actual prior medication use strata and country.
    Comparison groups
    FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI v Non-ELLIPTA MITT
    Number of subjects included in analysis
    883
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.103
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 4.53

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious AEs (non-SAEs) were collected from the start of study treatment up to Week 24
    Adverse event reporting additional description
    Data is reported for the ITT Population which comprised of all randomized participants (who received a randomization number), excluding those who were randomized in error. All SAEs were collected. Non-SAEs which were only drug-related or that lead to withdrawal from study/study treatment were collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    FF/UMEC/VI 100/62.5/25
    Reporting group description
    		 Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.

    Reporting group title
    Non-Ellipta MITT
    Reporting group description
    		 Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician.

    Serious adverse events
    		 FF/UMEC/VI 100/62.5/25 Non-Ellipta MITT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    114 / 1545 (7.38%)
    114 / 1547 (7.37%)
         number of deaths (all causes)
    8
    8
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 1545 (0.06%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 1545 (0.06%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 1545 (0.06%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung squamous cell carcinoma stage II
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mesothelioma
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer limited stage
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma stage IV
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    2 / 1545 (0.13%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 1545 (0.06%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypertensive crisis
         subjects affected / exposed
    2 / 1545 (0.13%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         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
    Chest pain
         subjects affected / exposed
    0 / 1545 (0.00%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 1545 (0.00%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    26 / 1545 (1.68%)
    28 / 1547 (1.81%)
         occurrences causally related to treatment / all
    2 / 28
    1 / 29
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pleural effusion
         subjects affected / exposed
    0 / 1545 (0.00%)
    4 / 1547 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 1545 (0.19%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 1545 (0.06%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 1545 (0.19%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 1545 (0.00%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia aspiration
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 1545 (0.13%)
    3 / 1547 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    2 / 1545 (0.13%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    2 / 1545 (0.13%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 1545 (0.00%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         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
    5 / 1545 (0.32%)
    5 / 1547 (0.32%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiac failure
         subjects affected / exposed
    3 / 1545 (0.19%)
    7 / 1547 (0.45%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    4 / 1545 (0.26%)
    5 / 1547 (0.32%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    5 / 1545 (0.32%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 1545 (0.13%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac asthma
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular hypokinesia
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Syncope
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral venous thrombosis
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reversible ischaemic neurological deficit
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory loss
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vestibular disorder
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal polyp haemorrhage
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 1545 (0.00%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder perforation
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         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
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteolysis
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    26 / 1545 (1.68%)
    30 / 1547 (1.94%)
         occurrences causally related to treatment / all
    5 / 27
    4 / 30
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    6 / 1545 (0.39%)
    9 / 1547 (0.58%)
         occurrences causally related to treatment / all
    3 / 6
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 1545 (0.19%)
    2 / 1547 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cellulitis
         subjects affected / exposed
    2 / 1545 (0.13%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 1545 (0.06%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corynebacterium infection
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Necrotising fasciitis
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder abscess
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Fluid retention
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 1545 (0.06%)
    0 / 1547 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock hypoglycaemic
         subjects affected / exposed
    0 / 1545 (0.00%)
    1 / 1547 (0.06%)
         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: 1%
    Non-serious adverse events
    		 FF/UMEC/VI 100/62.5/25 Non-Ellipta MITT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 1545 (2.07%)
    3 / 1547 (0.19%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    32 / 1545 (2.07%)
    3 / 1547 (0.19%)
         occurrences all number
    32
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2018
    Amendment 01: Addition of health Canada requirements for reporting of unusual failure in efficacy for new drugs to the marketed health products directorate in the section: additional adverse event reporting requirements for Canadian investigators; change to allow collection of both pre-and postbronchodilator spirometry at Visit 1 in the section: study assessment and procedures: lung function; collection of participant pulmonary rehabilitation programme details in the section: treatments: concomitant therapy; wording added to describe the reporting requirements for medical devices and defective inhalers in the section: safety assessments; consenting Visit 0 added the maximum time allowed between consent, screening and randomization was set to 6 weeks in schedule of activities; editing for clarity/ consistency and corrections of typographical errors throughout the document.
    28 Sep 2018
    Amendment 02: Addition of requirement to collect the most recent historical eosinophil count data in schedule of activities; changed source of safety information used by the investigator for Trelegy from the summary of participant characteristics to the investigator brochure in the section: risk mitigation; addition of requirement to collect the most recent historical eosinophil count data in the section: data collection; rationale for collection of historical eosinophil counts, whole blood count and % eosinophils was added; changed source of safety information used by the investigator for Trelegy from the summary of participant characteristics to the investigator brochure in the section: treatment of overdose; to provide clarity on the reporting requirements and what a drug/device combination is in the section: GSK medical device GSK drug/device combinations incidents; changed source of safety information used by the investigator for Trelegy from the summary of participant characteristics to the investigator brochure in the section: medications; addition of references to provide background to eosinophil data collection in the section: references.

    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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