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    Clinical Trial Results:
    The objective of the study was to evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to Chronic Obstructive Pulmonary Disorder (COPD) participants at high risk of exacerbations despite the use of optimized COPD maintenance therapy.

    Summary
    EudraCT number
    		 2018-001540-56
    Trial protocol
    		 PL   HU   ES   NL   DK   BE   DE   SE   IE   IT   GR   AT  
    Global end of trial date
    08 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Aug 2025
    First version publication date
    20 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    208657
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04133909
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    79 New Oxford Street, London, United Kingdom, WC1A 1DG
    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
    08 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study was to evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to COPD participants at high risk of exacerbations despite the use of optimized Chronic Obstructive Pulmonary Disorder (COPD) maintenance therapy.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    India: 79
    Country: Number of subjects enrolled
    Israel: 119
    Country: Number of subjects enrolled
    New Zealand: 29
    Country: Number of subjects enrolled
    Belgium: 10
    Country: Number of subjects enrolled
    Denmark: 68
    Country: Number of subjects enrolled
    France: 52
    Country: Number of subjects enrolled
    Germany: 377
    Country: Number of subjects enrolled
    Greece: 21
    Country: Number of subjects enrolled
    Ireland: 6
    Country: Number of subjects enrolled
    Italy: 20
    Country: Number of subjects enrolled
    Netherlands: 41
    Country: Number of subjects enrolled
    Spain: 108
    Country: Number of subjects enrolled
    Sweden: 41
    Country: Number of subjects enrolled
    United Kingdom: 549
    Country: Number of subjects enrolled
    Hungary: 74
    Country: Number of subjects enrolled
    Poland: 270
    Country: Number of subjects enrolled
    China: 179
    Country: Number of subjects enrolled
    Korea, Republic of: 37
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    Argentina: 371
    Country: Number of subjects enrolled
    Brazil: 28
    Country: Number of subjects enrolled
    Mexico: 18
    Country: Number of subjects enrolled
    Canada: 46
    Country: Number of subjects enrolled
    United States: 746
    Worldwide total number of subjects
    3306
    EEA total number of subjects
    1088
    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)
    1357
    From 65 to 84 years
    1926
    85 years and over
    23

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study enrolled 806 participants from multiple locations and regions worldwide.

    Pre-assignment
    Screening details
    		 Among 806 participants, 2 were randomized in error and subsequently withdrawn from study (1 from the Mepolizumab 100 mg group and 1 from the Placebo group) without receiving any study intervention. The modified intention-to- treat (mITT) population consisted of 804 participants who were randomized and received at least 1 dose of trial medication.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mepolizumab 100 mg
    Arm description
    		 Participants with Chronic Obstructive Pulmonary Disease (COPD) received a 100 milligrams (mg) dose of mepolizumab as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mepolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Eligible participants received Mepolizumab 100 mg SC injection every 4 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Participants with COPD received a matching placebo as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received matching placebo every 4 weeks.

    Number of subjects in period 1 [1]
    		Mepolizumab 100 mg Placebo
    Started
    403
    401
    Completed
    339
    331
    Not completed
    64
    70
         Adverse event, serious fatal
    11
    11
         Physician decision
    4
    7
         Consent withdrawn by subject
    40
    35
         Adverse event, non-fatal
    4
    5
         Lost to follow-up
    3
    5
         Lack of efficacy
    2
    7
    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: Total 3306 participants enrolled, 806 participants were randomized. Among 806 participants 2 participants were randomized in error and subsequently withdrawn from the study (one from the Mepolizumab 100 mg group and one from the Placebo group) without receiving any study intervention.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mepolizumab 100 mg
    Reporting group description
    		 Participants with Chronic Obstructive Pulmonary Disease (COPD) received a 100 milligrams (mg) dose of mepolizumab as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with COPD received a matching placebo as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.

    Reporting group values
    		 Mepolizumab 100 mg Placebo Total
    Number of subjects
    		 403 401 804
    Age categorical
    Units: Subjects
        19-64 years
    		 143 173 316
        >=65 years
    		 260 228 488
    Age continuous
    The Modified Intent-to-treat (mITT) population consisted of 804 participants who were randomized and received at least one dose of the trial medication.
    Units: years
        arithmetic mean (standard deviation)
    		 66.4 ( 8.10 ) 66 ( 7.91 ) -
    Sex: Female, Male
    The mITT population consisted of 804 participants who were randomized and received at least one dose of the trial medication.
    Units: Participants
        Female
    		 127 126 253
        Male
    		 276 275 551
    Race/Ethnicity, Customized
    The ‘All Other Races’ category (Asian, American Indian or Alaska Native, Black or African American, and Mixed Race where 0<n<11) are combined into one category to maintain participant confidentiality and privacy. The mITT population consisted of 804 participants who were randomized and received at least one dose of the trial medication.
    Units: Subjects
        White
    		 338 335 673
        All Other Races
    		 65 66 131

    End points

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    End points reporting groups
    Reporting group title
    Mepolizumab 100 mg
    Reporting group description
    		 Participants with Chronic Obstructive Pulmonary Disease (COPD) received a 100 milligrams (mg) dose of mepolizumab as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with COPD received a matching placebo as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.

    Primary: Annualized rate of moderate or severe exacerbations

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    End point title
    		 Annualized rate of moderate or severe exacerbations
    End point description
    Annualized rate of moderate or severe exacerbations were assessed. Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral or systemic corticosteroids and/or antibiotics. Severe exacerbations are defined per protocol as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to [>=] 24 hours) or result in death. The analysis was performed on Modified Intent-to-Treat (mITT) population which included all randomized participants who received at least one dose of trial medication. Participants were analyzed by randomized treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 104
    End point values
    		 Mepolizumab 100 mg Placebo
    Number of subjects analysed
    403
    401
    Units: Exacerbations per year
        least squares mean (confidence interval 95%)
    0.80 (0.70 to 0.91)
    1.01 (0.89 to 1.15)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate or severe exacerbations in previous year (less than or equal to [<=]2, 3, >=4 as ordinal), baseline percent (%) predicted Forced expiratory volume in one second (FEV1) and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable.
    Comparison groups
    Placebo v Mepolizumab 100 mg
    Number of subjects included in analysis
    804
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Negative binomial model
    Parameter type
    		 Rate ratio (Mepolizumab 100 mg/Placebo)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.94

    Secondary: Time to first moderate or severe exacerbation

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    End point title
    		 Time to first moderate or severe exacerbation
    End point description
    The time to first moderate or severe exacerbation was determined as the number of days from the date of first dose to the date of the first moderate or severe exacerbation. Kaplan-Meier estimate of the cumulative percentage of participants with a moderate or severe exacerbation within each treatment arm over time were produced. The analysis was performed on mITT population which included all randomized participants who received at least one dose of trial medication. Participants were analyzed by randomized treatment.
    End point type
    Secondary
    End point timeframe
    At week 8,16, 24, 32, 40, 48, 52, 56, 64, 72, 80, 88, 96, 104
    End point values
    		 Mepolizumab 100 mg Placebo
    Number of subjects analysed
    403
    401
    Units: Percentage of Participants
    number (confidence interval 95%)
        At week 8
    11.3 (8.5 to 14.8)
    15.1 (11.9 to 19.0)
        At week 16
    21.6 (17.9 to 26.0)
    25.6 (21.6 to 30.2)
        At week 24
    28.3 (24.2 to 33.1)
    35.4 (30.9 to 40.3)
        At week 32
    33.6 (29.1 to 38.5)
    41.6 (36.9 to 46.7)
        At week 40
    39.8 (35.1 to 44.8)
    47.1 (42.3 to 52.2)
        At week 48
    44.9 (40.1 to 50.1)
    51.4 (46.6 to 56.5)
        At week 52
    46.1 (41.2 to 51.2)
    53.4 (48.5 to 58.5)
        At week 56
    46.7 (41.7 to 51.9)
    54.0 (49.0 to 59.2)
        At week 64
    51.4 (45.8 to 57.2)
    58.9 (53.3 to 64.6)
        At week 72
    55.9 (49.8 to 62.2)
    60.5 (54.7 to 66.4)
        At week 80
    59.0 (52.6 to 65.5)
    62.3 (56.2 to 68.4)
        At week 88
    60.6 (54.1 to 67.2)
    64.2 (57.9 to 70.5)
        At week 96
    62.3 (55.6 to 69.0)
    67.2 (60.5 to 73.8)
        At week 104
    64.5 (57.5 to 71.4)
    68.3 (61.4 to 74.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Estimated from a Cox Proportional Hazards Model with covariates of treatment group, geographic region, number of moderate or severe exacerbations in previous year (<=2, 3, >=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs former).
    Comparison groups
    Mepolizumab 100 mg v Placebo
    Number of subjects included in analysis
    804
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.93

    Secondary: Percentage of COPD Assessment test (CAT) Responders with >=2 point Reduction from Baseline at Week 52

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    End point title
    		 Percentage of COPD Assessment test (CAT) Responders with >=2 point Reduction from Baseline at Week 52
    End point description
    The CAT is an 8-item questionnaire used to measure the health status of participants with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), with a scoring range of 0-40. Higher scores indicate greater disease impact, and lower score indicates lesser disease impact. Participants were considered responders if they had a 2-point or more improvement (reduction) in CAT Score from baseline. Participants who withdrew from the study prior to Week 52 were included in the analysis as non-responders. The baseline value was the last measurement collected prior to the first dose of investigational product. The analysis was performed on mITT population which included all randomized participants who received at least one dose of trial medication. Participants were analyzed by randomized treatment. Only those participants with data available at the baseline were analyzed. Percentages were rounded-off to the nearest whole number.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Mepolizumab 100 mg Placebo
    Number of subjects analysed
    391
    394
    Units: Percentage of participants
        number (not applicable)
    41
    46
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).
    Comparison groups
    Placebo v Mepolizumab 100 mg
    Number of subjects included in analysis
    785
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.09

    Secondary: Percentage of St. George's Respiratory Questionnaire for COPD (SGRQ) Total Score Responders with >=4-point Reduction from Baseline at Week 52

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    End point title
    		 Percentage of St. George's Respiratory Questionnaire for COPD (SGRQ) Total Score Responders with >=4-point Reduction from Baseline at Week 52
    End point description
    The St George’s Respiratory Questionnaire for COPD (SGRQ-C) is a 40-item questionnaire. The total SGRQ score is calculated by summing up the weights of all positively answered items across the entire questionnaire, dividing by the total possible weight for all questionnaire items. The total score was expressed as a percentage of overall impairment, with 0 (best possible health status) and 100 (the worst possible health status). Higher scores indicated greater impairment of health, and lower scores indicate a lesser impairment on health. A participant was considered a responder if they had a 4-point or more improvement (reduction) in the SGRQ-C total score from baseline. Participants who withdrew from the study prior to Week 52 were included in the analysis as non- responders. mITT population involved. Participants were analyzed by randomized treatment. Only those participants with data available at the baseline were analyzed. Percentages were rounded off to the nearest whole number.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Mepolizumab 100 mg Placebo
    Number of subjects analysed
    390
    393
    Units: Percentage of participants
        number (not applicable)
    50
    46
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).
    Comparison groups
    Placebo v Mepolizumab 100 mg
    Number of subjects included in analysis
    783
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.291
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.57

    Secondary: Annualized rate of Exacerbations Requiring Emergency Department (ED) visit and/or Hospitalization

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    End point title
    		 Annualized rate of Exacerbations Requiring Emergency Department (ED) visit and/or Hospitalization
    End point description
    Annualized rate of exacerbations requiring ED visit or hospitalization were evaluated. This included moderate exacerbations which led to a visit to the Emergency Department (ED) and severe exacerbations, were defined as clinically significant exacerbations that require in-patient hospitalization (>= 24 hours) or result in death. The analysis was performed on mITT population which included all randomized participants who received at least one dose of trial medication. Participants were analyzed by randomized treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 104
    End point values
    		 Mepolizumab 100 mg Placebo
    Number of subjects analysed
    403
    401
    Units: Exacerbations per year
        least squares mean (confidence interval 95%)
    0.13 (0.10 to 0.18)
    0.20 (0.15 to 0.27)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (<=2, 3, >=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable. Estimates based on weighting applied to each level of class variable determined from observed proportions.
    Comparison groups
    Mepolizumab 100 mg v Placebo
    Number of subjects included in analysis
    804
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 Negative binomial model
    Parameter type
    		 Rate ratio (Mepolizumab 100/Placebo)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 0.96

    Secondary: Percentage of Evaluating Respiratory Symptoms in COPD (E-RS: COPD) responders with >=2 point reduction from Baseline

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    End point title
    		 Percentage of Evaluating Respiratory Symptoms in COPD (E-RS: COPD) responders with >=2 point reduction from Baseline
    End point description
    E-RS: COPD consists of 11 items from 14 item Exacerbations of Chronic Pulmonary Disease Tool (EXACT) instrument (completed each evening using an eDiary). E-RS: COPD is intended to capture information related to respiratory symptoms of COPD: breathlessness, cough, sputum production, chest congestion, and chest tightness. The E-RS: COPD has a scoring range of 0 (no symptoms)-40 (most severe symptoms), higher scores indicate more severe symptoms. A participant is considered a responder if they have a 2-unit or more improvement (reduction) in their average E-RS: COPD total score during a 4-week period prior to Week 52 (Weeks 49-52) compared to baseline. Average of daily scores in 4-weekly intervals were calculated; data is presented for Weeks 49-52. Participants who withdrew from study prior to start of Weeks 49-52 time-period were included in analysis as a non-responder. mITT population involved, including only those with baseline data. Percentages were rounded to nearest whole number.
    End point type
    Secondary
    End point timeframe
    Baseline and 4-weeks prior to Week 52
    End point values
    		 Mepolizumab 100 mg Placebo
    Number of subjects analysed
    403
    399
    Units: Percentage of participants
        number (not applicable)
    31
    34
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).
    Comparison groups
    Placebo v Mepolizumab 100 mg
    Number of subjects included in analysis
    802
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.209
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.12

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 104
    Adverse event reporting additional description
    Data for All-Cause Mortality, Serious and Other (Non-Serious) Adverse Events were collected for the mITT population (all randomized participants, excluding those who were randomized in error). Safety population included all randomized participants who received at least one dose of trial medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants with COPD received a matching placebo as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.

    Reporting group title
    Mepolizumab 100 mg
    Reporting group description
    		 Participants with Chronic Obstructive Pulmonary Disease (COPD) received a 100 milligrams (mg) dose of mepolizumab as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.

    Serious adverse events
    		 Placebo Mepolizumab 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    115 / 401 (28.68%)
    101 / 403 (25.06%)
         number of deaths (all causes)
    11
    11
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage I
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioma
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell carcinoma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tracheal cancer
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Chest discomfort
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 401 (0.25%)
    3 / 403 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    56 / 401 (13.97%)
    48 / 403 (11.91%)
         occurrences causally related to treatment / all
    0 / 78
    0 / 74
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Chronic respiratory disease
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung opacity
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 401 (0.50%)
    4 / 403 (0.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 401 (0.75%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 401 (0.75%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device loosening
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Brain scan abnormal
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium tuberculosis complex test negative
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         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
    Femur fracture
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoconiosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 401 (0.50%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (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
    1 / 401 (0.25%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    0 / 401 (0.00%)
    3 / 403 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         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
    1 / 401 (0.25%)
    4 / 403 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Ventricular tachycardia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         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 occlusion
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (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 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Large intestine polyp
         subjects affected / exposed
    3 / 401 (0.75%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal polyp
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin plaque
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiokeratoma
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    2 / 401 (0.50%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         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
    Arthritis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 401 (0.25%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    6 / 401 (1.50%)
    4 / 403 (0.99%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Bronchitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 401 (0.50%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    5 / 401 (1.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    17 / 401 (4.24%)
    14 / 403 (3.47%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 401 (0.25%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 401 (0.00%)
    2 / 403 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site abscess
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypervolaemia
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 401 (0.25%)
    0 / 403 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 401 (0.00%)
    1 / 403 (0.25%)
         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: 3%
    Non-serious adverse events
    		 Placebo Mepolizumab 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    182 / 401 (45.39%)
    195 / 403 (48.39%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    26 / 401 (6.48%)
    16 / 403 (3.97%)
         occurrences all number
    29
    16
    Nervous system disorders
    Headache
         subjects affected / exposed
    28 / 401 (6.98%)
    32 / 403 (7.94%)
         occurrences all number
    41
    62
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 401 (2.99%)
    22 / 403 (5.46%)
         occurrences all number
    19
    23
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    15 / 401 (3.74%)
    13 / 403 (3.23%)
         occurrences all number
    17
    15
    Dyspnoea
         subjects affected / exposed
    21 / 401 (5.24%)
    19 / 403 (4.71%)
         occurrences all number
    38
    30
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    17 / 401 (4.24%)
    23 / 403 (5.71%)
         occurrences all number
    20
    29
    Back pain
         subjects affected / exposed
    23 / 401 (5.74%)
    26 / 403 (6.45%)
         occurrences all number
    38
    46
    Infections and infestations
    COVID-19
         subjects affected / exposed
    47 / 401 (11.72%)
    48 / 403 (11.91%)
         occurrences all number
    48
    52
    Influenza
         subjects affected / exposed
    18 / 401 (4.49%)
    19 / 403 (4.71%)
         occurrences all number
    20
    24
    Nasopharyngitis
         subjects affected / exposed
    35 / 401 (8.73%)
    41 / 403 (10.17%)
         occurrences all number
    46
    57
    Upper respiratory tract infection
         subjects affected / exposed
    20 / 401 (4.99%)
    24 / 403 (5.96%)
         occurrences all number
    30
    40
    Pneumonia
         subjects affected / exposed
    17 / 401 (4.24%)
    18 / 403 (4.47%)
         occurrences all number
    20
    24
    Urinary tract infection
         subjects affected / exposed
    7 / 401 (1.75%)
    18 / 403 (4.47%)
         occurrences all number
    7
    20

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 May 2019
    Amendment 1
    18 Jul 2019
    Amendment 3
    13 Sep 2019
    Amendment 4
    16 Oct 2020
    Amendment 5
    06 Dec 2021
    Amendment 6

    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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