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    Clinical Trial Results:
    Study 201312: A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects with a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial

    Summary
    EudraCT number
    		 2014-000314-54
    Trial protocol
    		 IT   DE   NL   ES   GB   BE   CZ   Outside EU/EEA  
    Global end of trial date
    05 Oct 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 May 2018
    First version publication date
    14 Apr 2018
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    201312
    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, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To provide extended treatment with mepolizumab to subjects with a history of life threatening or seriously debilitating asthma and a history of improved disease control while receiving mepolizumab as defined by this protocol
    Protection of trial subjects
    Numbing cream or spray was permitted at the site of injection and rescue medications (salbutamol/albuterol) are available to the participant throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 May 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Ethical reason
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 18
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    France: 42
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Netherlands: 19
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Ukraine: 11
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    Argentina: 11
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    Canada: 24
    Country: Number of subjects enrolled
    Chile: 10
    Country: Number of subjects enrolled
    Japan: 25
    Country: Number of subjects enrolled
    Russian Federation: 11
    Country: Number of subjects enrolled
    United States: 33
    Country: Number of subjects enrolled
    Korea, Republic of: 19
    Worldwide total number of subjects
    339
    EEA total number of subjects
    183
    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)
    6
    Adults (18-64 years)
    277
    From 65 to 84 years
    56
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was an open-label, long-term study of mepolizumab 100 milligram (mg) administered subcutaneously (SC), in addition to standard of care (SOC), in eligible participants with severe eosinophilic asthma, who completed the MEA115661 Exit Visit (Visit 14). The study enrolled participants across 18 countries.

    Pre-assignment
    Screening details
    		 A total of 340 participants were screened for the study, of which one participant was screening failure, and 339 participants received the study treatment.

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

    Arms
    Arm title
    		 Mepolizumab 100 mg SC
    Arm description
    		 Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mepolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks.

    Number of subjects in period 1
    		Mepolizumab 100 mg SC
    Started
    339
    Completed
    0
    Not completed
    339
         Study closed/terminated
    153
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    15
         Adverse event, non-fatal
    2
         Product commercially available
    159
         Lost to follow-up
    4
         Subject met Liver Stopping Criteria
    1
         Lack of efficacy
    2
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.

    Reporting group values
    		 Mepolizumab 100 mg SC Total
    Number of subjects
    		 339
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.9 ± 13.08 -
    Gender categorical
    Units: Subjects
        Female
    		 178 178
        Male
    		 161 161
    Race/Ethnicity, Customized
    Units: Subjects
        Asian-Central/South Asian Heritage
    		 2 2
        Asian-East Asian Heritage
    		 19 19
        Asian-Japanese Heritage
    		 26 26
        Asian-South East Asian Heritage
    		 4 4
        Black or African American
    		 4 4
        White-Arabic/North African Heritage
    		 7 7
        White-White/Caucasian/European Heritage
    		 277 277

    End points

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    End points reporting groups
    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.

    Primary: Annualized rate of on-treatment exacerbations per year

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    End point title
    		 Annualized rate of on-treatment exacerbations per year [1]
    End point description
    Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids intravenous (IV) or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. On-Treatment data between first dose date and earliest of Withdrawal date/last dose + 28 days was considered for analysis. Analysis of the number of exacerbations was performed using a negative binomial generalized linear model. As Treated (AT) Population included all participants who received at least one dose of mepolizumab within study 201312.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) to Week 172
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [2]
    Units: Exacerbations per year
    arithmetic mean (confidence interval 95%)
        Exacerbations per year
    0.93 (0.81 to 1.06)
    Notes
    [2] - AT Population
    No statistical analyses for this end point

    Primary: Number of participants with any on-treatment adverse event (AE) or on-treatment serious AE (SAE)

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    End point title
    		 Number of participants with any on-treatment adverse event (AE) or on-treatment serious AE (SAE) [3]
    End point description
    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose+28 days.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) to Week 172
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [4]
    Units: Participants
        Any AE
    315
        Any SAE
    84
    Notes
    [4] - AT Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in asthma control questionnaire (ACQ)-5 on-treatment score

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    End point title
    		 Mean change from Baseline in asthma control questionnaire (ACQ)-5 on-treatment score
    End point description
    The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 168
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [5]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 12, n=333
    -0.16 ± 1.096
        Week 24, n=333
    -0.15 ± 1.131
        Week 36, n=326
    -0.21 ± 1.089
        Week 48, n=328
    -0.17 ± 0.965
        Week 60, n=307
    -0.18 ± 1.066
        Week 72, n=282
    -0.08 ± 1.145
        Week 84, n=254
    -0.03 ± 1.151
        Week 96, n=212
    -0.12 ± 0.976
        Week 108, n=190
    -0.06 ± 1.057
        Week 120, n=164
    -0.01 ± 1.244
        Week 132, n=135
    -0.09 ± 1.089
        Week 144, n=73
    0.34 ± 1.220
        Week 156, n=23
    0.07 ± 0.962
        Week 168, n=6
    -0.33 ± 0.935
    Notes
    [5] - AT Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in on-treatment clinic pre-bronchodilator FEV1

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    End point title
    		 Mean change from Baseline in on-treatment clinic pre-bronchodilator FEV1
    End point description
    FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline and Weeks 24, 48, 72, 96, 120, 144 and 168. Spirometry was performed within 1 hour of the Baseline assessment. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Data between first dose date and earliest of Withdrawal date/last dose + 28 days considered on-treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 168
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [6]
    Units: Milliliter
    arithmetic mean (standard deviation)
        Week 24, n=332
    67 ± 382.9
        Week 48, n=325
    27 ± 404.6
        Week 72, n=289
    30 ± 406.0
        Week 96, n=223
    47 ± 433.7
        Week 120, n=169
    34 ± 369.9
        Week 144, n=88
    14 ± 374.9
        Week 168, n=15
    78 ± 302.9
    Notes
    [6] - AT Population
    No statistical analyses for this end point

    Secondary: Number of participants withdrawn from the study due to lack of efficacy and adverse events

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    End point title
    		 Number of participants withdrawn from the study due to lack of efficacy and adverse events
    End point description
    AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Number of participants withdrawn due to lack of efficacy and adverse events from the study have been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 172
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [7]
    Units: Participants
        Withdrawals due to lack of efficacy
    2
        Withdrawals due to adverse events
    3
    Notes
    [7] - AT Population
    No statistical analyses for this end point

    Secondary: Number of participants hospitalized due to adverse events including asthma exacerbations

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    End point title
    		 Number of participants hospitalized due to adverse events including asthma exacerbations
    End point description
    AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of mepolizumab date and before/on last dose of mepolizumab + 28 days.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 172
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [8]
    Units: Participants
        Participants
    78
    Notes
    [8] - AT Population
    No statistical analyses for this end point

    Secondary: Number of participants with AEs including both systemic (allergic and non-allergic) and local site reactions

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    End point title
    		 Number of participants with AEs including both systemic (allergic and non-allergic) and local site reactions
    End point description
    AEs were collected from the Baseline visit until the follow-up visit (Week 172). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. Number of participants with AEs including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions have been presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 172
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [9]
    Units: Participants
        Any systemic events
    2
        Any local site reactions
    14
    Notes
    [9] - AT Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in QT interval corrected by Bazett's method (QTcB) and QT interval corrected by Fridericia's method (QTcF) values for 12-lead electrocardiogram (ECG)

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    End point title
    		 Mean change from Baseline in QT interval corrected by Bazett's method (QTcB) and QT interval corrected by Fridericia's method (QTcF) values for 12-lead electrocardiogram (ECG)
    End point description
    Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)..
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 172
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [10]
    Units: Milliseconds
    arithmetic mean (standard deviation)
        QTcB, Week 24, n=301
    0.1 ± 16.90
        QTcB, Week 48, n=294
    -0.9 ± 17.27
        QTcB, Week 72, n=269
    -2.9 ± 18.13
        QTcB, Week 96, n=221
    -0.6 ± 17.96
        QTcB, Week 144, n=131
    0.5 ± 21.07
        QTcB, Week 172, n=16
    1.8 ± 22.08
        QTcF, Week 24, n=301
    -1.1 ± 14.61
        QTcF, Week 48, n=294
    -1.3 ± 14.08
        QTcF, Week 72, n=269
    -3.7 ± 15.68
        QTcF, Week 96, n=221
    -0.8 ± 16.18
        QTcF, Week 144, n=131
    0.0 ± 17.88
        QTcF, Week 172, n=16
    1.7 ± 17.06
    Notes
    [10] - AT Population
    No statistical analyses for this end point

    Secondary: Number of participants with maximum change from Baseline in QTcB and QTcF interval for ECG assessed at any time post Baseline

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    End point title
    		 Number of participants with maximum change from Baseline in QTcB and QTcF interval for ECG assessed at any time post Baseline
    End point description
    Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Participants with maximum change from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 172
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    305 [11]
    Units: Participants
        QTcB, <-60
    0
        QTcB, >=-60 to <-30
    1
        QTcB, >=-30 to < 0
    70
        QTcB, >= 0 to < 30
    196
        QTcB, >= 30 to < 60
    35
        QTcB, >=60
    3
        QTcF, <-60
    0
        QTcF, >=-60 to <-30
    1
        QTcF, >=-30 to < 0
    77
        QTcF, >= 0 to < 30
    199
        QTcF, >= 30 to < 60
    28
        QTcF, >=60
    0
    Notes
    [11] - AT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in systolic blood pressure and diastolic blood pressure

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    End point title
    		 Change from Baseline in systolic blood pressure and diastolic blood pressure
    End point description
    Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). 99999 indicates data is not available as n=1 at this time point and standard deviation could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 168
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [12]
    Units: Millimeter of mercury
    arithmetic mean (standard deviation)
        SBP, Week 4, n=333
    1.8 ± 11.26
        SBP, Week 8, n=334
    0.6 ± 11.75
        SBP, Week 12, n=337
    1.5 ± 12.48
        SBP, Week 16, n=334
    2.0 ± 12.35
        SBP, Week 20, n=327
    1.2 ± 13.69
        SBP, Week 24, n=333
    1.8 ± 13.35
        SBP, Week 28, n=330
    1.4 ± 13.56
        SBP, Week 32, n=324
    1.0 ± 13.43
        SBP, Week 36, n=330
    0.8 ± 13.00
        SBP, Week 40, n=327
    1.6 ± 13.44
        SBP, Week 44, n=327
    1.2 ± 12.75
        SBP, Week 48, n=329
    1.8 ± 13.22
        SBP, Week 52, n=325
    1.5 ± 13.31
        SBP, Week 56, n=324
    2.0 ± 13.52
        SBP, Week 60, n=315
    2.0 ± 13.17
        SBP, Week 64, n=307
    2.5 ± 13.37
        SBP, Week 68, n=286
    2.5 ± 13.46
        SBP, Week 72, n=281
    2.3 ± 13.35
        SBP, Week 76, n=274
    2.3 ± 12.31
        SBP, Week 80, n=265
    3.5 ± 13.58
        SBP, Week 84, n=255
    2.7 ± 14.01
        SBP, Week 88, n=245
    1.5 ± 13.70
        SBP, Week 92, n=218
    0.7 ± 13.24
        SBP, Week 96, n=208
    1.2 ± 13.39
        SBP, Week 100, n=199
    1.0 ± 12.43
        SBP, Week 104, n=197
    2.4 ± 13.38
        SBP, Week 108, n=192
    1.7 ± 12.76
        SBP, Week 112, n=182
    1.8 ± 14.12
        SBP, Week 116, n=177
    1.9 ± 14.66
        SBP, Week 120, n=167
    1.9 ± 13.63
        SBP, Week 124, n=152
    2.5 ± 14.88
        SBP, Week 128, n=151
    2.6 ± 14.15
        SBP, Week 132, n=139
    1.0 ± 14.37
        SBP, Week 136, n=112
    2.3 ± 14.94
        SBP, Week 140, n=91
    -0.9 ± 16.53
        SBP, Week 144, n=77
    2.3 ± 14.13
        SBP, Week 148, n=62
    0.6 ± 13.02
        SBP, Week 152, n=35
    0.6 ± 11.33
        SBP, Week 156, n=32
    1.5 ± 15.73
        SBP, Week 160, n=14
    4.4 ± 9.48
        SBP, Week 164, n=8
    7.0 ± 15.07
        SBP, Week 168, n=1
    -4.0 ± 99999
        DBP, Week 4, n=333
    0.1 ± 8.41
        DBP, Week 8, n=334
    -0.8 ± 8.81
        DBP, Week 12, n=337
    0.2 ± 9.25
        DBP, Week 16, n=334
    0.5 ± 9.30
        DBP, Week 20, n=327
    -0.7 ± 10.35
        DBP, Week 24, n=333
    -0.2 ± 9.40
        DBP, Week 28, n=330
    0.1 ± 8.88
        DBP, Week 32, n=324
    -0.1 ± 10.44
        DBP, Week 36, n=330
    -0.4 ± 10.12
        DBP, Week 40, n=327
    -0.6 ± 9.24
        DBP, Week 44, n=327
    0.1 ± 9.39
        DBP, Week 48, n=329
    0.2 ± 9.71
        DBP, Week 52, n=325
    -0.1 ± 9.83
        DBP, Week 56, n=324
    0.7 ± 9.77
        DBP, Week 60, n=315
    -0.5 ± 10.40
        DBP, Week 64, n=307
    -0.4 ± 9.92
        DBP, Week 68, n=286
    -0.1 ± 10.04
        DBP, Week 72, n=281
    -0.3 ± 10.13
        DBP, Week 76, n=274
    -0.2 ± 9.92
        DBP, Week 80, n=265
    0.7 ± 9.83
        DBP, Week 84, n=255
    -0.6 ± 10.05
        DBP, Week 88, n=245
    -0.3 ± 9.22
        DBP, Week 92, n=218
    -0.9 ± 9.10
        DBP, Week 96, n=208
    -0.2 ± 9.17
        DBP, Week 100, n=199
    -0.7 ± 10.04
        DBP, Week 104, n=197
    0.1 ± 10.21
        DBP, Week 108, n=192
    0.1 ± 9.89
        DBP, Week 112, n=182
    0.0 ± 10.17
        DBP, Week 116, n=177
    -0.1 ± 10.31
        DBP, Week 120, n=167
    0.4 ± 9.74
        DBP, Week 124, n=152
    -0.3 ± 11.11
        DBP, Week 128, n=151
    0.6 ± 9.58
        DBP, Week 132, n=139
    -0.5 ± 10.10
        DBP, Week 136, n=112
    0.1 ± 9.89
        DBP, Week 140, n=91
    -1.8 ± 9.68
        DBP, Week 144, n=77
    -0.6 ± 10.92
        DBP, Week 148, n=62
    -0.7 ± 11.03
        DBP, Week 152, n=35
    -1.0 ± 8.97
        DBP, Week 156, n=32
    -2.0 ± 10.42
        DBP, Week 160, n=14
    2.9 ± 7.92
        DBP, Week 164, n=8
    1.9 ± 8.06
        DBP, Week 168, n=1
    5.0 ± 99999
    Notes
    [12] - AT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in pulse rate

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    End point title
    		 Change from Baseline in pulse rate
    End point description
    Vital sign measurements including pulse rate was done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). 99999 indicates data is not available as n=1 at this time point and standard deviation could not be calculated.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 168
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [13]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Pulse rate, Week 4, n=334
    2.1 ± 9.98
        Pulse rate, Week 8, n=333
    2.3 ± 10.65
        Pulse rate, Week 12, n=337
    2.6 ± 11.05
        Pulse rate, Week 16, n=334
    2.1 ± 11.03
        Pulse rate, Week 20, n=327
    2.7 ± 11.10
        Pulse rate, Week 24, n=333
    1.2 ± 11.22
        Pulse rate, Week 28, n=330
    2.8 ± 10.43
        Pulse rate, Week 32, n=324
    2.7 ± 11.44
        Pulse rate, Week 36, n=330
    2.6 ± 11.02
        Pulse rate, Week 40, n=327
    2.7 ± 11.09
        Pulse rate, Week 44, n=327
    2.7 ± 12.05
        Pulse rate, Week 48, n=329
    0.4 ± 10.63
        Pulse rate, Week 52, n=325
    1.7 ± 10.48
        Pulse rate, Week 56, n=324
    2.1 ± 11.36
        Pulse rate, Week 60, n=315
    2.1 ± 10.97
        Pulse rate, Week 64, n=307
    2.7 ± 10.96
        Pulse rate, Week 68, n=286
    2.9 ± 11.32
        Pulse rate, Week 72, n=281
    2.0 ± 11.15
        Pulse rate, Week 76, n=274
    2.8 ± 11.15
        Pulse rate, Week 80, n=265
    3.3 ± 11.45
        Pulse rate, Week 84, n=255
    3.2 ± 12.21
        Pulse rate, Week 88, n=245
    2.4 ± 11.98
        Pulse rate, Week 92, n=218
    2.4 ± 12.42
        Pulse rate, Week 96, n=208
    0.0 ± 11.16
        Pulse rate, Week 100, n=199
    1.8 ± 12.30
        Pulse rate, Week 104, n=197
    2.3 ± 12.29
        Pulse rate, Week 108, n=192
    2.2 ± 11.34
        Pulse rate, Week 112, n=182
    2.3 ± 12.35
        Pulse rate, Week 116, n=177
    2.0 ± 12.06
        Pulse rate, Week 120, n=167
    1.2 ± 12.19
        Pulse rate, Week 124, n=152
    2.3 ± 12.56
        Pulse rate, Week 128, n=151
    1.5 ± 11.69
        Pulse rate, Week 132, n=139
    2.2 ± 12.46
        Pulse rate, Week 136, n=112
    2.0 ± 11.68
        Pulse rate, Week 140, n=92
    0.7 ± 11.45
        Pulse rate, Week 144, n=77
    -1.5 ± 11.92
        Pulse rate, Week 148, n=62
    -0.5 ± 11.68
        Pulse rate, Week 152, n=35
    -0.6 ± 13.80
        Pulse rate, Week 156, n=32
    -0.4 ± 12.94
        Pulse rate, Week 160, n=14
    1.5 ± 13.24
        Pulse rate, Week 164, n=8
    1.4 ± 21.23
        Pulse rate, Week 168, n=1
    36.0 ± 99999
    Notes
    [13] - AT Population
    No statistical analyses for this end point

    Secondary: Number of participants with positive anti-mepolizumab binding antibodies (ADA) and neutralizing antibodies (NAb)

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    End point title
    		 Number of participants with positive anti-mepolizumab binding antibodies (ADA) and neutralizing antibodies (NAb)
    End point description
    Blood samples were collected for the determination of ADA just prior to administration of mepolizumab. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. The highest value post-Baseline visit are based on each participant's highest post-Baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-Baseline would be positive for a participant who had both negative and positive post-Baseline results. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 172
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [14]
    Units: Participants
        Highest value post-Baseline, ADA, positive, n=335
    6
        Highest value post-Baseline, ADA, Negative, n=335
    329
        Highest value post-Baseline, NAb, positive, n=6
    0
        Highest value post-Baseline, NAb, Negative, n=6
    6
    Notes
    [14] - AT Population
    No statistical analyses for this end point

    Secondary: Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range for clinical chemistry parameters at any time post-Baseline

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    End point title
    		 Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range for clinical chemistry parameters at any time post-Baseline
    End point description
    Blood samples were collected to assess clinical chemistry laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the "To Normal or No Change" category. Alanine Aminotransferase=ALT. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 172
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    339 [15]
    Units: Participants
        Glucose, To low, n=336
    1
        Glucose, To Normal or No Change, n=336
    334
        Glucose, To high, n=336
    1
        ALT, To low, n=337
    0
        ALT, To Normal or No Change, n=337
    337
        ALT, To high, n=337
    0
        Calcium, To low, n=336
    0
        Calcium, To Normal or No Change, n=336
    336
        Calcium, To high, n=336
    0
        Phosphate, To low, n=336
    0
        Phosphate, To Normal or No Change, n=336
    336
        Phosphate, To high, n=336
    0
        Potassium, To low, n=336
    0
        Potassium, To Normal or No Change, n=336
    336
        Potassium, To high, n=336
    0
        Sodium, To low, n=336
    1
        Sodium, To Normal or No Change, n=336
    335
        Sodium, To high, n=336
    0
    Notes
    [15] - AT Population
    No statistical analyses for this end point

    Secondary: Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range for hematology parameters at any time post-Baseline

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    End point title
    		 Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range for hematology parameters at any time post-Baseline
    End point description
    Blood samples were collected to assess hematology laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the "To Normal or No Change" category.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 172
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    336 [16]
    Units: Participants
        Hematocrit, To low
    1
        Hematocrit, To Normal or No Change
    335
        Hematocrit, To high
    0
        Hemoglobin, To low
    1
        Hemoglobin, To Normal or No Change
    335
        Hemoglobin, To high
    0
        Leukocytes, To low
    1
        Leukocytes, To Normal or No Change
    335
        Leukocytes, To high
    0
        Platelets, To low
    1
        Platelets, To Normal or No Change
    335
        Platelets, To high
    0
    Notes
    [16] - AT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 172 weeks)
    Adverse event reporting additional description
    AEs and SAEs were collected for all participants within the As Treated Population which comprised of all participants who received at least one dose of mepolizumab.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.

    Serious adverse events
    		 Mepolizumab 100 mg SC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    84 / 339 (24.78%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Superficial spreading melanoma stage unspecified
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Food allergy
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    34 / 339 (10.03%)
         occurrences causally related to treatment / all
    0 / 51
         deaths causally related to treatment / all
    0 / 1
    Nasal polyps
         subjects affected / exposed
    4 / 339 (1.18%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    3 / 339 (0.88%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Fracture
         subjects affected / exposed
    2 / 339 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Congenital anomaly
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Glaucoma
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 339 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dental cyst
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Neurodermatitis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    2 / 339 (0.59%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    6 / 339 (1.77%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 339 (0.88%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 339 (0.88%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 339 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 339 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    2 / 339 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 339 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Mepolizumab 100 mg SC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    288 / 339 (84.96%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    14 / 339 (4.13%)
         occurrences all number
    15
    Nervous system disorders
    Headache
         subjects affected / exposed
    57 / 339 (16.81%)
         occurrences all number
    160
    Dizziness
         subjects affected / exposed
    15 / 339 (4.42%)
         occurrences all number
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    16 / 339 (4.72%)
         occurrences all number
    23
    Influenza like illness
         subjects affected / exposed
    15 / 339 (4.42%)
         occurrences all number
    17
    Injection site reaction
         subjects affected / exposed
    15 / 339 (4.42%)
         occurrences all number
    48
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    16 / 339 (4.72%)
         occurrences all number
    17
    Nausea
         subjects affected / exposed
    15 / 339 (4.42%)
         occurrences all number
    16
    Vomiting
         subjects affected / exposed
    14 / 339 (4.13%)
         occurrences all number
    32
    Gastrooesophageal reflux disease
         subjects affected / exposed
    11 / 339 (3.24%)
         occurrences all number
    13
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    52 / 339 (15.34%)
         occurrences all number
    78
    Oropharyngeal pain
         subjects affected / exposed
    25 / 339 (7.37%)
         occurrences all number
    31
    Cough
         subjects affected / exposed
    22 / 339 (6.49%)
         occurrences all number
    27
    Dyspnoea
         subjects affected / exposed
    13 / 339 (3.83%)
         occurrences all number
    14
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    14 / 339 (4.13%)
         occurrences all number
    17
    Rash
         subjects affected / exposed
    14 / 339 (4.13%)
         occurrences all number
    18
    Pruritus
         subjects affected / exposed
    13 / 339 (3.83%)
         occurrences all number
    17
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    17 / 339 (5.01%)
         occurrences all number
    18
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    41 / 339 (12.09%)
         occurrences all number
    51
    Arthralgia
         subjects affected / exposed
    32 / 339 (9.44%)
         occurrences all number
    48
    Pain in extremity
         subjects affected / exposed
    15 / 339 (4.42%)
         occurrences all number
    16
    Musculoskeletal pain
         subjects affected / exposed
    14 / 339 (4.13%)
         occurrences all number
    16
    Myalgia
         subjects affected / exposed
    11 / 339 (3.24%)
         occurrences all number
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    143 / 339 (42.18%)
         occurrences all number
    270
    Bronchitis
         subjects affected / exposed
    64 / 339 (18.88%)
         occurrences all number
    106
    Upper respiratory tract infection
         subjects affected / exposed
    64 / 339 (18.88%)
         occurrences all number
    110
    Sinusitis
         subjects affected / exposed
    62 / 339 (18.29%)
         occurrences all number
    115
    Influenza
         subjects affected / exposed
    42 / 339 (12.39%)
         occurrences all number
    52
    Respiratory tract infection
         subjects affected / exposed
    20 / 339 (5.90%)
         occurrences all number
    23
    Gastroenteritis
         subjects affected / exposed
    19 / 339 (5.60%)
         occurrences all number
    20
    Lower respiratory tract infection
         subjects affected / exposed
    18 / 339 (5.31%)
         occurrences all number
    28
    Rhinitis
         subjects affected / exposed
    18 / 339 (5.31%)
         occurrences all number
    31
    Urinary tract infection
         subjects affected / exposed
    17 / 339 (5.01%)
         occurrences all number
    19
    Pharyngitis
         subjects affected / exposed
    15 / 339 (4.42%)
         occurrences all number
    22
    Ear infection
         subjects affected / exposed
    12 / 339 (3.54%)
         occurrences all number
    15
    Viral upper respiratory tract infection
         subjects affected / exposed
    12 / 339 (3.54%)
         occurrences all number
    14
    Pneumonia
         subjects affected / exposed
    11 / 339 (3.24%)
         occurrences all number
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2014
    Amendment 1: The primary purpose of Amendment 01 was to change three entry criteria to ensure those participants with a history of seriously debilitating asthma and a history of improved disease control continue to receive mepolizumab in 201312. The amendment also included a number of additional corrections and edits.
    14 Nov 2014
    Amendment 2: The primary reason for Amendment 2 was to insert entry criterion number 8. There are also minor changes to clarify the participant scenarios added during Amendment 1 and an administrative change to update the Medical Monitors.
    19 Jun 2015
    Amendment 3: The primary reason for Amendment 3 was to increase the treatment duration and to remove the Follow-up visit. There was also a change to the investigational product (IP) administration process and clarification to the IP post dose monitoring process. The amendment also included a standardization of the collection of concomitant medications.
    06 Jul 2015
    Amendment 4: To correct some errors in Appendix 9 to reflect the amendments made within the main protocol.

    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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