Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    MEA115661: A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects who participated in the MEA115588 or MEA115575 trials

    Summary
    EudraCT number
    		 2012-001644-21
    Trial protocol
    		 BE   GB   DE   IT   ES   NL   CZ  
    Global end of trial date
    13 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2016
    First version publication date
    10 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MEA115661
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile of mepolizumab in subjects receiving long-term treatment
    Protection of trial subjects
    Numbing cream or spray was permitted at the site of injection and rescue medications (salbuterol/albuterol) are available to the participant throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 May 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 40 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 40
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Belgium: 20
    Country: Number of subjects enrolled
    Canada: 51
    Country: Number of subjects enrolled
    Chile: 22
    Country: Number of subjects enrolled
    Czech Republic: 13
    Country: Number of subjects enrolled
    France: 77
    Country: Number of subjects enrolled
    Germany: 83
    Country: Number of subjects enrolled
    Italy: 51
    Country: Number of subjects enrolled
    Japan: 43
    Country: Number of subjects enrolled
    Korea, Republic of: 42
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Netherlands: 23
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Russian Federation: 17
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Ukraine: 16
    Country: Number of subjects enrolled
    United Kingdom: 27
    Country: Number of subjects enrolled
    United States: 66
    Worldwide total number of subjects
    651
    EEA total number of subjects
    335
    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)
    23
    Adults (18-64 years)
    531
    From 65 to 84 years
    97
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was an extension of MEA115588 (NCT01691521) and MEA115575 (NCT01691508). Participants who completed the prior studies were offered to enroll in this study. Assessments that were captured as part of exit visit for MEA115588 and MEA115575 served as Baseline visit for this study.

    Pre-assignment
    Screening details
    		 651 participants who completed the study MEA115588 or MEA115575 were enrolled in this study. Participants meeting all the inclusion criteria and none of the exclusion criteria received their first mepolizumab dose at Visit 1 and continued to receive mepolizumab subcutaneous (SC) injections approximately every 4 weeks for 12 months.

    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 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. 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
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Mepolizumab 100mg was administered subcutaneously into the upper arm or thigh approximately every 4 weeks for 12 months. Prior to administration, each vial of mepolizumab was reconstituted and swirled gently to enable complete dissolution of the product.

    Number of subjects in period 1
    		Mepolizumab 100 mg SC
    Started
    651
    Completed
    585
    Not completed
    66
         Consent withdrawn by subject
    14
         Physician decision
    9
         Adverse event, non-fatal
    11
         Protocol defined stopping criteria
    2
         Lost to follow-up
    3
         Lack of efficacy
    19
         Protocol deviation
    8

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. 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
    		 651 651
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.1 ± 13.87 -
    Gender categorical
    Units: Subjects
        Female
    		 360 360
        Male
    		 291 291
    Customized, Race
    Units: Subjects
        African American/African Heritage
    		 14 14
        American Indian or Alaskan Native
    		 2 2
        Asian - Central/South Asian Heritage
    		 3 3
        Asian - East Asian Heritage
    		 44 44
        Asian - Japanese Heritage
    		 45 45
        Asian - South East Asian Heritage
    		 7 7
        Native Hawaiian or Other Pacific Islander
    		 1 1
        White - Arabic/North African Heritage
    		 13 13
        White - White/Caucasian/European Heritage
    		 517 517
        Mixed Race
    		 5 5

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.

    Primary: Number of participants with adverse events (AEs) including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions

    		 Close Top of page
    End point title
    		 Number of participants with adverse events (AEs) including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions [1]
    End point description
    AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, 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.
    End point type
    Primary
    End point timeframe
    From Baseline visit until the follow-up visit (approximately [approx.] 12 weeks post-last dose)
    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
    651 [2]
    Units: Participants
    number (not applicable)
        Any AEs
    558
        AEs related to study treatment
    119
        Any SAEs
    94
        SAEs related to study treatment
    1
        Fatal SAEs
    0
    Notes
    [2] - As Treated (AT) Population: all participants who received at least 1 dose of open label mepolizumab.
    No statistical analyses for this end point

    Secondary: Number of participants with positive anti-mepolizumab binding antibodies and neutralizing antibodies (NAb) at the indicated time points

    		 Close Top of page
    End point title
    		 Number of participants with positive anti-mepolizumab binding antibodies and neutralizing antibodies (NAb) at the indicated time points
    End point description
    Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. 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.
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651
    Units: Participants
    number (not applicable)
        Highest value post-baseline, ADA, positive, n=646
    31
        Highest value post-baseline, ADA, negative, n=646
    615
        Highest value post-baseline, NAb, positive, n=31
    0
        Highest value post-baseline, NAb, negative, n=31
    31
    No statistical analyses for this end point

    Secondary: Annualized rate of exacerbations per year

    		 Close Top of page
    End point title
    		 Annualized rate of exacerbations per year
    End point description
    Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (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. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.
    End point type
    Secondary
    End point timeframe
    Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651 [3]
    Units: Exacerbations per year
        arithmetic mean (confidence interval 95%)
    0.93 (0.83 to 1.04)
    Notes
    [3] - AT Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in asthma control questionnaire (ACQ) score

    		 Close Top of page
    End point title
    		 Mean change from Baseline in asthma control questionnaire (ACQ) 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). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651
    Units: Score on scale
    arithmetic mean (standard deviation)
        Week 4, n=603
    -0.09 ± 0.812
        Week 16, n=592
    -0.11 ± 0.92
        Week 28, n=577
    -0.05 ± 1.021
        Week 40, n=564
    -0.1 ± 0.944
        Week 52, n=556
    -0.09 ± 0.99
        Follow-up visit, n=338
    0.2 ± 1.132
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in clinic pre-bronchodilator FEV1 over the 52-week treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in clinic pre-bronchodilator FEV1 over the 52-week treatment period
    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, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    From Baseline and up to Week 52
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651
    Units: Milliliters (mL)
    arithmetic mean (standard deviation)
        Week 16, n=632
    67 ± 362.7
        Week 28, n=615
    50 ± 409.8
        Week 52, n=602
    29 ± 406.2
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of participants withdrawn due to lack of efficacy and adverse events from the study
    End point description
    AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, 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. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651 [4]
    Units: Participants
    number (not applicable)
        Withdrawals due to lack of efficacy
    19
        Withdrawals due to adverse events
    11
    Notes
    [4] - AT Population.
    No statistical analyses for this end point

    Secondary: Number of participants hospitalized due to exacerbations and adverse events

    		 Close Top of page
    End point title
    		 Number of participants hospitalized due to exacerbations and adverse events
    End point description
    AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (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.
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651 [5]
    Units: Participants
    number (not applicable)
        No hospitalisation due to exacerbations
    612
        One time hospitalisation due to exacerbations
    29
        Two times hospitalisation due to exacerbations
    4
        Three times hospitalisation due to exacerbations
    4
        Four times hospitalisation due to exacerbations
    0
        Five times hospitalisation due to exacerbations
    0
        Six times hospitalisation due to exacerbations
    1
        Seven times hospitalisation due to exacerbations
    0
        Eight times hospitalisation due to exacerbations
    0
        Nine times hospitalisation due to exacerbations
    0
        Ten times hospitalisation due to exacerbations
    1
        No hospitalisation due to AEs
    560
        One time hospitalisation due to AEs
    61
        Two times hospitalisation due to AEs
    13
        Three times hospitalisation due to AEs
    11
        Four times hospitalisation due to AEs
    4
        Five times hospitalisation due to AEs
    0
        Six times hospitalisation due to AEs
    1
        Seven times hospitalisation due to AEs
    0
        Eight times hospitalisation due to AEs
    0
        Nine times hospitalisation due to AEs
    0
        Ten times hospitalisation due to AEs
    0
        Eleven times hospitalisation due to AEs
    0
        Twelve times hospitalisation due to AEs
    0
        Thirteen times hospitalisation due to AEs
    0
        Fourteen times hospitalisation due to AEs
    0
        Fifteen times hospitalisation due to AEs
    0
        Sixteen times hospitalisation due to AEs
    1
    Notes
    [5] - AT Population
    No statistical analyses for this end point

    Secondary: Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions

    		 Close Top of page
    End point title
    		 Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions
    End point description
    Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgEmediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651 [6]
    Units: Participants
    number (not applicable)
        Any systemic infusion/injection site reaction
    13
        Injection related reaction
    7
        Hypersensitvity
    4
        Type IV hypersensitivity reaction
    3
        Any local infusion/injection site reaction
    29
    Notes
    [6] - AT Population
    No statistical analyses for this end point

    Secondary: Number of participants with electrocardiogram (ECG) findings at any time post Baseline

    		 Close Top of page
    End point title
    		 Number of participants with electrocardiogram (ECG) findings at any time post Baseline
    End point description
    12-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. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS).
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    638 [7]
    Units: Participants
    number (not applicable)
        Normal
    262
        A-NCS
    295
        A-CS
    81
    Notes
    [7] - AT Population, only participants with ECG results post-baseline were analyzed
    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 ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose)

    		 Close Top of page
    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 ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose)
    End point description
    12-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. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651
    Units: Milliseconds (msec)
    arithmetic mean (standard deviation)
        QTcB, Week 28, n=592
    -5.5 ± 19.1
        QTcB, Week 52, n=573
    -3.2 ± 18.9
        QTcB, Follow-up, n=299
    -3.4 ± 19.67
        QTcF, Week 28, n=592
    -7.1 ± 16.15
        QTcF, Week 52, n=573
    -3.5 ± 15.68
        QTcF, Follow-up, n=299
    -5.5 ± 17.01
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of participants with maximum change from Baseline in QTcF interval for ECG assessed at any time post Baseline
    End point description
    12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) 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. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    614 [8]
    Units: Participants
    number (not applicable)
        MC <-60, n=614
    2
        MC >=-60 to <-30, n=614
    11
        MC >=-30 to <0, n=614
    252
        MC >=0 to <30, n=614
    328
        MC >=30 to <60, n=614
    20
        MC >=60, n=614
    1
    Notes
    [8] - AT Population
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of participants with maximum change from Baseline in QTcB interval for ECG assessed at any time post Baseline
    End point description
    12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    614 [9]
    Units: participants
    number (not applicable)
        MC <-60, n=614
    3
        MC >=-60 to <-30, n=614
    16
        MC >=-30 to <0, n=614
    222
        MC >=0 to <30, n=614
    330
        MC >=30 to <60, n=614
    41
        MC >=60, n=614
    2
    Notes
    [9] - AT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in systolic blood pressure and diastolic blood pressure assessed at Week 52

    		 Close Top of page
    End point title
    		 Change from Baseline in systolic blood pressure and diastolic blood pressure assessed at Week 52
    End point description
    Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements 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. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    581 [10]
    Units: Millimeter of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP, Week 52, n=581
    0.3 ± 12.9
        DBP, Week 52, n=581
    -0.4 ± 9.47
    Notes
    [10] - AT Population.
    No statistical analyses for this end point

    Secondary: Change from Baseline in pulse rate assessed at Week 52

    		 Close Top of page
    End point title
    		 Change from Baseline in pulse rate assessed at Week 52
    End point description
    Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements 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.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    581 [11]
    Units: Beats per minute (BPM)
        arithmetic mean (standard deviation)
    0.2 ± 10.52
    Notes
    [11] - AT Population
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinical Chemistry Parameters outside the Normal Range at Any Time Post-baseline

    		 Close Top of page
    End point title
    		 Number of Participants With Clinical Chemistry Parameters outside the Normal Range at Any Time Post-baseline
    End point description
    Clinical chemistry laboratory parameters: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651 [12]
    Units: Participants
    number (not applicable)
        Alanine aminotransferase, High, n=649
    70
        Albumin, Low, n=649
    1
        Albumin, High, n=649
    23
        Alkaline phosphatase, High, n=649
    37
        Aspartate aminotransferase, High, n=649
    53
        Bilirubin, High, n=649
    38
        Calcium, Low, n=649
    19
        Calcium, High, n=649
    49
        Chloride, Low, n=649
    9
        Chloride, High, n=649
    126
        Cholesterol, High, n=649
    492
        Creatine kinase, High, n=649
    178
        Creatinine, Low, n=649
    170
        Creatinine, High, n=649
    18
        Direct bilirubin, High, n=649
    10
        Gamma glutamyl transferase, High, n=649
    146
        HDL cholesterol, Low, n=616
    22
        Indirect bilirubin, High, n=649
    12
        LDL cholesterol, High, n=604
    207
        Lactate dehydrogenase, High, n=649
    36
        Phosphate, Low, n=649
    149
        Phosphate, High, n=649
    84
        Plasma/serum protein, Low, n=649
    29
        Potassium, Low, n=649
    24
        Potassium, High, n=649
    22
        Serum glucose, Low, n=649
    62
        Serum glucose, High, n=649
    239
        Sodium, Low, n=649
    25
        Sodium, High, n=649
    9
        Triglycerides, High, n=617
    102
        Urea, Low, n=649
    17
        Urea, High, n=649
    53
        VLDL cholesterol, Low, n=605
    13
        VLDL cholesterol, High, n=605
    99
    Notes
    [12] - AT Population.
    No statistical analyses for this end point

    Secondary: Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post baseline

    		 Close Top of page
    End point title
    		 Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post baseline
    End point description
    Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/ leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit. AT Population.
    End point type
    Secondary
    End point timeframe
    From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])
    End point values
    		 Mepolizumab 100 mg SC
    Number of subjects analysed
    651 [13]
    Units: Participants
    number (not applicable)
        Basophils, High, n=649
    2
        Basophils/Leukocytes, High, n=649
    3
        Blood Erythrocytes, Low, n=649
    52
        Blood Erythrocytes, High, n=649
    36
        Blood Leukocytes, Low, n=649
    25
        Blood Leukocytes, High, n=649
    146
        Eosinophils, Low, n=649
    429
        Eosinophils, High, n=649
    51
        Eosinophils/Leukocytes, High, n=649
    60
        MCHC, Low, n=649
    276
        MCH, Low, n=649
    58
        MCH, High, n=649
    26
        MCV, Low, n=649
    32
        MCV, High, n=649
    32
        EDW, High, n=649
    322
        Hematocrit, Low, n=649
    57
        Hematocrit, High, n=649
    94
        Hemoglobin, Low, n=649
    116
        Hemoglobin, High, n=649
    14
        Lymphocytes, Low, n=649
    48
        Lymphocytes, High, n=649
    25
        Lymphocytes/Leukocytes, Low, n=649
    168
        Lymphocytes/Leukocytes, High, n=649
    68
        Monocytes, Low, n=649
    156
        Monocytes, High, n=649
    15
        Monocytes/Leukocytes, High, n=649
    45
        NS, Low, n=649
    31
        NS, High, n=649
    151
        Neutrophils/Leukocytes, Low, n=649
    39
        Neutrophils/Leukocytes, High, n=649
    226
        Platelets, Low, n=649
    8
        Platelets, High, n=649
    58
        Reticulocytes, Low, n=649
    77
        Reticulocytes, High, n=649
    294
    Notes
    [13] - Only those available at the specified time points were analyzed (n=X in the category titles).
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) and Serious adverse events (SAEs) were collected from the first dose of study treatment until 28 days after the last dose of mepolizumab, up to the follow-up visit (approx. week 60 [12 weeks post-last dose]).
    Adverse event reporting additional description
    Serious adverse events (SAEs) and Non-serious AEs were collected in members of As-Treated (AT) Population, comprised of all participants who received at least one dose of open label mepolizumab medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Mepolizumab 100 mg SC
    Reporting group description
    		 Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. 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
    94 / 651 (14.44%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 651 (0.15%)
         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 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Type IV hypersensitivity reaction
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 651 (0.15%)
         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
    38 / 651 (5.84%)
         occurrences causally related to treatment / all
    0 / 67
         deaths causally related to treatment / all
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nasal polyps
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Ejection fraction decreased
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain contusion
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    3 / 651 (0.46%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyskinesia oesophageal
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gallbladder disorder
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrocalcinosis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract pain
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 651 (0.61%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 651 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 651 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 651 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 651 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngeal abscess
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 651 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
         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
    461 / 651 (70.81%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    87 / 651 (13.36%)
         occurrences all number
    212
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    29 / 651 (4.45%)
         occurrences all number
    65
    Fatigue
         subjects affected / exposed
    24 / 651 (3.69%)
         occurrences all number
    28
    Gastrointestinal disorders
    Nausea
    alternative dictionary used: MedDRA MedDRA
         subjects affected / exposed
    27 / 651 (4.15%)
         occurrences all number
    30
    Diarrhoea
    alternative dictionary used: MedDRA MedDRA
         subjects affected / exposed
    21 / 651 (3.23%)
         occurrences all number
    25
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    61 / 651 (9.37%)
         occurrences all number
    89
    Oropharyngeal pain
         subjects affected / exposed
    34 / 651 (5.22%)
         occurrences all number
    38
    Cough
         subjects affected / exposed
    26 / 651 (3.99%)
         occurrences all number
    32
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    46 / 651 (7.07%)
         occurrences all number
    49
    Arthralgia
         subjects affected / exposed
    44 / 651 (6.76%)
         occurrences all number
    52
    Pain in extremity
         subjects affected / exposed
    21 / 651 (3.23%)
         occurrences all number
    23
    Musculoskeletal pain
         subjects affected / exposed
    21 / 651 (3.23%)
         occurrences all number
    22
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    196 / 651 (30.11%)
         occurrences all number
    320
    Bronchitis
         subjects affected / exposed
    78 / 651 (11.98%)
         occurrences all number
    106
    Upper respiratory tract infection
         subjects affected / exposed
    99 / 651 (15.21%)
         occurrences all number
    143
    Sinusitis
         subjects affected / exposed
    66 / 651 (10.14%)
         occurrences all number
    100
    Influenza
         subjects affected / exposed
    28 / 651 (4.30%)
         occurrences all number
    31
    Lower respiratory tract infection
         subjects affected / exposed
    26 / 651 (3.99%)
         occurrences all number
    30
    Rhinitis
         subjects affected / exposed
    23 / 651 (3.53%)
         occurrences all number
    28
    Urinary tract infection
         subjects affected / exposed
    21 / 651 (3.23%)
         occurrences all number
    28

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2013
    The primary purpose of Amendment 01 was to remove the entry criterion requiring a positive neutralizing antibody status based upon any sample obtained during the MEA115588 or the MEA115575 study. The amendment also included a number of additional corrections and edits (Appendix 7).
    21 Jun 2013
    The primary purpose of Amendment 02 is to permit use of the 100mg vial presentation as soon as it is available at the site versus the original switch point of Visit 8. This amendment also includes additional corrections/clarifications noted since Amendment 01 (Appendix 8).
    28 Jun 2013
    The primary purpose of Amendment 03 is to remove the dose given at Visit 14. This amendment also includes additional corrections/clarifications noted since Amendment 02 (Appendix 9).
    19 Feb 2014
    The primary purpose of Amendment 04 is to allow subjects in MEA115661 who have life-threatening or severely debilitating asthma to continue to receive treatment after the end of the treatment period (Appendix 10).

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 22:59:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA