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    Clinical Trial Results:
    A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma

    Summary
    EudraCT number
    		 2011-002790-28
    Trial protocol
    		 SK   SE   CZ   BG   IT   DE   GB  
    Global end of trial date
    13 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    27 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5896C00027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01444430
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca Research and Development
    Sponsor organisation address
    AstraZeneca Pepparedsleden 1, Mölndal, Sweden,
    Public contact
    Carin Jorup, AstraZeneca Research and Development, +46 31 7761000, Carin.Jorup@astrazeneca.com
    Scientific contact
    Carin Jorup, Global Clinical Lead (GCL) SYMBICORT, AstraZeneca Research and Development, +46 31 7761000, Carin.Jorup@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study was to evaluate whether treatment with SYMBICORT pMDI increases the incidence of serious asthma-related events compared to treatment with budesonide alone in adult and adolescent (≥12 years of age) patients with persistent asthma.
    Protection of trial subjects
    Patients were followed at least on a monthly basis by the research site, either by clinic visits or telephone contacts. Criteria for unstable asthma was assessed between study visits on a daily basis via telephone calls to the Interactive Voice Response System (IVRS). In these telephone calls patients recorded missed days of work/school, rescue medication use, asthma symptoms, ability to perform daily activities and night time awakenings. The patient and, if applicable, the patient’s parent/legal guardian was trained by the investigational team and also supplied with written instructions on how to enter data and where to turn if problems occurred. A reminder about intake of study medication was given in connection to the IVRS call. The Investigator received an electronic alert to contact patients with unstable asthma. Patients in need of treatment due to an exacerbation could obtain additional medication while remaining on randomized treatment. Site staff reviewed study medication compliance with the patient at each scheduled study visit (Visits 3, 5 and EoT) and monthly telephone contacts and made a note in Medical records. A daily reminder was also addressed via IVRS. If the patient was not compliant, he or she received additional training on how to use the pMDI. In addition to standard protocolized criteria for discontinuation of investigational product, the study included 3 study-specific discontinuation criteria to optimize safety related to asthma exacerbations: - Experience of more than 1 asthma exacerbation within 13 weeks (during the randomized treatment period) or more than 2 asthma exacerbations within 26 weeks (during the randomized treatment period) will necessitate withdrawal. - A patient whose exacerbation is not responding to therapy in the judgment of the investigator or is not responding to 14 days of treatment with systemic corticosteroids. - A patient requires intubation for asthma.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Dec 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 3515
    Country: Number of subjects enrolled
    Argentina: 1006
    Country: Number of subjects enrolled
    France: 50
    Country: Number of subjects enrolled
    Germany: 91
    Country: Number of subjects enrolled
    Italy: 109
    Country: Number of subjects enrolled
    United Kingdom: 132
    Country: Number of subjects enrolled
    Bulgaria: 624
    Country: Number of subjects enrolled
    Czech Republic: 267
    Country: Number of subjects enrolled
    Poland: 827
    Country: Number of subjects enrolled
    Romania: 402
    Country: Number of subjects enrolled
    Russian Federation: 788
    Country: Number of subjects enrolled
    Slovakia: 201
    Country: Number of subjects enrolled
    Ukraine: 726
    Country: Number of subjects enrolled
    Brazil: 358
    Country: Number of subjects enrolled
    Chile: 194
    Country: Number of subjects enrolled
    Colombia: 71
    Country: Number of subjects enrolled
    Mexico: 836
    Country: Number of subjects enrolled
    Panama: 36
    Country: Number of subjects enrolled
    Peru: 211
    Country: Number of subjects enrolled
    Philippines: 438
    Country: Number of subjects enrolled
    South Africa: 552
    Country: Number of subjects enrolled
    Korea, Republic of: 301
    Country: Number of subjects enrolled
    India: 433
    Country: Number of subjects enrolled
    Thailand: 151
    Country: Number of subjects enrolled
    Vietnam: 141
    Worldwide total number of subjects
    12460
    EEA total number of subjects
    2703
    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)
    1305
    Adults (18-64 years)
    9752
    From 65 to 84 years
    1389
    85 years and over
    14

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study started with an assessment visit where inclusion/exclusion criteria were reviewed and informed consent obtained. Eligible patients were randomized at the next visit. Patients then entered a 26 weeks double-blind treatment period followed by a 1 week follow-up telephone contact. Patients were recruited in 25 countries with 25% in the US.

    Pre-assignment
    Screening details
    		 Eligible adult and adolescent patients were stratified at randomization visit (Visit 2) to one of the two dose levels of Symbicort/budesonide based upon assessment of ACQ and prior asthma therapy. Patients received rescue medication (Albuterol or Salbutamol) throughout the study.

    Pre-assignment period milestones
    Number of subjects started
    		 12460
    Number of subjects completed
    		 11693

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Eligibility criteria not fulfilled: 704
    Reason: Number of subjects
    		 Consent withdrawn by subject: 34
    Reason: Number of subjects
    		 Other: 29
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Symbicort
    Arm description
    		 Participants were randomized to one of following treatments: Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
    Arm type
    		 Experimental

    Investigational medicinal product name
    budesonide/formoterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    pMDI (HFA) for oral inhalation with Actuation Counter Module, 80/4.5μg or 160/4.5μg

    Arm title
    		 budesonide
    Arm description
    		 Participants were randomized to one of following treatments: budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    pMDI (HFA) for oral inhalation with Actuation Counter Module (ACM), 80 μg or 160 μg

    Number of subjects in period 1 [1]
    		Symbicort budesonide
    Started
    5846
    5847
    Completed
    5785
    5766
    Not completed
    61
    81
         Adverse event, serious fatal
    6
    8
         Consent withdrawn by subject
    53
    72
         CRF termination module not completed.
    -
    1
         Lost to follow-up
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: AEs were not collected unless they lead to discontinuation or qualified as an SAE.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Symbicort
    Reporting group description
    		 Participants were randomized to one of following treatments: Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).

    Reporting group title
    budesonide
    Reporting group description
    		 Participants were randomized to one of following treatments: budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).

    Reporting group values
    		 Symbicort budesonide Total
    Number of subjects
    		 5846 5847 11693
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 632 636 1268
        Adults (18-64 years)
    		 4572 4568 9140
        From 65 years
    		 642 643 1285
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 43.4 ( 17.4 ) 43.5 ( 17.3 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 3849 3820 7669
        Male
    		 1997 2027 4024
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 4050 4003 8053
        Black/African American
    		 396 401 797
        Asian
    		 848 907 1755
        Native Hawaiian/Pacific Islander
    		 3 3 6
        American Indian/Alaska Native
    		 225 207 432
        Other
    		 324 326 650

    End points

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    End points reporting groups
    Reporting group title
    Symbicort
    Reporting group description
    		 Participants were randomized to one of following treatments: Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).

    Reporting group title
    budesonide
    Reporting group description
    		 Participants were randomized to one of following treatments: budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).

    Primary: Time to first event in composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization)

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    End point title
    		 Time to first event in composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization)
    End point description
    Time to first event included in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
    End point type
    Primary
    End point timeframe
    Up to 27 weeks
    End point values
    		 Symbicort budesonide
    Number of subjects analysed
    5846
    5847
    Units: Participants
    43
    40
    Statistical analysis title
    		 Cox regression
    Statistical analysis description
    Full analysis set (FAS) population comprised of all patients randomized to study drug.
    Comparison groups
    budesonide v Symbicort
    Number of subjects included in analysis
    11693
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.073
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.698
         upper limit
    		 1.65
    Notes
    [1] - The upper limit of the 95% CI of the hazard ratio will be used to assess statistical non-inferiority (non-inferiority margin=2).

    Primary: Time to first event included in the definition of asthma exacerbation

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    End point title
    		 Time to first event included in the definition of asthma exacerbation
    End point description
    Time to first asthma exacerbation, defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
    End point type
    Primary
    End point timeframe
    Up to 26 weeks
    End point values
    		 Symbicort budesonide
    Number of subjects analysed
    5846
    5847
    Units: Participants
    539
    633
    Statistical analysis title
    		 Cox regression
    Statistical analysis description
    The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.
    Comparison groups
    Symbicort v budesonide
    Number of subjects included in analysis
    11693
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.835
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.745
         upper limit
    		 0.937

    Secondary: Percent of days with no asthma symptoms

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    End point title
    		 Percent of days with no asthma symptoms
    End point description
    Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
    End point type
    Secondary
    End point timeframe
    Daily up to 26 weeks
    End point values
    		 Symbicort budesonide
    Number of subjects analysed
    5784
    5796
    Units: Percentage
        least squares mean (standard error)
    81.1 ( 0.4 )
    76.8 ( 0.4 )
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.
    Comparison groups
    Symbicort v budesonide
    Number of subjects included in analysis
    11580
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 5.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5

    Secondary: Percent of days with activity limitation due to asthma

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    End point title
    		 Percent of days with activity limitation due to asthma
    End point description
    Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
    End point type
    Secondary
    End point timeframe
    Daily up to 26 weeks
    End point values
    		 Symbicort budesonide
    Number of subjects analysed
    4895
    5045
    Units: Percentage
        least squares mean (standard error)
    19.7 ( 0.4 )
    19.1 ( 0.4 )
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    Full analysis set (FAS) population comprised of all patients randomized to study drug. The analysis set comprises of all patients with at least one day with asthma symptoms, i.e. the denominator is the number of days with asthma symptoms.
    Comparison groups
    Symbicort v budesonide
    Number of subjects included in analysis
    9940
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.272
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6

    Secondary: Mean number of puffs of rescue medication per 24 hours

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    End point title
    		 Mean number of puffs of rescue medication per 24 hours
    End point description
    Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
    End point type
    Secondary
    End point timeframe
    Daily up to 26 weeks
    End point values
    		 Symbicort budesonide
    Number of subjects analysed
    5784
    5796
    Units: Inhalations/day
        least squares mean (standard error)
    0.8 ( 0 )
    0.9 ( 0 )
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.
    Comparison groups
    Symbicort v budesonide
    Number of subjects included in analysis
    11580
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0

    Secondary: Asthma Control Questionnaire (ACQ6)

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    End point title
    		 Asthma Control Questionnaire (ACQ6)
    End point description
    The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide. The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions.
    End point type
    Secondary
    End point timeframe
    baseline, day 28, day 84, day 182
    End point values
    		 Symbicort budesonide
    Number of subjects analysed
    5701
    5698
    Units: ACQ6 overall score change from baseline
        least squares mean (standard error)
    -0.7 ( 0.01 )
    -0.62 ( 0.01 )
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    Full analysis set (FAS) population comprised of all patients randomized to study drug with at least one post-baseline ACQ6 score.
    Comparison groups
    Symbicort v budesonide
    Number of subjects included in analysis
    11399
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 -0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01

    Secondary: Percent of nights with awakening(s) due to asthma

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    End point title
    		 Percent of nights with awakening(s) due to asthma
    End point description
    Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
    End point type
    Secondary
    End point timeframe
    Daily up to 26 weeks
    End point values
    		 Symbicort budesonide
    Number of subjects analysed
    5784
    5796
    Units: Percentage
        least squares mean (standard error)
    4 ( 0.2 )
    4.7 ( 0.2 )
    Statistical analysis title
    		 ANOVA
    Statistical analysis description
    Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.
    Comparison groups
    Symbicort v budesonide
    Number of subjects included in analysis
    11580
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2

    Secondary: Time to discontinuation of investigational product due to a protocol defined asthma exacerbation

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    End point title
    		 Time to discontinuation of investigational product due to a protocol defined asthma exacerbation
    End point description
    Time to discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
    End point type
    Secondary
    End point timeframe
    Up to 26 weeks
    End point values
    		 Symbicort budesonide
    Number of subjects analysed
    5846
    5847
    Units: Participants
    53
    71
    Statistical analysis title
    		 Cox regression
    Statistical analysis description
    The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.
    Comparison groups
    Symbicort v budesonide
    Number of subjects included in analysis
    11693
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.739
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.518
         upper limit
    		 1.055

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and discontinuation of treatment with investigational product due to adverse event (DAEs) were recorded from the time of informed consent through the treatment period and including the follow-up period.
    Adverse event reporting additional description
    AEs were not collected unless they lead to discontinuation or qualified as an SAE.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Symbicort
    Reporting group description
    		 Participants were randomized to one of following treatments: Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).

    Reporting group title
    budesonide
    Reporting group description
    		 Participants were randomized to one of following treatments: budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: AEs were not collected unless they lead to discontinuation or qualified as an SAE.
    Serious adverse events
    		 Symbicort budesonide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    125 / 5846 (2.14%)
    123 / 5847 (2.10%)
         number of deaths (all causes)
    6
    8
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Astrocytoma malignant
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 5846 (0.03%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Hyperemesis gravidarum
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Device dislocation
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 5846 (0.02%)
    2 / 5847 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic granulomatous angiitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Menometrorrhagia
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic prolapse
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    35 / 5846 (0.60%)
    36 / 5847 (0.62%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 39
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 5846 (0.02%)
    2 / 5847 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory distress
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis allergic
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord disorder
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Depression
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns first degree
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electric shock
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Tibia fracture
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angina pectoris
         subjects affected / exposed
    3 / 5846 (0.05%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 5846 (0.03%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 5846 (0.00%)
    3 / 5847 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 5846 (0.03%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypertensive heart disease
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocarditis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 5846 (0.00%)
    2 / 5847 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 5846 (0.00%)
    3 / 5847 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    3 / 5846 (0.05%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy mediastinal
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 5846 (0.03%)
    2 / 5847 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 5846 (0.00%)
    3 / 5847 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 5846 (0.03%)
    2 / 5847 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 5846 (0.03%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 5846 (0.00%)
    3 / 5847 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 5846 (0.00%)
    2 / 5847 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 5846 (0.00%)
    2 / 5847 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycoplasma infection
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    12 / 5846 (0.21%)
    6 / 5847 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 5846 (0.03%)
    3 / 5847 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 5846 (0.03%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 5846 (0.00%)
    2 / 5847 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculous pleurisy
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 5846 (0.03%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 5846 (0.02%)
    0 / 5847 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperosmolar hyperglycaemic state
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 5846 (0.00%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    2 / 5846 (0.03%)
    1 / 5847 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Symbicort budesonide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5846 (0.00%)
    0 / 5847 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2011
    Revision of sections relating to study committees to clarify that the TDMC was responsible for monitoring the primary safety variable of the study but also all other aspects of safety in the study. Text added to clarify that if a patient was re-screened 3 months or more after the last signing of the ICF, the patient had to re-consent to the study. Additional text added to inclusion criterion 6 to include the ability to read the ACQ6 questionnaire: “Availability and ability to perform the necessary maneuvers and procedures required by the study (eg, read the ACQ6 questionnaire, use a pMDI, and perform daily telephone calls).” Procedures for handling patients incorrectly enrolled or randomized re worded: “Patients who fail to meet the inclusion/exclusion criteria should not, under any circumstances, be enrolled or receive study medication. There can be no exceptions to this rule.”
    11 Apr 2013
    Text added to clarify instructions for collection and recording of patient’s compliance. Procedures for handling patients incorrectly enrolled or randomized were updated to clarify procedures to be taken by AstraZeneca study team, physician, and investigator where minor violations of inclusion or exclusion criteria were detected.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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