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    Clinical Trial Results:
    Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) versus Placebo

    Summary
    EudraCT number
    		 2013-001119-54
    Trial protocol
    		 GB   DE   IT   SE   ES  
    Global end of trial date
    17 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2018
    First version publication date
    04 Mar 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    H8A-MC-LZAX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01900665
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15136
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Aug 2013
    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
    Canada: 127
    Country: Number of subjects enrolled
    Sweden: 52
    Country: Number of subjects enrolled
    United States: 1078
    Country: Number of subjects enrolled
    Japan: 132
    Country: Number of subjects enrolled
    Poland: 102
    Country: Number of subjects enrolled
    Italy: 98
    Country: Number of subjects enrolled
    United Kingdom: 89
    Country: Number of subjects enrolled
    Australia: 68
    Country: Number of subjects enrolled
    France: 173
    Country: Number of subjects enrolled
    Germany: 96
    Country: Number of subjects enrolled
    Spain: 114
    Worldwide total number of subjects
    2129
    EEA total number of subjects
    724
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    370
    From 65 to 84 years
    1636
    85 years and over
    123

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were excluded after study enrollment,if PET imaging or CSF results did not show evidence of brain amyloid pathology,a screening MRI with results >4 ARIA-H(amyloid-related imaging abnormality-hemorrhage/hemosiderin deposition) or presence of ARIA-E(amyloid-related imaging abnormality-edema/effusions) and abnormal lab results were found.

    Period 1
    Period 1 title
    Placebo Controlled Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Solanezumab
    Arm description
    		 Participants received Solanezumab 400 milligrams (mg)Intravenously (IV) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solanezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks

    Number of subjects in period 1
    		Solanezumab Placebo
    Started
    1057
    1072
    Received at Least 1 Dose of Study Drug
    1054
    1067
    Completed
    914
    908
    Not completed
    143
    164
         Adverse event, serious fatal
    9
    16
         Consent withdrawn by subject
    33
    45
         Physician decision
    11
    7
         Adverse event, non-fatal
    48
    39
         Caregiver Decision
    33
    41
         Lost to follow-up
    3
    -
         Entry Criteria Not Met
    5
    9
         Protocol deviation
    1
    7
    Period 2
    Period 2 title
    Open Label Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Solanezumab
    Arm description
    		 Participants received Solanezumab 400 milligrams (mg)Intravenously (IV) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solanezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks ofassessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.

    Number of subjects in period 2 [1]
    		Solanezumab Placebo
    Started
    881
    859
    Completed
    0
    0
    Not completed
    881
    859
         Adverse event, serious fatal
    5
    6
         Parent/Caregiver Decision
    33
    34
         Physician decision
    4
    4
         Consent withdrawn by subject
    20
    28
         Adverse event, non-fatal
    16
    20
         Sponsor Decision
    802
    765
         Lost to follow-up
    1
    1
         Protocol deviation
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects from Placebo Controlled Period were not required to enter into Open Label Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Solanezumab
    Reporting group description
    		 Participants received Solanezumab 400 milligrams (mg)Intravenously (IV) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.

    Reporting group values
    		 Solanezumab Placebo Total
    Number of subjects
    		 1057 1072 2129
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.69 ( 7.814 ) 73.26 ( 7.966 ) -
    Gender categorical
    Units: Subjects
        Female
    		 600 631 1231
        Male
    		 457 441 898
    Sex: Female, Male
    Units: Subjects
        Female
    		 600 631 1231
        Male
    		 457 441 898
    Ethnicity (NIH/OMB)
    All randomized participants who had baseline ethnicity data.
    Units: Subjects
        Hispanic or Latino
    		 49 49 98
        Not Hispanic or Latino
    		 921 937 1858
        Unknown or Not Reported
    		 87 86 173
    Race (NIH/OMB)
    All randomized participants who had baseline race data.
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 75 71 146
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Black or African American
    		 14 19 33
        White
    		 878 894 1772
        More than one race
    		 2 2 4
        Unknown or Not Reported
    		 87 86 173
    Region of Enrollment
    Units: Subjects
        Canada
    		 61 66 127
        Sweden
    		 26 26 52
        United States
    		 537 541 1078
        Japan
    		 67 65 132
        Poland
    		 52 50 102
        Italy
    		 46 52 98
        United Kingdom
    		 45 44 89
        Australia
    		 32 36 68
        France
    		 87 86 173
        Germany
    		 48 48 96
        Spain
    		 56 58 114

    End points

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    End points reporting groups
    Reporting group title
    Solanezumab
    Reporting group description
    		 Participants received Solanezumab 400 milligrams (mg)Intravenously (IV) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
    Reporting group title
    Solanezumab
    Reporting group description
    		 Participants received Solanezumab 400 milligrams (mg)Intravenously (IV) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.

    Primary: Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)

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    End point title
    		 Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)
    End point description
    The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 14 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Primary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    1053
    1067
    Units: Units on a scale
        least squares mean (standard error)
    6.65 ( 0.355 )
    7.44 ( 0.356 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.73
         upper limit
    		 0.14
    Notes
    [1] - The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.

    Secondary: Change from Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)

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    End point title
    		 Change from Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)
    End point description
    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    908
    896
    Units: Units on a scale
        least squares mean (standard error)
    -6.17 ( 0.318 )
    -7.17 ( 0.320 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1804
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 1.83

    Secondary: Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)

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    End point title
    		 Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)
    End point description
    The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    1053
    1067
    Units: Units on a scale
        least squares mean (standard error)
    5.22 ( 0.284 )
    5.90 ( 0.285 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.068
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.41
         upper limit
    		 0.05

    Secondary: Change from Baseline in Mini-Mental State Examination (MMSE)

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    End point title
    		 Change from Baseline in Mini-Mental State Examination (MMSE)
    End point description
    MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    893
    876
    Units: Units on a scale
        least squares mean (standard error)
    -3.17 ( 0.154 )
    -3.66 ( 0.156 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1769
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.88

    Secondary: Change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

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    End point title
    		 Change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
    End point description
    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    908
    897
    Units: Units on a scale
        least squares mean (standard error)
    -7.42 ( 0.386 )
    -8.77 ( 0.387 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1805
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 2.37

    Secondary: Change from Baseline in Functional Activities Questionnaire (FAQ)

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    End point title
    		 Change from Baseline in Functional Activities Questionnaire (FAQ)
    End point description
    FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant’s ability to perform a variety of activities ranging from financial management, shopping, playing games, food preparation, traveling, keeping appointments, keeping track of current events, and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome). LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    907
    892
    Units: Units on a scale
        least squares mean (standard error)
    5.17 ( 0.212 )
    5.57 ( 0.213 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1799
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.14
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.93
         upper limit
    		 0.13

    Secondary: Change from Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)

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    End point title
    		 Change from Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
    End point description
    CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    903
    895
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.91 ( 2.442 )
    2.23 ( 2.692 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1798
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Change from Baseline in Neuropsychiatric Inventory (NPI)

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    End point title
    		 Change from Baseline in Neuropsychiatric Inventory (NPI)
    End point description
    NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    909
    891
    Units: Units on a scale
        least squares mean (standard error)
    2.26 ( 3.11 )
    0.382 ( 0.387 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1800
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.082
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.82
         upper limit
    		 0.11

    Secondary: Change from Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)

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    End point title
    		 Change from Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)
    End point description
    Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    909
    891
    Units: Number of hospitalizations
    least squares mean (standard error)
        Basic ADL
    0.34 ( 0.058 )
    0.35 ( 0.058 )
        Instrumental ADL
    0.55 ( 0.099 )
    0.50 ( 0.100 )
        Sum of Basic and Instrumental ADL
    0.91 ( 0.132 )
    0.86 ( 0.134 )
        Supervision
    0.72 ( 0.125 )
    0.88 ( 0.127 )
    Statistical analysis title
    		 Statistical analysis 1: Basic ADL
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1800
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.14
    Statistical analysis title
    		 Statistical analysis 2: Instrumental ADL
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1800
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.3
    Statistical analysis title
    		 Statistical analysis 3: Basic and Instrumental ADL
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1800
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.786
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.38
    Statistical analysis title
    		 Statistical analysis 4: Supervision
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1800
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.329
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 0.16

    Secondary: Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)

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    End point title
    		 Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)
    End point description
    Assesses QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant’s primary caregiver asked to complete same measure. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. QoL-AD self- report score was reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    853
    812
    Units: Units on a scale
        least squares mean (standard error)
    -0.55 ( 0.158 )
    -0.72 ( 0.161 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1665
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.381
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.56

    Secondary: Change from Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)

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    End point title
    		 Change from Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)
    End point description
    EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. Visual analog scale (VAS) assesses caregiver's impression of participant's health state; score ranges: 0 to 100 millimeter (mm). Lower scores=greater disease severity LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    904
    892
    Units: mm
        least squares mean (standard error)
    -1.10 ( 0.556 )
    -2.61 ( 0.562 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1796
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 2.87

    Secondary: Change from Baseline in Integrated Alzheimer’s Disease Rating Scale (iADRS)

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    End point title
    		 Change from Baseline in Integrated Alzheimer’s Disease Rating Scale (iADRS)
    End point description
    Integrated Alzheimer’s Disease Rating Scale is used to assess that solanezumab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of ADAS-Cog 13 or 14 and the ADCS-iADL. The scale ranges from 0 to 146, where lower scores indicate worse performance. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    903
    883
    Units: units on a scale
        least squares mean (standard error)
    -12.92 ( 0.533 )
    -14.59 ( 0.537 )
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1786
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 3.06

    Secondary: Percentage of Participants of Cognitive and Functional Responders

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    End point title
    		 Percentage of Participants of Cognitive and Functional Responders
    End point description
    Assess the proportion of participants who reach certain levels of cognitive and functional decline. Decline in cognition was defined as worsening from baseline by at least 6 or 9 points on the ADAS Cog14. If there is a cognitive decline of a specified cut-off or more at any time then the participant is considered a nonresponder. Functional nonresponders are participants who have not had any of the following at any time point: Clinically evident decline in ability to perform one or more basic ADL present at baseline; A clinically evident decline in ability to perform 20% or more of the instrumental ADL present at baseline; An increase in global CDR score of 1 point or more compared with baseline.A decline from no impairment to mild impairment (bADL, iADL is not considered clinically significant, but other declines of 1 or more points and any participant discontinuation within the first 6 months will be considered a non-responder.Analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    1057
    1072
    Units: percentage of participants
    number (not applicable)
        Cognitive Responders: Cut-off 6
    35.7
    35.3
        Cognitive Responders: Cut-off 9
    55.2
    52.3
        Functional Responders
    38.0
    36.8
    Statistical analysis title
    		 Statistical analysis 1:Cognitive: Cut-off 6
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.891
    Method
    		 Fisher exact
    Parameter type
    		 Fishers exact test
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2:Cognitive: Cut-off 9
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.203
    Method
    		 Fisher exact
    Parameter type
    		 Fishers exact test
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3:Functional Responders
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.588
    Method
    		 Fisher exact
    Parameter type
    		 Fishers exact test
    Confidence interval

    Secondary: Change from Baseline in Plasma Amyloid-Beta (Aβ) Species

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    End point title
    		 Change from Baseline in Plasma Amyloid-Beta (Aβ) Species
    End point description
    Concentration of amino acid peptide known as Aβ 1-42 in plasma. The change in plasma Aβ analytes after treatment were assessed separately for each plasma Aβ parameter. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    1057
    1072
    Units: Picogram/milliliter
    least squares mean (standard error)
        Modified amyloid beta 1-40
    172754.36 ( 1613.534 )
    262.98 ( 1609.006 )
        Modified amyloid beta1-42
    18485.26 ( 104.913 )
    15.75 ( 105.237 )
    Statistical analysis title
    		 Statistical analysis 1: Modified amyloid beta 1-40
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    172491.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 168131.33
         upper limit
    		 176851.43
    Statistical analysis title
    		 Statistical analysis 2: Modified amyloid beta 1-42
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18469.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18187.59
         upper limit
    		 18751.44

    Secondary: Change from Baseline in volumetric Magnetic Resonance Imaging (vMRI)

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    End point title
    		 Change from Baseline in volumetric Magnetic Resonance Imaging (vMRI)
    End point description
    The vMRI assessment of right and left hippocampal atrophy, is reported. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    1057
    1072
    Units: Cubic millimeter (mm^3)
    arithmetic mean (standard deviation)
        Right hippocampal atrophy
    -145.7 ( 75.42 )
    -154.1 ( 81.06 )
        Left hippocampal atrophy
    -142.3 ( 74.27 )
    -146.3 ( 78.04 )
        Right hippocampal atrophy+Left hippocampal atrophy
    -288.0 ( 135.19 )
    -300.4 ( 138.52 )
        Right entorhinal cortex atrophy
    -77.3 ( 45.18 )
    -80.8 ( 45.16 )
        Left entorhinal cortex atrophy
    -91.6 ( 47.60 )
    -95.2 ( 53.46 )
        Right+Left entorhinal cortex atrophy
    -169.0 ( 79.65 )
    -176.0 ( 86.11 )
        Atrophy of whole brain volume
    -22725.6 ( 11920.78 )
    -23500.5 ( 12000.09 )
        Enlargement of Ventricular volume
    7055.4 ( 4580.36 )
    7226.6 ( 4545.73 )
    Statistical analysis title
    		 Statistical analysis 1: Right hippocampal atrophy
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2: Left hippocampal atrophy
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 3: Right + Left hippocampal atrophy
    Statistical analysis description
    Statistical Analysis 3 (SA 3)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.077
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 4: Right entorhinal cortex atrophy
    Statistical analysis description
    Statistical analysis 4 (SA 4)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.186
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 5: Left entorhinal cortex atrophy
    Statistical analysis description
    Statistical analysis 5 (SA 5)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.126
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 6: Right + Left entorhinal cortex atrophy
    Statistical analysis description
    Statistical analysis 6 (SA 6)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.099
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 7: Atrophy of whole brain volume
    Statistical analysis description
    Statistical analysis 7 (SA 7)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 8: Enlargement of Ventricular volume
    Statistical analysis description
    Statistical analysis 8 (SA 8)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.227
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Secondary: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)

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    End point title
    		 Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430) [2]
    End point description
    Area Under the Concentration versus Time Curve was evaluated for Solanezumab. Analysis population included all randomized participants who received at least 1 dose of study medication (Solanezumab) with evaluable Solanezumab PK data.
    End point type
    Secondary
    End point timeframe
    Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No inferential statistics were planned or conducted for this endpoint.
    End point values
    		 Solanezumab
    Number of subjects analysed
    1044
    Units: milligram*hour per milliliter (mg*h/mL)
        geometric mean (geometric coefficient of variation)
    43.2 ( 24.3 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Florbetapir Positron Emission Tomography (PET) Scan

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    End point title
    		 Change from Baseline in Florbetapir Positron Emission Tomography (PET) Scan
    End point description
    Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 standardized to subject-specific white matter. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    915
    924
    Units: Composite summary
    least squares mean (standard error)
        Subject specific white matter corrected
    0.02 ( 0.002 )
    0.02 ( 0.002 )
        Mean whole cerebellum
    -0.01 ( 0.005 )
    0.00 ( 0.005 )
    Statistical analysis title
    		 SA1: Subject specific white matter corrected
    Statistical analysis description
    Statistical analysis 1 (SA1)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1839
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.131
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA2: Mean whole cerebellum
    Statistical analysis description
    Statistical analysis 2 (SA2)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    1839
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.181
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Confidence interval

    Secondary: Change from Baseline in Cerebrospinal Fluid (CSF) Aβ Levels

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    End point title
    		 Change from Baseline in Cerebrospinal Fluid (CSF) Aβ Levels
    End point description
    Concentration of CSF parameters includes amino acid peptide known as Aβ 1-40 and Aβ 1-42. Analyses of these CSF biomarkers was conducted in a subset of participants (as an addendum to the protocol). The dependent variable for each CSF parameter was its change from baseline to endpoint. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. Analysis population included all randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 80
    End point values
    		 Solanezumab Placebo
    Number of subjects analysed
    1057
    1072
    Units: picogram/milliliter
    least squares mean (standard error)
        Free amyloid beta 1-40, CSF
    -714.60 ( 177.828 )
    -319.97 ( 182.519 )
        Free amyloid beta 1-42, CSF
    -37.33 ( 7.507 )
    -9.27 ( 8.175 )
        Modified amyloid beta 1-40, CSF
    1093.81 ( 624.059 )
    -2336.68 ( 637.126 )
        Modified amyloid beta 1-42, CSF
    315.69 ( 42.620 )
    -107.91 ( 42.907 )
    Statistical analysis title
    		 SA 1: Free amyloid beta 1-40, CSF
    Statistical analysis description
    Statistical analysis 1 (SA 1)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 2: Free amyloid beta 1-42, CSF
    Statistical analysis description
    Statistical analysis 2 (SA 2)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 3: Modified amyloid beta 1-40, CSF
    Statistical analysis description
    Statistical analysis 3 (SA 3)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
    Statistical analysis title
    		 SA 4: Modified amyloid beta 1-42, CSF
    Statistical analysis description
    Statistical analysis 4 (SA 4)
    Comparison groups
    Solanezumab v Placebo
    Number of subjects included in analysis
    2129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up To 80 Weeks
    Adverse event reporting additional description
    All randomized participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Solanezumab 400mg - Double-Blind Phase
    Reporting group description
    		 Participants received Solanezumab 400 mg IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who completed the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.

    Reporting group title
    Placebo - Double-Blind Phase
    Reporting group description
    		 Participants received Placebo IV every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.

    Reporting group title
    Solanezumab 400mg: Solanezumab 400mg Open Label
    Reporting group description
    		 Participants who complete 80 weeks treatment/assessment of the double-blind period were entered into open-label period. Participants received Solanezumab 400 mg IV every 4 weeks for 180 weeks with an additional 4 weeks of assessments.

    Reporting group title
    Placebo: Solanezumab 400mg Open Label
    Reporting group description
    		 Participants who complete 80 weeks treatment/assessment of the double-blind period were entered into open-label period. Participants received Placebo IV every 4 weeks for 180 weeks with an additional 4 weeks of assessments.

    Serious adverse events
    		 Solanezumab 400mg - Double-Blind Phase Placebo - Double-Blind Phase Solanezumab 400mg: Solanezumab 400mg Open Label Placebo: Solanezumab 400mg Open Label
    Total subjects affected by serious adverse events
         subjects affected / exposed
    175 / 1054 (16.60%)
    203 / 1067 (19.03%)
    102 / 879 (11.60%)
    114 / 856 (13.32%)
         number of deaths (all causes)
    9
    17
    5
    5
         number of deaths resulting from adverse events
    2
    2
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    abdominal neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    adenocarcinoma of colon
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    b-cell lymphoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    basal cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    benign small intestinal neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bladder cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bladder neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    breast cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    breast cancer metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac myxoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    clear cell renal cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colon adenoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colon cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endometrial adenocarcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [1]
    0 / 599 (0.00%)
    1 / 627 (0.16%)
    0 / 501 (0.00%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    glioblastoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    glioblastoma multiforme
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatic neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    intraductal proliferative breast lesion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    invasive ductal breast carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lip squamous cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung adenocarcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung cancer metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung neoplasm malignant
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant melanoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant melanoma in situ
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metastases to central nervous system
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metastatic neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oesophageal adenocarcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian cancer stage iv
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [2]
    0 / 599 (0.00%)
    1 / 627 (0.16%)
    0 / 501 (0.00%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatic neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    parathyroid tumour benign
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    plasma cell myeloma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [3]
    2 / 455 (0.44%)
    0 / 440 (0.00%)
    2 / 378 (0.53%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostate cancer metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [4]
    1 / 455 (0.22%)
    1 / 440 (0.23%)
    0 / 378 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal adenocarcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    small cell lung cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma of the tongue
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transitional cell cancer of renal pelvis and ureter metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transitional cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    uterine cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [5]
    1 / 599 (0.17%)
    0 / 627 (0.00%)
    0 / 501 (0.00%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    aortic aneurysm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    0 / 1067 (0.00%)
    2 / 879 (0.23%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    aortic stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    deep vein thrombosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypertension
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    2 / 879 (0.23%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypertensive crisis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lymphoedema
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    orthostatic hypotension
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    cephalhaematoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    2 / 879 (0.23%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chest discomfort
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chest pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    death
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    gait disturbance
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    general physical health deterioration
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    generalised oedema
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    multiple organ dysfunction syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    7 / 1054 (0.66%)
    5 / 1067 (0.47%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 7
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    stent-graft endoleak
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sudden death
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    systemic inflammatory response syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    immobilisation prolonged
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    respite care
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    asthma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    2 / 879 (0.23%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [6]
    1 / 455 (0.22%)
    1 / 440 (0.23%)
    3 / 378 (0.79%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    epistaxis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    organising pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pharyngeal mass
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pleurisy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia aspiration
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostatitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [7]
    1 / 455 (0.22%)
    0 / 440 (0.00%)
    0 / 378 (0.00%)
    0 / 348 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 1054 (0.38%)
    2 / 1067 (0.19%)
    1 / 879 (0.11%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    respiratory arrest
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vulvar dysplasia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [8]
    0 / 599 (0.00%)
    1 / 627 (0.16%)
    0 / 501 (0.00%)
    0 / 508 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    abnormal behaviour
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    affective disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    aggression
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    1 / 879 (0.11%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    agitation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    2 / 1067 (0.19%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    anxiety
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    behavioural and psychiatric symptoms of dementia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    2 / 879 (0.23%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    confusional state
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    1 / 1067 (0.09%)
    2 / 879 (0.23%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    delirium
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    5 / 1067 (0.47%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    delusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    disorientation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hallucination
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    4 / 1067 (0.37%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 4
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    phobia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    psychotic disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    heart rate irregular
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    troponin t increased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    weight decreased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    alcohol poisoning
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    animal bite
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ankle fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arthropod sting
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervical vertebral fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chest injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    clavicle fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    concussion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    contusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary vascular graft occlusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    craniocerebral injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    24 / 1054 (2.28%)
    24 / 1067 (2.25%)
    5 / 879 (0.57%)
    12 / 856 (1.40%)
         occurrences causally related to treatment / all
    2 / 26
    1 / 27
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femoral neck fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 1054 (0.57%)
    5 / 1067 (0.47%)
    3 / 879 (0.34%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fibula fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fracture displacement
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fractured coccyx
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal stoma complication
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gun shot wound
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    head injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 1054 (0.47%)
    6 / 1067 (0.56%)
    3 / 879 (0.34%)
    3 / 856 (0.35%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 6
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    humerus fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint dislocation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    laceration
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ligament sprain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar vertebral fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pelvic fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    1 / 879 (0.11%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    periprosthetic fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative ileus
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pubis fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    radius fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    4 / 1067 (0.37%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    skull fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal compression fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    1 / 879 (0.11%)
    3 / 856 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sternal fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    subdural haematoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    4 / 1067 (0.37%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wrist fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    adams-stokes syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    aortic valve stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arrhythmia supraventricular
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 1054 (0.47%)
    9 / 1067 (0.84%)
    4 / 879 (0.46%)
    5 / 856 (0.58%)
         occurrences causally related to treatment / all
    2 / 5
    2 / 9
    1 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrioventricular block
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrioventricular block complete
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrioventricular block second degree
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bradycardia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    2 / 1067 (0.19%)
    2 / 879 (0.23%)
    3 / 856 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    3 / 1067 (0.28%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    cardiac failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    3 / 1067 (0.28%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    2 / 879 (0.23%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    4 / 1067 (0.37%)
    2 / 879 (0.23%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    myocardial ischaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinus bradycardia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    3 / 856 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinus node dysfunction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    altered state of consciousness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    basal ganglia infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    carotid artery stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebellar haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    cerebellar infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    cerebral infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    3 / 879 (0.34%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    5 / 1067 (0.47%)
    0 / 879 (0.00%)
    3 / 856 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    cognitive disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dementia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dementia alzheimer's type
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    4 / 856 (0.47%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 0
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    dementia of the alzheimer's type, with delirium
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dizziness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    embolic stroke
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    encephalopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    epilepsy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    generalised tonic-clonic seizure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhage intracranial
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhagic stroke
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    headache
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    3 / 1067 (0.28%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypertensive encephalopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypoaesthesia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lacunar infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    loss of consciousness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metabolic encephalopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    presyncope
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    seizure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    4 / 1067 (0.37%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    somnolence
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal cord compression
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal epidural haematoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    8 / 1054 (0.76%)
    14 / 1067 (1.31%)
    5 / 879 (0.57%)
    7 / 856 (0.82%)
         occurrences causally related to treatment / all
    3 / 11
    4 / 14
    1 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thalamic infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thalamus haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    thrombotic cerebral infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tonic convulsion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lymphadenitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    2 / 879 (0.23%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vertigo positional
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    glaucoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    open angle glaucoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    retinal detachment
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    3 / 1067 (0.28%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    abdominal pain upper
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colitis ulcerative
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    duodenal perforation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastric ulcer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    2 / 1067 (0.19%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhoids
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hernial eventration
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hiatus hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    inguinal hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal perforation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal polyp
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    large intestine polyp
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lower gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mallory-weiss syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oesophageal rupture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peptic ulcer haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal prolapse
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    retroperitoneal haematoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    3 / 1067 (0.28%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    3 / 1067 (0.28%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    bile duct stone
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholangitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystitis acute
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    2 / 879 (0.23%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gallbladder perforation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatotoxicity
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    jaundice cholestatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    portal vein thrombosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    angioedema
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    3 / 1067 (0.28%)
    2 / 879 (0.23%)
    3 / 856 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal colic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    2 / 879 (0.23%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary bladder polyp
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary incontinence
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary retention
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    2 / 879 (0.23%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    toxic nodular goitre
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    foot deformity
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar spinal stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    3 / 1067 (0.28%)
    2 / 879 (0.23%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteonecrosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rhabdomyolysis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spondylolisthesis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tenosynovitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    abdominal abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    appendicitis perforated
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atypical mycobacterial pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atypical pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bacteraemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bacterial infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bacterial sepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    2 / 879 (0.23%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chronic sinusitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    clostridium difficile infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    escherichia sepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    extradural abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    furuncle
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis viral
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatitis e
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes zoster
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    1 / 1067 (0.09%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral discitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    localised infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meningoencephalitis herpetic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oesophageal candidiasis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ophthalmic herpes zoster
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    orchitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed [9]
    0 / 455 (0.00%)
    0 / 440 (0.00%)
    0 / 378 (0.00%)
    1 / 348 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteomyelitis bacterial
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    paraspinal abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pelvic abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peritonitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    11 / 1054 (1.04%)
    8 / 1067 (0.75%)
    3 / 879 (0.34%)
    5 / 856 (0.58%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    pneumonia influenzal
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    3 / 1067 (0.28%)
    1 / 879 (0.11%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    septic shock
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    tooth infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 1054 (0.19%)
    8 / 1067 (0.75%)
    2 / 879 (0.23%)
    3 / 856 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    3 / 879 (0.34%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    1 / 879 (0.11%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    cachexia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    decreased appetite
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    2 / 1067 (0.19%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 1054 (0.28%)
    4 / 1067 (0.37%)
    3 / 879 (0.34%)
    2 / 856 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diabetic ketoacidosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    1 / 1067 (0.09%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypovolaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 1054 (0.09%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    0 / 856 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metabolic acidosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 1054 (0.00%)
    0 / 1067 (0.00%)
    0 / 879 (0.00%)
    1 / 856 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Solanezumab 400mg - Double-Blind Phase Placebo - Double-Blind Phase Solanezumab 400mg: Solanezumab 400mg Open Label Placebo: Solanezumab 400mg Open Label
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    536 / 1054 (50.85%)
    530 / 1067 (49.67%)
    255 / 879 (29.01%)
    260 / 856 (30.37%)
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    146 / 1054 (13.85%)
    144 / 1067 (13.50%)
    67 / 879 (7.62%)
    80 / 856 (9.35%)
         occurrences all number
    195
    207
    97
    109
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    61 / 1054 (5.79%)
    57 / 1067 (5.34%)
    23 / 879 (2.62%)
    29 / 856 (3.39%)
         occurrences all number
    66
    65
    24
    31
    headache
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    86 / 1054 (8.16%)
    86 / 1067 (8.06%)
    28 / 879 (3.19%)
    29 / 856 (3.39%)
         occurrences all number
    96
    151
    34
    42
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    76 / 1054 (7.21%)
    87 / 1067 (8.15%)
    23 / 879 (2.62%)
    17 / 856 (1.99%)
         occurrences all number
    86
    109
    24
    18
    nausea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    54 / 1054 (5.12%)
    46 / 1067 (4.31%)
    23 / 879 (2.62%)
    15 / 856 (1.75%)
         occurrences all number
    69
    63
    32
    18
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    44 / 1054 (4.17%)
    58 / 1067 (5.44%)
    25 / 879 (2.84%)
    18 / 856 (2.10%)
         occurrences all number
    53
    69
    27
    22
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    54 / 1054 (5.12%)
    58 / 1067 (5.44%)
    15 / 879 (1.71%)
    17 / 856 (1.99%)
         occurrences all number
    57
    59
    18
    17
    depression
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    60 / 1054 (5.69%)
    57 / 1067 (5.34%)
    18 / 879 (2.05%)
    20 / 856 (2.34%)
         occurrences all number
    62
    57
    18
    20
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    44 / 1054 (4.17%)
    56 / 1067 (5.25%)
    21 / 879 (2.39%)
    22 / 856 (2.57%)
         occurrences all number
    51
    62
    23
    22
    back pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    63 / 1054 (5.98%)
    60 / 1067 (5.62%)
    26 / 879 (2.96%)
    23 / 856 (2.69%)
         occurrences all number
    70
    67
    26
    23
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    89 / 1054 (8.44%)
    80 / 1067 (7.50%)
    29 / 879 (3.30%)
    32 / 856 (3.74%)
         occurrences all number
    114
    99
    31
    36
    upper respiratory tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    64 / 1054 (6.07%)
    54 / 1067 (5.06%)
    23 / 879 (2.62%)
    21 / 856 (2.45%)
         occurrences all number
    74
    61
    25
    23
    urinary tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    58 / 1054 (5.50%)
    72 / 1067 (6.75%)
    38 / 879 (4.32%)
    36 / 856 (4.21%)
         occurrences all number
    79
    103
    47
    46

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Sep 2014
    The duration of the protocol was extended to include a 24-month open-label period, which followed the initial 18-month treatment period. Added secondary objectives and corresponding statistical analyses for the open-label period including the delayed-start-analyses.
    29 Jan 2016
    Changed from cognitive and functional coprimary endpoints (ADAS-Cog14 and ADCS-iADL) to a single primary cognitive endpoint (ADAS-Cog14) with function (ADCS-iADL) as a key secondary endpoint. Added a secondary objective and corresponding analysis for the iADRS to incorporate an additional measure of both cognition and function.
    03 Aug 2016
    The open-label extension period was extended to include a second 24-month open-label period.

    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.

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